Efficacy and Safety of Atacicept in Systemic Lupus Erythematosus (ADDRESS II)

Merck KGaA (EMD Serono)

Status and phase: Completed; Phase 2

Conditions: Lupus Erythematosus, Systemic

Treatments: Drug: Placebo; Drug: Atacicept 75 milligram (mg); Drug: Atacicept 150 mg

Study type: Interventional

Funder types: Industry

Identifiers

NCT01972568

700461-023

2013-002773-21 (EudraCT Number)

Details and patient eligibility

About

This is a multi-center, double-blind, randomized, Phase 2b trial to evaluate the efficacy of atacicept in subjects with systemic lupus erythematosus (SLE).

Enrollment: 306 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Eligible male and female subjects, aged 18 years or older
• Must have at least moderately active SLE, as defined as SLE Disease Activity Index-2000 (SLEDAI-2K) score greater than or equal to [>=] 6 at screening visit
• At least 4 of the 11 American college of rheumatology (ACR) classification criteria for SLE (diagnosed >= 6 months prior to the screening visit)
• Be seropositive for anti-nuclear antibodies (ANA) and/or anti-double-stranded deoxyribonucleic acid (anti-dsDNA) antibodies
• Other protocol defined inclusion criteria could apply

Exclusion criteria

• Subjects have demyelinating disorder
• Severe central nervous system SLE
• Use of cyclophosphamide within 3 months of the screening visit
• Urine protein:creatinine ratio (UPCr) >= 2 milligram per milligram (mg/mg) per day
• Other protocol defined exclusion criteria could apply

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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306 participants in 3 patient groups, including a placebo group

Atacicept 75 mg

Experimental group

Treatment:

Drug: Atacicept 75 milligram (mg)

Atacicept 150 mg

Experimental group

Treatment:

Drug: Atacicept 150 mg

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo