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NCT07158242 · ClinicalTrials.gov registry record · Phase 3
A Study to Evaluate the Pharmacokinetics, Safety and Efficacy of Afimkibart (RO7790121) in Children With Moderately to Severely Active Ulcerative Colitis
A Phase 3 study of Moderately to Severely Active Ulcerative Colitis, sponsored by Hoffmann-La Roche.
- Recruiting
- Registry status
- Phase 3
- Development phase
- 100
- Enrollment target
- 4
- Study locations
NCT07158242 is a Phase 3 study of Moderately to Severely Active Ulcerative Colitis that is actively recruiting participants, run by Hoffmann-La Roche. The registered enrollment target is 100 participants. The trial reports 4 study locations across 3 states.
The verdict
NCT07158242, a Phase 3 study of Moderately to Severely Active Ulcerative Colitis, is actively recruiting participants, sponsored by Hoffmann-La Roche.
- RECRUITING
- Registry status
- Phase 3
- Development phase
- 100 participants
- Enrollment target
- 4
- Study locations
Study Summary
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).
Conditions Studied
Interventions
- DRUG Afimkibart
Study Locations (4)
Other
- National Taiwan University Hospital - Taipei
- Addenbrooke's Hospital - Cambridge
Georgia
- Children's Healthcare of Atlanta - Atlanta
New York
- NYU School of Medicine - New York
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 100 participants |
| Start Date | 2026-03-31 |
| Est. Completion | 2031-03-31 |
| Phase | Phase 3 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT07158242
The ClinicalTrials.gov registry entry for NCT07158242 describes a study currently listed as recruiting, categorized as Phase 3. The registered enrollment target is 100 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Hoffmann-La Roche, which has 909 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Moderately to Severely Active Ulcerative Colitis appearing as the primary indexed condition, and to 1 intervention - of which Afimkibart is the first listed.
NCT07158242 reports 4 study locations spanning 3 distinct geographic areas - top geographies include Other, Georgia, New York.
Frequently Asked Questions
What is clinical trial NCT07158242 about?
NCT07158242 is a clinical study titled "A Study to Evaluate the Pharmacokinetics, Safety and Efficacy of Afimkibart (RO7790121) in Children With Moderately to Severely Active Ulcerative Colitis". 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).
What is the current status of trial NCT07158242?
This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 100 participants. The study started on 2026-03-31. Estimated completion is 2031-03-31.
What conditions does trial NCT07158242 study?
This clinical trial studies the following conditions: Moderately to Severely Active Ulcerative Colitis.
What interventions are being tested in trial NCT07158242?
The interventions under investigation include: Afimkibart (DRUG).
Who is sponsoring clinical trial NCT07158242?
This trial is sponsored by Hoffmann-La Roche, which has 909 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT07158242 being conducted?
This trial has 4 study locations across Georgia, New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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A Study to Assess the Efficacy and Safety of Induction Therapy With Afimkibart (Also Known as RO7790121) in Participants With Moderately to Severely Active Ulcerative Colitis
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A Study to Assess the Efficacy and Safety of Afimkibart (Also Known as RO7790121) for Induction and Maintenance Therapy in Participants With Moderately to Severely Active Ulcerative Colitis
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Read our methodology - how this data is sourced, computed, and verified.
Related
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