A Research Study to Assess if CC-930 is Safe in Treating Subjects With Discoid Lupus Erythematosus (NCT01466725) | Clinical Trial Compass
TerminatedPhase 2
A Research Study to Assess if CC-930 is Safe in Treating Subjects With Discoid Lupus Erythematosus
Stopped: The benefit/risk profile does not support continuation of this study.
United States5 participantsStarted 2011-11-01
Plain-language summary
The purpose of the study is to assess if CC-930 is safe and tolerable in treating subjects with Discoid Lupus Erythematosus. Pharmacokinetic and pharmacodynamics will also be evaluated.
Who can participate
Age range18 Years – 64 Years
SexALL
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Inclusion criteria
✓. Male or female with clinical diagnosis of Discoid Lupus Erythematosus (DLE) aged 18 to 64 years
✓. Good health as assessed by Investigator
✓. DLE for at least 16 weeks prior to screening and consistent histological findings.
✓. Considered a candidate for systemic therapy. May be naïve to systemic therapy or experiencing incomplete or refractory disease on systemic therapy.
✓. Cutaneous Lupus Area and Severity Index (CLASI) activity score of at least 10, as determined by investigator.
✓. Subjects using hydroxychloroquine, chloroquine, or quinacrine must have documented ophthalmologic exam within 24 weeks of baseline visit.
✓. Must meet laboratory criteria for white blood cells, absolute neutrophils, platelets, serum creatinine, aspartate aminotransferase (AST), alanine aminotransferase (ALT), bilirubin and hemoglobin.
✓. Subjects, male and female, must agree to strict pregnancy prevention and testing requirements.
Exclusion criteria
✕. Significant illnesses as determined by physician.
✕. History of significant cardiac conditions or interventions within prior 6 months including abnormal electrocardiogram (ECG) findings.
✕. Systolic blood pressure \< 95 or \> 150 mm Hg
✕. Other dermatological conditions that would interfere with CLASI Activity Score assessments.
✕. History of or active; malignancy, human immunodeficiency virus (HIV), tuberculosis infection, other mycobacterial infection, congenital or acquired immunodeficiency, Hepatitis B and C.
✕. Clinically significant abnormality on chest X-ray.