A Phase 2b, Dose-ranging Study to Evaluate the Efficacy and Safety of Sifalimumab in Adults with Systemic Lupus Erythematosus

MedImmune0 个研究点目标入组 6 人开始时间: 待定最近更新: 2021年11月24日

试验速览

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•Fulfils at least 4 of the 11 American College of Rheumatology (ACR) classification criteria for SLE, one of which must be:
•a) Significantly positive antinuclear antibody (ANA) test at screening by immunofluorescent assay (IFA) at central lab; OR
•b) Elevated anti-dsDNA or Sm antibody at screening as determined by central lab
•Disease history of SLE less or equal 24 weeks at screening
•Weight less than 40 kg Currently receiving stable dose of oral prednisone 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
•Females with an intact cervix must have no evidence of cervical malignancy documented on a Pap smear with 6 months of baseline
•Females must be willing to avoid pregnancy throughout the study including the 180 day follow-up safety period
•Negative TB test or newly positive TB test due to latent TB for which treatment must be initiated at or before randomization

•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 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
•Herpes Zoster within 3 months of screening,
•History of cancer other than basal cancer or cervical cancer treated with apparent success less or equal 1 year prior to randomization,
•Receipt of a biologic agent within 5 half-lives or prior to loss of
•pharmacodynamic and/or clinical effect (whichever is longer) prior to screening,
•Live or attenuated vaccine within 4 weeks prior to screening,
•Subjects with substance abuse,
•Subjects with significant laboratory abnormalities in the hepatic, renal or hematologic systems

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