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

Phase 2

Completed

• Conditions: Cutaneous Lupus Erythematosus
• Interventions: Drug: CC-11050; Other: Placebo

• Registration Number: NCT01300208
• Lead Sponsor: Amgen

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2010-10-01
• Study First Submitted: 2010-10-18
• Study First Submitted QC: 2011-02-17
• Study First Posted: 2011-02-21
• Primary Completion: 2013-01-01
• Study Completion: 2013-03-01
• Disposition First Submitted: 2013-09-25
• Disposition First Submitted QC: 2013-09-25
• Disposition First Posted: 2013-10-25
• Status Verified: 2020-06
• Last Update Submitted: 2020-06-18
• Last Update Posted: 2020-06-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 48

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cohort 1	Placebo	CC-11050 (50 milligrams twice per day and Placebo)
Cohort 3	Placebo	CC-11050 (200 milligrams twice per day and Placebo)
Cohort 2	Placebo	CC-11050 (100 milligrams twice per day and Placebo)
Cohort 2	CC-11050	CC-11050 (100 milligrams twice per day and Placebo)
Cohort 1	CC-11050	CC-11050 (50 milligrams twice per day and Placebo)
Cohort 3	CC-11050	CC-11050 (200 milligrams twice per day and Placebo)

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Pharmacokinetics (PK)	Up to 21 weeks	To describe the volume of distribution (Vz/F) of CC-11050 and M15 in plasma
Pharmacokinetics	Up to 21 weeks	To describe the lowest serum concentration (Cmin)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

Trial Locations

Locations (19)

Northwest Arkansas Clinical Trials Center, PLLC; 🇺🇸 Rogers, Arkansas, United States

Dermatology Research Associates; 🇺🇸 Los Angeles, California, United States

Medderm Associates; 🇺🇸 San Diego, California, United States

Emory Univ. School of Medicine; 🇺🇸 Atlanta, Georgia, United States

Peachtree Dermatology Associates Research Center; 🇺🇸 Atlanta, Georgia, United States

Central Medaphase Inc; 🇺🇸 Newnan, Georgia, United States

Northwestern University; 🇺🇸 Chicago, Illinois, United States

Dawes Fretzin Clinical Research Group, LLC; 🇺🇸 Indianapolis, Indiana, United States

DermResearch, PLLC; 🇺🇸 Louisville, Kentucky, United States

Dermatology & Advanced Aesthetics; 🇺🇸 Lake Charles, Louisiana, United States

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