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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.

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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).

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

FieldValue
Enrollment Target 100 participants
Start Date 2026-03-31
Est. Completion 2031-03-31
Phase Phase 3

Sponsor

Hoffmann-La Roche

909 total trials

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.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.