Efficacy and Safety of BMS-986165 In Subjects with Psoriasis
Research type
Research Study
Full title
A Multi-Center, Randomized, Double-Blind, Placebo- and Active Comparator-Controlled Phase 3 Study to Evaluate the Efficacy and Safety of BMS-986165 in Subjects with Moderate-to-Severe Plaque Psoriasis
IRAS ID
250639
Contact name
Richard Warren
Contact email
Sponsor organisation
Bristol-Myers Squibb International Corporation
Eudract number
2018-001926-25
Clinicaltrials.gov Identifier
Clinicaltrials.gov Identifier
131,993, IND
Duration of Study in the UK
1 years, 1 months, 22 days
Research summary
Psoriasis is a chronic inflammatory skin disorder, characterised primarily by scaly plaques, affecting up to 3% of the general population. BMS-986165 is an investigational medicine. Other research studies showed that BMS-986165 may help control the immune system which is responsible for the signs and symptoms of psoriasis by regulating the molecules in the body responsible for inflammation within the skin. The study is planned to involve 600 people (men and women aged 18 years or older) who have moderate-to-severe plaque psoriasis. Participants are expected to be in the study for 60 weeks, involving 52 weeks of treatment and 18 visits to the study site. This study will be conducted at NHS and non-NHS sites in the UK.
The purpose of this study is to measure how safe and effective BMS-986165 is in treating participants with psoriasis.
During the study participants will be asked to undergo procedures including eligibility assessments, safety measurements and laboratory tests. In addition, participants will be asked to complete questionnaires and a study diary daily.Participants will be assigned to 1 of 3 groups at random and will receive either the BMS-986165, placebo (no active ingredients) or apremilast. Participants will have a 1 in 2 chance of receiving BMS-986165 and a 1 in 4 chance of receiving apremilast or placebo. At week 16 those receiving placebo will transition onto BMS-986165, at week 24 those receiving apremilast will transition onto BMS-986165 or remain on apremilast. In this study neither the participant nor the study doctor will know what treatment participants are receiving.
Apremilast is already approved for moderate-to-severe plaque psoriasis however, many participants still feel their treatment is inadequate, therefore there is an unmet need for more effective oral treatment options. This study will assess whether BMS-986165 works as well as or better than the apremilast or placebo.
REC name
East of England - Cambridge South Research Ethics Committee
REC reference
18/EE/0381
Date of REC Opinion
11 Feb 2019
REC opinion
Further Information Favourable Opinion