A Study to Assess the Efficacy and Safety of Golimumab in Pediatric Participants With Moderately to Severely Active Ulcerative Colitis

Summary

The purpose of this study is to evaluate efficacy of golimumab in inducing clinical remission as assessed by the Mayo score, in pediatric participants with moderately to severely active ulcerative colitis (UC). In addition, the safety profile of golimumab, in pediatric participants with moderately to severely active UC will be assessed.

Timeline

Start

2018-10-29

Primary completion

2023-11-21

Completion

2027-02-01

Outcome

Met primary endpoint

release “In the Phase 3 PURSUIT 2 study, the primary endpoint of clinical remission at Week 6 was achieved by 32% of patients.” jnj.com ↗

Publications

• Turner D, Lomax KG, Veereman G, Griffiths AM, Kierkus J, Kang B, Berezny K, Padgett L, Mao G, Zitser Y, Strauss RS, Verhoeven J, Adedokun OJ, Hyams JS. Efficacy, Safety, and Pharmacokinetics of Golimumab in Children with Moderately-To-Severely Active Ulcerative Colitis: Results from the PURSUIT 2 Study. Inflamm Bowel Dis. 2026 Jun 1;32(6):1052-1061. doi: 10.1093/ibd/izaf322.

Drugs

Indications