Atacicept Phase 2/3 in Generalized Systemic Lupus Erythematosus (APRIL-SLE)
A Randomised, Double-blind, Placebo Controlled, Multicentre Prospective Dose-finding Phase II/III Study With Atacicept Given Subcutaneously to Subjects Having Recently Experienced a Flare of Systemic Lupus Erythematosus (SLE)
Sponsor: EMD Serono + Merck KGaA, Darmstadt, Germany
No open prediction endpoints
Endpoints are classified and published by ProgramSignal analysts.
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Primary Endpoints (CT.gov)
Percentage of Participants Experiencing a New Flare as Defined by British Isles Lupus Assessment Group (BILAG) Score A or B
Time frame: From screening up to Week 52
Secondary Endpoints
Time to First New Flare as Defined by BILAG Score A or B
Percentage of Participants Experiencing a New Flare as Defined by BILAG Score A or B During Initial 24 Weeks
Percentage of Participants Within Ordinal Response Categories for British Isles Lupus Assessment Group (BILAG) Flares
Eligibility Criteria
Inclusion Criteria: * Male or female 16 years of age or older * Disease history of at least six months meeting at least 4 out of the 11 American College of Rheumatology (ACR) criteria for SLE * Active SLE with at least one British Isles Lupus Assessment Group (BILAG) flare A or B at screening requiring a change in the dose of corticosteroids * Positive antinuclear antibody (ANA) or anti-double-stranded deoxyribonucleic acid (dsDNA) at screening * Female subjects must be willing to avoid pregnancy by using an adequate method of contraception for 4 weeks prior to Study Day 1, during the trial and 24 weeks after the last dose of study medication * Other protocol defined inclusion criteria could apply Exclusion Criteria: * Active moderate to severe glomerulonephritis (kidney impairment) as defined in the protocol * Active central nervous system SLE deemed to be severe/progressive and/or associated with significant cognitive impairment leading to inability to provide informed consent and…
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