Study to Evaluate Effectiveness and Safety in Subjects With Moderate to Severe Psoriasis

Psoriasis Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02931838
• Other study ID #: IM011-011
• Status: Completed
• Phase: Phase 2
• 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
• 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

Related Conditions & MeSH terms

• Psoriasis

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

External Links

•   BMS Clinical Trial Patient Recruiting
•   Investigator Inquiry Form