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



Status:Completed
Conditions:Lupus
Therapuetic Areas:Immunology / Infectious Diseases
Healthy:No
Age Range:Any
Updated:2/4/2013
Start Date:October 2010
End Date:March 2013
Contact:Daniel Aversa, Sr. Study Manager
Email:daversa@celgene.com
Phone:732-652-5671

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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


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


Key Inclusion Criteria:

- Subjects with a clinical diagnosis of discoid lupus erythematosus or sub acute lupus
erythematosus for > 16 weeks prior to screening and consistent histological findings
on skin biopsy based on Gilliam classification who are candidates for systemic
therapies (as determined by the Investigator)

- Must, in the opinion of the Investigator, have active skin lesions of sufficient
severity at Screening and Baseline (a Cutaneous Lupus Area and Severity Index
Activity Score of ≥ 10)

- All subjects taking hydroxychloroquine, chloroquine or quinacrine during the study
must have documentation of an ophthalmologic exam performed within 24 weeks of the
Baseline Visit.

- Must meet the following laboratory criteria:

- White blood cell count ≥3000/mm3 (≥ 3.0 x 109/L) and < 14,000/mm3 (< 14 x 109/L)

- Absolute neutrophil count (ANC) > 1500 cells/μL (1.5 x 109/L)

- Platelet count ≥ 100,000/μL (≥ 100 x 109/L)

- Serum creatinine ≤ 1.5 mg/dL (≤ 132.6 μmol/L)

- Aspartate aminotransferase (AST/SGOT) and alanine aminotransferase (ALT/SGPT)

- ≤ 1.5 X upper limit of normal (ULN)

- Total bilirubin < 2mg/dL

- Hemoglobin > 11 g/dL Key Exclusion Criteria

- Participation in multiple CC-11050 cohorts or previous exposure to CC-11050

- Presence or history of SLE based on investigators' clinical evaluation where subject
exhibits medically significant (as determined by the Investigator) LE-related
pleuritis, pericarditis, neurologic, renal and/or other major SLE-related organ
system involvement(SLE-related to SLE joint involvement is acceptable).

- Use of topical or any local therapy known to possibly benefit discoid lupus
erythematosus or SCLE sub acute lupus erythematosus within 2 weeks of the Screening
Visit

- Use of concomitant disease modifying anti-rheumatic drugs (DMARDs) with the exception
of anti-malarials within 4 weeks of screening- Use of topical or any local therapy
known to possibly benefit discoid lupus erythematosus or SCLE sub acute lupus
erythematosus within 2 weeks of the Screening Visit

- Use of immunosuppressives (eg, azathioprine, mycophenolate mofetil, methotrexate,
etc.) within 4 weeks of screening
We found this trial at
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201 East Huron Street
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Ann Arbor, Michigan 48103
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Boston, Massachusetts 02115
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