An Investigation of Oral BT051 in Subjects With Moderately to Severely Active Ulcerative Colitis (UC)

Summary

This is a randomised, double-blind, placebo-controlled study to assess the safety and tolerability of multiple ascending doses of BT051 in subjects with moderately to severely active ulcerative colitis. Subjects will be randomised using a 3 active:1 placebo ratio to 3 ascending dose cohorts of 8 subjects and will be dosed daily for 28 days. The 3 initial dose levels will be 200 mg, 800 mg and 3200 mg per day. Progression to the next cohort will be based on the safety and tolerability of the previous cohort.

Timeline

Start

2021-11-30

Primary completion

2022-11-30

Completion

2022-11-30

Publications

• Allegretti JR, Cheifetz AS, Dulai PS, Stevens AC, Chapas-Reed J, Chesnel L, Dixit B, Farquhar R, Ghahramani P, Miller BW, Murphy CK, Quintas M, Tanase R, Telia T, Wozniak-Stolarska B, Gupta R. Safety, Pharmacokinetics, and Clinical Efficacy of ADS051, a Neutrophil Modulator, in Ulcerative Colitis: Results of a Randomized Phase 1b Trial. Am J Gastroenterol. 2024 Dec 31;120(7):1624-1635. doi: 10.14309/ajg.0000000000003269.

Drugs

Indications