CA45905 Afimkibart in Paediatric Ulcerative Colitis

• Research type

  Research Study

• Full title

  A PHASE III RANDOMIZED DOUBLE-BLIND MULTI-CENTER TREAT-THROUGH STUDY TO EVALUATE THE PHARMACOKINETICS, SAFETY AND EFFICACY OF INDUCTION AND MAINTENANCE THERAPY WITH AFIMKIBART (RO7790121) IN CHILDREN AGED 2 - 17 YEARS WITH MODERATELY TO SEVERELY ACTIVE ULCERATIVE COLITIS

• IRAS ID

  1012708

• Contact name

  N/A N/A

• Contact email

  medinfo.uk@roche.com

• Sponsor organisation

  F. Hoffmann-La Roche AG

• ISRCTN Number

  N/A

• Clinicaltrials.gov Identifier

  N/A

• Research summary

  Ulcerative colitis (UC) is a chronic inflammatory condition affecting the colon and rectum, causing symptoms such as abdominal pain, diarrhoea, and bleeding. UC is a form of inflammatory bowel disease (IBD) and requires ongoing treatment. While treatment options, including biologics and small-molecule therapies, have expanded, there is a need for therapies in paediatric UC that effectively manage symptoms and have an acceptable safety profile.
  This study evaluates afimkibart, a new medicine, for children aged 2–18 with moderately to severely active UC who have not responded well to previous treatments. Eligible participants must have a confirmed UC diagnosis and meet defined criteria on prior treatment history.
  Participants will be divided into two groups (Cohorts 1 and 2) based on body weight. In Cohort 1, high-bodyweight participants (Groups 1 and 2) will be randomly assigned to treatment with either Dose A or Dose B (1:1 ratio). Low-bodyweight participants (Group 3) will receive Dose A only. In Cohort 2, all participants, regardless of body weight, will be randomized to Dose A or Dose B in a 1:1 ratio, using a permuted-block randomization to ensure balance across body weight and prior therapy use at baseline.
  The study will enrol 100 participants globally, including 10 from the UK across five sites. Spanning approximately three years, the study includes an 18-month recruitment phase and an 18-month induction and maintenance phase, with a potential 4-year open-label extension (OLE).
  The study is sponsored by F. Hoffmann- La Roche
  Research Summary; Version 1 dated 26-Aug-2025

• REC name

  South West - Central Bristol Research Ethics Committee

• REC reference

  25/SW/0111

• Date of REC Opinion

  7 Nov 2025

• REC opinion

  Further Information Favourable Opinion