BMS-986165 in Subjects with Active Psoriatic Arthritis (PsA)
Research type
Research Study
Full title
A Randomized, Placebo-Controlled, Double-blind, Multicenter Study to Assess the Efficacy and\nSafety of Multiple Doses of BMS-986165 in Subjects with Active Psoriatic Arthritis (PsA)
IRAS ID
259472
Contact name
Hasan Tahir
Contact email
Sponsor organisation
Bristol-Myers Squibb International Corporation
Eudract number
2018-004293-10
Clinicaltrials.gov Identifier
Clinicaltrials.gov Identifier
137, 455, EX-US: Non-IND, US IND:
Duration of Study in the UK
1 years, 8 months, 17 days
Research summary
Psoriatic arthritis (PsA) is a chronic inflammatory disease, associated with psoriasis. Over time, without adequate treatment, this condition can lead to disability and reduced quality of life. The sponsor BMS is running a research study to see if the test medicine, BMS-986165, will help in the treatment of Psoriatic Arthritis and how safe it is to use in people.\n\nThe study is planned to involve 180 participants. Participants will be randomised to one of three treatment groups:\n-BMS-986165 6mg daily\n-BMS-986165 12mg daily \n-Placebo (dummy medication) matching BMS-986165 daily \nThe assigned treatment will be given orally for 16 weeks.\n\nNeither participants nor the study doctor will know which treatment is assigned. Participation will last 24 weeks including a Screening Period (up to 4 weeks), Treatment Period (16 weeks; Part A), and a Safety Follow-up Period (4 weeks). Participants will need to attend 8 visits.\n\nAfter completion of 16 weeks of treatment, participants will have the option to take part in Part B of the study, being assigned to one of the following 3 treatment groups:\n-Ustekinumab (a prescription medication) subcutaneous injection (an injection under the skin) at Weeks 16, 20, 32, and 44 PLUS Placebo matching BMS-986165 daily (orally) for 36 weeks\n-BMS-986165 6 mg daily (orally) for 36 weeks PLUS Placebo matching ustekinumab subcutaneous injection at Weeks 16, 20, 32, and 44\n-BMS-986165 12 mg daily (orally) for 36 weeks PLUS Placebo matching ustekinumab subcutaneous injection at Weeks 16, 20, 32, and 44\nA Safety Follow-up Period after the 36 weeks of additional treatment will be completed. In Part B participants will attend an additional 10 visits. \n\nStudy procedures involve medical history review, physical exams, body weight, vital signs, electrocardiograms, blood and urine tests, chest x-ray, questionnaires, review of medications and side effects, dispensing of medications.
REC name
East of England - Cambridgeshire and Hertfordshire Research Ethics Committee
REC reference
19/EE/0213
Date of REC Opinion
12 Aug 2019
REC opinion
Further Information Favourable Opinion