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

Discoid Lupus Clinical Trial

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)

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01466725
• Other study ID #: CC-930-DLE-002
• Status: Terminated
• Phase: Phase 2
• Start date: November 1, 2011
• Est. completion date: July 30, 2012

Study information

• Verified date: November 2019
• Source: Celgene
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 5
• Est. completion date: July 30, 2012
• Est. primary completion date: July 30, 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 64 Years

Eligibility

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.

Related Conditions & MeSH terms

• Discoid Lupus
• Lupus Erythematosus, Discoid

Intervention

Drug:
• CC-930

• Placebo
Placebo

Locations

Country	Name	City	State
United States	John Hopkins University	Baltimore	Maryland
United States	UAB Dermatology	Birmingham	Alabama
United States	Boston Cancer Center	Boston	Massachusetts
United States	Medical University of South Carolina	Charleston	South Carolina
United States	Rush Medical Center	Chicago	Illinois
United States	Ohio State Univ Medical Center, Division of Dermatology	Columbus	Ohio
United States	Dermatology and Research	Dallas	Texas
United States	University of Texas Dermatology	Houston	Texas
United States	The Regents of the University of California	Irvine	California
United States	Advanced Pharma, CR, LLC	Miami	Florida
United States	University of Miami - Department of Dermatology	Miami	Florida
United States	University of Minnesota-Department of Dermatology	Minneapolis	Minnesota
United States	Tulane University School of Medicine	New Orleans	Louisiana
United States	Rhode Island Hospital University Dermatology, Inc.	Providence	Rhode Island
United States	University of Rochester Medical Center	Rochester	New York
United States	Sun Research Institute	San Antonio	Texas
United States	North Shore University Health System	Skokie	Illinois
United States	SIU School of Medicine	Springfield	Illinois
United States	Medical Faculty Associates	Washington	District of Columbia

Sponsors (1)

Lead Sponsor	Collaborator
Celgene

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of subjects with adverse events		4 to 6 weeks
Secondary	To describe the pharmacokinetics of CC-930 in subjects with recalcitrant DLE.		18 months