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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:
ClinicalTrials.gov Identifier:
NCT01300208
First Posted: February 21, 2011
Last Update Posted: May 25, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Celgene Corporation
October 18, 2010
February 21, 2011
May 25, 2016
October 2010
January 2013   (Final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT01300208 on ClinicalTrials.gov Archive Site
  • Pharmacokinetics (PK) [ Time Frame: 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 [ Time Frame: 12 weeks ]
  • Pharmacokinetics (PK) [ Time Frame: Up to 21 weeks ]
    To describe the peak serum concentration (Cmax) of CC-11050 and M15 in plasma
  • Pharmacokinetics [ Time Frame: Up to 21 weeks ]
    To describe the lowest serum concentration (Cmin)of CC-11050 and M15 in plasma
  • Pharmacokinetics (PK) [ Time Frame: Up to 21 weeks ]
    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 ]
    To describe the half life (t1/2) of CC-11050 and M15 in plasma
  • Pharmacokinetics (PK) [ Time Frame: Up to 21 weeks ]
    To describe the oral clearance (CL/F) of CC-11050 and M15 in plasma
  • Pharmacokinetics (PK) [ Time Frame: Up to 21 weeks ]
    To describe the volume of distribution (Vz/F) of CC-11050 and M15 in plasma
Same as current
Not Provided
Not Provided
 
To Evaluate the Preliminary Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Efficacy of CC-11050 in Subjects With Discoid Lupus Erythematosus and Subacute Cutaneous Lupus Erythematosus
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
This is the first study in cutaneous lupus erythematosus subjects to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and efficacy of CC-11050.
Not Provided
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Cutaneous Lupus Erythematosus
  • 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
  • Other: Placebo
  • Experimental: Cohort 1
    CC-11050 (50 milligrams twice per day and Placebo)
    Interventions:
    • Drug: CC-11050
    • Other: Placebo
  • Experimental: Cohort 2
    CC-11050 (100 milligrams twice per day and Placebo)
    Interventions:
    • Drug: CC-11050
    • Other: Placebo
  • Experimental: Cohort 3
    CC-11050 (200 milligrams twice per day and Placebo)
    Interventions:
    • Drug: CC-11050
    • Other: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
48
March 2013
January 2013   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01300208
CC-11050-CLE-002
Yes
Not Provided
Not Provided
Celgene Corporation
Celgene Corporation
Not Provided
Study Director: Tong Li, MD Celgene Corporation
Celgene Corporation
April 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP