At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 331 enrolled
Drug / intervention
RHB-104 +1 moredrug
Likely dose
RHB-104 95 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Randomized, Double Blind, Placebo-controlled, Multicenter, Parallel Group Study to Assess the Efficacy and Safety of Fixed-dose Combination RHB-104 in Subjects With Moderately to Severely Active Crohn's Disease
In Brief
A Phase 3 clinical trial evaluating RHB-104 and Placebo for Crohn's Disease. Completed, enrolled 331 participants across 103 sites in 10 countries.
Detailed Summary
The investigators hypothesize that RHB-104 will have greater efficacy than placebo in Crohn's disease.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCrohn's Disease
CountriesAustralia, Bulgaria, Canada, Czechia, Israel, New Zealand, Poland, Serbia, Slovakia, United States
Collaborators--
Timeline
Phase 3CompletedFinished
2014201520162017201820192020202120222023202420252026
Enrollment StartSep 2013
First PostedSep 2013
Primary CompletionMay 2018
Study CompletionAug 2019
TodayJul 2026
First PostedSep 26, 2013
Enrollment StartSep 1, 2013
Primary CompletionMay 1, 2018
Study CompletionAug 1, 2019
TodayJul 2, 2026
Enrollment to primary: 4.7 yearsPosted 12.8 years ago
Interventions
RHB-104drug
95 mg clarithromycin, 45 mg rifabutin, and 10 mg clofazimine
Placebodrug
5 placebo capsules administered orally BID