Recruiting NCT07158242
A Study to Evaluate the Pharmacokinetics, Safety and Efficacy of Afimkibart (RO7790121) in Children With Moderately to Severely Active Ulcerative Colitis
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Afimkibart.
- Who it may be relevant to
- Registry conditions: Moderately to Severely Active Ulcerative Colitis. Basic parameters: 2 years — 17 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States, Australia, China, South Africa, Taiwan +2
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
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
Overview
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).
Interventions
- Drug Afimkibart
Afimkibart will be administered as IV infusion. Afimkibart will be administered as SC injection.
Primary outcome measures
- Percentage of Participants with Clinical Remission at Week 12 [Time frame: At Week 12]
- Percentage of Participants with Clinical Remission at Week 52 [Time frame: At Week 52]
Secondary outcome measures (12)
- Change from Baseline in Pediatric Ulcerative Colitis Activity Index (PUCAI) Response [Time frame: From Baseline, at Week 12]
- Percentage of Participants with PUCAI Remission [Time frame: At Week 12]
- Change from Baseline in Tummy Ulcerative Colitis (TUMMY-UC) Scores [Time frame: From Baseline to Week 12]
- Percentage of Participants with Endoscopic Improvement [Time frame: At Week 12]
- Percentage of Participants with Histologic Improvement [Time frame: At Week 12]
- Percentage of Participants with Histologic-endoscopic Mucosal Improvement [Time frame: At Week 12]
- Percentage of Participants with Histologic-endoscopic Mucosal Remission [Time frame: At Week 12]
- Change from Baseline in PUCAI Response at Week 52 [Time frame: From Baseline, at Week 52]
- Percentage of Participants with PUCAI Remission at Week 52 [Time frame: At Week 52]
- Change from Baseline in TUMMY-UC Scores [Time frame: From Baseline to Week 52]
- Percentage of Participants with Endoscopic Improvement [Time frame: At Week 52]
- Percentage of Participants with Histologic Improvement [Time frame: At Week 52]
Eligibility criteria
Inclusion criteria
- Bodyweight >= 10 kilogram (kg)
- Confirmed diagnosis of UC
- 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)
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Quadruple blind
- Primary purpose
- Treatment
Study locations
United States · 3 centers
- University of South Florida — Tampa
- Children's Healthcare of Atlanta — Atlanta
- NYU Langone Health — New York
Australia · 3 centers
- Mater Hospital Brisbane — South Brisbane
- Royal Children's Hospital — Parkville
- Perth Children's Hospital — Nedlands
Thailand · 3 centers
- Chulalongkorn University — Bangkok
- Siriraj Hospital — Bangkok
- Ramathibodi Hospital — Bangkok
United Kingdom · 3 centers
- Birmingham Children's Hospital — Birmingham
- Addenbrooke's Hospital — Cambridge
- Sheffield Childrens Hospital — Sheffield
China · 1 center
- Children's Hospital ZheJiang University School of Medicine — Hangzhou
South Africa · 1 center
- Emmed Research — Pretoria
Taiwan · 1 center
- National Taiwan University Hospital — Taipei
Identifiers
NCT: NCT07158242 · CA45905 · 2025-522518-22-00