Clinical trial NCT02931838: Study to Evaluate Effectiveness and Safety in Subjects With Moderate to Severe Psoriasis
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Psoriasis
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2016-10-13
Enrollment: 268
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility criteria: 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

Primary outcomes:
measure: 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)
timeFrame: Day 1 to Day 85
measure: Number of Participants With Adverse Events
timeFrame: Day 1 to day 115
Secondary outcomes:
measure: Percentage of Participants on Day 85 With PASI-50, PASI-90, PASI-100.
timeFrame: Day 1 to Day 85
measure: Percentage of Participants on Day 85 With sPGA Score of 0 or 1 (sPGA0/1 Response Rate).
timeFrame: Day 1 to Day 85
measure: Change From Baseline in DLQI Scores on Day 85
timeFrame: Day 1 to Day 85
measure: Change From Baseline in BSA on Day 85
timeFrame: Day 1 to Day 85
measure: Trough Observed Plasma Concentration of BMS-986165 (Ctrough)
timeFrame: Days 8, 15, 29, 57, 85
Other outcomes:
Locations:
city: Irvine
country: United States
facility: University of California Irvine
state: California
city: San Diego
country: United States
facility: University of California San Diego
state: California
city: Ocala
country: United States
facility: Renstar Medical Research
state: Florida
city: Macon
country: United States
facility: Dermatologic Surgery Specialists, PC
state: Georgia
city: Champaign
country: United States
facility: PMG Research of Christie Clinic, LLC
state: Illinois
city: Skokie
country: United States
facility: NorthShore University Health System
state: Illinois
city: Indianapolis
country: United States
facility: Dawes Fretzin Clinical Research Group, LLC
state: Indiana
city: Lebanon
country: United States
facility: Dartmouth-Hitchcock Medical Center-Norris Cotton Cancer Center
state: New Hampshire
city: Charlotte
country: United States
facility: Piedmont Plastic Surgery & Dermatology - Charlotte/Blakeney Location
state: North Carolina
city: Rocky Mount
country: United States
facility: PMG Research of Rocky Mount, LLC
state: North Carolina
city: Wilmington
country: United States
facility: PMG Research of Wilmington, PLC
state: North Carolina
city: Norman
country: United States
facility: Central Sooner Research
state: Oklahoma
city: Rapid City
country: United States
facility: Health Concepts
state: South Dakota
city: Goodlettsville
country: United States
facility: Rivergate Dermatology Clinical Research Center, Pllc
state: Tennessee
city: Knoxville
country: United States
facility: Local Institution
state: Tennessee
city: Austin
country: United States
facility: Austin Dermatology Associates
state: Texas
city: Kogarah
country: Australia
facility: Local Institution
state: New South Wales
city: Wolloongabba
country: Australia
facility: Local Institution
state: Queensland
city: Melbourne
country: Australia
facility: Local Institution
state: Victoria
city: Nedlands
country: Australia
facility: Local Institution
state: Western Australia
city: Calgary
country: Canada
facility: Local Institution
state: Alberta
city: Edmonton
country: Canada
facility: Local Institution
state: Alberta
city: Vancouver
country: Canada
facility: Local Institution
state: British Columbia
city: Hamilton
country: Canada
facility: Local Institution
state: Ontario
city: Markham
country: Canada
facility: Local Institution
state: Ontario
city: Mississauga
country: Canada
facility: Local Institution
state: Ontario
city: Peterborough
country: Canada
facility: Local Institution
state: Ontario
city: Toronto
country: Canada
facility: Local Institution
state: Ontario
city: Waterloo
country: Canada
facility: Local Institution
state: Ontario
city: Windsor
country: Canada
facility: Local Institution
state: Ontario
city: Montreal
country: Canada
facility: Local Institution
state: Quebec
city: Dresden
country: Germany
facility: Local Institution
city: Gera
country: Germany
facility: Local Institution
city: Hamburg
country: Germany
facility: Local Institution
city: Hamburg
country: Germany
facility: Local Institution
city: Kiel
country: Germany
facility: Local Institution
city: Kiel
country: Germany
facility: Local Institution
city: Luebeck
country: Germany
facility: Local Institution
city: Mahlow
country: Germany
facility: Local Institution
city: Mainz
country: Germany
facility: Local Institution
city: Schwerin
country: Germany
facility: Local Institution
city: Stuttgart
country: Germany
facility: Local Institution
city: Nagoya-shi
country: Japan
facility: Local Institution
state: Aichi
city: Fukuoka City
country: Japan
facility: Local Institution
state: Fukuoka
city: Sapporo
country: Japan
facility: Local Institution
state: Hokkaido
city: Kobe
country: Japan
facility: Local Institution
state: Hyogo
city: Kamigyo-ku
country: Japan
facility: Local Institution
state: Kyoto
city: Shimotsuke-shi
country: Japan
facility: Local Institution
state: Tochigi
city: Minato-ku
country: Japan
facility: Local Institution
state: Tokyo
city: Shinagawa-Ku
country: Japan
facility: Local Institution
state: Tokyo
city: Shinjuku-ku
country: Japan
facility: Local Institution
state: Tokyo
city: Skinjuku-ku
country: Japan
facility: Local Institution
state: Tokyo
city: Kumamoto
country: Japan
facility: Local Institution
city: Osaka
country: Japan
facility: Local Institution
city: Tokyo
country: Japan
facility: Local Institution
city: Daugavpils
country: Latvia
facility: Local Institution
city: Riga
country: Latvia
facility: Local Institution
city: Riga
country: Latvia
facility: Local Institution
city: Riga
country: Latvia
facility: Local Institution
city: Riga
country: Latvia
facility: Local Institution
city: Ventspils
country: Latvia
facility: Local Institution
city: Zapopan
country: Mexico
facility: Local Institution
state: Jalisco
city: Monterey
country: Mexico
facility: Local Institution
state: Nuevo LEON
city: Krakow
country: Poland
facility: Local Institution
city: Lodz
country: Poland
facility: Local Institution
city: Lublin
country: Poland
facility: Local Institution
city: Osielsko
country: Poland
facility: Local Institution
city: Siedlce
country: Poland
facility: Local Institution
city: Skierniewice
country: Poland
facility: Local Institution
city: Warszawa
country: Poland
facility: Local Institution
city: Warszawa
country: Poland
facility: Local Institution
city: Warszawa
country: Poland
facility: Local Institution
city: Warszawa
country: Poland
facility: Local Institution
city: Warszawa
country: Poland
facility: Local Institution
city: Wroc?aw
country: Poland
facility: Local Institution
city: Wroclaw
country: Poland
facility: Local Institution
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References:
citation: Thaci D, Strober B, Gordon KB, Foley P, Gooderham M, Morita A, Papp KA, Puig L, Menter MA, Colombo MJ, Elbez Y, Kisa RM, Ye J, Napoli AA, Wei L, Banerjee S, Merola JF, Gottlieb AB. Deucravacitinib in Moderate to Severe Psoriasis: Clinical and Quality-of-Life Outcomes in a Phase 2 Trial. Dermatol Ther (Heidelb). 2022 Feb;12(2):495-510. doi: 10.1007/s13555-021-00649-y. Epub 2022 Jan 13.
citation: Catlett IM, Hu Y, Gao L, Banerjee S, Gordon K, Krueger JG. Molecular and clinical effects of selective tyrosine kinase 2 inhibition with deucravacitinib in psoriasis. J Allergy Clin Immunol. 2022 Jun;149(6):2010-2020.e8. doi: 10.1016/j.jaci.2021.11.001. Epub 2021 Nov 10.
citation: Papp K, Gordon K, Thaci D, Morita A, Gooderham M, Foley P, Girgis IG, Kundu S, Banerjee S. Phase 2 Trial of Selective Tyrosine Kinase 2 Inhibition in Psoriasis. N Engl J Med. 2018 Oct 4;379(14):1313-1321. doi: 10.1056/NEJMoa1806382. Epub 2018 Sep 11.