A Study With GB004 in Adult Subjects With Active Ulcerative Colitis (UC)

Phase 2 Terminated 236 enrolled GB004, Inc.

RandomizedParallel-groupTriple-blindTreatment

Summary

A 2-part study, comprising of a 36-week placebo-controlled period (PCP) and a 24-week open-label extension (OLE) period, to assess the efficacy and safety of 2 dose regimens of GB004 when added to background UC therapy of 5-aminosalicylate (5-ASA) with or without systemic steroids.

Timeline

Start: 2020-10-19
Primary completion: 2022-06-01
Completion: 2022-06-01

Outcome

Missed primary endpoint

Stopped: “Study terminated due to lack of treatment benefit.”

registry analysis (superiority test); PCP Placebo vs PCP GB004 480 mg QD; p = 0.6694; Risk Difference (RD) -2.6 (95% CI -15.2 to 10.2) NCT04556383 ↗

registry analysis (superiority test); PCP Placebo vs PCP GB004 480 mg BID; p = 0.4719; Risk Difference (RD) 4.6 (95% CI -9.0 to 17.8) NCT04556383 ↗

Publications

Danese S, Levesque BG, Feagan BG, Jucov A, Bhandari BR, Pai RK, Taylor Meadows K, Kirby BJ, Bruey JM, Olson A, Osterhout R, Van Biene C, Ford J, Aranda R, Raghupathi K, Sandborn WJ. Randomised clinical trial: a phase 1b study of GB004, an oral HIF-1alpha stabiliser, for treatment of ulcerative colitis. Aliment Pharmacol Ther. 2022 Feb;55(4):401-411. doi: 10.1111/apt.16753. Epub 2022 Jan 10.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	IZILENDUSTAT	Small molecule	480 mg	Oral