Crohn's Disease
Conditions
Brief summary
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.
Interventions
DRUGRR110 (Tamibarotene)
1 mg RR110
Sponsors
R&R Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients with CDAI score ranging from 220 to 450 * Patients with CRP \> 1 mg/dL * Patients who can be hospitalized at least 2 weeks after first administration
Exclusion criteria
* Patients who have previously used anti-TNF antibody, cyclosporine, methotrexate or tacrolimus within 12 weeks of screening * Patients who have had surgical bowel resections within 4 weeks of screening * Patients who have previously used total parental nutrition or more than 900 kcal/day of enteral nutrition within 4 weeks of screening
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in Crohn's disease active index (CDAI) score | 8 weeks |
Secondary
| Measure | Time frame |
|---|---|
| Rate of clinical response as defined by CDAI decrease > 70 or 100 from baseline | 8 weeks |
| Rate of clinical remission as defined by CDAI < 150 | 8 weeks |
| Change in CRP, SAA, and fibrinogen levels, and IBDQ and CDEIS scores | 10 weeks |
| Safety parameters | 10 weeks |
Countries
Japan
Outcome results
None listed