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

R&R Inc.

Status and phase: Completed; Phase 2

Conditions: Crohn's Disease

Treatments: Drug: RR110 (Tamibarotene)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00417391

1101-01

Details and patient eligibility

About

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.

Enrollment: 24 estimated patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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24 participants in 2 patient groups

1 mg RR110

Experimental group

Description:

1 mg RR110

Treatment:

Drug: RR110 (Tamibarotene)

Drug: RR110 (Tamibarotene)

4 mg RR110

Experimental group

Description:

4 mg RR110

Treatment:

Drug: RR110 (Tamibarotene)

Drug: RR110 (Tamibarotene)