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 |
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
23
sites
Emory University School of Medicine Emory University School of Medicine has 2,359 full- and part-time...
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Northwestern University Northwestern is recognized both nationally and internationally for the quality of its educational...
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3400 Spruce St
Philadelphia, Pennsylvania 19104
Philadelphia, Pennsylvania 19104
(215) 662-4000
Hospital of the University of Pennsylvania The Hospital of the University of Pennsylvania (HUP) is...
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New York University Langone Medical Center NYU NYU Langone Medical Center, a world-class, patient-centered, integrated,...
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University of Pittsburgh Medical Center UPMC is one of the leading nonprofit health systems in...
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