NCT03009396

Open Label Efficacy and Safety of Anti-MAP (Mycobacterium Avium Ssp. Paratuberculosis) Therapy in Adult Crohn's Disease

An Open Label Study to Assess the Efficacy and Safety of Fixed-Dose Combination RHB-104 in Subjects With Active Crohn's Disease Despite 26 Weeks of Participation in the MAP US RHB-104-01 Study

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 54 (actual)
• Sponsor: RedHill Biopharma Limited · Industry
• Sex: All
• Age: 18 Years – 76 Years
• Healthy volunteers: Not accepted

Summary

An open label extension to the RHB-104-01 Study.

Detailed description

An Open Label Phase III Study to Assess the Efficacy and Safety of Fixed-Dose Combination RHB-104 in Subjects with Active Crohn's Disease Despite 26 Weeks of Participation in the MAP US RHB-104-01 Study.

Conditions

• Crohn Disease

Interventions

Type	Name	Description
DRUG	RHB-104 (fixed-dose combination: 95 mg clarithromycin, 45 mg rifabutin, and 10 mg clofazimine)	For patients on ACTIVE or PLACEBO in the parent study (RHB-104-01), who were not in remission after 26 weeks

Timeline

• Start date: 2017-03-18
• Primary completion: 2018-11-13
• Completion: 2019-08-19
• First posted: 2017-01-04
• Last updated: 2021-02-24
• Results posted: 2021-02-24

Locations

24 sites across 7 countries: United States, Canada, Czechia, Israel, New Zealand, Poland, Serbia

Regulatory

• FDA-regulated drug study