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

Phase 2

Terminated

• Conditions: Discoid Lupus
• Interventions: Drug: CC-930; Drug: Placebo

• Registration Number: NCT01466725
• Lead Sponsor: Celgene

Brief Summary

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.

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 Timeline

• Study Start: 2011-11-01
• Study First Submitted: 2011-11-04
• Study First Submitted QC: 2011-11-04
• Study First Posted: 2011-11-08
• Primary Completion: 2012-07-30
• Study Completion: 2012-07-30
• Disposition First Submitted: 2013-08-16
• Disposition First Submitted QC: 2013-08-16
• Disposition First Posted: 2013-08-26
• Status Verified: 2019-11
• Last Update Submitted: 2019-11-14
• Last Update Posted: 2019-11-19

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 5

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cohort 2	Placebo	50 mg once daily for 4 weeks (8 active/2 control)
Cohort 3	CC-930	100 mg daily for 6 weeks (8 active/2 control)
Cohort 3	Placebo	100 mg daily for 6 weeks (8 active/2 control)
Cohort 4	CC-930	100 mg twice daily for 6 weeks (8 active/2 control)
Cohort 4	Placebo	100 mg twice daily for 6 weeks (8 active/2 control)
Cohort 1	CC-930	25 mg daily for 4 weeks (8 active/2 control)
Cohort 1	Placebo	25 mg daily for 4 weeks (8 active/2 control)
Cohort 2	CC-930	50 mg once daily for 4 weeks (8 active/2 control)

Primary Outcome Measures

Name	Time	Method
Number of subjects with adverse events	4 to 6 weeks

Secondary Outcome Measures

Name	Time	Method
To describe the pharmacokinetics of CC-930 in subjects with recalcitrant DLE.	18 months

Trial Locations

Locations (19)

Dermatology and Research; 🇺🇸 Dallas, Texas, United States

Advanced Pharma, CR, LLC; 🇺🇸 Miami, Florida, United States

University of Miami - Department of Dermatology; 🇺🇸 Miami, Florida, United States

Rush Medical Center; 🇺🇸 Chicago, Illinois, United States

University of Minnesota-Department of Dermatology; 🇺🇸 Minneapolis, Minnesota, United States

University of Texas Dermatology; 🇺🇸 Houston, Texas, United States

Sun Research Institute; 🇺🇸 San Antonio, Texas, United States

Boston Cancer Center; 🇺🇸 Boston, Massachusetts, United States

North Shore University Health System; 🇺🇸 Skokie, Illinois, United States

Medical Faculty Associates; 🇺🇸 Washington, District of Columbia, United States

SIU School of Medicine; 🇺🇸 Springfield, Illinois, United States

John Hopkins University; 🇺🇸 Baltimore, Maryland, United States

University of Rochester Medical Center; 🇺🇸 Rochester, New York, United States

Rhode Island Hospital University Dermatology, Inc.; 🇺🇸 Providence, Rhode Island, United States

Ohio State Univ Medical Center, Division of Dermatology; 🇺🇸 Columbus, Ohio, United States

The Regents of the University of California; 🇺🇸 Irvine, California, United States

UAB Dermatology; 🇺🇸 Birmingham, Alabama, United States

Tulane University School of Medicine; 🇺🇸 New Orleans, Louisiana, United States

Medical University of South Carolina; 🇺🇸 Charleston, South Carolina, United States