Status:
TERMINATED
A Research Study to Assess if CC-930 is Safe in Treating Subjects With Discoid Lupus Erythematosus
Lead Sponsor:
Celgene
Conditions:
Discoid Lupus
Eligibility:
All Genders
18-64 years
Phase:
PHASE2
Brief 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.
Detailed Description
Enrollment will occur in sequential, ascending, dose-sequence design, where a higher CC-930 dose level and longer duration of dosing (cohort) will not be initiated until supportive safety profile is d...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
November 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 30 2012
Estimated Enrollment :
5 Patients enrolled
Trial Details
Trial ID
NCT01466725
Start Date
November 1 2011
End Date
July 30 2012
Last Update
November 19 2019
Active Locations (19)
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1
UAB Dermatology
Birmingham, Alabama, United States, 35233
2
The Regents of the University of California
Irvine, California, United States, 92697
3
Medical Faculty Associates
Washington D.C., District of Columbia, United States, 20037
4
Advanced Pharma, CR, LLC
Miami, Florida, United States, 33136