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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)


Phase 2
18 Years
64 Years
Not Enrolling
Both
Discoid Lupus

Thank you

Trial Information

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)


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


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.

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Number of subjects with adverse events

Outcome Time Frame:

4 to 6 weeks

Safety Issue:

Yes

Principal Investigator

Tong Li, MD

Investigator Role:

Study Director

Investigator Affiliation:

Celgene Corporation

Authority:

United States: Food and Drug Administration

Study ID:

CC-930-DLE-002

NCT ID:

NCT01466725

Start Date:

November 2011

Completion Date:

April 2013

Related Keywords:

  • Discoid Lupus
  • Lupus
  • Discoid Lupus
  • DLE
  • Cutaneous Lupus
  • Lupus Erythematosus, Discoid
  • Lupus Erythematosus, Systemic

Name

Location

SIU School of MedicineSpringfield, Illinois  62702
Medical University of South CarolinaCharleston, South Carolina  29425-0721
Tulane University School of MedicineNew Orleans, Louisiana  70112
University of Rochester Medical CenterRochester, New York  14642
Rush Medical CenterChicago, Illinois  60612
John Hopkins UniversityBaltimore, Maryland  21231
UAB DermatologyBirmingham, Alabama  35233
The Regents of the University of CaliforniaIrvine, California  92697
Medical Faculty AssociatesWashington, D.C., District of Columbia  20037
Advanced Pharma, CR, LLCMiami, Florida  33136
University of Miami - Department of DermatologyMiami, Florida  33136
North Shore University Health SystemSkokie, Illinois  60077
Boston Cancer CenterBoston, Massachusetts  02118
University of Minnesota-Department of DermatologyMinneapolis, Minnesota  55455
Ohio State Univ Medical Center, Division of DermatologyColumbus, Ohio  43221
Rhode Island Hospital University Dermatology, Inc.Providence, Rhode Island  02903
Dermatology and ResearchDallas, Texas  75230
University of Texas DermatologyHouston, Texas  77030
Sun Research InstituteSan Antonio, Texas  78215