Study to Evaluate Effectiveness and Safety in Subjects With Moderate to Severe Psoriasis
NCT ID: NCT02931838
Last Updated: 2020-11-27
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
268 participants
INTERVENTIONAL
2016-11-15
2017-11-16
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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BMS-986165 Dose 1
Specified dose of BMS-986165 on specified days.
BMS-986165
BMS-986165 Dose 2
Specified dose of BMS-986165 on specified days.
BMS-986165
BMS-986165 Dose 3
Specified dose of BMS-986165 on specified days.
BMS-986165
BMS-986165 Dose 4
Specified dose of BMS-986165 on specified days.
BMS-986165
BMS-986165 Dose 5
Specified dose of BMS-986165 on specified days.
BMS-986165
Placebo
Specified dose of Placebo for BMS-986165 on specified days.
Placebo for BMS-986165
Interventions
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BMS-986165
Placebo for BMS-986165
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
70 Years
ALL
No
Sponsors
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Bristol-Myers Squibb
INDUSTRY
Responsible Party
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Principal Investigators
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Bristol-Myers Squibb
Role: STUDY_DIRECTOR
Bristol-Myers Squibb
Locations
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University of California Irvine
Irvine, California, United States
University of California San Diego
San Diego, California, United States
Renstar Medical Research
Ocala, Florida, United States
Dermatologic Surgery Specialists, PC
Macon, Georgia, United States
PMG Research of Christie Clinic, LLC
Champaign, Illinois, United States
NorthShore University Health System
Skokie, Illinois, United States
Dawes Fretzin Clinical Research Group, LLC
Indianapolis, Indiana, United States
Dartmouth-Hitchcock Medical Center-Norris Cotton Cancer Center
Lebanon, New Hampshire, 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
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
Rivergate Dermatology Clinical Research Center, Pllc
Goodlettsville, Tennessee, United States
Local Institution
Knoxville, Tennessee, United States
Austin Dermatology Associates
Austin, Texas, United States
Local Institution
Kogarah, New South Wales, Australia
Local Institution
Wolloongabba, Queensland, Australia
Local Institution
Melbourne, Victoria, Australia
Local Institution
Nedlands, Western Australia, Australia
Local Institution
Calgary, Alberta, Canada
Local Institution
Edmonton, Alberta, Canada
Local Institution
Vancouver, British Columbia, Canada
Local Institution
Hamilton, Ontario, Canada
Local Institution
Markham, Ontario, Canada
Local Institution
Mississauga, Ontario, Canada
Local Institution
Peterborough, Ontario, Canada
Local Institution
Toronto, Ontario, Canada
Local Institution
Waterloo, Ontario, Canada
Local Institution
Windsor, Ontario, Canada
Local Institution
Montreal, Quebec, Canada
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
Lübeck, , Germany
Local Institution
Mahlow, , Germany
Local Institution
Mainz, , Germany
Local Institution
Schwerin, , Germany
Local Institution
Stuttgart, , Germany
Local Institution
Nagoya, Aichi-ken, Japan
Local Institution
Fukuoka, Fukuoka, Japan
Local Institution
Sapporo, Hokkaido, Japan
Local Institution
Kobe, Hyōgo, Japan
Local Institution
Kamigyō-ku, Kyoto, Japan
Local Institution
Shimotsuke-shi, Tochigi, Japan
Local Institution
Minato-ku, Tokyo, Japan
Local Institution
Shinagawa-Ku, Tokyo, Japan
Local Institution
Shinjuku-ku, Tokyo, Japan
Local Institution
Skinjuku-ku, Tokyo, Japan
Local Institution
Kumamoto, , Japan
Local Institution
Osaka, , Japan
Local Institution
Tokyo, , Japan
Local Institution
Daugavpils, , Latvia
Local Institution
Riga, , Latvia
Local Institution
Riga, , Latvia
Local Institution
Riga, , Latvia
Local Institution
Riga, , Latvia
Local Institution
Ventspils, , Latvia
Local Institution
Zapopan, Jalisco, Mexico
Local Institution
Monterrey, Nuevo León, Mexico
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
Warsaw, , Poland
Local Institution
Warsaw, , Poland
Local Institution
Warsaw, , Poland
Local Institution
Warsaw, , Poland
Local Institution
Warsaw, , Poland
Local Institution
Wroc?aw, , Poland
Local Institution
Wroclaw, , Poland
Countries
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References
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Catlett IM, Gao L, Hu Y, Banerjee S, Krueger JG. Pharmacodynamic Response to Deucravacitinib, an Oral, Selective, Allosteric TYK2 Inhibitor, in a Global, Phase 2, Randomized, Double-Blind, Placebo-Controlled Psoriasis Trial. Dermatol Ther (Heidelb). 2024 Oct;14(10):2827-2839. doi: 10.1007/s13555-024-01262-5. Epub 2024 Sep 16.
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.
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.
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.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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BMS Clinical Trial Patient Recruiting
Investigator Inquiry Form
Other Identifiers
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IM011-011
Identifier Type: -
Identifier Source: org_study_id