A Study to Evaluate the Pharmacokinetics, Safety and Efficacy of Afimkibart (RO7790121) in Children With Moderately to Severely Active Ulcerative Colitis

ClinicalTrials.gov ID: NCT07158242

Public ClinicalTrials.gov record NCT07158242. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

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ClinicalTrials.gov public records Last synced Sep 9, 2026, 6:28 AM EDT

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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

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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).

Study identification

NCT ID: NCT07158242
Recruitment status: Recruiting
Study type: Interventional
Phase: Phase 3
Lead sponsor: Hoffmann-La Roche; Industry
Enrollment: 100 participants

Conditions and interventions

Conditions

Moderately to Severely Active Ulcerative Colitis

Interventions

Afimkibart Drug

Drug

Eligibility (public fields only)

Age range: 2 Years to 17 Years
Sex: All
Healthy volunteers: Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date: Apr 14, 2026
Primary completion: Mar 30, 2030
Completion: Mar 30, 2031
Last update posted: Sep 7, 2026

2026 – 2031

United States locations

U.S. sites: 5
U.S. states: 4
U.S. cities: 5

Facility	City	State	ZIP	Site status
Children's Hospital Colorado	Aurora	Colorado	80045	Recruiting
University of South Florida	Tampa	Florida	33612	Recruiting
Children's Healthcare of Atlanta	Atlanta	Georgia	30342	Recruiting
Northwell Health	Lake Success	New York	11042	Recruiting
NYU Langone Health	New York	New York	10016	Recruiting

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 17 non-U.S. sites.

About this trial record page

What this page shows: Public field values for ClinicalTrials.gov record NCT07158242, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do: No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from: Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh: Last update posted Sep 7, 2026 · Synced Sep 9, 2026

Open the official record

The complete protocol, eligibility criteria, and contact information for NCT07158242 live on ClinicalTrials.gov.

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