Efficacy and Safety of Adalimumab in Pediatric Subjects With Moderate to Severe Ulcerative Colitis

Summary

The purpose of the study is to demonstrate the efficacy and safety, and to assess the pharmacokinetics of adalimumab administered subcutaneously (SC) in pediatric subjects with moderate to severe ulcerative colitis (UC).

Timeline

Start

2014-10-13

Primary completion

2020-02-07

Completion

2020-02-07

Outcome

Met primary endpoint

paper a significantly higher proportion of patients were in PMS remission at week 8 (28 [60%] of 47) compared with external placebo (19·8%; p=0·0001). PMID 34153231 ↗

paper FMS remission at week 52 in children who were week 8 PMS responders was reported in a significantly higher proportion of patients PMID 34153231 ↗

release “This approval is based on results from the pivotal Phase 3 ENVISION I study, which showed that HUMIRA achieved the co-primary endpoints” abbvie.com ↗

Publications

• Croft NM, Faubion WA Jr, Kugathasan S, Kierkus J, Ruemmele FM, Shimizu T, Mostafa NM, Venetucci M, Finney-Hayward T, Sanchez Gonzalez Y, Bereswill M, Lazar A, Turner D. Efficacy and safety of adalimumab in paediatric patients with moderate-to-severe ulcerative colitis (ENVISION I): a randomised, controlled, phase 3 study. Lancet Gastroenterol Hepatol. 2021 Aug;6(8):616-627. doi: 10.1016/S2468-1253(21)00142-4. Epub 2021 Jun 19.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Adalimumab	Monoclonal antibody	0.6 mg/kg	Subcutaneous

Indications