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

NCT ID: NCT01300208

Last Updated: 2020-06-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 48 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-10-01
• Study Completion Date: 2013-03-01

Brief Summary

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

Conditions

Cutaneous Lupus Erythematosus

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Cohort 1

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

Group Type: EXPERIMENTAL

CC-11050

Intervention Type: DRUG

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

Placebo

Intervention Type: OTHER

Cohort 2

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

Group Type: EXPERIMENTAL

CC-11050

Intervention Type: DRUG

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

Placebo

Intervention Type: OTHER

Cohort 3

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

Group Type: EXPERIMENTAL

CC-11050

Intervention Type: DRUG

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

Placebo

Intervention Type: OTHER

Interventions

CC-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

Intervention Type: DRUG

Placebo

Intervention Type: OTHER

Eligibility Criteria

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

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Amgen

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

MD

Role: STUDY_DIRECTOR

Amgen

Locations

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

Central Dermatology, P.C.

St Louis, Missouri, United States

NYU Langone Medical Center

New York, New York, United States

University Hospitals Case Medical Center

Cleveland, Ohio, United States

Altoona Center for Clinical Research

Duncansville, Pennsylvania, United States

Penn State Hershey Dermatology

Hershey, Pennsylvania, United States

Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, United States

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, United States

Clinical Partners, LLC

Johnston, Rhode Island, United States

UT Southwestern Medical Center Dallas

Dallas, Texas, United States

Countries

United States

Other Identifiers

CC-11050-CLE-002

Identifier Type: -

Identifier Source: org_study_id