GA45329: AMETRINE1, Induction+maintenance with RO7790121 in moderate-severe ulcerative colitis

• Research type

  Research Study

• Full title

  A Phase III, Multicenter, Double-Blind, Placebo-Controlled, Treat-Through Study to Assess the Efficacy and Safety of Induction and Maintenance Therapy with RO7790121 in Patients with Moderately to Severely Active Ulcerative Colitis

• IRAS ID

  1010412

• Contact name

  Anthony Lei

• Contact email

  welwyn.uk_ethics@roche.com

• Sponsor organisation

  F. Hoffmann-La Roche AG

• Eudract number

  0000-000000-00

• ISRCTN Number

  N/A

• Clinicaltrials.gov Identifier

  N/A

• Research summary

  The purpose of this study is to assess the efficacy and safety of RO7790121 in patients with moderately to severely active ulcerative colitis (UC). RO7790121 is a monoclonal antibody TL1A which plays a role in the regulation of gut mucosal immunity and is involved in inflammatory bowel disease.
  A high unmet medical need remains for treatments with better benefit-risk profiles that provide sustained control to improve the long-term prognosis of patients with UC.
  Potential participants will undergo screening tests, and if deemed eligible to take part in the study, will be randomised to a treatment group; there will be a 60% chance of being assigned to the study drug group and a 40% chance of being assigned to the placebo group.

  The treatment part of the study will have three phases:
  Induction Phase - Participants will receive treatment via IV infusion on the first day of the study, then 2 weeks later, and then every 4 weeks until Week 10.
  Maintenance Phase - Visits approximately every 4 weeks. Treatment given via subcutaneous injection every 4 weeks from the 12th week until the 52nd week of the study.
  Open-Label Extension Phase (optional) - all participants will receive the study drug (including participants who previously were given placebo). If a participant decides not to take part in the open-label extension phase of the study, they will be asked to return for three more follow-up visits.
  During the open-label extension phase of the study, participants will continue to have study visits and receive the study drug treatment via subcutaneous injections (given under the skin) approximately every 2-4 weeks until the study drug 1 becomes commercially available in the UK. Participants may have the option of being seen at home for these visits.

  This study will be running in approximately 25 countries with 400 patients taking part, at least 16 from the UK.
  
  The study is sponsored by Roche

• REC name

  East of Scotland Research Ethics Service REC 2

• REC reference

  24/ES/0067

• Date of REC Opinion

  1 Oct 2024

• REC opinion

  Further Information Favourable Opinion