To Evaluate the Preliminary Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Efficacy… (NCT01300208) | Clinical Trial Compass
CompletedPhase 2
To Evaluate the Preliminary Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Efficacy of CC-11050 in Subjects With Discoid Lupus Erythematosus and Subacute Cutaneous Lupus Erythematosus
United States48 participantsStarted 2010-10-01
Plain-language summary
This is the first study in cutaneous lupus erythematosus subjects to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and efficacy of CC-11050.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 SL…
What they're measuring
1
Laboratory values from chemistry, hematology, urinalysis, inflammation/immunology panel that reveal clinically significant abnormalities and that may constitute a safety concern