A Study of the Efficacy and Safety of MEDI-546 in Systemic Lupus Erythematosus

MedImmune

Status and phase: Completed; Phase 2

Conditions: Systemic Lupus Erythematosus

Treatments: Other: Placebo; Biological: Anifrolumab 300 mg; Biological: Anifrolumab 1000 mg

Study type: Interventional

Funder types: Industry

Identifiers

NCT01438489

CD-IA-MEDI-546-1013

Details and patient eligibility

About

The purpose of this study is to evaluate the efficacy and safety of MEDI-546 compared to placebo in subjects with chronic, moderately-to-severely active systemic lupus erythematosus (SLE) with an inadequate response to standard of care treatment for SLE.

Full description

This is a Phase 2, multinational, multicenter, randomized, double-blind, placebo controlled, parallel-group study to evaluate the efficacy and safety of 2 intravenous (IV) treatment regimens in adult participants with chronic, moderately-to-severely active SLE with an inadequate response to SOC SLE. The investigational product (anifrolumab or placebo) will be administered as a fixed dose every 4 weeks (28 days) for a total of 13 doses.

Enrollment: 626 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Fulfills at least 4 of the 11 American College of Rheumatology (ACR) criteria for systemic lupus erythematosus (SLE) including a positive antinuclear antibody (ANA) greater than or equal to 1:80 or elevated anti-double-stranded DNA or anti-Smith antibody at screening
• Pediatric or adult SLE with chronic disease activity for greater than or equal to 24 weeks
• Weight greater than or equal to 40 kg
• Currently receiving stable dose of oral prednisone (or equivalent) less than or equal to 40 mg/day and/or antimalarials/immunosuppressives
• Active moderate to severe SLE disease based on SLE disease activity score (SLEDAI) and British Isles Lupus Assessment Group Index (BILAG) and Physicians Global Assessment
• No evidence of cervical malignancy on Pap smear within 2 years of randomization
• Female participants must be willing to avoid pregnancy
• Negative tuberculosis (TB) test or newly positive TB test due to latent TB for which treatment must be initiated at or before randomization.

Exclusion criteria

• Active severe SLE-driven renal disease or unstable renal disease prior to screening
• Active severe or unstable neuropsychiatric SLE
• Clinically significant active infection including ongoing and chronic infections
• History of human immunodeficiency virus (HIV)
• Confirmed Positive tests for hepatitis B or positive test for hepatitis C
• History of severe herpes infection such as herpes encephalitis, ophthalmic herpes, disseminated herpes
• Live or attenuated vaccine within 4 weeks prior to screening
• Participants with significant hematologic abnormalities.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

626 participants in 3 patient groups, including a placebo group

Anifrolumab (MEDI-546) 300 mg

Experimental group

Description:

Participants will receive 300 milligram (mg) anifrolumab as an intravenous infusion every 4 weeks for 48 weeks.

Treatment:

Biological: Anifrolumab 300 mg

Anifrolumab (MEDI-546) 1000 mg

Experimental group

Description:

Participants will receive 1000 mg anifrolumab as an intravenous infusion every 4 weeks for 48 weeks.

Treatment:

Biological: Anifrolumab 1000 mg

Matching Placebo

Placebo Comparator group

Description:

Participants will receive placebo matched to anifrolumab intravenous (IV) infusion every 4 weeks for 48 weeks.

Treatment:

Other: Placebo