A Research Study to Assess if CC-930 is Safe in Treating Subjects With Discoid Lupus Erythematosus
NCT ID: NCT01466725
Last Updated: 2019-11-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE2
5 participants
INTERVENTIONAL
2011-11-01
2012-07-30
Brief Summary
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Detailed Description
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Cohort 1: 25 mg once daily for 4 weeks Cohort 2: 50 mg once daily for 4 weeks Cohort 3: 100 mg once daily for 6 weeks Cohort 4: 100 mg twice daily for 6 weeks
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Cohort 1
25 mg daily for 4 weeks (8 active/2 control)
CC-930
Placebo
Placebo
Cohort 2
50 mg once daily for 4 weeks (8 active/2 control)
CC-930
Placebo
Placebo
Cohort 3
100 mg daily for 6 weeks (8 active/2 control)
CC-930
Placebo
Placebo
Cohort 4
100 mg twice daily for 6 weeks (8 active/2 control)
CC-930
Placebo
Placebo
Interventions
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CC-930
Placebo
Placebo
Eligibility Criteria
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Inclusion Criteria
2. Good health as assessed by Investigator
3. DLE for at least 16 weeks prior to screening and consistent histological findings.
4. Considered a candidate for systemic therapy. May be naïve to systemic therapy or experiencing incomplete or refractory disease on systemic therapy.
5. Cutaneous Lupus Area and Severity Index (CLASI) activity score of at least 10, as determined by investigator.
6. Subjects using hydroxychloroquine, chloroquine, or quinacrine must have documented ophthalmologic exam within 24 weeks of baseline visit.
7. Must meet laboratory criteria for white blood cells, absolute neutrophils, platelets, serum creatinine, aspartate aminotransferase (AST), alanine aminotransferase (ALT), bilirubin and hemoglobin.
8. Subjects, male and female, must agree to strict pregnancy prevention and testing requirements.
Exclusion Criteria
2. History of significant cardiac conditions or interventions within prior 6 months including abnormal electrocardiogram (ECG) findings.
3. Systolic blood pressure \< 95 or \> 150 mm Hg
4. Diastolic blood pressure \> 90 mm Hg.
5. Pregnancy or breast feeding.
6. Other dermatological conditions that would interfere with CLASI Activity Score assessments.
7. History of or active; malignancy, human immunodeficiency virus (HIV), tuberculosis infection, other mycobacterial infection, congenital or acquired immunodeficiency, Hepatitis B and C.
8. Clinically significant abnormality on chest X-ray.
9. Participation in multiple CC-930 cohorts.
10. History of thrombolytic event.
11. Positive tests for lupus anticoagulant, anti-cardiolipin antibodies, antibodies to beta-2 glycoprotein 1 or phosphatidylserine at screening.
12. Positive antineutrophilic cytoplasmic antibody (ANCA) at screening.
13. Diagnosis of SLE.
14. Presence or history of medically significant Systemic Lupus Erythematosis (SLE) or Lupus Erythematosis (LE) comorbidities.
15. History of seizures, chorea or psychosis.
16. Presence or history of persistent proteinuria or urinary cellular casts.
17. Prohibited prior or concomitant medications.
18 Years
64 Years
ALL
No
Sponsors
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Celgene
INDUSTRY
Responsible Party
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Principal Investigators
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William Smith, MD
Role: STUDY_DIRECTOR
Celgene
Locations
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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
Countries
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Other Identifiers
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CC-930-DLE-002
Identifier Type: -
Identifier Source: org_study_id
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