Atacicept Phase 2/3 in Generalized Systemic Lupus Erythematosus (APRIL-SLE)

Merck KGaA (EMD Serono)

Status and phase: Completed; Phase 3; Phase 2

Conditions: Lupus Erythematosus, Systemic

Treatments: Drug: Atacicept 150 mg; Drug: Atacicept 75 mg; Other: Placebo Comparator

Study type: Interventional

Funder types: Industry

Identifiers

NCT00624338

27646

Details and patient eligibility

About

This study is to evaluate the efficacy and safety of atacicept compared to placebo in preventing new flares in subjects with systemic lupus erythematosus (SLE) and to confirm the optimal dose of atacicept for treatment of subjects with SLE and gain information on the effect of atacicept on markers specific to its mechanism of action (MoA) and their correlation to disease activity/progression. Study medication will be administered through subcutaneous (under the skin) injections, beginning with twice weekly injections for the first 4 weeks, followed by once weekly doses for 48 weeks. Following the last treatment, a safety follow-up period of 24 weeks will be conducted.

Enrollment: 461 patients

Sex: All

Ages: 16+ years old

Volunteers: No Healthy Volunteers

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/or comply with the protocol
• Previous treatment with rituximab, abatacept, or belimumab
• History of demyelinating disease such as multiple sclerosis (MS) or optic neuritis
• Other protocol defined exclusion criteria could apply

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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461 participants in 3 patient groups, including a placebo group

Atacicept 75 mg

Experimental group

Treatment:

Drug: Atacicept 75 mg

Atacicept 150 mg

Experimental group

Treatment:

Drug: Atacicept 150 mg

Placebo

Placebo Comparator group

Treatment:

Other: Placebo Comparator