This is the first study in cutaneous lupus erythematosus subjects to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and efficacy of CC-11050.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
48
Northwest Arkansas Clinical Trials Center, PLLC
Rogers, Arkansas, United States
Dermatology Research Associates
Laboratory values from chemistry, hematology, urinalysis, inflammation/immunology panel that reveal clinically significant abnormalities and that may constitute a safety concern
Time frame: Up to 21 weeks
Pharmacokinetics (PK)
To describe the area under the curve (AUC) of CC-11050 and M15 in plasma
Time frame: Up to 21 weeks
To assess the clinical response rate of CC-11050 in subjects with discoid lupus erythematosus or sub acute lupus erythematosus using the Cutaneous Lupus Area and Severity Index Activity Score following 12-weeks of treatment
Time frame: 12 weeks
Pharmacokinetics (PK)
To describe the peak serum concentration (Cmax) of CC-11050 and M15 in plasma
Time frame: Up to 21 weeks
Pharmacokinetics
To describe the lowest serum concentration (Cmin)of CC-11050 and M15 in plasma
Time frame: Up to 21 weeks
Pharmacokinetics (PK)
To describe the time after administration of a drug when the maxiumum plasma concentration is reached (tmax) of CC-11050 and M15 in plasma
Time frame: Up to 21 weeks
Pharmacokinetics (PK)
To describe the half life (t1/2) of CC-11050 and M15 in plasma
Time frame: Up to 21 weeks
Pharmacokinetics (PK)
To describe the oral clearance (CL/F) of CC-11050 and M15 in plasma
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Los Angeles, California, United States
Medderm Associates
San Diego, California, United States
Emory Univ. School of Medicine
Atlanta, Georgia, United States
Peachtree Dermatology Associates Research Center
Atlanta, Georgia, United States
Central Medaphase Inc
Newnan, Georgia, United States
Northwestern University
Chicago, Illinois, United States
Dawes Fretzin Clinical Research Group, LLC
Indianapolis, Indiana, United States
DermResearch, PLLC
Louisville, Kentucky, United States
Dermatology & Advanced Aesthetics
Lake Charles, Louisiana, United States
...and 9 more locations
Time frame: Up to 21 weeks
Pharmacokinetics (PK)
To describe the volume of distribution (Vz/F) of CC-11050 and M15 in plasma
Time frame: Up to 21 weeks