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

Phase 2
Completed
Conditions
Systemic Lupus Erythematosus
Interventions
Registration Number
NCT01305746
Lead Sponsor
Anthera Pharmaceuticals
Brief Summary

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

Detailed Description

Not available

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
382
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

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
A-623 high dose weeklyA-623High dose given subcutaneously once a week until A623 is approved for clinical use in SLE or the Sponsor discontinues the study
A-623 low dose weeklyA-623Low dose given subcutaneously once a week until A623 is approved for clinical use in SLE or the Sponsor discontinues the study
A-623 high dose every 4 weeksA-623High dose given subcutaneously once every 4 weeks until A623 is approved for clinical use in SLE or the Sponsor discontinues the study
Primary Outcome Measures
NameTimeMethod
To assess the long term safety of A-623 in subjects with SLEUntil the drug is approved or the Sponsor discontinues the study

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

Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (71)

Investigator Site 103

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Birmingham, Alabama, United States

Investigator Site 113

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Long Beach, California, United States

Investigator Site 110

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Upland, California, United States

Investigator Site 105

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Orlando, Florida, United States

Investigator Site 102

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Tampa, Florida, United States

Investigator Site 117

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Baltimore, Maryland, United States

Investigator Site 104

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Lansing, Michigan, United States

Investigator Site 106

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Lake Success, New York, United States

Investigator Site 114

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Smithtown, New York, United States

Investigator Site 101

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Greenville, North Carolina, United States

Scroll for more (61 remaining)
Investigator Site 103
🇺🇸Birmingham, Alabama, United States

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