Cutaneous Lupus Erythematosus
Conditions
Keywords
cutaneous lupus erythematosus, subacute lupus erythematosus, discoid lupus erythematosus, lupus
Brief summary
This is the first study in cutaneous lupus erythematosus subjects to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and efficacy of CC-11050.
Interventions
DRUGCC-11050
Cohort 1: 50 milligrams twice per day for 4 weeks Cohort 2: 100 milligrams twice per day for 8 weeks Cohort 3: 200 milligrams twice per day for 12 week
OTHERPlacebo
Sponsors
Amgen
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Key Inclusion Criteria: * Subjects with a clinical diagnosis of discoid lupus erythematosus or sub acute lupus erythematosus for \> 16 weeks prior to screening and consistent histological findings on skin biopsy based on Gilliam classification who are candidates for systemic therapies (as determined by the Investigator) * Must, in the opinion of the Investigator, have active skin lesions of sufficient severity at Screening and Baseline (a Cutaneous Lupus Area and Severity Index Activity Score of ≥ 10) * All subjects taking hydroxychloroquine, chloroquine or quinacrine during the study must have documentation of an ophthalmologic exam performed within 24 weeks of the Baseline Visit. * Must meet the following laboratory criteria: * White blood cell count ≥3000/mm3 (≥ 3.0 x 109/L) and \< 14,000/mm3 (\< 14 x 109/L) * Absolute neutrophil count (ANC) \> 1500 cells/μL (1.5 x 109/L) * Platelet count ≥ 100,000/μL (≥ 100 x 109/L) * Serum creatinine ≤ 1.5 mg/dL (≤ 132.6 μmol/L) * Aspartate aminotransferase (AST/SGOT) and alanine aminotransferase (ALT/SGPT) * ≤ 1.5 X upper limit of normal (ULN) * Total bilirubin \< 2mg/dL * Hemoglobin \> 11 g/dL Key
Exclusion criteria
* Participation in multiple CC-11050 cohorts or previous exposure to CC-11050 * Presence or history of SLE based on investigators' clinical evaluation where subject exhibits medically significant (as determined by the Investigator) LE-related pleuritis, pericarditis, neurologic, renal and/or other major SLE-related organ system involvement(SLE-related to SLE joint involvement is acceptable). * Use of topical or any local therapy known to possibly benefit discoid lupus erythematosus or SCLE sub acute lupus erythematosus within 2 weeks of the Screening Visit * Use of concomitant disease modifying anti-rheumatic drugs (DMARDs) with the exception of anti-malarials within 4 weeks of screening- Use of topical or any local therapy known to possibly benefit discoid lupus erythematosus or SCLE sub acute lupus erythematosus within 2 weeks of the Screening Visit * Use of immunosuppressives (eg, azathioprine, mycophenolate mofetil, methotrexate, etc.) within 4 weeks of screening
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Laboratory values from chemistry, hematology, urinalysis, inflammation/immunology panel that reveal clinically significant abnormalities and that may constitute a safety concern | Up to 21 weeks |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pharmacokinetics (PK) | Up to 21 weeks | To describe the area under the curve (AUC) of CC-11050 and M15 in plasma |
| To assess the clinical response rate of CC-11050 in subjects with discoid lupus erythematosus or sub acute lupus erythematosus using the Cutaneous Lupus Area and Severity Index Activity Score following 12-weeks of treatment | 12 weeks | — |
| Pharmacokinetics | Up to 21 weeks | To describe the lowest serum concentration (Cmin)of CC-11050 and M15 in plasma |
Countries
United States
Outcome results
None listed