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To Evaluate the Preliminary Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Efficacy of CC-11050 in Subjects With Discoid Lupus Erythematosus and Subacute Cutaneous Lupus Erythematosus - Trial NCT01300208

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.

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NCT01300208
Phase 2
Completed
drug
Trial Details
ClinicalTrials.gov โ€ข NCT01300208
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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

Study Focus

CC-11050

Interventional

drug

Sponsor & Location

Amgen

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 2

Oct 01, 2010

Mar 01, 2013

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 erythematosus
Lupus erythematosus
Discoid lupus erythematosus
Systemic lupus erythematosus
Systemic lupus erythematosus, unspecified

Data Source

ClinicalTrials.gov

NCT01300208

Non-Device Trial