Clinical Trial: To Evaluate the Preliminary Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Efficacy of CC-11050 in Subjects With Discoid Lupus Erythematosus and Subacute Cutaneous Lupus Erythematosus
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: A Phase 2, Pilot, Multicenter, Sequential, Ascending Dose Study to Evaluate the Preliminary Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Efficacy of CC-11050 in Subjects With Discoid L
Brief Summary: This is the first study in cutaneous lupus erythematosus subjects to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and efficacy of CC-11050.
Detailed Summary:
Sponsor: Celgene Corporation
Current Primary Outcome: 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 ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Pharmacokinetics (PK) [ Time Frame: Up to 21 weeks ]To describe the area under the curve (AUC) of CC-11050 and M15 in plasma
- 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) [ Time Frame: Up to 21 weeks ]To describe the peak serum concentration (Cmax) of CC-11050 and M15 in plasma
- Pharmacokinetics [ Time Frame: Up to 21 weeks ]To describe the lowest serum concentration (Cmin)of CC-11050 and M15 in plasma
- Pharmacokinetics (PK) [ Time Frame: Up to 21 weeks ]To describe the time after administration of a drug when the maxiumum plasma concentration is reached (tmax) of CC-11050 and M15 in plasma
- Pharmacokinetics (PK) [ Time Frame: Up to 21 weeks ]To describe the half life (t1/2) of CC-11050 and M15 in plasma
- Pharmacokinetics (PK) [ Time Frame: Up to 21 weeks ]To describe the oral clearance (CL/F) of CC-11050 and M15 in plasma
- Pharmacokinetics (PK) [ Time Frame: Up to 21 weeks ]To describe the volume of distribution (Vz/F) of CC-11050 and M15 in plasma
Original Secondary Outcome: Same as current
Information By: Celgene Corporation
Dates:
Date Received: October 18, 2010
Date Started: October 2010
Date Completion:
Last Updated: April 26, 2016
Last Verified: April 2016