A Research Study to Assess if CC-930 is Safe in Treating Subjects With Discoid Lupus Erythematosus

A Phase 2, Pilot, Multicenter, Randomized, Placebo-Controlled Sequential, Ascending Dose Study to Characterize the Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Activity of CC-930 in Subjects With Recalcitrant Discoid Lupus Erythematosus (DLE)

The purpose of the study is to assess if CC-930 is safe and tolerable in treating subjects with Discoid Lupus Erythematosus. Pharmacokinetic and pharmacodynamics will also be evaluated.

Study Overview

• Status: Terminated
• Conditions: Discoid Lupus
• Intervention / Treatment: Drug: Placebo; Drug: CC-930

Detailed Description

Enrollment will occur in sequential, ascending, dose-sequence design, where a higher CC-930 dose level and longer duration of dosing (cohort) will not be initiated until supportive safety profile is demonstrated in the preceding cohort. There will be 4 cohorts as described here;

Cohort 1: 25 mg once daily for 4 weeks Cohort 2: 50 mg once daily for 4 weeks Cohort 3: 100 mg once daily for 6 weeks Cohort 4: 100 mg twice daily for 6 weeks

• Study Type: Interventional
• Enrollment (Actual): 5
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States, 35233
      • UAB Dermatology
  • California
    • Irvine, California, United States, 92697
      • The Regents of the University of California
  • District of Columbia
    • Washington, District of Columbia, United States, 20037
      • Medical Faculty Associates
  • Florida
    • Miami, Florida, United States, 33136
      • Advanced Pharma, CR, LLC
    • Miami, Florida, United States, 33136
      • University of Miami - Department of Dermatology
  • Illinois
    • Chicago, Illinois, United States, 60612
      • Rush Medical Center
    • Skokie, Illinois, United States, 60077
      • North Shore University Health System
    • Springfield, Illinois, United States, 62702
      • SIU School of Medicine
  • Louisiana
    • New Orleans, Louisiana, United States, 70112
      • Tulane University School of Medicine
  • Maryland
    • Baltimore, Maryland, United States, 21205
      • John Hopkins University
  • Massachusetts
    • Boston, Massachusetts, United States, 02118
      • Boston Cancer Center
  • Minnesota
    • Minneapolis, Minnesota, United States, 55455
      • University of Minnesota-Department of Dermatology
  • New York
    • Rochester, New York, United States, 14623
      • University of Rochester Medical Center
  • Ohio
    • Columbus, Ohio, United States, 43221
      • Ohio State Univ Medical Center, Division of Dermatology
  • Rhode Island
    • Providence, Rhode Island, United States, 02903
      • Rhode Island Hospital University Dermatology, Inc.
  • South Carolina
    • Charleston, South Carolina, United States, 29425
      • Medical University of South Carolina
  • Texas
    • Dallas, Texas, United States, 75230
      • Dermatology and Research
    • Houston, Texas, United States, 77030
      • University of Texas Dermatology
    • San Antonio, Texas, United States, 78215
      • Sun Research Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 64 years (ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Male or female with clinical diagnosis of Discoid Lupus Erythematosus (DLE) aged 18 to 64 years
2. Good health as assessed by Investigator
3. DLE for at least 16 weeks prior to screening and consistent histological findings.
4. Considered a candidate for systemic therapy. May be naïve to systemic therapy or experiencing incomplete or refractory disease on systemic therapy.
5. Cutaneous Lupus Area and Severity Index (CLASI) activity score of at least 10, as determined by investigator.
6. Subjects using hydroxychloroquine, chloroquine, or quinacrine must have documented ophthalmologic exam within 24 weeks of baseline visit.
7. Must meet laboratory criteria for white blood cells, absolute neutrophils, platelets, serum creatinine, aspartate aminotransferase (AST), alanine aminotransferase (ALT), bilirubin and hemoglobin.
8. Subjects, male and female, must agree to strict pregnancy prevention and testing requirements.

Exclusion Criteria:

1. Significant illnesses as determined by physician.
2. History of significant cardiac conditions or interventions within prior 6 months including abnormal electrocardiogram (ECG) findings.
3. Systolic blood pressure < 95 or > 150 mm Hg
4. Diastolic blood pressure > 90 mm Hg.
5. Pregnancy or breast feeding.
6. Other dermatological conditions that would interfere with CLASI Activity Score assessments.
7. History of or active; malignancy, human immunodeficiency virus (HIV), tuberculosis infection, other mycobacterial infection, congenital or acquired immunodeficiency, Hepatitis B and C.
8. Clinically significant abnormality on chest X-ray.
9. Participation in multiple CC-930 cohorts.
10. History of thrombolytic event.
11. Positive tests for lupus anticoagulant, anti-cardiolipin antibodies, antibodies to beta-2 glycoprotein 1 or phosphatidylserine at screening.
12. Positive antineutrophilic cytoplasmic antibody (ANCA) at screening.
13. Diagnosis of SLE.
14. Presence or history of medically significant Systemic Lupus Erythematosis (SLE) or Lupus Erythematosis (LE) comorbidities.
15. History of seizures, chorea or psychosis.
16. Presence or history of persistent proteinuria or urinary cellular casts.
17. Prohibited prior or concomitant medications.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Cohort 1; 25 mg daily for 4 weeks (8 active/2 control)	Drug: Placebo; Placebo; Drug: CC-930
EXPERIMENTAL: Cohort 2; 50 mg once daily for 4 weeks (8 active/2 control)	Drug: Placebo; Placebo; Drug: CC-930
EXPERIMENTAL: Cohort 3; 100 mg daily for 6 weeks (8 active/2 control)	Drug: Placebo; Placebo; Drug: CC-930
EXPERIMENTAL: Cohort 4; 100 mg twice daily for 6 weeks (8 active/2 control)	Drug: Placebo; Placebo; Drug: CC-930

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Number of subjects with adverse events	4 to 6 weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
To describe the pharmacokinetics of CC-930 in subjects with recalcitrant DLE.	18 months

Collaborators and Investigators

• Sponsor: Celgene
• Investigators: Study Director: William Smith, MD, Celgene

Study record dates

Study Major Dates

• Study Start (ACTUAL): November 1, 2011
• Primary Completion (ACTUAL): July 30, 2012
• Study Completion (ACTUAL): July 30, 2012

Study Registration Dates

• First Submitted: November 4, 2011
• First Submitted That Met QC Criteria: November 4, 2011
• First Posted (ESTIMATE): November 8, 2011

Study Record Updates

• Last Update Posted (ACTUAL): November 19, 2019
• Last Update Submitted That Met QC Criteria: November 14, 2019
• Last Verified: November 1, 2019

More Information

Terms related to this study

• Keywords: Lupus; Discoid Lupus; Cutaneous Lupus; DLE
• Additional Relevant MeSH Terms: Skin Diseases; Connective Tissue Diseases; Lupus Erythematosus, Cutaneous; Lupus Erythematosus, Discoid
• Other Study ID Numbers: CC-930-DLE-002