AbbVie’s Pediatric Ulcerative Colitis Study: A Potential Game-Changer

Abbvie ((ABBV)), Abbvie (($CC:ABBV.CUR)) announced an update on their ongoing clinical study.

AbbVie is conducting a Phase 3 clinical study titled ‘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.' The study aims to assess the movement, safety, and efficacy of Risankizumab in treating pediatric patients with ulcerative colitis, a chronic inflammatory bowel disease.

The intervention being tested is Risankizumab, a drug already approved for moderate to severe ulcerative colitis in adults. The study will explore its use in children aged 2 to less than 18 years, with the goal of expanding its application to pediatric patients.

This interventional study uses a randomized, sequential model with double masking for participants and investigators. It primarily focuses on treatment, involving three cohorts of pediatric participants who will undergo different phases of treatment with Risankizumab.

The study began on July 28, 2025, with its primary completion and estimated study completion dates yet to be announced. The most recent update was submitted on August 12, 2025. These dates are crucial for tracking the study’s progress and potential market entry.

This study could significantly impact AbbVie’s stock performance and investor sentiment, as successful results may lead to expanded use of Risankizumab in pediatric ulcerative colitis, potentially increasing market share. Investors should also consider the competitive landscape, as other companies may pursue similar pediatric indications.

The study is currently recruiting, with further details available on the ClinicalTrials portal.