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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT03920267
Registration number
NCT03920267
Ethics application status
Date submitted
27/03/2019
Date registered
18/04/2019
Date last updated
30/05/2024
Titles & IDs
Public title
Long-Term Safety and Efficacy Study of Deucravacitinib in Participants With Systemic Lupus Erythematosus
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Scientific title
A Multi-Center Study to Characterize the Long-Term Safety and Efficacy of BMS-986165 in Subjects With Systemic Lupus Erythematosus
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Secondary ID [1]
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2018-003471-35
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Secondary ID [2]
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IM011-074
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Systemic Lupus Erythematosus
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Cancer
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Advanced Solid Tumors
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Triple-Negative Breast Cancer (TNBC)
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Non-small-cell-lung-cancer (NSCLC)
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Metastatic Solid Tumors
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Condition category
Condition code
Human Genetics and Inherited Disorders
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Other human genetics and inherited disorders
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Inflammatory and Immune System
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Rheumatoid arthritis
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Musculoskeletal
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Other muscular and skeletal disorders
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Inflammatory and Immune System
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Autoimmune diseases
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Other
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Research that is not of generic health relevance and not applicable to specific health categories listed above
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Respiratory
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Other respiratory disorders / diseases
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Reproductive Health and Childbirth
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Complications of newborn
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Injuries and Accidents
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Other injuries and accidents
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Cancer
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Lung - Non small cell
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Cancer
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Breast
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Cancer
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Malignant melanoma
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Cancer
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Lymphoma (non Hodgkin's lymphoma) - High grade lymphoma
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Cancer
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Lymphoma (non Hodgkin's lymphoma) - Low grade lymphoma
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Cancer
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Leukaemia - Acute leukaemia
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Cancer
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0
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Leukaemia - Chronic leukaemia
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Cancer
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Children's - Leukaemia & Lymphoma
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Respiratory
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Chronic obstructive pulmonary disease
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - BMS-986165
Treatment: Drugs - CFZ533
Other interventions - Placebo
Treatment: Drugs - Sugammadex 4 mg/kg
Treatment: Drugs - Neostigmine + Glycopyrrolate
Treatment: Drugs - Neostigmine + Atropine
Treatment: Drugs - ABBV-927
Treatment: Drugs - ABBV-368
Treatment: Drugs - ABBV-181
Treatment: Drugs - Carboplatin
Treatment: Drugs - Nab-paclitaxel
Treatment: Drugs - JNJ-67856633
Treatment: Drugs - RO6874281
Treatment: Drugs - Pembrolizumab
Treatment: Drugs - Bisoprolol
Treatment: Drugs - Placebo Oral Tablet
Experimental: Cohort 1/Arm D1 - CFZ533 dose 1 (from week 24)
Experimental: BMS-986165 Dose 1 -
Experimental: BMS-986165 Dose 2 -
Experimental: BMS-986165 Dose 3 -
Experimental: Cohort 2/Arm E - CFZ533 dose 1
Placebo comparator: Cohort 2/Arm F - Placebo dose (up to week 24)
Experimental: Cohort 2/Arm F1 - CFZ533 dose 2 (from week 24)
Experimental: Dose Escalation Arm A: ABBV-927 + ABBV-368 Solid Tumors - Participants with Solid Tumors will receive various doses of ABBV-927 by intravenous (IV) infusion plus ABBV-368. This will determine the recommended phase two dose (RP2D) of ABBV-927.
Experimental: Dose Escalation Arm B: ABBV-927 + ABBV-368 + ABBV-181 NSCLC - Participants with non-small-cell-lung-cancer (NSCLC) will receive ABBV-927 IV at various dose levels + ABBV-368 + ABBV-181. This will determine the recommended phase two dose (RP2D) of ABBV-927 + ABBV-368 + ABBV-181.
Experimental: Dose Expansion Arm 1: ABBV-927 + Carboplatin + ABBV-368 TNBC - Participants with Triple Negative Breast Cancer (TNBC) will receive ABBV-927 (at the RP2D established in Arm A) + Carboplatin + ABBV-368 by IV.
Experimental: Dose Expansion Arm 2: ABBV-927 + Carboplatin + ABBV-181 TNBC - Participants with TNBC will receive ABBV-927 (at the RP2D established in Arm A) + Carboplatin + ABBV-181 by IV.
Experimental: Dose Expansion Arm 3: ABBV-927 + Carboplatin TNBC - Participants with TNBC will receive ABBV-927 (at the RP2D established in Arm A) + Carboplatin by IV.
Experimental: Dose Expansion Arm 4: ABBV-927+ Nab-paclitaxel + ABBV-368 TNBC - Participants with TNBC will receive ABBV-927 (at the RP2D established in Arm A) + Nab-paclitaxel + ABBV-368 by IV.
Experimental: Dose Expansion Arm 5: ABBV-927 + ABBV-368 + ABBV-181 NSCLC - Participants with NSCLC will receive ABBV-927 (at the RP2D established in Arm B) + ABBV-368 + ABBV-181 by IV.
Experimental: Part 2 (Cohort Expansion): JNJ-67856633 - Participants will receive JNJ-67856633 at the recommended Phase 2 dose (RP2D) determined in Part 1.
Experimental: Part I Safety Run in: RO6874281 + Pembrolizumab - Cohort 1.1 (CPI naive and experienced melanoma participants):
Participants will receive RO6874281 in combination with Pembrolizumab every 3 weeks (Q3W) and will be observed for 2 cycles (ie: 6 weeks) in order to confirm the safety of the proposed dose and schedule that will be used in Part II of this study.
Cohort 1.2 (CPI experienced melanoma participants only):
Participants will receive RO6874281 in combination with Pembrolizumab via an induction and maintenance schedule for RO6874281: QW three times (D1, D8, D15) followed by Q3W dosing (D22 and subsequent). Pembrolizumab is to be administered Q3W, starting on Day 1. Participants will be observed for 2 pembrolizumab cycles (ie: 6 weeks) in order to confirm the safety of the proposed dose and schedule that will be used in Part III of this study.
Experimental: Part II Expansion: RO6874281 + Pembrolizumab - Part II will start once all participants in Part I Cohort 1.1 have completed the observation period. Approximately 34 participants will receive RO6874281 in combination with Pembrolizumab every 3 weeks (Q3W) and will be observed for 2 cycles (ie: 6 weeks).
Experimental: Part III Expansion: RO6874281 + Pembrolizumab - Part III will start once all participants in Part I Cohorts 1.1 and 1.2 have completed the observation period. Approximately 80 participants will be randomised to receive RO6874281 in combination with Pembrolizumab in either a Q3W or QW/Q3W schedule.
Placebo comparator: Placebo - 1.25, 2.5 or 5mg of matched placebo daily
Treatment: Drugs: BMS-986165
Specified dose on specified days
Treatment: Drugs: CFZ533
Biological
Other interventions: Placebo
liquid placebo for injections
Treatment: Drugs: Sugammadex 4 mg/kg
For deep NMB reversal, a single IV bolus of sugammadex (4 mg/kg) will be given after final dose of NMBA (rocuronium or vecuronium) and within 2 minutes of detection of a target of 1 to 2 post-tetanic counts and no response to TOF stimulations (TOF=0).
Treatment: Drugs: Neostigmine + Glycopyrrolate
For moderate NMB reversal, a single i.v. bolus containing both neostigmine (50 µg/kg; up to 5 mg maximum dose) as well as glycopyrrolate (10 µg/kg) will be given after final dose of NMBA (rocuronium or vecuronium) and within 2 minutes of the reappearance of T2 in response to TOF stimulations.
Treatment: Drugs: Neostigmine + Atropine
For moderate NMB reversal, a single i.v. bolus containing both neostigmine (50 µg/kg; up to 5 mg maximum dose) as well as atropine (20 µg/kg) will be given after final dose of NMBA (rocuronium or vecuronium) and within 2 minutes of the reappearance of T2 in response to TOF stimulations.
Treatment: Drugs: ABBV-927
Intravenous (IV) Infusion
Treatment: Drugs: ABBV-368
Intravenous (IV) Infusion
Treatment: Drugs: ABBV-181
Intravenous (IV) Infusion
Treatment: Drugs: Carboplatin
Intravenous (IV) Infusion
Treatment: Drugs: Nab-paclitaxel
Intravenous (IV) Infusion
Treatment: Drugs: JNJ-67856633
JNJ-67856633 capsule will be administered orally.
Treatment: Drugs: RO6874281
Part I Safety Run in:
Cohort 1.1: RO6874281 will be administered by intravenous (IV) infusion; 10 mg (Q3W) every 3 weeks and will be observed over 2 administration cycles (i.e. 6 weeks) in order to confirm the safety of the proposed dose and schedule that will be used in Part II of this study.
Cohort 1.2: RO6874281 will be administered by IV infusion via an induction and maintenance phase; 10 mg (QW) every week for 3 weeks followed by 10 mg (Q3W) every 3 weeks and will be observed over 2 administration cycles (6 weeks) to confirm safety of the proposed dose and schedule to be used in Part III of this study.
Part II Expansion: RO6874281 will be administered by IV infusion; 10 mg (Q3W) every 3 weeks (or lower dose level depending on Part I Cohort 1.1 outcome).
Part III Expansion: RO6874281 will be administered by IV infusion; 10 mg (QW) every week or 10mg (Q3W) every 3 weeks (or lower dose level depending on Part I Cohorts 1.1 and 1.2 outcomes) in either a Q3W or QW/Q3W schedule.
Treatment: Drugs: Pembrolizumab
Part I Safety Run in (Cohorts 1.1 and 1.2): Pembrolizumab will be administered by IV; 200 mg Q3W and will be observed over 2 administration cycles (i.e. 6 weeks).
Part II Expansion: Pembrolizumab will be administered by IV; 200 mg Q3W (or lower dose level depending on Part I Cohort 1.1 outcome)
Part III Expansion: Pembrolizumab will be administered by IV; 200 mg Q3W (or lower dose level depending on Part I Cohorts 1.1 and 1.2 outcomes)
Treatment: Drugs: Bisoprolol
As in arm description
Treatment: Drugs: Placebo Oral Tablet
As in arm description
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Intervention code [1]
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Treatment: Drugs
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Intervention code [2]
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Other interventions
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Number of participants with Adverse Events (AEs)
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Assessment method [1]
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Timepoint [1]
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Up to 30 days after last treatment dose (approximately 178 weeks)
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Primary outcome [2]
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Number of participants with Serious Adverse Events (SAEs)
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Assessment method [2]
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Timepoint [2]
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Up to 30 days after last treatment dose (approximately 178 weeks)
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Primary outcome [3]
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Number of participants with AEs leading to discontinuation
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Assessment method [3]
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Timepoint [3]
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Up to 30 days after last treatment dose (approximately 178 weeks)
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Primary outcome [4]
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Number of participants with abnormal change from baseline in laboratory measurements over time
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Assessment method [4]
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Timepoint [4]
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Up to 30 days after last treatment dose (approximately 178 weeks)
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Primary outcome [5]
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Number of participants with abnormal change from baseline in vital signs over time
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Assessment method [5]
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Timepoint [5]
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Up to 30 days after last treatment dose (approximately 178 weeks)
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Primary outcome [6]
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Change in EULAR Sjögren Syndrome Disease Activity Index (ESSDAI) score from baseline at 24 weeks as compared to placebo
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Assessment method [6]
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Cohort 1 - Efficacy
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Timepoint [6]
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24 weeks
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Primary outcome [7]
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Change in EULAR Sjögren Syndrome Patient Reported Index (ESSPRI) score from baseline at 24 weeks as compared to placebo.
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Assessment method [7]
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Cohort 2 - Efficacy
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Timepoint [7]
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24 weeks
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Primary outcome [8]
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Part A. Area Under the Plasma Concentration Time Curve (AUC) for Sugammadex
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Assessment method [8]
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The AUC for sugammadex in plasma will be calculated.
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Timepoint [8]
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Baseline and 2, 15, 30, 60, 240 to 360, and 600 to 720 minutes post-dose
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Primary outcome [9]
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Part A. Plasma Clearance (CL) of Sugammadex
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Assessment method [9]
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The CL for sugammadex will be calculated.
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Timepoint [9]
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Baseline and 2, 15, 30, 60, 240 to 360, and 600 to 720 minutes post-dose
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Primary outcome [10]
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Part A. Apparent Volume of Distribution (Vz) for Sugammadex
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Assessment method [10]
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The Vz for sugammadex will be calculated.
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Timepoint [10]
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Baseline and 2, 15, 30, 60, 240 to 360, and 600 to 720 minutes post-dose
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Primary outcome [11]
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Part A. Apparent Volume of Distribution at Steady State (Vss) for Sugammadex
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Assessment method [11]
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The Vss for sugammadex will be calculated.
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Timepoint [11]
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Baseline and 2, 15, 30, 60, 240 to 360, and 600 to 720 minutes post-dose
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Primary outcome [12]
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Part A. Maximum Plasma Concentration (Cmax) of Sugammadex
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Assessment method [12]
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The Cmax for sugammadex will be calculated.
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Timepoint [12]
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Baseline and 2, 15, 30, 60, 240 to 360, and 600 to 720 minutes post-dose
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Primary outcome [13]
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Part A. Half-Life (t1/2) of Sugammadex in Plasma
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Assessment method [13]
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The t1/2 for sugammadex will be calculated.
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Timepoint [13]
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Baseline and 2, 15, 30, 60, 240 to 360, and 600 to 720 minutes post-dose
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Primary outcome [14]
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Part B. Time to Neuromuscular Recovery
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Assessment method [14]
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Time to neuromuscular recovery will be reported, defined as the interval from administration of reversal agent to time to neuromuscular recovery.
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Timepoint [14]
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Within Day 1
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Primary outcome [15]
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Parts A and B. Adverse Events (AEs)
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Assessment method [15]
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The number of participants experiencing an AE will be reported.
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Timepoint [15]
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Up to 7 days
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Primary outcome [16]
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Dose Expansion: Objective Response Rate (ORR)
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Assessment method [16]
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ORR is defined as the percentage of participants with either complete response (CR) or partial response (PR) based on Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.
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Timepoint [16]
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Up to approximately 2 years following the first dose of study drug
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Primary outcome [17]
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Dose-Escalation Phase: Recommended Phase 2 Dose (RP2D) of ABBV-927 + ABBV-368
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Assessment method [17]
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The RP2D of ABBV-927 + ABBV-368 will be determined during the dose-escalation phase of the study. RP2D will be determined using available safety and pharmacokinetics data.
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Timepoint [17]
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Up to approximately 6 months
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Primary outcome [18]
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Dose-Escalation Phase: Recommended Phase 2 Dose (RP2D) of ABBV-927 + ABBV-368 + ABBV-181
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Assessment method [18]
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The RP2D of ABBV-927 + ABBV-368 + ABBV-181 will be determined during the dose-escalation phase of the study. RP2D will be determined using available safety and pharmacokinetics data.
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Timepoint [18]
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Up to approximately 6 months
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Primary outcome [19]
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Part 1: Dose-Limiting Toxicity (DLT)
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Assessment method [19]
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The DLTs are based on drug related adverse events and defined as any of the following events: any toxicity that would require discontinuation of treatment; and/or hematological / non-hematological toxicity of Grade 3 or higher.
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Timepoint [19]
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Approximately 21 days
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Primary outcome [20]
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Part 1 and Part 2: Number of Participants with Adverse Events (AEs) as a Measure of Safety and Tolerability
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Assessment method [20]
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An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study.
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Timepoint [20]
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Up to 4 years and 11 months
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Primary outcome [21]
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Percentage of participants with adverse events
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Assessment method [21]
0
0
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Timepoint [21]
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Baseline to end of study (approximately 24 months)
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Primary outcome [22]
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All-cause mortality
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Assessment method [22]
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Composite outcome of the following that will be analysed using a win-ratio apprach according to clinical importance
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Timepoint [22]
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Baseline to 24 months
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Primary outcome [23]
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Hospitalisation for COPD exacerbation
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Assessment method [23]
0
0
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Timepoint [23]
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Baseline to 24 months
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Primary outcome [24]
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Hospitalisation for primary cardiac cause (ischaemia, arrhythmia, heart failure or ischaemic stroke)
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Assessment method [24]
0
0
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Timepoint [24]
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Baseline to 24 months
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Primary outcome [25]
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Moderate COPD exacerbation - not hospitalised by treated with oral corticosteroids/antibiotics or both
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Assessment method [25]
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0
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Timepoint [25]
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Baseline to 24 months
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Primary outcome [26]
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Cardiac Hospitalisation for cardiac cause other than ischemia, arrythmia or heart failure
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Assessment method [26]
0
0
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Timepoint [26]
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Baseline to 24 months
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Primary outcome [27]
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Respiratory hospitalisation for a respiratory cause other than COPD exacerbation
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Assessment method [27]
0
0
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Timepoint [27]
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Baseline to 24 months
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Primary outcome [28]
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Decrease in FEV1 or greatest FEV1% drop - largest decrease in FEV1 from post-bronchodiliator spirometry at baseline
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Assessment method [28]
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0
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Timepoint [28]
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Baseline to 24 months
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Primary outcome [29]
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Mild COPD exacerbation - treated with increased inhalers/inhaler technique/addition of theophylline
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Assessment method [29]
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0
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Timepoint [29]
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Baseline to 24 months
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Primary outcome [30]
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Higher SGRQ score (clinically important change >= 4)
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Assessment method [30]
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0
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Timepoint [30]
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Baseline to 12 and 24 months
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Primary outcome [31]
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Higher CAT score (clinically important change >= 2)
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Assessment method [31]
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0
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Timepoint [31]
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Baseline to 12 and 24 months
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Secondary outcome [1]
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Change from baseline in ESSPRI at Week 24
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Assessment method [1]
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0
Cohort 1 - Efficacy (Patient Reported Outcomes)
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Timepoint [1]
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24 weeks
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Secondary outcome [2]
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0
Change from baseline in score of Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F) questionnaire at Week 24
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Assessment method [2]
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0
Cohort 1\&2 - Efficacy (Patient Reported Outcomes)
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Timepoint [2]
0
0
24 weeks
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Secondary outcome [3]
0
0
Change from baseline in Physician Global Assessment (PhGA) at Week 24
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Assessment method [3]
0
0
Cohort 1\&2 - Efficacy (Clinical Outcome Measures)
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Timepoint [3]
0
0
24 weeks
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Secondary outcome [4]
0
0
Change from baseline in ESSDAI at Week 24
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Assessment method [4]
0
0
Cohort 2 - Efficacy (Clinical Outcome Measures)
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Timepoint [4]
0
0
24 weeks
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Secondary outcome [5]
0
0
Proportion of subjects with at least 12 points improvement measured by score of Impact of Dry Eye on Everyday Life (IDEEL) questionnaire symptom bother module at Week 24.
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Assessment method [5]
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0
Cohort 2 - Efficacy (Patient Reported Outcomes)
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Timepoint [5]
0
0
24 weeks
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Secondary outcome [6]
0
0
Incidence of adverse events (AEs), serious adverse events (SAEs) from baseline to Week 24 and from week 24 to the end of study
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Assessment method [6]
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0
Cohort 1\&2 - Safety
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Timepoint [6]
0
0
60 weeks
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Secondary outcome [7]
0
0
Serum Free Light Chain (FLC) levels at analysis visit up to end of study
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Assessment method [7]
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0
Cohort 1\&2 - Biomarkers (1)
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Timepoint [7]
0
0
60 weeks
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Secondary outcome [8]
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0
Immunoglobulin IgG and IgM levels at analysis visits up to end of study
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Assessment method [8]
0
0
Cohort 1\&2 - Biomarkers (2)
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Timepoint [8]
0
0
60 weeks
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Secondary outcome [9]
0
0
Percent change from baseline in plasma CXCL-13 levels at analysis visits up to end of study
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Assessment method [9]
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0
Cohort 1\&2 - Biomarkers (3)
Chemokine (C-X-C motif) ligand 13 (CXCL13), also known as B lymphocyte chemoattractant (BLC) or B cell-attracting chemokine 1 (BCA-1), is a protein ligand that in humans is encoded by the CXCL13 gene.
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Timepoint [9]
0
0
60 weeks
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Secondary outcome [10]
0
0
Part B. Time to Extubation
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Assessment method [10]
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0
Time to extubation will be reported, defined as the interval from administration of reversal agent to removal of the endotracheal tube.
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Timepoint [10]
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0
Within Day 1
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Secondary outcome [11]
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0
Dose-Expansion Phase: Progression-free Survival (PFS)
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Assessment method [11]
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PFS is defined as the time from date of first study drug exposure to disease progression or death, whichever occurs first.
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Timepoint [11]
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Up to approximately 2 years since the first dose of study drug
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Secondary outcome [12]
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0
Dose-Expansion Phase: Duration of Response (DOR)
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Assessment method [12]
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DOR defined as the time from the participant's initial response to study drug therapy to disease progression or death, whichever occurs first.
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Timepoint [12]
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0
Up to approximately 2 years since the first dose of study drug
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Secondary outcome [13]
0
0
Maximum Serum Concentration (Cmax)
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Assessment method [13]
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0
Maximum Serum Concentration (Cmax)
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Timepoint [13]
0
0
Up to approximately 12 weeks after participant's initial dose of study drug
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Secondary outcome [14]
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0
Time to Maximum Observed Serum Concentration (Tmax)
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Assessment method [14]
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0
Time to Maximum Observed Serum Concentration (Tmax)
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Timepoint [14]
0
0
Up to approximately 12 weeks after participant's initial dose of study drug
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Secondary outcome [15]
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0
Area Under the Serum Concentration Versus Time Curve from Time 0 to the Time of the Last Measurable Concentration (AUCt)
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Assessment method [15]
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0
Area under the serum concentration versus time curve from time 0 to the time of the last measurable concentration (AUCt).
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Timepoint [15]
0
0
Up to approximately 12 weeks after participant's initial dose of study drug
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Secondary outcome [16]
0
0
Terminal Phase Elimination Half-life (t1/2)
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Assessment method [16]
0
0
Terminal Phase Elimination Half-life (t1/2)
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Timepoint [16]
0
0
Up to approximately 4 weeks after participant's initial dose of study drug
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Secondary outcome [17]
0
0
JNJ-67856633 Plasma Concentrations
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Assessment method [17]
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0
Concentration assessment will be done to evaluate the effect of JNJ-67856633.
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Timepoint [17]
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0
Up to 4 years and 11 months
Query!
Secondary outcome [18]
0
0
Part 1 and Part 2: Overall Response Rate (ORR)
Query!
Assessment method [18]
0
0
ORR is defined as the percentage of participants who have a partial response (PR) and complete response (CR) according to the International Workshop on Chronic Lymphocytic Leukemia (iwCLL), non-Hodgkin lymphoma and Waldenstrom macroglobulinemia response criteria.
Query!
Timepoint [18]
0
0
Up to 4 years and 11 months
Query!
Secondary outcome [19]
0
0
Part 1 and Part 2: Complete Response Rate
Query!
Assessment method [19]
0
0
Complete response rate is defined as the percentage of participants who achieve a best response of CR according to the iwCLL, non-Hodgkin lymphoma and Waldenstrom macroglobulinemia response criteria.
Query!
Timepoint [19]
0
0
Up to 4 years and 11 months
Query!
Secondary outcome [20]
0
0
Part 1 and Part 2: Time to Response (TTR)
Query!
Assessment method [20]
0
0
TTR is defined for participants who achieved PR or CR as the time from the first dose of study drug to first response of PR or CR.
Query!
Timepoint [20]
0
0
Up to 4 years and 11 months
Query!
Secondary outcome [21]
0
0
Part 1 and Part 2: Duration of Response (DoR)
Query!
Assessment method [21]
0
0
DoR is defined for participants who achieved PR or CR as the time between the date of initial documentation of PR or CR to the date of first documented evidence of disease progression or death, whichever comes first.
Query!
Timepoint [21]
0
0
Up to 4 years and 11 months
Query!
Secondary outcome [22]
0
0
Objective Response Rate (ORR)
Query!
Assessment method [22]
0
0
Query!
Timepoint [22]
0
0
Time from first occurrence of a documented objective response until the time of documented disease progression or death from any cause during treatment (whichever occurs first) until the end of study (approximately 24 months)
Query!
Secondary outcome [23]
0
0
Complete Response Rate (CRR)
Query!
Assessment method [23]
0
0
Query!
Timepoint [23]
0
0
Baseline to end of study (approximately 24 months)
Query!
Secondary outcome [24]
0
0
Disease Control Rate (DCR)
Query!
Assessment method [24]
0
0
Query!
Timepoint [24]
0
0
Baseline to end of study (approximately 24 months)
Query!
Secondary outcome [25]
0
0
Duration of Response
Query!
Assessment method [25]
0
0
Query!
Timepoint [25]
0
0
Time from first occurrence of a documented objective response until the time of documented disease progression or death from any cause during treatment (whichever occurs first) until the end of study (approximately 24 months)
Query!
Secondary outcome [26]
0
0
Progression Free Survival (PFS)
Query!
Assessment method [26]
0
0
Query!
Timepoint [26]
0
0
Time from study treatment initiation to the first occurrence of documented disease progression (based on Investigator's assessment) or death from any cause during treatment (whichever occurs first) until the end of study (approximately 24 months)
Query!
Secondary outcome [27]
0
0
Baseline PD-L1
Query!
Assessment method [27]
0
0
Query!
Timepoint [27]
0
0
Baseline to end of study (approximately 24 months)
Query!
Secondary outcome [28]
0
0
Fibroblast Activation Protein-a (FAP)
Query!
Assessment method [28]
0
0
Query!
Timepoint [28]
0
0
Baseline to end of study (approximately 24 months)
Query!
Secondary outcome [29]
0
0
Change from baseline in density (cell/mm2) of immune cells including CD8+, FOXP3, and PD-L1
Query!
Assessment method [29]
0
0
Query!
Timepoint [29]
0
0
Baseline to end of study (approximately 24 months)
Query!
Secondary outcome [30]
0
0
Time to first moderate-severe COPD Exacerbation
Query!
Assessment method [30]
0
0
Query!
Timepoint [30]
0
0
Baseline to 24 months
Query!
Secondary outcome [31]
0
0
Severe (hospital admission) COPD exacerbation rate (annualised)
Query!
Assessment method [31]
0
0
Query!
Timepoint [31]
0
0
Baseline to 24 months
Query!
Secondary outcome [32]
0
0
Number of events of composite (annualised) cardio-respiratory hospital admissions and MACE
Query!
Assessment method [32]
0
0
Query!
Timepoint [32]
0
0
Baseline to 24 months
Query!
Secondary outcome [33]
0
0
Quality of life assessed by St George's Respiratory Questionnaire (SGRQ)
Query!
Assessment method [33]
0
0
The SGRQ is a 50-item questionnaire developed to measure health status (quality of life) in patients with diseases of airways obstruction.
Scores are calculated for three domains:
Symptoms, Activity and Impacts (Psycho-social) as well as a total score.
Psychometric testing has demonstrated its repeatability, reliability and validity. Sensitivity has been demonstrated in clinical trials.
A minimum change in score of 4 units was established as clinically relevant after patient and clinician testing. The SGRQ has been used in a range of disease groups including asthma, chronic obstructive pulmonary disease (COPD) and bronchiectasis, and in a range of settings such as randomised controlled therapy trials and population surveys.
Query!
Timepoint [33]
0
0
Baseline to 24 months
Query!
Secondary outcome [34]
0
0
EuroQoL Group 5-5 Dimension self-report questionnaire (EQ-5D-5L) to assess health state utilities
Query!
Assessment method [34]
0
0
EQ-5D-5L consists of 2pg: the EQ-5D descriptive system and the EQ visual analogue scale (EQ VAS).
Five dimensions: mobility, self-care, usual activities, pain/discomfort, anxiety/depression.
Each dimension 5 levels: no problems, slight problems, moderate problems, severe problems, extreme problems.
Patient indicates their health state by ticking most appropriate statement in each of the five dimensions.
This decision results in a 1-digit number that expresses the level selected for that dimension. The digits for the five dimensions can be combined into a 5-digit number that describes the patient's health state.
EQ VAS records patient's self-rated health on a vertical visual analogue scale. Endpoints are labelled 'The best health you can imagine' and 'The worst health you can imagine'. The VAS can be used as a quantitative measure of health outcome that reflect the patient's own judgement.
Query!
Timepoint [34]
0
0
Baseline to 24 months
Query!
Secondary outcome [35]
0
0
Healthcare utilisation costs and Quality Adjusted Life Years (QALYs) evaluation of the treatment intervention
Query!
Assessment method [35]
0
0
Mean differences in healthcare utilisation costs and Quality Adjusted Life Years between both treatment groups will be estimated.
Costs will be ascertained from participants and study records. Health care utilisation will be on the basis of self-reported GP and hospital attendances and changes in concomitant medication. Health state utilities will be estimated via the EQ-5D-5L and will be used to weight survival up to 24 months to determine Quality Adjusted Life Years.
Query!
Timepoint [35]
0
0
Baseline to 24 months
Query!
Secondary outcome [36]
0
0
Health status assessed by COPD Assessment Test (CAT)
Query!
Assessment method [36]
0
0
Query!
Timepoint [36]
0
0
Baseline to 24 months
Query!
Secondary outcome [37]
0
0
Clinic spirometry: post-bronchodilator FEV1 (Forced Expiratory Volume) (L)
Query!
Assessment method [37]
0
0
Query!
Timepoint [37]
0
0
Baseline to 24 months
Query!
Secondary outcome [38]
0
0
Clinic spirometry: % predicted post-bronchodilator
Query!
Assessment method [38]
0
0
Query!
Timepoint [38]
0
0
Baseline to 24 months
Query!
Secondary outcome [39]
0
0
Hospital admissions for all respiratory causes
Query!
Assessment method [39]
0
0
Query!
Timepoint [39]
0
0
Baseline to 24 months
Query!
Secondary outcome [40]
0
0
Hospital admissions for all cardiac causes
Query!
Assessment method [40]
0
0
All cardiac causes includes ischaemia, arrhythmia, heart failure, acute arrhythmia, non-ST-elevation myocardial infarction, urgent revascularisation (stent/angioplasty/coronary artery bypass grafting), and MACE events (includes myocardial infarction, sudden death, cardiac death or a fatal event in system organ classes for cardiac and vascular disorders, and serious and non-serious stroke).
Query!
Timepoint [40]
0
0
Baseline to 24 months
Query!
Secondary outcome [41]
0
0
Total Number of cardiac events: MACE plus acute arrhythmia, Non-ST-elevation myocardial infarction (NSTEMI), urgent revascularisation (stent/angioplasty/Coronary artery bypass grafting [CABGs]) and clinically diagnosed heart failure episodes.
Query!
Assessment method [41]
0
0
Query!
Timepoint [41]
0
0
Baseline to 24 months
Query!
Secondary outcome [42]
0
0
Time to a composite outcome (includes any) of: all-case mortality; hospitalisation for COPD exacerbation, hospitalisation for primary cardiac cause (arrytmmia, ischaemia or heart failure) or MACE
Query!
Assessment method [42]
0
0
Query!
Timepoint [42]
0
0
Baseline to 24 months
Query!
Secondary outcome [43]
0
0
COPD exacerbation rate (annualised)
Query!
Assessment method [43]
0
0
Query!
Timepoint [43]
0
0
Baseline to 24 months
Query!
Eligibility
Key inclusion criteria
* Completion of SLE Study (NCT03252587) through the protocol-required treatment period, and currently receiving blinded study drug. Note: If a subject is not receiving blinded study drug due to exceptional circumstances (eg, missed investigational product [IP] due to COVID-19 pandemic, delays in study approval, etc), the subject may be allowed to enroll with approval from the BMS Clinical Trial Physician or designee.
Query!
Minimum age
18
Years
Query!
Query!
Maximum age
75
Years
Query!
Query!
Sex
Both males and females
Query!
Can healthy volunteers participate?
No
Query!
Key exclusion criteria
* Any disease or medical condition that, in the opinion of the investigator, would make the subject unsuitable for this study, would interfere with the interpretation of subject safety or study results, or considered unsuitable by the investigator for any other reason
* Evidence of active tuberculosis (TB)
Other protocol-defined inclusion/exclusion criteria apply
Query!
Study design
Purpose of the study
Treatment
Query!
Allocation to intervention
Randomised controlled trial
Query!
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Query!
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Query!
Masking / blinding
Blinded (masking used)
Query!
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Query!
Query!
Query!
Query!
Intervention assignment
Parallel
Query!
Other design features
Query!
Phase
Phase 2
Query!
Type of endpoint/s
Query!
Statistical methods / analysis
Query!
Recruitment
Recruitment status
Active, not recruiting
Query!
Data analysis
Query!
Reason for early stopping/withdrawal
Query!
Other reasons
Query!
Date of first participant enrolment
Anticipated
Query!
Actual
26/03/2019
Query!
Date of last participant enrolment
Anticipated
Query!
Actual
Query!
Date of last data collection
Anticipated
31/03/2025
Query!
Actual
Query!
Sample size
Target
Query!
Accrual to date
Query!
Final
261
Query!
Recruitment in Australia
Recruitment state(s)
WA,QLD,NSW,VIC
Query!
Recruitment hospital [1]
0
0
Novartis Investigative Site - Nedlands
Query!
Recruitment hospital [2]
0
0
Queensland Children's Hospital - South Brisbane
Query!
Recruitment hospital [3]
0
0
Perth Children's Hospital - Perth
Query!
Recruitment hospital [4]
0
0
Children's Hospital at Westmead - Sydney
Query!
Recruitment hospital [5]
0
0
The Children s Hospital at Westmead ( Site 3805) - Westmead
Query!
Recruitment hospital [6]
0
0
Queensland Children s Hospital ( Site 3806) - South Brisbane
Query!
Recruitment hospital [7]
0
0
Royal Childrens Hospital Melbourne ( Site 3801) - Parkville
Query!
Recruitment hospital [8]
0
0
Icon Cancer Centre /ID# 224084 - South Brisbane
Query!
Recruitment hospital [9]
0
0
Monash Medical Centre - Clayton
Query!
Recruitment hospital [10]
0
0
Peter MacCallum Cancer Centre - Melbourne
Query!
Recruitment hospital [11]
0
0
Linear Clinical Research Ltd - Nedlands
Query!
Recruitment hospital [12]
0
0
Scientia Clinical Research - Randwick
Query!
Recruitment hospital [13]
0
0
Melanoma Institute Australia - North Sydney
Query!
Recruitment hospital [14]
0
0
Peter Maccallum Cancer Institute; Clinical Trial Unit - Melbourne
Query!
Recruitment hospital [15]
0
0
Campbelltown Hospital - Campbelltown
Query!
Recruitment hospital [16]
0
0
Liverpool Hospital - Liverpool
Query!
Recruitment hospital [17]
0
0
John Hunter Hospital & Hunter Medical Research Institute - Newcastle
Query!
Recruitment hospital [18]
0
0
Concord Repatriation General Hospital - Sydney
Query!
Recruitment hospital [19]
0
0
Westmead Hospital - Sydney
Query!
Recruitment hospital [20]
0
0
Prince Charles Hospital - Brisbane
Query!
Recruitment hospital [21]
0
0
Princess Alexandra Hospital - Brisbane
Query!
Recruitment hospital [22]
0
0
Gold Coast University Hospital - Southport
Query!
Recruitment hospital [23]
0
0
Fiona Stanley Hospital - Murdoch
Query!
Recruitment hospital [24]
0
0
TrialsWest Pty Ltd - Perth
Query!
Recruitment hospital [25]
0
0
Institute for Respiratory Health - Perth
Query!
Recruitment postcode(s) [1]
0
0
6009 - Nedlands
Query!
Recruitment postcode(s) [2]
0
0
- South Brisbane
Query!
Recruitment postcode(s) [3]
0
0
6840 - Perth
Query!
Recruitment postcode(s) [4]
0
0
- Sydney
Query!
Recruitment postcode(s) [5]
0
0
2145 - Westmead
Query!
Recruitment postcode(s) [6]
0
0
4101 - South Brisbane
Query!
Recruitment postcode(s) [7]
0
0
3052 - Parkville
Query!
Recruitment postcode(s) [8]
0
0
3168 - Clayton
Query!
Recruitment postcode(s) [9]
0
0
3000 - Melbourne
Query!
Recruitment postcode(s) [10]
0
0
2031 - Randwick
Query!
Recruitment postcode(s) [11]
0
0
2060 - North Sydney
Query!
Recruitment postcode(s) [12]
0
0
2560 - Campbelltown
Query!
Recruitment postcode(s) [13]
0
0
2170 - Liverpool
Query!
Recruitment postcode(s) [14]
0
0
2305 - Newcastle
Query!
Recruitment postcode(s) [15]
0
0
2139 - Sydney
Query!
Recruitment postcode(s) [16]
0
0
2145 - Sydney
Query!
Recruitment postcode(s) [17]
0
0
4032 - Brisbane
Query!
Recruitment postcode(s) [18]
0
0
4102 - Brisbane
Query!
Recruitment postcode(s) [19]
0
0
4215 - Southport
Query!
Recruitment postcode(s) [20]
0
0
6150 - Murdoch
Query!
Recruitment postcode(s) [21]
0
0
6000 - Perth
Query!
Recruitment postcode(s) [22]
0
0
6009 - Perth
Query!
Recruitment outside Australia
Country [1]
0
0
United States of America
Query!
State/province [1]
0
0
Alabama
Query!
Country [2]
0
0
United States of America
Query!
State/province [2]
0
0
California
Query!
Country [3]
0
0
United States of America
Query!
State/province [3]
0
0
Connecticut
Query!
Country [4]
0
0
United States of America
Query!
State/province [4]
0
0
Florida
Query!
Country [5]
0
0
United States of America
Query!
State/province [5]
0
0
Georgia
Query!
Country [6]
0
0
United States of America
Query!
State/province [6]
0
0
New York
Query!
Country [7]
0
0
United States of America
Query!
State/province [7]
0
0
North Carolina
Query!
Country [8]
0
0
United States of America
Query!
State/province [8]
0
0
Oklahoma
Query!
Country [9]
0
0
United States of America
Query!
State/province [9]
0
0
Pennsylvania
Query!
Country [10]
0
0
United States of America
Query!
State/province [10]
0
0
South Carolina
Query!
Country [11]
0
0
United States of America
Query!
State/province [11]
0
0
Tennessee
Query!
Country [12]
0
0
United States of America
Query!
State/province [12]
0
0
Texas
Query!
Country [13]
0
0
Argentina
Query!
State/province [13]
0
0
Buenos Aires
Query!
Country [14]
0
0
Argentina
Query!
State/province [14]
0
0
Santa FE
Query!
Country [15]
0
0
Argentina
Query!
State/province [15]
0
0
Tucuman
Query!
Country [16]
0
0
Argentina
Query!
State/province [16]
0
0
Caba
Query!
Country [17]
0
0
Argentina
Query!
State/province [17]
0
0
Cordoba
Query!
Country [18]
0
0
Argentina
Query!
State/province [18]
0
0
Mendoza
Query!
Country [19]
0
0
Brazil
Query!
State/province [19]
0
0
Bahia
Query!
Country [20]
0
0
Brazil
Query!
State/province [20]
0
0
Goias
Query!
Country [21]
0
0
Brazil
Query!
State/province [21]
0
0
Minas Gerais
Query!
Country [22]
0
0
Brazil
Query!
State/province [22]
0
0
Parana
Query!
Country [23]
0
0
Brazil
Query!
State/province [23]
0
0
RIO Grande DO SUL
Query!
Country [24]
0
0
Brazil
Query!
State/province [24]
0
0
SAO Paulo
Query!
Country [25]
0
0
Brazil
Query!
State/province [25]
0
0
Sao Paulo
Query!
Country [26]
0
0
Canada
Query!
State/province [26]
0
0
Alberta
Query!
Country [27]
0
0
Canada
Query!
State/province [27]
0
0
Ontario
Query!
Country [28]
0
0
Colombia
Query!
State/province [28]
0
0
Barranquilla
Query!
Country [29]
0
0
Colombia
Query!
State/province [29]
0
0
Bogot
Query!
Country [30]
0
0
Colombia
Query!
State/province [30]
0
0
Chia
Query!
Country [31]
0
0
Colombia
Query!
State/province [31]
0
0
Zipaquira
Query!
Country [32]
0
0
Hungary
Query!
State/province [32]
0
0
Debrecen
Query!
Country [33]
0
0
Hungary
Query!
State/province [33]
0
0
Gyula
Query!
Country [34]
0
0
Hungary
Query!
State/province [34]
0
0
Szeged
Query!
Country [35]
0
0
Japan
Query!
State/province [35]
0
0
Chiba
Query!
Country [36]
0
0
Japan
Query!
State/province [36]
0
0
Fukuoka
Query!
Country [37]
0
0
Japan
Query!
State/province [37]
0
0
Hokkaido
Query!
Country [38]
0
0
Japan
Query!
State/province [38]
0
0
Miyagi
Query!
Country [39]
0
0
Japan
Query!
State/province [39]
0
0
Tochigi
Query!
Country [40]
0
0
Japan
Query!
State/province [40]
0
0
Tokyo
Query!
Country [41]
0
0
Korea, Republic of
Query!
State/province [41]
0
0
Seoul
Query!
Country [42]
0
0
Korea, Republic of
Query!
State/province [42]
0
0
Suwon
Query!
Country [43]
0
0
Mexico
Query!
State/province [43]
0
0
Distrito Federal
Query!
Country [44]
0
0
Mexico
Query!
State/province [44]
0
0
Guanajuato
Query!
Country [45]
0
0
Mexico
Query!
State/province [45]
0
0
Jalisco
Query!
Country [46]
0
0
Mexico
Query!
State/province [46]
0
0
Nuevo LEON
Query!
Country [47]
0
0
Mexico
Query!
State/province [47]
0
0
San Luis Potosi
Query!
Country [48]
0
0
Poland
Query!
State/province [48]
0
0
Bydgoszcz
Query!
Country [49]
0
0
Poland
Query!
State/province [49]
0
0
Koscian
Query!
Country [50]
0
0
Poland
Query!
State/province [50]
0
0
Krakow
Query!
Country [51]
0
0
Poland
Query!
State/province [51]
0
0
Lublin
Query!
Country [52]
0
0
Poland
Query!
State/province [52]
0
0
Poznan
Query!
Country [53]
0
0
Poland
Query!
State/province [53]
0
0
Sosnowiec
Query!
Country [54]
0
0
Poland
Query!
State/province [54]
0
0
Warsaw
Query!
Country [55]
0
0
Poland
Query!
State/province [55]
0
0
Warszawa
Query!
Country [56]
0
0
Poland
Query!
State/province [56]
0
0
Wroclaw
Query!
Country [57]
0
0
Romania
Query!
State/province [57]
0
0
Brasov
Query!
Country [58]
0
0
Romania
Query!
State/province [58]
0
0
Galati
Query!
Country [59]
0
0
Romania
Query!
State/province [59]
0
0
Ramnicu Valcea
Query!
Country [60]
0
0
Russian Federation
Query!
State/province [60]
0
0
Ekaterinburg
Query!
Country [61]
0
0
Russian Federation
Query!
State/province [61]
0
0
Kemerovo
Query!
Country [62]
0
0
Russian Federation
Query!
State/province [62]
0
0
Novosibirsk
Query!
Country [63]
0
0
Russian Federation
Query!
State/province [63]
0
0
Orenburg
Query!
Country [64]
0
0
Russian Federation
Query!
State/province [64]
0
0
Saint - Petersburg
Query!
Country [65]
0
0
Russian Federation
Query!
State/province [65]
0
0
Smolensk
Query!
Country [66]
0
0
Russian Federation
Query!
State/province [66]
0
0
St. Petersburg
Query!
Country [67]
0
0
Russian Federation
Query!
State/province [67]
0
0
Vladimir
Query!
Country [68]
0
0
Russian Federation
Query!
State/province [68]
0
0
Yaroslavl
Query!
Country [69]
0
0
Spain
Query!
State/province [69]
0
0
Malaga
Query!
Country [70]
0
0
Spain
Query!
State/province [70]
0
0
Sabadell
Query!
Country [71]
0
0
Spain
Query!
State/province [71]
0
0
Sevilla
Query!
Country [72]
0
0
Taiwan
Query!
State/province [72]
0
0
Taichung
Query!
Country [73]
0
0
Taiwan
Query!
State/province [73]
0
0
Taipei City
Query!
Country [74]
0
0
Taiwan
Query!
State/province [74]
0
0
Taipei
Query!
Country [75]
0
0
United States of America
Query!
State/province [75]
0
0
Indiana
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Country [76]
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
Bristol-Myers Squibb
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Address
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Other collaborator category [1]
0
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Government body
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National Heart, Lung, and Blood Institute (NHLBI)
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Other
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University Medical Center Groningen
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0
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Other
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Boston Children's Hospital
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Other
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University Hospitals Cleveland Medical Center
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Ethics approval
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Summary
Brief summary
The main objective of the trial is to characterize the long-term safety and tolerability of BMS-986165 in subjects with Systemic Lupus Erythematosus (SLE).
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Trial website
https://clinicaltrials.gov/study/NCT03920267
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Trial related presentations / publications
Martin A, Hancox RJ, Chang CL, Beasley R, Wrobel J, McDonald V, Dobler CC, Yang IA, Farah CS, Cochrane B, Hillis GS, Scowcroft CP, Aggarwal A, Di Tanna GL, Balicki G, Galgey S, Jenkins C. Preventing adverse cardiac events (PACE) in chronic obstructive pulmonary disease (COPD): study protocol for a double-blind, placebo controlled, randomised controlled trial of bisoprolol in COPD. BMJ Open. 2021 Aug 27;11(8):e053446. doi: 10.1136/bmjopen-2021-053446.
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Public notes
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Contacts
Principal investigator
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0
Bristol-Myers Squibb
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Bristol-Myers Squibb
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Contact person for scientific queries
No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT03920267
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