A Trial for Subjects With Systemic Lupus Erythematosus Who Have Completed Protocol AN-SLE3321

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the long-term safety of A-623 in subjects with SLE.

Official Title
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An Open-Label Long-term Safety Extension Trial for Subjects With Systemic Lupus Erythematosus Who Have Completed Protocol AN-SLE3321 (PEARL-SC)

Conditions
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Systemic Lupus Erythematosus

Intervention / Treatment
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* Drug: A-623
* Drug: A-623
* Drug: A-623


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Completed the treatment period specified in study AN-SLE3321 or were enrolled in study AN-SLE3321 prior to November 30, 2010 Exclusion Criteria: Developed a new medical disease or condition that has made the subject unsuitable for this study in the opinion of the Investigator, including interference with written informed consent, study evaluation, completion, and/or procedures Pregnant or nursing Any prior administration of a B-cell modulating therapy other than A-623 Received cyclophosphamide, cyclosporine, anti-TNF alpha therapies, transfusion, plasmapheresis or plasma exchange, IV immunoglobulin, or live vaccines according to listed wash-out periods

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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: A-623 high dose weekly<br>High dose given subcutaneously once a week until A623 is approved for clinical use in SLE or the Sponsor discontinues the study | Drug: A-623<br>* High dose given subcutaneously once a week until A623 is approved for clinical use in SLE or the Sponsor discontinues the study<br>|
| Experimental: A-623 low dose weekly<br>Low dose given subcutaneously once a week until A623 is approved for clinical use in SLE or the Sponsor discontinues the study | Drug: A-623<br>* Low dose given subcutaneously once a week until A623 is approved for clinical use in SLE or the Sponsor discontinues the study<br>|
| Experimental: A-623 high dose every 4 weeks<br>High dose given subcutaneously once every 4 weeks until A623 is approved for clinical use in SLE or the Sponsor discontinues the study | Drug: A-623<br>* High dose given subcutaneously once every 4 weeks until A623 is approved for clinical use in SLE or the Sponsor discontinues the study<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To assess the long term safety of A-623 in subjects with SLE | Safety assessments such as AEs, SAEs, vital signs, ECG, clinical chemistry, hematology, and immunogenicity will be analyzed in a descriptive manner and will include infections, malignancies, injection site reactions and immunogenicity, neuropsychiatric events, and deaths | Until the drug is approved or the Sponsor discontinues the study | 

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