A Research Study to Assess if CC-930 is Safe in Treating Subjects With Discoid Lupus Erythematosus

Stopped early · Phase 2 · Has a placebo group

Conditions studied: Discoid Lupus

In brief

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.

Key facts

Study ID

NCT01466725

Run by

Celgene

People needed

5

Starts

2011-11-01

Expected to finish

2012-07-30

Last updated by the study team

2019-11-19

Who can join

Age: 18 and older, up to 64. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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
• Diastolic blood pressure > 90 mm Hg.
• Pregnancy or breast feeding.
• 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.
• Participation in multiple CC-930 cohorts.
• History of thrombolytic event.
• Positive tests for lupus anticoagulant, anti-cardiolipin antibodies, antibodies to beta-2 glycoprotein 1 or phosphatidylserine at screening.
• Positive antineutrophilic cytoplasmic antibody (ANCA) at screening.
• Diagnosis of SLE.
• Presence or history of medically significant Systemic Lupus Erythematosis (SLE) or Lupus Erythematosis (LE) comorbidities.
• History of seizures, chorea or psychosis.
• Presence or history of persistent proteinuria or urinary cellular casts.
• Prohibited prior or concomitant medications.

Where it is running

• UAB Dermatology — Birmingham, Alabama, United States
• The Regents of the University of California — Irvine, California, United States
• Medical Faculty Associates — Washington D.C., District of Columbia, United States
• Advanced Pharma, CR, LLC — Miami, Florida, United States
• University of Miami - Department of Dermatology — Miami, Florida, United States
• Rush Medical Center — Chicago, Illinois, United States
• North Shore University Health System — Skokie, Illinois, United States
• SIU School of Medicine — Springfield, Illinois, United States
• Tulane University School of Medicine — New Orleans, Louisiana, United States
• John Hopkins University — Baltimore, Maryland, United States
• Boston Cancer Center — Boston, Massachusetts, United States
• University of Minnesota-Department of Dermatology — Minneapolis, Minnesota, United States
• University of Rochester Medical Center — Rochester, New York, United States
• Ohio State Univ Medical Center, Division of Dermatology — Columbus, Ohio, United States
• Rhode Island Hospital University Dermatology, Inc. — Providence, Rhode Island, United States
• Medical University of South Carolina — Charleston, South Carolina, United States
• Dermatology and Research — Dallas, Texas, United States
• University of Texas Dermatology — Houston, Texas, United States
• Sun Research Institute — San Antonio, Texas, United States

Full record on ClinicalTrials.gov

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