Phase II Study of RR110 in Patients With Active Crohn's Disease

Phase 2

Completed

• Conditions: Crohn's Disease
• Interventions: Drug: RR110 (Tamibarotene)

• Registration Number: NCT00417391
• Lead Sponsor: R&R Inc.

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2006-12
• Study First Submitted: 2006-12-28
• Study First Submitted QC: 2006-12-28
• Study First Posted: 2007-01-01
• Status Verified: 2008-05
• Primary Completion: 2008-05
• Study Completion: 2008-05
• Last Update Submitted: 2008-05-25
• Last Update Posted: 2008-05-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1 mg RR110	RR110 (Tamibarotene)	1 mg RR110
4 mg RR110	RR110 (Tamibarotene)	4 mg RR110

Primary Outcome Measures

Name	Time	Method
Change in Crohn's disease active index (CDAI) score	8 weeks

Secondary Outcome Measures

Name	Time	Method
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