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Looking for participantsPhase3

A Study to Evaluate the Pharmacokinetics, Safety and Efficacy of Afimkibart (RO7790121) in Children With Moderately to Severely Active Ulcerative Colitis

Sponsor: Hoffmann-La Roche

NCT ID: NCT07158242

View on ClinicalTrials.gov ↗

At a glance

What the study gets you
Access to the study treatment being tested
Type of study
Interventional (receives a drug or procedure)
Time in hospital
In-person visits at study sites — visit count not specified by the sponsor
Drug or intervention
Afimkibart (drug)
How long the study runs
Study runs about 59 months (dates as stated)
About the drug or intervention
Afimkibart — drug: Afimkibart will be administered as IV infusion.
Patient visit burden
Not specified by the sponsor
Type of study
Testing a treatment
Ages
2 Years to 17 Years
Who
All
Number of participants
100
Started
2026-04-15
Last checked
2026-10

Plain English Summary

What is this study?

  • • Testing a new treatment for moderately to severely active ulcerative colitis
  • • Phase3 - 100 participants
  • • 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)

Who can take part?

  • • Ages 2 Years to 17 Years
  • • Diagnosed with moderately to severely active ulcerative colitis

Where?

  • • Birmingham - Birmingham Children's Hospital
  • • Cambridge - Addenbrooke's Hospital
  • • Sheffield - Sheffield Childrens Hospital

This is a simplified summary. Always discuss with your doctor before making any decisions.

About This Trial

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).

Moderately to Severely Active Ulcerative Colitis

How this trial compares with your answers

Answer 2 more questions to improve match

What we know so far

Condition· Matched your search
Age· Tell us your age for better matching
Gender· Tell us your sex for better matching

Still need:

  • • Tell us your age for better matching
  • • Tell us your sex for better matching

Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.

Eligibility at a Glance

Key info

  • Age: 2 Years - 17 Years
  • Who can join: All genders

Biomarkers mentioned

suggested by positive

What the study is looking for

  • ✓Bodyweight \>= 10 kilogram (kg)
  • ✓Confirmed diagnosis of UC

Who cannot take part

  • ✗Monogenic disorder pertaining to infant onset inflammatory bowel disease (IBD)
  • ✗Presence of an ostomy or ileoanal pouch
  • ✗Current diagnosis or suspicion of primary sclerosing cholangitis
  • ✗Any major surgery within 6 weeks prior to screening or a major planned surgery during the study
  • ✗Active tuberculosis (TB) infection suggested by positive TB testing, clinical symptoms, and/or chest imaging (X-ray...
See the full criteria
Inclusion Criteria: * 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 Exclusion Criteria: * 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 * Presence of an ostomy or ileoanal pouch * Current diagnosis or suspicion of primary sclerosing cholangitis * Any major surgery within 6 weeks prior to screening or a major planned surgery during the study * Active tuberculosis (TB) infection suggested by positive TB testing, clinical symptoms, and/or chest imaging (X-ray or CT)

Where Is This Study? (3 UK sites)

Birmingham Children's Hospital

Birmingham B4 6NH, United Kingdom

Recruiting
Hospital R&D contact (matched)

Sarah Pountain Head of Research Governance

R&D@uhb.nhs.uk0121 371 4185

Addenbrooke's Hospital

Cambridge CB2 0QQ, United Kingdom

Recruiting
Hospital R&D contact (matched)

Stephen Kelleher

cuh.research@nhs.net01223 348490

Sheffield Childrens Hospital

Sheffield S10 2TH, United Kingdom

Recruiting
Hospital R&D contact (matched)

Alessia Dunn

STH.ResearchAdministration@nhs.net0114 2712550

How to Get in Touch

Reference Study ID Number: CA45905 https://forpatients.roche.com/ No attachments to email below.

Sponsor contact

CONTACT

888-662-6728 (U.S. and Canada) global-roche-genentech-trials@gene.com

Fastest response: use the inquiry form. https://www.gene.com/contact-us/submit-medical-inquiry

Sponsor contact

CONTACT

Data sourced from ClinicalTrials.gov · Last verified: 2026-10