Phase 2a Study of MK-8690 in Participants with Moderate to Severe UC

• Research type

  Research Study

• Full title

  A Phase 2a Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of MK-8690 in Adult Participants with Moderately to Severely Active Ulcerative Colitis

• IRAS ID

  1013702

• Contact name

  - -

• Contact email

  N/A

• Sponsor organisation

  Merck Sharp & Dohme LLC

• Clinicaltrials.gov Identifier

  NCT07463183

• Research summary

  This study is investigating a new unlicensed medicine, MK-8690, for adults with moderate to severe ulcerative colitis. Ulcerative colitis is a long term condition that causes inflammation of the bowel and can result in symptoms such as diarrhoea, abdominal pain and bleeding. The aim of the study is to assess how effective and safe MK 8690 is in reducing bowel inflammation and improving symptoms in people whose disease has not responded well, or has stopped responding, to standard treatments.

  Adults aged 18 to 75 years with a confirmed diagnosis of moderately to severely active ulcerative colitis may be eligible. Participants must have previously tried at least one standard or advanced treatment that was ineffective, stopped working, or could not be tolerated. People with other bowel diseases, certain infections, or significant medical conditions will not be eligible.

  The study will take place at around 65 sites worldwide, including at 4 NHS hospitals in the UK.

  Each participant may take part for up to approximately a year and a half. After a screening period of up to 6 weeks to check eligibility, participants will enter a 12 week treatment phase. During this time, they will be randomly assigned to receive either MK 8690 or placebo by injection.
  What happens next depends on how symptoms respond. Participants whose condition improves will move into a longer extension phase, where everyone receives MK 8690, given once every 4 or 8 weeks. Participants whose symptoms do not improve may enter an additional 12 week treatment phase with MK 8690.

  Throughout the study, participants will attend clinic visits, have blood and urine tests, complete questionnaires, and undergo endoscopy procedures. After the final treatment dose, all participants will take part in a follow up period with safety checks for several months."

• REC name

  London - London Bridge Research Ethics Committee

• REC reference

  26/LO/0223

• Date of REC Opinion

  5 May 2026

• REC opinion

  Further Information Favourable Opinion