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

This study has been terminated.
(The benefit/risk profile does not support continuation of this study.)
Sponsor:
Information provided by (Responsible Party):
Celgene Corporation
ClinicalTrials.gov Identifier:
NCT01466725
First received: November 4, 2011
Last updated: August 16, 2013
Last verified: August 2013
  Purpose

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.


Condition Intervention Phase
Discoid Lupus
Drug: CC-930
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: 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)

Resource links provided by NLM:


Further study details as provided by Celgene Corporation:

Primary Outcome Measures:
  • Number of subjects with adverse events [ Time Frame: 4 to 6 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • To describe the pharmacokinetics of CC-930 in subjects with recalcitrant DLE. [ Time Frame: 18 months ] [ Designated as safety issue: No ]

Enrollment: 5
Study Start Date: November 2011
Study Completion Date: July 2012
Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Cohort 1
25 mg daily for 4 weeks (8 active/2 control)
Drug: CC-930
Cohort 1: 25 mg orally once daily for 4 weeks Cohort 2: 50 mg orally once daily for 4 weeks Cohort 3: 100 mg orally once daily for 6 weeks Cohort 4: 100 mg orally twice daily for 6 weeks
Drug: Placebo
Placebo
Experimental: Cohort 2
50 mg once daily for 4 weeks (8 active/2 control)
Drug: CC-930
Cohort 1: 25 mg orally once daily for 4 weeks Cohort 2: 50 mg orally once daily for 4 weeks Cohort 3: 100 mg orally once daily for 6 weeks Cohort 4: 100 mg orally twice daily for 6 weeks
Drug: Placebo
Placebo
Experimental: Cohort 3
100 mg daily for 6 weeks (8 active/2 control)
Drug: CC-930
Cohort 1: 25 mg orally once daily for 4 weeks Cohort 2: 50 mg orally once daily for 4 weeks Cohort 3: 100 mg orally once daily for 6 weeks Cohort 4: 100 mg orally twice daily for 6 weeks
Drug: Placebo
Placebo
Experimental: Cohort 4
100 mg twice daily for 6 weeks (8 active/2 control)
Drug: CC-930
Cohort 1: 25 mg orally once daily for 4 weeks Cohort 2: 50 mg orally once daily for 4 weeks Cohort 3: 100 mg orally once daily for 6 weeks Cohort 4: 100 mg orally twice daily for 6 weeks
Drug: Placebo
Placebo

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

  Eligibility

Ages Eligible for Study:   18 Years to 64 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01466725

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

No publications provided

Responsible Party: Celgene Corporation
ClinicalTrials.gov Identifier: NCT01466725     History of Changes
Other Study ID Numbers: CC-930-DLE-002
Study First Received: November 4, 2011
Last Updated: August 16, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Celgene Corporation:
Lupus
Discoid Lupus
DLE
Cutaneous Lupus

Additional relevant MeSH terms:
Lupus Erythematosus, Discoid
Lupus Erythematosus, Systemic
Lupus Erythematosus, Cutaneous
Connective Tissue Diseases
Skin Diseases
Autoimmune Diseases
Immune System Diseases

ClinicalTrials.gov processed this record on August 21, 2014