Recent Updates
Recently added Catalysts

RHB-104

Phase 3

Crohn's Disease | Small molecule | Gastrointestinal |Redhill Biopharma Ltd.|Last Updated: Dec 8, 2020

Success Probability
Subscribe to view
Market & Valuation
Subscribe to view
Trial Design
RandomizedDouble-BlindPLACEBO_CONTROLLEDDMC
Total Trials1
Total Enrollment331
FDA Designations
No designations recorded
Clinical trial landscape

RHB-104 · 2 trials · 2 indications

Phase 3 1Phase 2 1
NCT01951326Efficacy and Safety of Anti-MAP Therapy in Adult Crohn's DiseaseCrohn's Disease
COMPLETED331 Analytics
PHASE3COMPLETED
Efficacy and Safety of Anti-MAP Therapy in Adult Crohn's Disease
Crohn's DiseaseUnlock trial analytics
Study Endpoints
Primary Endpoints
Remission at Week 26
Week 26

Reduction of the total Crohn's Disease Activity Index (CDAI) score to less than 150. Lower CDAI scores indicate a better outcome.

Combined Unique Active lesions
Baseline through Wk 24
Secondary Endpoints
Response at Week 26
Week 26
Remission at Week 52
Week 52
Durable Remission Week 26 Through Week 52
Week 26 through week 52
Unlock Study Endpoints
Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
RHB-104ACTIVE_COMPARATOR5 RHB-104 capsules administered orally BID
PlaceboPLACEBO_COMPARATOR5 placebo capsules administered orally BID
Interventions
NameTypeDescription
RHB-104DRUG95 mg clarithromycin, 45 mg rifabutin, and 10 mg clofazimine
PlaceboDRUG5 placebo capsules administered orally BID
Unlock Study Design Details
Eligibility Criteria
Age Range18 Years to 75 Years
SexALL
Healthy VolunteersNo
Study Sites103

Inclusion Criteria 1. Signed fully informed consent provided as per this protocol. 2. Diagnosis of Crohn's Disease confirmed by endoscopy or radiography and/or histology at least 6 months prior to randomization into the study. 3. CD involving the ileum and/or colon 4. Moderately to severely active ...

Countries:United StatesAustraliaBulgariaCanadaCzechiaIsraelNew ZealandPolandSerbiaSlovakia
Unlock Eligibility Criteria