Overview

This trial is active, not recruiting.

Condition lupus erythematosus, systemic
Treatments atacicept 75 milligram (mg), atacicept 150 mg, placebo
Phase phase 2
Sponsor EMD Serono
Start date December 2013
End date April 2016
Trial size 306 participants
Trial identifier NCT01972568, 2013-002773-21, 700461-023

Summary

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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (subject, investigator)
Primary purpose treatment
Arm
(Experimental)
atacicept 75 milligram (mg)
Atacicept 75 mg will be administered as subcutaneous injection once weekly for 24 weeks.
(Experimental)
atacicept 150 mg
Atacicept 150 mg will be administered as subcutaneous injection once weekly for 24 weeks.
(Placebo Comparator)
placebo
Placebo matched to atacicept will be administered as subcutaneous injection once weekly for 24 weeks.

Primary Outcomes

Measure
Percentage of subjects with SLE responder index (SRI) response at Week 24 compared to screening
time frame: Screening and Week 24

Secondary Outcomes

Measure
Percentage of subjects at Week 24 whose prednisone-equivalent corticosteroid dose has reduced from Screening by >= 25 percent and to a dose of =< 7.5 milligram per day (mg/day), and have no BILAG A or 2B flare in disease activity during Weeks 16 to 24
time frame: Screening and Week 24
Percentage of subjects in the patient global impression of change (PGIC) categories at Week 24
time frame: Week 24
Change from screening visit to Week 24 in prednisone-equivalent corticosteroid (CS) daily dose
time frame: Screening and Week 24
Time to first SRI response during the treatment period
time frame: 24 Weeks
Percentage of subjects responding to treatment according to British Isles Lupus Assessment Group (BILAG)-based Combined Lupus Assessment (BICLA)
time frame: Week 24
Change from Day 1 in medical outcomes study 36-item short form health survey (SF-36)-physical component summary (PCS) and mental component summary (MCS)
time frame: Week 24
Number of subjects with adverse events (AEs)
time frame: Screening up to 48 weeks

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title 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)
Trial information was received from ClinicalTrials.gov and was last updated in May 2016.
Information provided to ClinicalTrials.gov by EMD Serono.