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