BMS-986165 in Participants with Crohn’s Disease or Ulcerative Colitis (IM011-077)
Research type
Research Study
Full title
An Open-label, Multi-center Extension Study to Evaluate the Long-term Safety and Efficacy of BMS-986165 in Participants with Moderate to Severe Crohn’s Disease or Moderate to Severe Ulcerative Colitis
IRAS ID
1004046
Contact name
Head of the Global Submission Management - Clinical Trials
Contact email
Sponsor organisation
Bristol-Myers Squibb International Corporation
Eudract number
2020-004461-40
Clinicaltrials.gov Identifier
Research summary
The aim of this Phase 2 Extension study is to assess whether BMS-986165 can be used to treat patients who have either moderate to severe Crohn’s Disease or ulcerative colitis long term, and to assess the safety of this medication. BMS-986165 is a new medicine, not available on the market. It works by blocking a specific molecule involved in inflammation (TYK2).
Approximately 300 participants are expected to rollover from parent studies into this study. 10 are expected from the UK. All participants must have completed 1 of the parent studies (studies IM011-023, IM011-024, IM011-127) and must meet all eligibility criteria. The study will be carried out over 296 weeks (approximately 6 years), which will be divided over 3 periods: screening, treatment and follow-up. The treatment duration is 288 weeks and the follow-up duration is 4 weeks.
When the screening visit (Day 1) occurs on the same day as the last visit of the parent study, only one set of samples will be taken, and the results will be used in both studies.
During the treatment period, all eligible participants will receive BMS-986165 6 mg in the form of an oral tablet to be taken twice daily. Participants will attend 1 in-person hospital visit every 12 weeks. They will undergo the following procedures: vital signs (temperature, heart rate and blood pressure), physical exams, ECGs, blood sampling, urine sampling, stool sample collection and annual endoscopies with tissue sample collection. They will complete questionnaires on how they are feeling. They will be given an electronic diary to complete each day at home.
Participants will have follow-up visits during the 4 weeks after the end of treatment. These visits are mainly to check the patient is well and not suffering any ill effects from the treatment.
REC name
East of Scotland Research Ethics Service REC 2
REC reference
21/ES/0093
Date of REC Opinion
8 Nov 2021
REC opinion
Further Information Favourable Opinion