A Research Study to Assess if CC-930 is Safe in Treating Subjects With Discoid Lupus Erythematosus

Discoid Lupus Clinical Trial

Official title: A Phase 2, Pilot, Multicenter, Randomized, Placebo-Controlled Sequential, Ascending Dose Study to Characterize the Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Activity of CC-930 in Subjects With Recalcitrant Discoid Lupus Erythematosus (DLE)

Status Terminated

Clinical Trial Summary

The purpose of the study is to assess if CC-930 is safe and tolerable in treating subjects with Discoid Lupus Erythematosus. Pharmacokinetic and pharmacodynamics will also be evaluated.

Clinical Trial Description

Enrollment will occur in sequential, ascending, dose-sequence design, where a higher CC-930 dose level and longer duration of dosing (cohort) will not be initiated until supportive safety profile is demonstrated in the preceding cohort. There will be 4 cohorts as described here;

Cohort 1: 25 mg once daily for 4 weeks Cohort 2: 50 mg once daily for 4 weeks Cohort 3: 100 mg once daily for 6 weeks Cohort 4: 100 mg twice daily for 6 weeks ;

Related Conditions & MeSH terms

• Discoid Lupus
• Lupus Erythematosus, Discoid

• NCT number: NCT01466725
• Study type: Interventional
• Source: Celgene
• Status: Terminated
• Phase: Phase 2
• Start date: November 1, 2011
• Completion date: July 30, 2012