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How risankizumab works in children and teens with ulcerative colitis

A Phase 3, Multi-Center Study to Evaluate the Pharmacokinetics, Efficacy, and Safety of Risankizumab With Open-Label Induction, Randomized Double-Blind Maintenance, and Open-Label Long-Term Extension Periods in Pediatric Subjects (2 to < 18 Years of Age) With Moderately to Severely Active Ulcerative Colitis

PHASE3 · AbbVie · NCT07071519

This trial tests risankizumab in children and adolescents with moderate to severe ulcerative colitis to see how the medicine moves through their bodies and whether it is safe and helps their condition.

Quick facts

PhasePHASE3
Study typeInterventional
Enrollment120 (estimated)
Ages2 Years to 17 Years
SexAll
SponsorAbbVie (industry)
Drugs / interventionsprednisone, Risankizumab
Locations45 sites (Phoenix, Arizona and 44 other locations)
Trial IDNCT07071519 on ClinicalTrials.gov

What this trial studies

This Phase 3 pediatric program uses weight‑based risankizumab dosing across three age cohorts to characterize pharmacokinetics, safety, and clinical effect. Cohort 1 includes ages 6 to <18 years, Cohort 2 includes ages 2 to <6 years, and Cohort 3 includes ages 2 to <18 years, with participants possibly entering up to three substudies. Substudy 1 is an open‑label induction period with weight‑based dosing, and a later substudy includes a double‑blind maintenance period. Key outcome measures include drug levels, adverse events, and changes in disease activity by modified Mayo Score and endoscopic subscore confirmed by a central reader.

Who should consider this trial

Good fit: Children and adolescents aged 2 to under 18 with documented moderate to severely active ulcerative colitis (modified Mayo Score 5–9 and endoscopic subscore 2–3) who have had inadequate response or intolerance to prior therapies are the intended participants.

Not a fit: Patients with recent major surgery, active infection, colonic dysplasia or malignancy, or those with mild disease or who do not meet the specified scoring and prior‑therapy criteria are unlikely to benefit from participation.

Why it matters

Potential benefit: If successful, this could expand an approved adult treatment to children and teens, providing a new option to reduce inflammation and control symptoms.

How similar studies have performed: Adult clinical trials have demonstrated risankizumab efficacy and safety in moderate to severe ulcerative colitis, but pediatric data are limited so this pediatric program is applying those findings to younger patients.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

* Active ulcerative colitis (UC) with an modified Mayo Score (mMS) of 5 to 9 points and endoscopic subscore of 2 to 3 (confirmed by central reader).
* Demonstrated intolerance or inadequate response (IR) to one or more of the following categories of drugs:

aminosalicylates (except in countries where failure of this drug class is not sufficient for eligibility), oral locally acting corticosteroids, systemic steroids (prednisone or equivalent), immunomodulators (IMMs), and/or biologic therapies, as outlined in the protocol.

\- Subjects must have a documented history of UC for at least 3 months prior to Baseline, confirmed by colonoscopy during the screening period, with exclusion of current infection, colonic dysplasia and/or malignancy. Documentation of pathology results consistent with the diagnosis of UC must be available.

Exclusion Criteria:

* Participants who have had a major surgery performed within 12 weeks prior to Baseline or planned during the conduct of the study (e.g., inguinal hernia repair, cholecystectomy, intestinal resection).
* Participants who have concurrent clinically significant medical conditions other than the indication being studied or any other reason that the investigator determines would interfere with the subject's participation in this study, would make the subject an unsuitable candidate to receive study treatment, or would put the subject at risk by participating in the study.

Where this trial is running

Phoenix, Arizona and 44 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.

View on ClinicalTrials.gov →

Conditions: Ulcerative Colitis, risankizumab

Last reviewed 2026-05-15 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.