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A Study to Evaluate the Pharmacokinetics, Safety and Efficacy of Afimkibart (RO7790121) in Children With Moderately to Severely Active Ulcerative Colitis
NCT07158242 · View on ClinicalTrials.gov ↗
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 |
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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. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. 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 758 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT07158242 reports 4 study locations spanning 3 distinct geographic areas — top geographies include Other, Georgia, New York. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT07158242?
The interventions under investigation include: Afimkibart (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT07158242?
This trial is sponsored by Hoffmann-La Roche, which has 758 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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.
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