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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

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.
 
ClinicalTrials.gov Identifier: NCT01300208
Recruitment Status : Completed
First Posted : February 21, 2011
Last Update Posted : June 23, 2020
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Cutaneous Lupus Erythematosus Drug: CC-11050 Other: Placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 48 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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
Actual Study Start Date : October 1, 2010
Actual Primary Completion Date : January 1, 2013
Actual Study Completion Date : March 1, 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lupus

Arm Intervention/treatment
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

Other: Placebo
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

Other: Placebo
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

Other: Placebo



Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. Pharmacokinetics (PK) [ Time Frame: Up to 21 weeks ]
    To describe the area under the curve (AUC) of CC-11050 and M15 in plasma

  2. 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 ]
  3. Pharmacokinetics (PK) [ Time Frame: Up to 21 weeks ]
    To describe the peak serum concentration (Cmax) of CC-11050 and M15 in plasma

  4. Pharmacokinetics [ Time Frame: Up to 21 weeks ]
    To describe the lowest serum concentration (Cmin)of CC-11050 and M15 in plasma

  5. 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

  6. Pharmacokinetics (PK) [ Time Frame: Up to 21 weeks ]
    To describe the half life (t1/2) of CC-11050 and M15 in plasma

  7. Pharmacokinetics (PK) [ Time Frame: Up to 21 weeks ]
    To describe the oral clearance (CL/F) of CC-11050 and M15 in plasma

  8. Pharmacokinetics (PK) [ Time Frame: Up to 21 weeks ]
    To describe the volume of distribution (Vz/F) of CC-11050 and M15 in plasma



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01300208


Locations
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Sponsors and Collaborators
Amgen
Investigators
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Study Director: MD Amgen
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Responsible Party: Amgen
ClinicalTrials.gov Identifier: NCT01300208    
Other Study ID Numbers: CC-11050-CLE-002
First Posted: February 21, 2011    Key Record Dates
Last Update Posted: June 23, 2020
Last Verified: June 2020
Keywords provided by Amgen:
cutaneous lupus erythematosus
subacute lupus erythematosus
discoid lupus erythematosus
lupus
Additional relevant MeSH terms:
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Lupus Erythematosus, Systemic
Lupus Erythematosus, Cutaneous
Lupus Erythematosus, Discoid
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Skin Diseases