IM011-127_Safety, Efficacy and Biomarker Response of BMS-986165 in Subjects with Ulcerative Colitis

• Research type

  Research Study

• Full title

  A Phase 2 Randomized, Double-Blind, Placebo-Controlled Study of the Safety, Efficacy, and Biomarker Response of BMS-986165 in Subjects with Moderate to Severe Ulcerative Colitis.

• IRAS ID

  1003324

• Contact name

  Head of the Global Submission Management - Clinical Trials

• Contact email

  mg-gsm-ct@bms.com

• Sponsor organisation

  Bristol-Myers Squibb International Corporation

• Eudract number

  2019-004878-26

• Clinicaltrials.gov Identifier

  NCT04613518

• Research summary

  The aim of this Phase 2 study is to assess whether BMS-986165 can be used to treat patients who have moderate to severe ulcerative colitis, 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).

  50 patients will take part in this study, with 6 in the UK.

  The study will be carried out over a period of 60 weeks, which will be divided over 3 periods: screening, treatment and follow-up. The treatment duration is 52 weeks. This is divided into 2 parts: the double-blind treatment period (12 weeks) and the open-label extension period (40 weeks).
  During the first part of the treatment period, patients will be randomly assigned to one of three treatment groups:
  1. BMS-986165 12 mg taken twice daily, OR
  2. BMS-986165 6 mg taken twice daily, OR
  3. Placebo taken twice daily

  The patient or study doctor will not know which group the patient is in (blinding). At the end of 12 weeks patients will be assessed to see how well their ulcerative colitis symptoms have responded to treatment. If the study doctor thinks they will benefit from continuing in the study the patient will begin the second part.

  During the open-label extension period patients will receive BMS 986165 6 mg twice a day.

  Patients will undergo the following procedures: vital signs (temperature, heart rate and blood pressure), physical exams, ECGs, chest X-ray, blood sampling, urine sampling, stool sample collection and endoscopies with tissue sample collection. They will complete questionnaires on how they are feeling. Patients 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

  Yorkshire & The Humber - Leeds West Research Ethics Committee

• REC reference

  21/YH/0109

• Date of REC Opinion

  27 Sep 2021

• REC opinion

  Further Information Favourable Opinion