A randomised, double-blind, placebo-controlled,multicentre prospective dose-finding Phase II/III studywith atacicept given subcutaneously to subjects havingrecently experienced a flare of systemic lupuserythematosus (SLE) - Atacicept in generalised SLE, Phase II/III(APRIL SLE)

Merck BV - An affiliate of Merck Serono S.A.0 个研究点目标入组 34 人开始时间: 待定最近更新: 2024年2月28日

研究概览

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•Complete lists of inclusion and exclusion criteria may be found in Section 5.2.;The trial will enrol subjects from 16 years old of either gender who have a diagnosis of SLE satisfying at least 4 of the 11 ACR criteria and a disease history of at least six months. Eligible subjects must have active SLE with at least one BILAG A or B score at screening (excluding a single B due to haematological values) requiring a change in the dose of corticosteroids, and must have a positive antinuclear antibody (ANA) test (HEp-2 ANA 1:80 and/or anti-dsDNA 30 IU/mL) at the initial screening visit.

•Complete lists of inclusion and exclusion criteria may be found in Section 5.2.;Subjects who have active moderate to severe glomerulonephritis will be excluded, as will those who have received any treatment with rituximab, abatacept or belimumab, those who have initiated new immunosuppressive drugs or have used cyclophosphamide, calcineurin inhibitors or investigational treatments within specified periods before screening, those who have had introduction of or increases in treatment regimen of azathioprine, mycophenolate mofetil, hydroxychloroquine, chloroquine or methotrexate within 2 months before the
•screening visit, and those who have clinically significant abnormalities on screening
•laboratory tests, or who have any condition that in the Investigator*s opinion constitutes a risk or a contraindication for participation to the trial or that could interfere with the trial objectives, conduct or evaluation.
•Pregnant women and breastfeeding women will also be excluded.
•History of any demyelinating disease, such as MS or ON.

发起方

Merck BV - An affiliate of Merck Serono S.A.