Phase 3 Program to Evaluate MK-7240 for Moderate to Severe UC

• Research type

  Research Study

• Full title

  A Phase 3, Randomized, Double-Blind, Placebo-Controlled Program to Evaluate the Efficacy and Safety of MK-7240 in Participants with Moderately to Severely Active Ulcerative Colitis.

• IRAS ID

  1008674

• Contact name

  - -

• Contact email

  N/A

• Sponsor organisation

  Merck Sharp & Dohme LLC

• Clinicaltrials.gov Identifier

  NCT06052059

• Research summary

  Researchers are looking for a new way to treat people with moderate to severe ulcerative colitis (UC) that is causing symptoms (active). UC is an inflammatory bowel disease (IBD) that causes swelling and ulcers (sores) in the digestive tract. UC symptoms often come and go, with periods of few or no symptoms of UC (remission).

  MK-7240 is a study medicine designed to treat active, moderate to severe UC. The goal of this study is to learn about the safety of MK-7240 and how well people tolerate it. Researchers also want to learn how well MK-7240 works to treat UC and if people who take MK-7240 have remission after treatment compared to people who took placebo. A placebo looks like the study medicine but has no study medicine in it.

  About 1,020 people with active, moderate to severe UC will be in the study. They will be 16 to 75 years and:
  • Have had UC for at least 3 months
  • Do not have Crohn’s disease or other type of IBD
  • Have taken other medicines that did not help their UC or they did not tolerate the medicine

  Participants will receive one or both:
  • MK-7240, at different dose levels
  • Placebo

  MK-7240 and placebo will be given through a needle in a vein or as an injection for 3-13 months or more.
  Participants whose UC symptoms are better after treatment may receive treatment with MK-7240 (injection) for another 3 years (called an extension).

  Participants will give samples (including colon biopsies), have physical examinations, answer questions, and have imaging tests (including an endoscopy, in which a doctor uses a camera to look at the inside of a person's digestive tract).

  Participants may be in the study for about 3 – 4.5 years.

• REC name

  London - Chelsea Research Ethics Committee

• REC reference

  24/LO/0007

• Date of REC Opinion

  29 Feb 2024

• REC opinion

  Further Information Favourable Opinion