PEARL-SC Trial: A Study of the Efficacy, Safety, and Tolerability of A 623 Administration in Subjects With Systemic Lupus Erythematosus

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the efficacy, safety and tolerability of three different doses of A-623 administered in addition to standard therapy in subjects with active SLE disease

Official Title
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A Randomized, Double-Blind Phase 2b Study to Evaluate the Efficacy, Safety, and Tolerability of A 623 Administration in Subjects With Systemic Lupus Erythematosus

Conditions
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Systemic Lupus Erythematosus

Intervention / Treatment
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* Drug: A-623
* Drug: A-623
* Drug: A-623
* Other: Placebo Comparator


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosis of SLE by American College of Rheumatology guidelines. On stable SLE treatment Active SLE disease Serologically active 18 years of age or older Receiving stable doses of prednisone between 7.5 mg and 40 mg per day Exclusion Criteria: Severe active vasculitis, active central nervous system lupus, active lupus nephritis, uncontrolled hypertension, or uncontrolled diabetes. Known to be positive for HIV and/or positive at the screening visit for hepatitis B, or hepatitis C. Liver disease. Anemia, neutropenia, or thrombocytopenia. Malignancy within past 5 years Active infection requiring hospitalization or treatment with parenteral antibiotics within the past 60 days or history of repeated herpetic viral infections. History of active tuberculosis or a history of tuberculosis infection. Participation in the active treatment arm of any Phase 2 or Phase 3 clinical trial for a molecule that primarily targets the B cell pathway in the past 18 months. Prior administration of any B cell depleting therapy in the past 18 months. Pregnant or nursing History of congenital immunodeficiency

Ages Eligible for Study
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Minimum Age: 18 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: A-623 high dose weekly<br> | Drug: A-623<br>* High dose given subcutaneously once a week for up to 52 weeks<br>|
| Experimental: A-623 low dose weekly<br> | Drug: A-623<br>* Low dose given subcutaneously once a week for up to 52 weeks<br>|
| Experimental: A-623 high dose every 4 weeks<br> | Drug: A-623<br>* High dose given subcutaneously once every 4 weeks for up to 52 weeks<br>|
| Placebo Comparator: Placebo<br> | Other: Placebo Comparator<br>* Placebo comparator is a matched volume given subcutaneously once a week or once every 4 weeks for up to 52 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| SLE response | The % of subjects with SLE response compared with baseline at the time of assessment | Various timepoints through Week 52 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| B cell reduction |  | Various timepoints through Week 52 | 
| Time to first flare |  | Various timepoints through Week 52 | 
| FACIT-fatigue score |  | Various timepoints through Week 52 | 
| Reduction in prednisone dose |  | Various timepoints through Week 52 | 
| Change in IgG, IgM,C3 and C4 |  | Various timepoints through Week 52 | 
| Flare rates |  | Various timepoints through Week 52 | 
| SRI, using improvements of SELENA-SLEDAI of 5, 6, 7, 8 and 9 |  | Various timepoints through Week 52 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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SLE, Lupus, Lupus Erythematosus, Systemic, Autoimmune Diseases, A-623, Blisibimod