The Phase 3 study (NCT02632175) investigating the long-term safety and efficacy of adalimumab in pediatric subjects with ulcerative colitis completed on 2025-04-08, according to ClinicalTrials.gov. This trial enrolled 59 participants to assess the drug's profile over time in this population.
Background
Adalimumab is an established therapy investigated for various inflammatory conditions. This study specifically focused on its long-term use in pediatric subjects diagnosed with ulcerative colitis.
Trial design
The study (NCT02632175) was a Phase 3, long-term safety and efficacy trial that enrolled 59 pediatric participants. The trial investigated adalimumab as an intervention for subjects with ulcerative colitis. The study's objective was to assess the long-term safety and efficacy of the drug in this specific patient population.
Key results
The study reported on the number of participants experiencing adverse events and achieving clinical remission.
- For "Number of Participants With Adverse Events (AEs)" in the Adalimumab group, counts of 55 and 15 participants were reported.
- For "Proportion of Participants Who Achieve Clinical Remission as Measured by Partial Mayo Score (PMS)" in the Adalimumab group, observed participant counts included 50, 47, 51, 43, 45, 40, 42, 42, 40, and 36 participants.
What this means
The completion of this Phase 3 long-term study provides data on the safety and efficacy profile of adalimumab in pediatric subjects with ulcerative colitis. The reported participant counts for adverse events and clinical remission contribute to the understanding of adalimumab's long-term use in this specific patient population, though the full implications will depend on further analysis and interpretation of the complete study data.
Source
The information for this article was obtained from ClinicalTrials.gov, a public database of clinical studies. The trial, NCT02632175, titled "Long-term Safety and Efficacy Study of Adalimumab in Pediatric Subjects With Ulcerative Colitis," completed on 2025-04-08 and is accessible on clinicaltrials.gov.