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
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
5
UAB Dermatology
Birmingham, Alabama, United States
The Regents of the University of California
Number of subjects with adverse events
Time frame: 4 to 6 weeks
To describe the pharmacokinetics of CC-930 in subjects with recalcitrant DLE.
Time frame: 18 months
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Irvine, California, United States
Medical Faculty Associates
Washington D.C., District of Columbia, United States
Advanced Pharma, CR, LLC
Miami, Florida, United States
University of Miami - Department of Dermatology
Miami, Florida, United States
Rush Medical Center
Chicago, Illinois, United States
North Shore University Health System
Skokie, Illinois, United States
SIU School of Medicine
Springfield, Illinois, United States
Tulane University School of Medicine
New Orleans, Louisiana, United States
John Hopkins University
Baltimore, Maryland, United States
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