Discoid Lupus
Conditions
Keywords
Lupus, Discoid Lupus, DLE, Cutaneous Lupus
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 demonstrated in the preceding cohort. There will be 4 cohorts as described here; 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
Interventions
DRUGCC-930
DRUGPlacebo
Placebo
Sponsors
Celgene
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 64 Years
Healthy volunteers
No
Inclusion criteria
1. Male or female with clinical diagnosis of Discoid Lupus Erythematosus (DLE) aged 18 to 64 years 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
1. Significant illnesses as determined by physician. 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of subjects with adverse events | 4 to 6 weeks |
Secondary
| Measure | Time frame |
|---|---|
| To describe the pharmacokinetics of CC-930 in subjects with recalcitrant DLE. | 18 months |
Countries
United States
Outcome results
None listed