NCT01972568PHASE2COMPLETED

Efficacy and Safety of Atacicept in Systemic Lupus Erythematosus

A Phase IIb, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Multidose, 24-Week Study to Evaluate the Efficacy and Safety of Atacicept in Subjects With Systemic Lupus Erythematosus (SLE)

Sponsor: EMD Serono

No open prediction endpoints

Endpoints are classified and published by ProgramSignal analysts.

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Key Facts

Study type

INTERVENTIONAL

Conditions

Lupus Erythematosus, Systemic

Interventions

Atacicept 75 milligram (mg), Atacicept 150 mg, Placebo

Enrollment

306 participants

Primary completion

Apr 2016

Study completion

Sep 2016

First posted

Oct 2013

Last updated

Jan 2018

Primary Endpoints (CT.gov)

Percentage of Subjects With Systemic Lupus Erythematosus (SLE) Responder Index (SRI) Response at Week 24 Using Screening Visit as Baseline

Time frame: Week 24

Percentage of Subjects With Systemic Lupus Erythematosus (SLE) Responder Index (SRI) Response at Week 24 Using Day 1 as Baseline

Time frame: Week 24

Secondary Endpoints

Percentage of Subjects at Week 24 Whose Prednisone-Equivalent Corticosteroid (CS) Dose Reduced From Screening by >=25% and to a Dose of =<7.5mg/Day, and no British Isles Lupus Assessment Group (BILAG) A or 2B Flare in Disease Activity

Percentage of Subjects With Patient Global Impression of Change (PGIC) Categories at Week 24

Change From Screening in Prednisolone-Equivalent Corticosteroid (CS) Daily Dose at Week 24

Eligibility Criteria

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

✦ Analyst Commentary

Expert commentary on why this trial matters and what to watch for.

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Source

Open on ClinicalTrials.gov