Clinical trial NCT01300208: To Evaluate the Preliminary Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Efficacy of CC-11050 in Subjects With Discoid Lupus Erythematosus and Subacute Cutaneous Lupus Erythematosus
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Cutaneous Lupus Erythematosus
Keywords: cutaneous lupus erythematosus
subacute lupus erythematosus
discoid lupus erythematosus
lupus
Lead sponsor: Amgen
Sponsor class: INDUSTRY
First posted: 2011-02-21
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility 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

Primary outcomes:
measure: Laboratory values from chemistry, hematology, urinalysis, inflammation/immunology panel that reveal clinically significant abnormalities and that may constitute a safety concern
timeFrame: Up to 21 weeks
Secondary outcomes:
measure: Pharmacokinetics (PK)
timeFrame: Up to 21 weeks
measure: 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
timeFrame: 12 weeks
measure: Pharmacokinetics (PK)
timeFrame: Up to 21 weeks
measure: Pharmacokinetics
timeFrame: Up to 21 weeks
measure: Pharmacokinetics (PK)
timeFrame: Up to 21 weeks
measure: Pharmacokinetics (PK)
timeFrame: Up to 21 weeks
measure: Pharmacokinetics (PK)
timeFrame: Up to 21 weeks
measure: Pharmacokinetics (PK)
timeFrame: Up to 21 weeks
Other outcomes:
Locations:
city: Rogers
country: United States
facility: Northwest Arkansas Clinical Trials Center, PLLC
state: Arkansas
city: Los Angeles
country: United States
facility: Dermatology Research Associates
state: California
city: San Diego
country: United States
facility: Medderm Associates
state: California
city: Atlanta
country: United States
facility: Emory Univ. School of Medicine
state: Georgia
city: Atlanta
country: United States
facility: Peachtree Dermatology Associates Research Center
state: Georgia
city: Newnan
country: United States
facility: Central Medaphase Inc
state: Georgia
city: Chicago
country: United States
facility: Northwestern University
state: Illinois
city: Indianapolis
country: United States
facility: Dawes Fretzin Clinical Research Group, LLC
state: Indiana
city: Louisville
country: United States
facility: DermResearch, PLLC
state: Kentucky
city: Lake Charles
country: United States
facility: Dermatology & Advanced Aesthetics
state: Louisiana
city: Saint Louis
country: United States
facility: Central Dermatology, P.C.
state: Missouri
city: New York
country: United States
facility: NYU Langone Medical Center
state: New York
city: Cleveland
country: United States
facility: University Hospitals Case Medical Center
state: Ohio
city: Duncansville
country: United States
facility: Altoona Center for Clinical Research
state: Pennsylvania
city: Hershey
country: United States
facility: Penn State Hershey Dermatology
state: Pennsylvania
city: Philadelphia
country: United States
facility: Hospital of the University of Pennsylvania
state: Pennsylvania
city: Pittsburgh
country: United States
facility: University of Pittsburgh Medical Center
state: Pennsylvania
city: Johnston
country: United States
facility: Clinical Partners, LLC
state: Rhode Island
city: Dallas
country: United States
facility: UT Southwestern Medical Center Dallas
state: Texas
Study officials:
affiliation: Amgen
name: MD
role: STUDY_DIRECTOR
References: