The investigators hypothesize that RHB-104 will have greater efficacy than placebo in Crohn's disease.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
331
Remission at Week 26
Reduction of the total Crohn's Disease Activity Index (CDAI) score to less than 150. Lower CDAI scores indicate a better outcome.
Time frame: Week 26
Response at Week 26
Reduction of Crohn's Disease Activity Index (CDAI) score by a minimum of 100 points. Lower CDAI scores indicate a better outcome.
Time frame: Week 26
Remission at Week 52
Reduction of the total Crohn's Disease Activity Index (CDAI) score to less than 150. Lower CDAI scores indicate a better outcome.
Time frame: Week 52
Durable Remission Week 26 Through Week 52
When a subject is in remission with a maximum CDAI score of 149 at every visit from Week 26 through and including Week 52
Time frame: Week 26 through week 52
Remission at Week 16
Reduction of the total Crohn's Disease Activity Index (CDAI) score to less than 150. Lower CDAI scores indicate a better outcome.
Time frame: Week 16
Steroid Free Remission at Week 52
Subjects who are maintained off steroids for a minimum of 3 weeks
Time frame: Week 52
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