To Evaluate the Preliminary Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Efficacy of CC-11050 in Subjects With Discoid Lupus Erythematosus and Subacute Cutaneous Lupus Erythematosus

Amgen

Status and phase: Completed; Phase 2

Conditions: Cutaneous Lupus Erythematosus

Treatments: Other: Placebo; Drug: CC-11050

Study type: Interventional

Funder types: Industry

Identifiers

NCT01300208

CC-11050-CLE-002

Details and patient eligibility

About

This is the first study in cutaneous lupus erythematosus subjects to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and efficacy of CC-11050.

Enrollment: 48 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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48 participants in 3 patient groups

Cohort 1

Experimental group

Description:

CC-11050 (50 milligrams twice per day and Placebo)

Treatment:

Other: Placebo

Drug: CC-11050

Cohort 2

Experimental group

Description:

CC-11050 (100 milligrams twice per day and Placebo)

Treatment:

Other: Placebo

Drug: CC-11050

Cohort 3

Experimental group

Description:

CC-11050 (200 milligrams twice per day and Placebo)

Treatment:

Other: Placebo

Drug: CC-11050