Trial results for a long-term safety and efficacy study of adalimumab in pediatric subjects with ulcerative colitis were posted on ClinicalTrials.gov on 2025-10-16. The study reported that 55 out of 59 participants experienced adverse events, while clinical remission, as measured by the Partial Mayo Score (PMS), was observed in 36 to 51 participants at various time points.
Background
Adalimumab is a biologic medication that has been investigated for the treatment of various inflammatory conditions. This particular study focused on its long-term use in pediatric subjects diagnosed with ulcerative colitis, a chronic inflammatory bowel disease affecting the colon.
Trial design
The study (NCT02632175) was a Phase 3, long-term safety and efficacy study that enrolled 59 pediatric participants with ulcerative colitis. The trial investigated adalimumab to assess its long-term safety and efficacy.
Key results
The trial reported on the number of participants experiencing adverse events and achieving clinical remission.
For safety outcomes, the "Number of Participants With Adverse Events (AEs)" was reported. In the adalimumab group, 55 participants experienced adverse events. Additionally, 15 participants in the adalimumab group were reported under the same adverse event outcome, indicating different reporting periods or categories not specified in the data.
For efficacy outcomes, specifically the "Proportion of Participants Who Achieve Clinical Remission as Measured by Partial Mayo Score (PMS)":
- At various time points, the number of participants achieving clinical remission in the adalimumab group included 50 participants, 47 participants, 51 participants, 43 participants, 45 participants, 40 participants, 42 participants, 42 participants, 40 participants, and 36 participants.
What this means
The results from this Phase 3 study provide long-term safety and efficacy data for adalimumab in pediatric patients with ulcerative colitis. The observed rates of clinical remission suggest that adalimumab maintained efficacy over time in a notable proportion of participants. The safety data indicates that adverse events were common within this population, which is important for clinicians to consider when managing pediatric ulcerative colitis patients on adalimumab.
Source
The information for these trial results was obtained from ClinicalTrials.gov, a public database of clinical studies. The results for study NCT02632175, titled "Long-term Safety and Efficacy Study of Adalimumab in Pediatric Subjects With Ulcerative Colitis," were posted on 2025-10-16 on clinicaltrials.gov.