CP45906 - Afimkibart in Paediatric Crohn's Disease

• 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 Crohn’s Disease

• IRAS ID

  1012876

• Contact name

  N/A N/A

• Contact email

  medinfo.uk@roche.com

• Sponsor organisation

  F. Hoffmann-La Roche AG

• Clinicaltrials.gov Identifier

  NCT07298421

• Research summary

  Crohn’s Disease (CD) an inflammatory bowel disease that causes chronic inflammation of the intestines, that extends from the stomach all the way down to the rectum.
  CD causes symptoms such as abdominal pain, diarrhoea, and bleeding and requires ongoing treatment.
  While treatment options have expanded, there is a need for therapies in paediatric CD that effectively manage symptoms and have an acceptable safety profile.
  This study evaluates afimkibart, a new medicine, for children aged 2–17 with moderately to severely active CD who have not responded well to previous treatments. Eligible participants must have a confirmed CD diagnosis and meet certain requirements on prior treatment history.
  All participants will be have a 50% chance of being randomly assigned to treatment with either Dose A or Dose B.
  The study will enrol 100 participants globally, including 10 from the UK across five sites. The study will last approximately three years, with an 18-month recruitment phase and an 18-month induction and maintenance phase. There is also a potential 4-year open- label extension (OLE) for those participants who choose to continue.
  The study is sponsored by F. Hoffmann- La Roche
  Research Summary; Version 1.0 dated 04-Nov-2025

• REC name

  South Central - Berkshire Research Ethics Committee

• REC reference

  25/SC/0397

• Date of REC Opinion

  26 Jan 2026

• REC opinion

  Further Information Favourable Opinion