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)
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
Interventional
Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Number of subjects with adverse events
4 to 6 weeks
Yes
Tong Li, MD
Study Director
Celgene Corporation
United States: Food and Drug Administration
CC-930-DLE-002
NCT01466725
November 2011
April 2013
Name | Location |
---|---|
SIU School of Medicine | Springfield, Illinois 62702 |
Medical University of South Carolina | Charleston, South Carolina 29425-0721 |
Tulane University School of Medicine | New Orleans, Louisiana 70112 |
University of Rochester Medical Center | Rochester, New York 14642 |
Rush Medical Center | Chicago, Illinois 60612 |
John Hopkins University | Baltimore, Maryland 21231 |
UAB Dermatology | Birmingham, Alabama 35233 |
The Regents of the University of California | Irvine, California 92697 |
Medical Faculty Associates | Washington, D.C., District of Columbia 20037 |
Advanced Pharma, CR, LLC | Miami, Florida 33136 |
University of Miami - Department of Dermatology | Miami, Florida 33136 |
North Shore University Health System | Skokie, Illinois 60077 |
Boston Cancer Center | Boston, Massachusetts 02118 |
University of Minnesota-Department of Dermatology | Minneapolis, Minnesota 55455 |
Ohio State Univ Medical Center, Division of Dermatology | Columbus, Ohio 43221 |
Rhode Island Hospital University Dermatology, Inc. | Providence, Rhode Island 02903 |
Dermatology and Research | Dallas, Texas 75230 |
University of Texas Dermatology | Houston, Texas 77030 |
Sun Research Institute | San Antonio, Texas 78215 |