drugset / Trial / NCT01300208

To Evaluate the Preliminary Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Efficacy of CC-11050 in Subjects With Discoid Lupus Erythematosus and Subacute Cutaneous Lupus Erythematosus

NCT01300208

Phase 2 Completed 48 enrolled Amgen
RandomizedParallel-groupQuadruple-blindTreatment

Summary

This is the first study in cutaneous lupus erythematosus subjects to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and efficacy of CC-11050.

Timeline

Start
2010-10-01
Primary completion
2013-01-01
Completion
2013-03-01

Drugs

EvaluationDrugModalityDoseRoute
Subject Dovramilast Small molecule 50 mg
Subject Dovramilast Small molecule 100 mg
Subject Dovramilast Small molecule 200 mg