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

Completed · Phase 2 · Has a placebo group

Conditions studied: Psoriasis

In brief

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

Key facts

Study ID

NCT02931838

Run by

Bristol-Myers Squibb

People needed

268

Starts

2016-11-15

Expected to finish

2017-11-16

Last updated by the study team

2020-11-27

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• 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
• University of California Irvine — Irvine, California, United States

Full record on ClinicalTrials.gov

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