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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT02931838
Registration number
NCT02931838
Ethics application status
Date submitted
3/10/2016
Date registered
13/10/2016
Date last updated
27/11/2020
Titles & IDs
Public title
Study to Evaluate Effectiveness and Safety in Subjects With Moderate to Severe Psoriasis
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Scientific title
A Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Phase 2 Study to Evaluate the Clinical Efficacy and Safety of BMS-986165 in Subjects With Moderate to Severe Psoriasis
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Secondary ID [1]
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IM011-011
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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:
Psoriasis
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Condition category
Condition code
Skin
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Dermatological conditions
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Skin
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Other skin conditions
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - BMS-986165
Treatment: Drugs - Placebo for BMS-986165
Experimental: BMS-986165 Dose 1 - Specified dose of BMS-986165 on specified days.
Experimental: BMS-986165 Dose 2 - Specified dose of BMS-986165 on specified days.
Experimental: BMS-986165 Dose 3 - Specified dose of BMS-986165 on specified days.
Experimental: BMS-986165 Dose 4 - Specified dose of BMS-986165 on specified days.
Experimental: BMS-986165 Dose 5 - Specified dose of BMS-986165 on specified days.
Placebo Comparator: Placebo - Specified dose of Placebo for BMS-986165 on specified days.
Treatment: Drugs: BMS-986165
Treatment: Drugs: Placebo for BMS-986165
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Intervention code [1]
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Treatment: Drugs
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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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The Percentage of Participants With Moderate to Severe Psoriasis Experiencing a 75% Improvement (Reduction From Baseline) in PASI Score (PASI-75 Response Rate) on Day 85 (Week 12)
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Assessment method [1]
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Psoriasis Area and Severity Index (PASI) 75 response: patients who achieved = 75% improvement (reduction) in PASI score compared to baseline were defined as PASI 75 responders. PASI scores can range from 0, corresponding to no signs of psoriasis up to theoretical maximum of 72.0, which means a higher PASI score reflects a higher psoriasis activity.
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Timepoint [1]
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Day 1 to Day 85
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Primary outcome [2]
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Number of Participants With Adverse Events
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Assessment method [2]
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The safety and tolerability of BMS-986195 as assessed by the number of subjects with adverse events (AEs); number of subjects with serious adverse events (SAEs); number of subjects with adverse events leading to discontinuation
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Timepoint [2]
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Day 1 to day 115
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Secondary outcome [1]
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Percentage of Participants on Day 85 With PASI-50, PASI-90, PASI-100.
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Assessment method [1]
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Percentage of patients achieving Psoriasis Area and Severity Index (PASI) 50, PASI 90 and PASI 100 responses on Day 85. PASI 50 response: patients who achieved = 50% improvement (reduction) in PASI score compared to baseline were defined as PASI 50 responders. PASI 90 response: patients who achieved = 90% improvement (reduction) in PASI score compared to baseline were defined as PASI 90 responders. PASI 100 response: patients who achieved = 100% improvement (reduction) in PASI score compared to baseline were defined as PASI 100 responders. PASI scores can range from 0, corresponding to no signs of psoriasis up to theoretical maximum of 72.0, which means a higher PASI score reflects a higher psoriasis activity.
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Timepoint [1]
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Day 1 to Day 85
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Secondary outcome [2]
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Percentage of Participants on Day 85 With sPGA Score of 0 or 1 (sPGA0/1 Response Rate).
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Assessment method [2]
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Percentage of participants achieving a clear (0) or almost clear (1) status on the Static Physician Global Assessment (sPGA) on Day 85. This index evaluates the physician's global assessment of the participant's psoriasis based on severity of induration, scaling, and erythema. The assessment was scored on a scale of 0 to 5, where 0 = clear, with no evidence of plaque elevation, erythema, or scale, and 5 = severe induration, erythema, and scaling.
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Timepoint [2]
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Day 1 to Day 85
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Secondary outcome [3]
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Change From Baseline in DLQI Scores on Day 85
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Assessment method [3]
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The DLQI is a participant reported quality of life index which consists of 10 questions concerning symptoms and feelings, daily activities, leisure, work, school, personal relationships, and treatment during the last week. Each question is scored on a scale of 0 to 3 by a tick box: "not at all", "a little", "a lot", or "very much". The scores are summed, giving a range from 0 (no impairment of life quality) to 30 (maximum impairment)
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Timepoint [3]
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Day 1 to Day 85
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Secondary outcome [4]
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Change From Baseline in BSA on Day 85
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Assessment method [4]
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Measurement of psoriasis body surface area (BSA) involvement is estimated using the handprint method with the size of a patient's handprint representing ~1% of body surface area involved.The total BSA = 100% with breakdown by body region as follows: head and neck = 10% (10 handprints), upper extremities = 20% (20 handprints), trunk including axillae and groin = 30% (30 handprints), lower extremities including buttocks = 40% (40 handprints). A decrease from Baseline indicates improvement. Change from Baseline was calculated as Baseline score - Day 85 score; a positive change from Baseline therefore indicates improvement.
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Timepoint [4]
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Day 1 to Day 85
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Secondary outcome [5]
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Trough Observed Plasma Concentration of BMS-986165 (Ctrough)
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Assessment method [5]
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Pharmacokinetics of BMS-986165 were derived from plasma concentration versus time data. Ctrough= Trough observed plasma concentration
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Timepoint [5]
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Days 8, 15, 29, 57, 85
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Eligibility
Key inclusion criteria
For more information regarding Bristol-Myers Squibb Clinical Trial participation, please
visit www.BMSStudyConnect.com
- Male and female, ages 18 to 70 years
- Diagnosis of plaque psoriasis for 6 months
- Women of childbearing potential (WOCBP) must have a negative serum or urine pregnancy
test, must not be pregnant, lactating, breastfeeding or planning pregnancy
- Males who are sexually active with WOCBP must agree to follow instructions for
method(s) of contraception for the duration of treatment plus 5 half-lives of the
study drug plus 90 days.
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Minimum age
18
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Maximum age
70
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
- Any significant acute or chronic medical illness
- Blood transfusion within 4 weeks of study drug administration
- Inability to tolerate oral medication
- Positive hepatitis-B (HBV) surface antigen
- Positive hepatitis-C (HCV) antibody
- Any history or risk for tuberculosis (TB)
- Any major illness/condition or evidence of an unstable clinical condition
- Chest X-ray findings suspicious of infection at screening
- has received ustekinumab, secukinumab or ixekizumab within 6 months of first
administration of study medication
- Has received anti-Tumor Necrosis Factor (TNF) inhibitor(s) within 2 months of first
administration of study medication
- Has received Rituximab within 6 months of first administration of study medication
- Topical medications/treatments for psoriasis within 2 weeks of the first
administration of any study medication
- Any systemic medications/treatments for psoriasis within 4 weeks of the first
administration of any study medication
Other protocol defined inclusion/exclusion criteria could apply
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 2
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
15/11/2016
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
16/11/2017
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Sample size
Target
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Accrual to date
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Final
268
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Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC,WA
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Recruitment hospital [1]
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Local Institution - Kogarah
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Recruitment hospital [2]
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Local Institution - Wolloongabba
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Recruitment hospital [3]
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Local Institution - Melbourne
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Recruitment hospital [4]
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Local Institution - Nedlands
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Recruitment postcode(s) [1]
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2217 - Kogarah
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Recruitment postcode(s) [2]
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4102 - Wolloongabba
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Recruitment postcode(s) [3]
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3053 - Melbourne
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Recruitment postcode(s) [4]
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6009 - Nedlands
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Recruitment outside Australia
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United States of America
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California
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Florida
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Georgia
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Illinois
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Mainz
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Wroclaw
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Funding & Sponsors
Primary sponsor type
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Name
Bristol-Myers Squibb
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Address
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Ethics approval
Ethics application status
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Summary
Brief summary
A Study to evaluate efficacy and safety in subjects with moderate to severe Psoriasis treated
with BMS-986165
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Trial website
https://clinicaltrials.gov/ct2/show/NCT02931838
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
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Bristol-Myers Squibb
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Address
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Bristol-Myers Squibb
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT02931838
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