The purpose of this study is to evaluate the safety, efficacy and pharmacokinetics profile of 1 and 4 mg/kg/day RR110 administrated orally for 8 weeks in patients with active Crohn's disease.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
24
1 mg RR110
4 mg RR110
Unnamed facility
Toyohashi, Aichi-ken, Japan
Unnamed facility
Sakura, Chiba, Japan
Unnamed facility
Sapporo, Hokkaido, Japan
Unnamed facility
Nishinomiya, Hyōgo, Japan
Change in Crohn's disease active index (CDAI) score
Time frame: 8 weeks
Rate of clinical response as defined by CDAI decrease > 70 or 100 from baseline
Time frame: 8 weeks
Rate of clinical remission as defined by CDAI < 150
Time frame: 8 weeks
Change in CRP, SAA, and fibrinogen levels, and IBDQ and CDEIS scores
Time frame: 10 weeks
Safety parameters
Time frame: 10 weeks
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Unnamed facility
Fujisawa, Kanagawa, Japan
Unnamed facility
Nakagami, Okinawa, Japan
Unnamed facility
Ōtsu, Shiga, Japan
Unnamed facility
Shinjuku, Tokyo, Japan