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NCT01300208

To Evaluate the Preliminary Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Efficacy of CC-11050 in Subjects With Discoid Lupus Erythematosus and Subacute Cutaneous Lupus Erythematosus

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 Lupus Erythematosus and Subacute Cutaneous Lupus Erythematosus
Amgen·Phase 2·ClinicalTrials.gov·drugCompleted
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Study focus
Disease/Condition
Cutaneous Lupus Erythematosus
Drug/Device/Intervention
CC-11050
Study type
Interventional
Intervention type
drug
Sponsor & location
Primary sponsor
Amgen
Location
Rogers,Los Angeles,San Diego,Atlanta,Atlanta,Newnan,Chicago,Indianapolis,Louisville,Lake Charles,Saint Louis,New York,Cleveland,Duncansville,Hershey,Philadelphia,Pittsburgh,Johnston,Dallas, United States of America
Timeline & enrollment
Phase
Phase 2
Start date
Oct 01, 2010
End date
Mar 01, 2013
Enrollment
48 participants
Primary outcome

Laboratory values from chemistry, hematology, urinalysis, inflammation/immunology panel that reveal clinically significant abnormalities and that may constitute a safety concern

Summary

This is the first study in cutaneous lupus erythematosus subjects to evaluate the safety,
 tolerability, pharmacokinetics, pharmacodynamics, and efficacy of CC-11050.

ICD-10 classifications
Subacute cutaneous lupus erythematosusLupus erythematosusDiscoid lupus erythematosusSystemic lupus erythematosusSystemic lupus erythematosus, unspecified
Data source
Registry
ClinicalTrials.gov
Trial ID
NCT01300208
Type
Non-Device Trial
About this record

Access comprehensive clinical trial information for NCT01300208 through Pure Global AI's free database. This Phase 2 trial is sponsored by Amgen and is currently Completed. The study focuses on Cutaneous Lupus Erythematosus. Target enrollment is 48 participants.

This page provides complete trial specifications, intervention details, outcomes, and location information. Pure Global AI offers free access to ClinicalTrials.gov data, helping medical device and pharmaceutical companies navigate clinical research efficiently.