Long-Term Safety and Efficacy of BMS-986165 in Subjects with Psoriasis
Research type
Research Study
Full title
An Open-Label, Multi-Center Extension Study to Characterize the Long-Term Safety and Efficacy of BMS-986165 in Subjects with Moderate-to-Severe Plaque Psoriasis
IRAS ID
272789
Contact name
Richard Warren
Contact email
Sponsor organisation
Bristol-Myers Squibb International Corporation
Eudract number
2019-000612-29
Clinicaltrials.gov Identifier
Clinicaltrials.gov Identifier
131993, IND
Duration of Study in the UK
4 years, 1 months, 1 days
Research summary
Psoriasis is a chronic inflammatory skin disorder, characterised primarily by erythematous scaly plaques affecting both men and women and the condition can present at any age. It can involve skin in any part of the body; particularly disabling is the involvement of specific regions such as hands and feet, face, scalp and nails. Psoriasis has a profound impact on quality of life, associated with an increased risk of depression, occurrence of sleep disturbances, social stigma and decreased work productivity.
This is an open-label long term extension study to provide additional safety, efficacy and patient-reported outcome data of BMS-986165 6mg once daily in participants who have previously been enrolled in an applicable BMS-986165 parent psoriasis treatment study. Applicable parent studies include, but are not limited to IM011046, IM011047, IM011065 and IM011066. The total number of participants will be based on the number who complete the psoriasis parent studies and continue into this IM011075 study. Participants will receive the investigational medication BMS-986165 for at least 96 weeks during treatment, and will be administered orally at a dose of 6mg once daily.
The purpose of the study is to evaluate the long-term safety, tolerability, and efficacy of BMS-986165 in the treatment of moderate-to-severe psoriasis. During the study, participants will be asked to undergo procedures including eligibility assessments, safety assessments, laboratory tests, and complete questionnaires.REC name
Yorkshire & The Humber - Sheffield Research Ethics Committee
REC reference
20/YH/0004
Date of REC Opinion
17 Mar 2020
REC opinion
Further Information Favourable Opinion