A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of UTTR1147A Compared With Placebo and With Vedolizumab in Participants With Moderate to Severe Ulcerative Colitis (UC)

Phase 2 Completed 195 enrolled Genentech, Inc.

RandomizedParallel-groupTriple-blindTreatment

Summary

This study is designed to evaluate the efficacy, safety, and pharmacokinetics of UTTR1147A compared with vedolizumab and with placebo in the treatment of participants with moderate to severe UC. This study will consist of two parts, Part A and Part B. Part A will test the induction of clinical remission and Part B will test the durability of clinical remission.

Timeline

Start: 2018-10-26
Primary completion: 2021-12-15
Completion: 2021-12-15

Outcome

Missed primary endpoint

paper Although efmarodocokin alfa did not show statistically significant improvement in clinical remission, clinical response, endoscopic healing, or endoscopic remission at week 8 compared with placebo PMID 39694207 ↗

Publications

Danese S, Rothenberg ME, Lim JJ, Ding HT, McBride JM, Chen Y, Dash A, Mar JS, Keir M, Peyrin-Biroulet L, Panes J, Colombel JF, Feagan B, Valentine JF, Schreiber S. A Randomized Phase II Study of Efmarodocokin Alfa, an interleukin-22 Agonist, Versus Vedolizumab in Patients With Ulcerative Colitis. Clin Gastroenterol Hepatol. 2025 Jul;23(8):1387-1397. doi: 10.1016/j.cgh.2024.11.013. Epub 2024 Dec 16.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	UTTR1147A	Protein / enzyme biologic	30 ug/kg	Intravenous
Subject	UTTR1147A	Protein / enzyme biologic	60 ug/kg	Intravenous
Subject	UTTR1147A	Protein / enzyme biologic	90 ug/kg	Intravenous
Comparator	Vedolizumab	Monoclonal antibody	—	Intravenous