Phase 2 Dose-finding IMU-838 for Ulcerative Colitis

NCT03341962 ↗

Phase 2 Terminated 263 enrolled Immunic AG

RandomizedParallel-groupTriple-blindTreatment

Summary

This is a phase 2, multicenter, randomized, double-blind, placebo-controlled, dose-finding study to evaluate the efficacy and safety of IMU-838 for induction and maintenance therapy with an option for open-label treatment extension in moderate-to-severe ulcerative colitis (CALDOSE-1).

Timeline

Start: 2018-03-15
Primary completion: 2022-11-16
Completion: 2022-11-16

Outcome

Missed primary endpoint

Stopped: “Considering the efficacy results of the induction phase (allowed use of corticosteroids as concomitant medication) in the study population and since IMU-838 did not show superiority over placebo, the OLE was prematurely closed by the sponsor.”

registry Combined IMU-838 (30 or 45 mg IMU-838, Induction Phase) vs Placebo (Induction Phase); p = 0.5836; Odds Ratio (OR) 1.0188 NCT03341962 ↗

Publications

D'Haens G, Stardelova KG, Sadiku E, Kizlova N, Skybalo S, Shehovtsova Y, Abramescu M, Vitt D, Kohlhof H, Muehler A. Vidofludimus Calcium in Patients With Moderate-to-Severe Ulcerative Colitis: A Randomized, Placebo-Controlled, Phase 2 Trial. Clin Transl Gastroenterol. 2025 Mar 1;16(3):e00813. doi: 10.14309/ctg.0000000000000813.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Vidofludimus	Small molecule	10 mg	—
Subject	Vidofludimus	Small molecule	30 mg	—
Subject	Vidofludimus	Small molecule	45 mg	—