Study to Evaluate Effectiveness and Safety in Subjects With Moderate to Severe Psoriasis
- Registration Number
- NCT02931838
- Lead Sponsor
- Bristol-Myers Squibb
- Brief Summary
A Study to evaluate efficacy and safety in subjects with moderate to severe Psoriasis treated with BMS-986165
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 268
- 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.
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description BMS-986165 Dose 1 BMS-986165 Specified dose of BMS-986165 on specified days. BMS-986165 Dose 2 BMS-986165 Specified dose of BMS-986165 on specified days. BMS-986165 Dose 4 BMS-986165 Specified dose of BMS-986165 on specified days. BMS-986165 Dose 5 BMS-986165 Specified dose of BMS-986165 on specified days. Placebo Placebo for BMS-986165 Specified dose of Placebo for BMS-986165 on specified days. BMS-986165 Dose 3 BMS-986165 Specified dose of BMS-986165 on specified days.
- Primary Outcome Measures
Name Time Method Number of Participants With Adverse Events Day 1 to day 115 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
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) Day 1 to Day 85 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.
- Secondary Outcome Measures
Name Time Method Percentage of Participants on Day 85 With PASI-50, PASI-90, PASI-100. Day 1 to Day 85 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.
Percentage of Participants on Day 85 With sPGA Score of 0 or 1 (sPGA0/1 Response Rate). Day 1 to Day 85 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.
Change From Baseline in DLQI Scores on Day 85 Day 1 to Day 85 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)
Change From Baseline in BSA on Day 85 Day 1 to Day 85 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.
Trough Observed Plasma Concentration of BMS-986165 (Ctrough) Days 8, 15, 29, 57, 85 Pharmacokinetics of BMS-986165 were derived from plasma concentration versus time data. Ctrough= Trough observed plasma concentration
Trial Locations
- Locations (16)
Renstar Medical Research
🇺🇸Ocala, Florida, United States
NorthShore University Health System
🇺🇸Skokie, Illinois, United States
Dawes Fretzin Clinical Research Group, LLC
🇺🇸Indianapolis, Indiana, United States
Rivergate Dermatology Clinical Research Center, Pllc
🇺🇸Goodlettsville, Tennessee, United States
University of California San Diego
🇺🇸San Diego, California, United States
Local Institution
🇵🇱Wroclaw, Poland
University of California Irvine
🇺🇸Irvine, California, United States
PMG Research of Christie Clinic, LLC
🇺🇸Champaign, Illinois, United States
Dartmouth-Hitchcock Medical Center-Norris Cotton Cancer Center
🇺🇸Lebanon, New Hampshire, United States
PMG Research of Wilmington, PLC
🇺🇸Wilmington, North Carolina, United States
Central Sooner Research
🇺🇸Norman, Oklahoma, United States
Health Concepts
🇺🇸Rapid City, South Dakota, United States
Dermatologic Surgery Specialists, PC
🇺🇸Macon, Georgia, United States
Piedmont Plastic Surgery & Dermatology - Charlotte/Blakeney Location
🇺🇸Charlotte, North Carolina, United States
PMG Research of Rocky Mount, LLC
🇺🇸Rocky Mount, North Carolina, United States
Austin Dermatology Associates
🇺🇸Austin, Texas, United States