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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: Recruiting Phase 3 study of Moderately to Severely Active Ulcerative Colitis, sponsored by Hoffmann-La Roche.
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, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (87% lower). The trial reports 4 study locations across 3 states. According to ClinicalTrials.gov, the official US trial registry.
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 |
What NCT07158242 shows while recruiting
NCT07158242 is an interventional study that assigns participants to a tested intervention. The registered 100 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (87% lower).
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 a single indexed study location in 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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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT07158242's enrollment target sits among peer trials
100 1682nd of 2000 higher than 288 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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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
RECRUITING · Phase 3
-
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
ACTIVE NOT RECRUITING · Phase 3
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