Efficacy and Safety of Anti-MAP Therapy in Adult Crohn's Disease

NCT01951326 ↗

Phase 3 Completed 331 enrolled RedHill Biopharma Limited

RandomizedParallel-groupDouble-blindTreatment

Summary

The investigators hypothesize that RHB-104 will have greater efficacy than placebo in Crohn's disease.

Timeline

Start: 2013-09
Primary completion: 2018-05
Completion: 2019-08

Outcome

Met primary endpoint

paper A greater proportion of RHB-104 versus placebo-treated patients met the primary endpoint-remission (i.e., CDAI < 150)-at week 26 (36.7% [61/166] vs. PMID 39199994 ↗

paper 95% CI for difference: 4.6, 24.0, p = 0.0048; chi-square test PMID 39199994 ↗

Publications

Graham DY, Naser SA, Borody T, Hebzda Z, Sarles H, Levenson S, Hardi R, Arlukowicz T, Svorcan P, Fathi R, Bibliowicz A, Anderson P, McLean P, Fehrmann C, Harris MS, Zhao S, Kalfus IN. Randomized, Double-Blind, Placebo-Controlled Study of Anti-Mycobacterial Therapy (RHB-104) in Active Crohn's Disease. Antibiotics (Basel). 2024 Jul 25;13(8):694. doi: 10.3390/antibiotics13080694.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Clarithromycin	Small molecule	475 mg	Oral
Subject	Clofazimine	Small molecule	50 mg	Oral
Subject	Rifabutin	Small molecule	225 mg	Oral