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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Celgene Corporation
ClinicalTrials.gov Identifier:
NCT01300208
First received: October 18, 2010
Last updated: September 25, 2013
Last verified: September 2013
  Purpose

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


Condition Intervention Phase
Cutaneous Lupus Erythematosus
Drug: CC-11050
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase 2, Pilot, Multicenter, Sequential, Ascending Dose Study to Evaluate the Preliminary Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Efficacy of CC-11050 in Subjects With Discoid Lupus Erythematosus and Subacute Cutaneous Lupus Erythematosus

Resource links provided by NLM:


Further study details as provided by Celgene Corporation:

Primary Outcome Measures:
  • Laboratory values from chemistry, hematology, urinalysis, inflammation/immunology panel that reveal clinically significant abnormalities and that may constitute a safety concern [ Time Frame: Up to 21 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Pharmacokinetics (PK) [ Time Frame: Up to 21 weeks ] [ Designated as safety issue: No ]
    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 [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Pharmacokinetics (PK) [ Time Frame: Up to 21 weeks ] [ Designated as safety issue: No ]
    To describe the peak serum concentration (Cmax) of CC-11050 and M15 in plasma

  • Pharmacokinetics [ Time Frame: Up to 21 weeks ] [ Designated as safety issue: No ]
    To describe the lowest serum concentration (Cmin)of CC-11050 and M15 in plasma

  • Pharmacokinetics (PK) [ Time Frame: Up to 21 weeks ] [ Designated as safety issue: No ]
    To describe the time after administration of a drug when the maxiumum plasma concentration is reached (tmax) of CC-11050 and M15 in plasma

  • Pharmacokinetics (PK) [ Time Frame: Up to 21 weeks ] [ Designated as safety issue: No ]
    To describe the half life (t1/2) of CC-11050 and M15 in plasma

  • Pharmacokinetics (PK) [ Time Frame: Up to 21 weeks ] [ Designated as safety issue: No ]
    To describe the oral clearance (CL/F) of CC-11050 and M15 in plasma

  • Pharmacokinetics (PK) [ Time Frame: Up to 21 weeks ] [ Designated as safety issue: No ]
    To describe the volume of distribution (Vz/F) of CC-11050 and M15 in plasma


Enrollment: 48
Study Start Date: October 2010
Study Completion Date: March 2013
Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Cohort 1
CC-11050 (50 milligrams twice per day and Placebo)
Drug: 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
Experimental: Cohort 2
CC-11050 (100 milligrams twice per day and Placebo)
Drug: 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
Experimental: Cohort 3
CC-11050 (200 milligrams twice per day and Placebo)
Drug: 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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01300208

Locations
United States, Arkansas
Northwest Arkansas Clinical Trials Center, PLLC
Rogers, Arkansas, United States, 72758
United States, California
Dermatology Research Associates
Los Angeles, California, United States, 90045
Medderm Associates
San Diego, California, United States, 92103
United States, Georgia
Emory Univ. School of Medicine
Atlanta, Georgia, United States, 30322
Peachtree Dermatology Associates Research Center
Atlanta, Georgia, United States, 30327
Central Medaphase Inc
Newnan, Georgia, United States, 30263
United States, Illinois
Northwestern University
Chicago, Illinois, United States, 60611
United States, Indiana
Dawes Fretzin Clinical Research Group, LLC
Indianapolis, Indiana, United States, 46256
United States, Kentucky
DermResearch, PLLC
Louisville, Kentucky, United States, 40217
United States, Louisiana
Dermatology & Advanced Aesthetics
Lake Charles, Louisiana, United States, 70605
United States, Missouri
Central Dermatology, P.C.
St. Louis, Missouri, United States, 63117
United States, New York
NYU Langone Medical Center
New York, New York, United States, 10016
United States, Ohio
University Hospitals Case Medical Center
Cleveland, Ohio, United States, 44106
United States, Pennsylvania
Altoona Center for Clinical Research
Duncansville, Pennsylvania, United States, 16635
Penn State Hershey Dermatology
Hershey, Pennsylvania, United States, 17033
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States, 15213
United States, Rhode Island
Clinical Partners, LLC
Johnston, Rhode Island, United States, 02919
United States, Texas
UT Southwestern Medical Center Dallas
Dallas, Texas, United States, 75390-9090
Sponsors and Collaborators
Celgene Corporation
Investigators
Study Director: Tong Li, MD Celgene Corporation
  More Information

No publications provided

Responsible Party: Celgene Corporation
ClinicalTrials.gov Identifier: NCT01300208     History of Changes
Other Study ID Numbers: CC-11050-CLE-002
Study First Received: October 18, 2010
Last Updated: September 25, 2013
Health Authority: United States: Institutional Review Board
United States: Food and Drug Administration

Keywords provided by Celgene Corporation:
cutaneous lupus erythematosus
subacute lupus erythematosus
discoid lupus erythematosus
lupus

Additional relevant MeSH terms:
Lupus Erythematosus, Systemic
Lupus Erythematosus, Cutaneous
Lupus Erythematosus, Discoid
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Skin Diseases

ClinicalTrials.gov processed this record on September 18, 2014