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

Study Overview
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Brief Summary
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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
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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

Official Title
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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)

Conditions
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Discoid Lupus

Intervention / Treatment
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* Drug: CC-930
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or female with clinical diagnosis of Discoid Lupus Erythematosus (DLE) aged 18 to 64 years Good health as assessed by Investigator DLE for at least 16 weeks prior to screening and consistent histological findings. Considered a candidate for systemic therapy. May be naïve to systemic therapy or experiencing incomplete or refractory disease on systemic therapy. Cutaneous Lupus Area and Severity Index (CLASI) activity score of at least 10, as determined by investigator. Subjects using hydroxychloroquine, chloroquine, or quinacrine must have documented ophthalmologic exam within 24 weeks of baseline visit. Must meet laboratory criteria for white blood cells, absolute neutrophils, platelets, serum creatinine, aspartate aminotransferase (AST), alanine aminotransferase (ALT), bilirubin and hemoglobin. Subjects, male and female, must agree to strict pregnancy prevention and testing requirements. Exclusion Criteria: Significant illnesses as determined by physician. History of significant cardiac conditions or interventions within prior 6 months including abnormal electrocardiogram (ECG) findings. Systolic blood pressure < 95 or > 150 mm Hg Diastolic blood pressure > 90 mm Hg. Pregnancy or breast feeding. Other dermatological conditions that would interfere with CLASI Activity Score assessments. History of or active; malignancy, human immunodeficiency virus (HIV), tuberculosis infection, other mycobacterial infection, congenital or acquired immunodeficiency, Hepatitis B and C. Clinically significant abnormality on chest X-ray. Participation in multiple CC-930 cohorts. History of thrombolytic event. Positive tests for lupus anticoagulant, anti-cardiolipin antibodies, antibodies to beta-2 glycoprotein 1 or phosphatidylserine at screening. Positive antineutrophilic cytoplasmic antibody (ANCA) at screening. Diagnosis of SLE. Presence or history of medically significant Systemic Lupus Erythematosis (SLE) or Lupus Erythematosis (LE) comorbidities. History of seizures, chorea or psychosis. Presence or history of persistent proteinuria or urinary cellular casts. Prohibited prior or concomitant medications.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 64 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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DLE, Lupus, Discoid Lupus, Cutaneous Lupus