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

Anthera Pharmaceuticals

Status and phase: Completed; Phase 2

Conditions: Systemic Lupus Erythematosus

Treatments: Drug: A-623

Study type: Interventional

Funder types: Industry

Identifiers

NCT01305746

AN-SLE3322

Details and patient eligibility

About

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

Enrollment: 382 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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382 participants in 3 patient groups

A-623 high dose weekly

Experimental group

Description:

High dose given subcutaneously once a week until A623 is approved for clinical use in SLE or the Sponsor discontinues the study

Treatment:

Drug: A-623

Drug: A-623

Drug: A-623

A-623 low dose weekly

Experimental group

Description:

Low dose given subcutaneously once a week until A623 is approved for clinical use in SLE or the Sponsor discontinues the study

Treatment:

Drug: A-623

Drug: A-623

Drug: A-623

A-623 high dose every 4 weeks

Experimental group

Description:

High dose given subcutaneously once every 4 weeks until A623 is approved for clinical use in SLE or the Sponsor discontinues the study

Treatment:

Drug: A-623

Drug: A-623

Drug: A-623