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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT06318273
Registration number
NCT06318273
Ethics application status
Date submitted
13/03/2024
Date registered
19/03/2024
Titles & IDs
Public title
A Study to Assess Adverse Events, and How Intravenously (IV) Infused ABBV-969 Moves Through the Bodies of Adult Participants With Metastatic Castration-Resistant Prostate Cancer
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Scientific title
A Phase 1 First-in-Human Study Evaluating Safety, Pharmacokinetics, and Efficacy of ABBV-969 in Adult Subjects With Metastatic Castration-Resistant Prostate Cancer
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Secondary ID [1]
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M24-742
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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:
Metastatic Castration-Resistant Prostate Cancer
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Condition category
Condition code
Cancer
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Prostate
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - ABBV-969
Experimental: Part 1: ABBV-969 Dose Escalation - Participants will receive escalating doses of ABBV-969.
Experimental: Part 2 A: ABBV-969 Dose Expansion - Participants will receive dose A of ABBV-969 from part 1.
Experimental: Part 2 B: ABBV-969 Dose Expansion - Participants will receive dose B of ABBV-969 from part 1.
Treatment: Drugs: ABBV-969
Intravenous (IV) Infusion
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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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Percentage of Participants With Adverse Events (AEs)
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Assessment method [1]
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An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment. The investigator assesses the relationship of each event to the use of study. A serious adverse event (SAE) is an event that results in death, is life-threatening, requires or prolongs hospitalization, results in a congenital anomaly, persistent or significant disability/incapacity or is an important medical event that, based on medical judgment, may jeopardize the participant and may require medical or surgical intervention to prevent any of the outcomes listed above.
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Timepoint [1]
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Up to 3 Years
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Primary outcome [2]
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Percentage of Participants Achieving Prostate Specific Antigen (PSA) response
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Assessment method [2]
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PSA response is defined as \>= 50% PSA decrease from baseline.
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Timepoint [2]
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Up to 3 Years
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Secondary outcome [1]
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Maximum Observed Plasma Concentration (Cmax) of ABBV-969
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Assessment method [1]
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Cmax is defined as the maximum observed plasma/serum concentration of ABBV-969.
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Timepoint [1]
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Up to 3 Years
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Secondary outcome [2]
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Time to Maximum Observed Concentration (Tmax) of ABBV-969
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Assessment method [2]
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Tmax is defined as the time to maximum observed concentration of ABBV-969.
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Timepoint [2]
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Up to 3 Years
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Secondary outcome [3]
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Terminal Phase Elimination Half-Life (t1/2) of ABBV-969
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Assessment method [3]
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Terminal phase elimination half-life of ABBV-969.
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Timepoint [3]
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Up to 3 Years
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Secondary outcome [4]
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Area Under the Plasma/Serum Concentration Versus Time Curve (AUC) of ABBV-969
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Assessment method [4]
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Area under the plasma/serum concentration versus time curve (AUC) of ABBV-969.
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Timepoint [4]
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Up to 3 Years
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Secondary outcome [5]
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Antidrug Antibody (ADA)
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Assessment method [5]
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Incidence and concentration of anti-drug antibodies.
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Timepoint [5]
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Up to 3 Years
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Secondary outcome [6]
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Neutralizing Antibodies (nAbs)
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Assessment method [6]
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Incidence and concentration of neutralizing antibodies.
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Timepoint [6]
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Up to 3 Years
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Secondary outcome [7]
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Recommended Phase 2 Dose (RP2D) of ABBV-969 (Dose-Escalation Phase)
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Assessment method [7]
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The RP2D of ABBV-969 will be determined during the dose-escalation phase of the study. RP2D will be determined using available safety and pharmacokinetics and pharmacodynamics data.
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Timepoint [7]
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Up to 2 Years
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Eligibility
Key inclusion criteria
* Histological, pathological, and/or cytological confirmation of adenocarcinoma of the prostate.
* Estimated life expectancy > 6 months.
* Must have progressed on prior novel hormonal agents (NHAs) (e.g., abiraterone acetate and/or enzalutamide) for the treatment of metastatic prostate cancer and/or castration-resistant prostate cancer (CRPC). Determination of progression is done per local investigator according to Response Evaluation Criteria in Solid Tumors (RECIST), version 1.1 and/or Prostate Cancer Working Group 3 (PCWG3).
* Serum testosterone levels <= 50 ng/dL (<= 1.73 nmol/L) within the screening period and prior to the first dose of the study drug.
* Must have received at least one NHA (e.g., enzalutamide and/or abiraterone). Additionally, participants must have received at least one taxane for prostate cancer (or have refused, or are intolerant to, or unable to get access to taxanes).
* Must have >= 1 metastatic lesion that is present on baseline computed tomography (CT), magnetic resonance imaging (MRI), or bone scan imaging obtained <= 28 days prior to beginning study therapy.
* Serum prostate specific antigen (PSA) level >= 1.0 ng/mL.
* Availability of representative baseline tumor tissue (most recent archived tumor tissue after any novel hormonal agent (NHA) and/or any Prostate-Specific Membrane Antigen (PSMA) targeted therapy or fresh biopsy collected during screening phase) suitable for immunohistochemistry (IHC) testing. This requirement may be waived at the discretion of the AbbVie Medical Monitor if collecting a biopsy at screening would place the subject at risk of harm or would require a technically complicated procedure based on tumor location as assessed by the investigator.
* Laboratory values meeting the criteria laid out in the protocol.
* QT interval corrected for heart rate (QTc) < 470 msec (using Fridericia's correction), no >= Grade 3 arrythmia, and no other clinically significant cardiac abnormalities.
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Minimum age
18
Years
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Maximum age
No limit
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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
* Unresolved Grade 2 or higher toxicities related to previous anticancer therapy except alopecia.
* History of other active malignancy, as laid out in the protocol.
* History of interstitial lung disease (ILD) or pneumonitis that required treatment with systemic steroids, nor any evidence of active ILD or pneumonitis on screening chest CT scan.
* History of or active idiopathic pulmonary fibrosis, organizing pneumonia (e.g., bronchiolitis obliterans), drug-induced pneumonitis, or idiopathic pneumonitis.
* History of or active clinically significant, intercurrent lung-specific illnesses including, but not limited to those listed in the protocol.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Non-randomised 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
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Other
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Other design features
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Phase
Phase 1
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Recruiting
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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
8/03/2024
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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
27/05/2027
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Actual
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Sample size
Target
120
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
NT,VIC
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Recruitment hospital [1]
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St Vincent's Hospital /ID# 264293 - Fitzroy
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Recruitment hospital [2]
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Ballarat Base Hospital /ID# 264294 - Ballarat
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Recruitment postcode(s) [1]
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3065 - Fitzroy
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Recruitment postcode(s) [2]
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3350 - Ballarat
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Recruitment outside Australia
Country [1]
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United States of America
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State/province [1]
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California
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Country [2]
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United States of America
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State/province [2]
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Florida
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Country [3]
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United States of America
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State/province [3]
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Michigan
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Country [4]
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United States of America
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State/province [4]
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North Carolina
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Country [5]
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United States of America
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State/province [5]
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Rhode Island
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Country [6]
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United States of America
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State/province [6]
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Texas
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Country [7]
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Israel
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State/province [7]
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Tel-Aviv
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Country [8]
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Israel
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State/province [8]
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Haifa
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Country [9]
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Israel
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State/province [9]
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Jerusalem
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Country [10]
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Japan
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State/province [10]
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Kyoto
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Country [11]
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Japan
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State/province [11]
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Tokyo
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
AbbVie
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief summary
Prostate cancer has the second highest incidence rate and is the fifth leading cause of cancer-related deaths among men worldwide. The purpose of this study is to assess safety, pharmacokinetics, and efficacy of ABBV-969 as a monotherapy. ABBV-969 is an investigational drug being developed for the treatment of metastatic castration-resistant prostate cancer (mCRPC). There are parts to this study. Participants will receive ABBV-969 as a single agent at different doses. Approximately 120 adult participants will be enrolled in the study across sites worldwide. In part 1 (dose escalation), ABBV-969 will be intravenously infused in escalating doses as a monotherapy. In part 2, multiple doses will be selected from Part 1 and mCRPC participants will be assigned to one of these doses in a randomized fashion to determine the recommended Phase 2 dose. The estimated duration of the study is up to 3 years. There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic and may require frequent medical assessments, blood tests, and scans.
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Trial website
https://clinicaltrials.gov/study/NCT06318273
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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ABBVIE INC.
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Address
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AbbVie
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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ABBVIE CALL CENTER
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Address
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Country
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Phone
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844-663-3742
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Fax
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Email
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[email protected]
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Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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No/undecided IPD sharing reason/comment
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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/NCT06318273