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Taking people in ThailandPhase 3

Tests afimkibart in children with active ulcerative colitis

Tests afimkibart in children aged 2 to 17 with moderate to severe ulcerative colitis.

Key facts

Who runs it
Hoffmann-La Roche
Where
Bangkok, ThailandSee the 3 sitesAlso in 8 other countries, 26 sites
Registry title
A Study to Evaluate the Pharmacokinetics, Safety and Efficacy of Afimkibart (RO7790121) in Children With Moderately to Severely Active Ulcerative Colitis
Status
Recruiting
Phase
Phase 3
People taking part
100 people, planned
Started
15 Apr 2026
Expected to end
31 Mar 2031
Type of study
Interventional, 2 groups
Treatments tested
  • Afimkibart
Record updated
5 November 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for children and teenagers aged 2 to 17 with moderately to severely active ulcerative colitis who did not do well on, or could not tolerate, earlier treatment.

Age
2 to 17 years
Sex
All sexes can join.
Disease stage
Confirmed ulcerative colitis that is moderately to severely active: modified Mayo Score of 5 to 9 points, with an endoscopic score of 2 or 3, confirmed by a central reading of the endoscopy.
Earlier treatment
Must have had intolerance or an inadequate response to one or more of: systemic corticosteroids, immunomodulators, and/or biologic therapies.

Main reasons for not taking part

  • Body weight under 10 kg (22 lb)
  • Crohn's disease or other kinds of colitis, fistula or abscess
  • An ostomy or ileoanal pouch
  • Primary sclerosing cholangitis, current or suspected
  • Major surgery within 6 weeks before screening, or planned during the study

The registry criteria, word for word

Show all 10 criteriaShow less

Who can take part

  • Bodyweight >= 10 kilogram (kg)
  • Confirmed diagnosis of UC
  • Moderately to severely active UC, defined as modified Mayo Score (mMS) or 5 to 9 points, including endoscopic score of 2 or 3, confirmed by centrally read endoscopy (flexible sigmoidoscopy or colonoscopy)
  • Demonstrated intolerance or inadequate response (IR) to one or more of the following categories of drugs: systemic corticosteroids, immunomodulators, and/or biologic therapies as outlined in the protocol

Who cannot take part

  • Any major surgery within 6 weeks prior to screening or a major planned surgery during the study
  • Monogenic disorder pertaining to infant onset inflammatory bowel disease (IBD)
  • Current diagnosis of Crohn's disease (CD), abdominal/intrabdominal/perianal fistula and/or abscess, indeterminant colitis, IBD-unclassified, microscopic colitis, ischemic colitis, infectious colitis, radiation colitis, or active diverticular disease
  • Active tuberculosis (TB) infection suggested by positive TB testing, clinical symptoms, and/or chest imaging (X-ray or CT)
  • Presence of an ostomy or ileoanal pouch
  • Current diagnosis or suspicion of primary sclerosing cholangitis

Check if you might fit

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

  • Are you between 2 and 17 years old?

Where in Thailand

Also in 8 other countries, 26 sites

  • Chulalongkorn UniversityBangkok, ThailandTaking people
  • Ramathibodi HospitalBangkok, ThailandTaking people
  • Siriraj HospitalBangkok, ThailandTaking people

About the trial

What the trial wants to find out

This Phase III, randomized, double-blind, multicenter, induction and maintenance study will evaluate the safety and efficacy of Afimkibart (RO7790121) in pediatric participants with moderate to severe active ulcerative colitis (UC).

The 2 groups in the trial

  • Afimkibart Dose ATreatment being tested

    Participants will receive Afimkibart intravenously (IV) followed by Afimkibart subcutaneous (SC) injection.

    Treatment: Afimkibart

  • Afimkibart Dose BTreatment being tested

    Participants will receive Afimkibart IV followed by Afimkibart SC.

    Treatment: Afimkibart

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov and on the EU's official list of trials (CTIS).
Official 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
Plain-language title
Tests afimkibart in children with active ulcerative colitisGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 12 November 2026.
Fit questions
Built from NCT07158242, who can take part
Record updated
5 November 2026