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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02931838
Other study ID # IM011-011
Secondary ID
Status Completed
Phase Phase 2
First received
Last updated
Start date November 15, 2016
Est. completion date November 16, 2017

Study information

Verified date October 2020
Source Bristol-Myers Squibb
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

A Study to evaluate efficacy and safety in subjects with moderate to severe Psoriasis treated with BMS-986165


Recruitment information / eligibility

Status Completed
Enrollment 268
Est. completion date November 16, 2017
Est. primary completion date November 16, 2017
Accepts healthy volunteers No
Gender All
Age group 18 Years to 70 Years
Eligibility For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com Inclusion Criteria: - 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. 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

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
BMS-986165

Placebo for BMS-986165


Locations

Country Name City State
Australia Local Institution Kogarah New South Wales
Australia Local Institution Melbourne Victoria
Australia Local Institution Nedlands Western Australia
Australia Local Institution Wolloongabba Queensland
Canada Local Institution Calgary Alberta
Canada Local Institution Edmonton Alberta
Canada Local Institution Hamilton Ontario
Canada Local Institution Markham Ontario
Canada Local Institution Mississauga Ontario
Canada Local Institution Montreal Quebec
Canada Local Institution Peterborough Ontario
Canada Local Institution Toronto Ontario
Canada Local Institution Vancouver British Columbia
Canada Local Institution Waterloo Ontario
Canada Local Institution Windsor Ontario
Germany Local Institution Dresden
Germany Local Institution Gera
Germany Local Institution Hamburg
Germany Local Institution Hamburg
Germany Local Institution Kiel
Germany Local Institution Kiel
Germany Local Institution Luebeck
Germany Local Institution Mahlow
Germany Local Institution Mainz
Germany Local Institution Schwerin
Germany Local Institution Stuttgart
Japan Local Institution Fukuoka City Fukuoka
Japan Local Institution Kamigyo-ku Kyoto
Japan Local Institution Kobe Hyogo
Japan Local Institution Kumamoto
Japan Local Institution Minato-ku Tokyo
Japan Local Institution Nagoya-shi Aichi
Japan Local Institution Osaka
Japan Local Institution Sapporo Hokkaido
Japan Local Institution Shimotsuke-shi Tochigi
Japan Local Institution Shinagawa-Ku Tokyo
Japan Local Institution Shinjuku-ku Tokyo
Japan Local Institution Skinjuku-ku Tokyo
Japan Local Institution Tokyo
Latvia Local Institution Daugavpils
Latvia Local Institution Riga
Latvia Local Institution Riga
Latvia Local Institution Riga
Latvia Local Institution Riga
Latvia Local Institution Ventspils
Mexico Local Institution Monterey Nuevo LEON
Mexico Local Institution Zapopan Jalisco
Poland Local Institution Krakow
Poland Local Institution Lodz
Poland Local Institution Lublin
Poland Local Institution Osielsko
Poland Local Institution Siedlce
Poland Local Institution Skierniewice
Poland Local Institution Warszawa
Poland Local Institution Warszawa
Poland Local Institution Warszawa
Poland Local Institution Warszawa
Poland Local Institution Warszawa
Poland Local Institution Wroc?aw
Poland Local Institution Wroclaw
United States Austin Dermatology Associates Austin Texas
United States PMG Research of Christie Clinic, LLC Champaign Illinois
United States Piedmont Plastic Surgery & Dermatology - Charlotte/Blakeney Location Charlotte North Carolina
United States Rivergate Dermatology Clinical Research Center, Pllc Goodlettsville Tennessee
United States Dawes Fretzin Clinical Research Group, LLC Indianapolis Indiana
United States University of California Irvine Irvine California
United States Local Institution Knoxville Tennessee
United States Dartmouth-Hitchcock Medical Center-Norris Cotton Cancer Center Lebanon New Hampshire
United States Dermatologic Surgery Specialists, PC Macon Georgia
United States Central Sooner Research Norman Oklahoma
United States Renstar Medical Research Ocala Florida
United States Health Concepts Rapid City South Dakota
United States PMG Research of Rocky Mount, LLC Rocky Mount North Carolina
United States University of California San Diego San Diego California
United States NorthShore University Health System Skokie Illinois
United States PMG Research of Wilmington, PLC Wilmington North Carolina

Sponsors (1)

Lead Sponsor Collaborator
Bristol-Myers Squibb

Countries where clinical trial is conducted

United States,  Australia,  Canada,  Germany,  Japan,  Latvia,  Mexico,  Poland, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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) 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. Day 1 to Day 85
Primary Number of Participants With Adverse Events 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 Day 1 to day 115
Secondary Percentage of Participants on Day 85 With PASI-50, PASI-90, PASI-100. 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. Day 1 to Day 85
Secondary Percentage of Participants on Day 85 With sPGA Score of 0 or 1 (sPGA0/1 Response Rate). 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. Day 1 to Day 85
Secondary Change From Baseline in DLQI Scores on 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) Day 1 to Day 85
Secondary Change From Baseline in BSA on 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. Day 1 to Day 85
Secondary Trough Observed Plasma Concentration of BMS-986165 (Ctrough) Pharmacokinetics of BMS-986165 were derived from plasma concentration versus time data. Ctrough= Trough observed plasma concentration Days 8, 15, 29, 57, 85
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