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.

Study Overview

• Status: Completed
• Conditions: Cutaneous Lupus Erythematosus
• Intervention / Treatment: Other: Placebo; Drug: CC-11050

• Study Type: Interventional
• Enrollment (Actual): 48
• Phase: Phase 2

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Cohort 1; CC-11050 (50 milligrams twice per day and Placebo)	Other: 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)	Other: 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)	Other: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Laboratory values from chemistry, hematology, urinalysis, inflammation/immunology panel that reveal clinically significant abnormalities and that may constitute a safety concern	Up to 21 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pharmacokinetics (PK)	To describe the area under the curve (AUC) of CC-11050 and M15 in plasma	Up to 21 weeks
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		12 weeks
Pharmacokinetics (PK)	To describe the peak serum concentration (Cmax) of CC-11050 and M15 in plasma	Up to 21 weeks
Pharmacokinetics	To describe the lowest serum concentration (Cmin)of CC-11050 and M15 in plasma	Up to 21 weeks
Pharmacokinetics (PK)	To describe the time after administration of a drug when the maxiumum plasma concentration is reached (tmax) of CC-11050 and M15 in plasma	Up to 21 weeks
Pharmacokinetics (PK)	To describe the half life (t1/2) of CC-11050 and M15 in plasma	Up to 21 weeks
Pharmacokinetics (PK)	To describe the oral clearance (CL/F) of CC-11050 and M15 in plasma	Up to 21 weeks
Pharmacokinetics (PK)	To describe the volume of distribution (Vz/F) of CC-11050 and M15 in plasma	Up to 21 weeks

Collaborators and Investigators

• Sponsor: Amgen

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2010
• Primary Completion (Actual): January 1, 2013
• Study Completion (Actual): March 1, 2013

Study Registration Dates

• First Submitted: October 18, 2010
• First Submitted That Met QC Criteria: February 17, 2011
• First Posted (Estimate): February 21, 2011

Study Record Updates

• Last Update Posted (Actual): June 23, 2020
• Last Update Submitted That Met QC Criteria: June 18, 2020
• Last Verified: June 1, 2020

More Information

Terms related to this study

• Keywords: lupus; cutaneous lupus erythematosus; discoid lupus erythematosus; subacute lupus erythematosus
• Additional Relevant MeSH Terms: Skin Diseases; Immune System Diseases; Autoimmune Diseases; Connective Tissue Diseases; Lupus Erythematosus, Systemic; Lupus Erythematosus, Cutaneous; Lupus Erythematosus, Discoid; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Phosphodiesterase Inhibitors; Phosphodiesterase 4 Inhibitors; CC-11050
• Other Study ID Numbers: CC-11050-CLE-002