An Open-label Study to Evaluate the Long-term Safety of MEDI-546, for the Treatment of SLE, in Adults

MedImmune

Status and phase: Completed; Phase 2

Conditions: Lupus Erythematosus, Systemic

Treatments: Biological: Anifrolumab

Study type: Interventional

Funder types: Industry

Identifiers

NCT01753193

CD-IA-MEDI-546-1145

2012-004619-30 (EudraCT Number)

Details and patient eligibility

About

The purpose of this study is to evaluate the long-term safety of anifrolumab (MEDI-546) in adults with moderate to severe active systemic lupus erythematosus (SLE).

Full description

This is an open-label extension study to evaluate long-term safety and tolerability of intravenous (IV) anifrolumab in adult participants with moderately-to-severely active SLE. Participants must have completed the qualifying Phase 2 study and meet this study criteria in order to be eligible.

Enrollment: 218 patients

Sex: All

Ages: 18 to 68 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Must be willing to use 2 methods of effective contraception
• Must have venous access
• Must be willing to forego participation in other clinical trials for SLE.

Exclusion criteria

• Any concurrent condition that in the opinion of the investigator would interfere with the evaluation of the investigational product
• Major surgery within 8 weeks before signing informed consent form (ICF)
• Elective major surgery planned during the study period
• Concomitant Medications within the last 12 weeks: Azathioprine > 200 mg/day, Mycophenolate mofetil/mycophenolic acid > 2.0 g/day, oral, subcutaneous, or intramuscular methotrexate > 25 mg/week
• A live or attenuated vaccine within 4 weeks of signing the ICF
• Bacillus of Calmette and Guérin (BCG) vaccine within 1 year of ICF

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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218 participants in 1 patient group

Anifrolumab

Experimental group

Description:

Participants will receive IV infusion of anifrolumab 1000 milligrams (mg) every 4 weeks (Q4W) from Day 1 (Week 0) until 12-Feb-2015 (approval of protocol amendment 4); and thereafter will receive 300 mg Q4W for up to 3 years or until the sponsor discontinued development of anifrolumab, whichever came first.

Treatment:

Biological: Anifrolumab