A Phase 2, Randomized Study to Evaluate the Efficacy and Safety of MEDI-546 in Subjects with SystemicLupus Erythematosus

MedImmune LLC a member of the AstraZeneca Group of0 个研究点目标入组 300 人开始时间: 待定最近更新: 2021年11月24日

试验速览

暂无简介。

•1.Fulfills at least 4 of the 11 American College of Rheumatology (ACR) criteria for systemic lupus erythematotus (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
•2.Pediatric or adult SLE with chronic disease activity for greater than or equal to 24 weeks
•3. Weight greater than or equal to 40 kg
•4. •Currently receiving stable dose of oral prednisone (or equivalent) less than or equal to 40 mg/day and/or antimalarials/immunosuppressives
•5.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
•6. No evidence of cervical malignancy on Pap smear within 2 years of randomization
•7.Female subjects must be willing to avoid pregnancy
•8. Negative tuberculosis (TB) test or newly positive TB test due to latent TB for which treatment must be initiated at or before randomization

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

发起方

MedImmune LLC a member of the AstraZeneca Group of