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Assessing Upadacitinib for Pediatric Ulcerative Colitis

A Phase 3 Multicenter Study to Evaluate Efficacy, Safety, and Pharmacokinetics of Upadacitinib With Open-Label Induction, Randomized, Double-Blind Maintenance and Open-Label Long-Term Extension in Pediatric Subjects With Moderately to Severely Active Ulcerative Colitis and Inadequate Response, Intolerance, or Medical Contraindications to Corticosteroids, Immunosuppressants, and/or Biologic Therapy

PHASE3 · AbbVie · NCT05782907

This study is testing if Upadacitinib can safely help children with moderate to severe ulcerative colitis feel better and manage their symptoms.

Quick facts

PhasePHASE3
Study typeInterventional
Enrollment110 (estimated)
Ages2 Years to 17 Years
SexAll
SponsorAbbVie (industry)
Drugs / interventionstofacitinib, baricitinib, filgotinib, upadacitinib
Locations85 sites (Phoenix, Arizona and 84 other locations)
Trial IDNCT05782907 on ClinicalTrials.gov

What this trial studies

This study evaluates the safety and effectiveness of Upadacitinib in treating pediatric patients with moderately to severely active ulcerative colitis. It consists of an 8-week open-label induction phase followed by a 44-week double-blind maintenance phase, and a subsequent 260-week open-label extension. Participants will be monitored for adverse events and changes in disease activity throughout the study. The goal is to determine how the drug is processed in the body and its impact on the condition.

Who should consider this trial

Good fit: Ideal candidates are pediatric patients with active ulcerative colitis who have not responded adequately to other treatments.

Not a fit: Patients who have previously been treated with JAK inhibitors or are pregnant or breastfeeding may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a new treatment option for children suffering from ulcerative colitis.

How similar studies have performed: Other studies have shown success with similar approaches in adult populations, but this specific application in pediatric patients is novel.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

* Active UC with an AMS of 5 to 9 points and endoscopic subscore of 2 to 3.
* Demonstrate an inadequate response, loss of response, intolerance, or medical contraindications to corticosteroids, immunosuppressants, and/or biologic therapy.

Exclusion Criteria:

* Partcipants with previous exposure to JAK inhibitors (e.g., tofacitinib, baricitinib, filgotinib, upadacitinib).
* Females who are pregnant, breastfeeding, or considering becoming pregnant during the study and for approximately 30 days after the last dose of study drug.

Where this trial is running

Phoenix, Arizona and 84 other locations

+35 more sites — see ClinicalTrials.gov for the full list.

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, Upadacitinib, RINVOQ, UC, Corticosteroids, Immunosuppressants, Biologic Therapy

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.