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)
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.
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
;
Status | Clinical Trial | Phase | |
---|---|---|---|
Terminated |
NCT01164917 -
Safety Study of AMG 811 in Subjects With Discoid Lupus Erythematosus
|
Phase 1 |