At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 306 enrolled
Drug / intervention
Atacicept 75 milligram (mg) +2 moredrug
Likely dose
Atacicept 75 milligram (mg)from record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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)
In Brief
A Phase 2 clinical trial evaluating Atacicept 75 milligram (mg), Atacicept 150 mg, and 1 other intervention for Lupus Erythematosus, Systemic. Completed, enrolled 306 participants across 138 sites in 18 countries.
Detailed 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).
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsLupus Erythematosus, Systemic
CountriesArgentina, Brazil, Bulgaria, Chile, Czechia, Germany, Italy, Japan, Mexico, Peru, Philippines, Poland, Russia, South Africa, South Korea, Spain, United Kingdom, United States
Collaborators--
Timeline
Phase 2CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedOct 2013
Enrollment StartDec 2013
Primary CompletionApr 2016
Study CompletionSep 2016
TodayJul 2026
First PostedOct 30, 2013
Enrollment StartDec 1, 2013
Primary CompletionApr 1, 2016
Study CompletionSep 1, 2016
TodayJul 2, 2026
Enrollment to primary: 2.3 yearsPosted 12.7 years ago
Interventions
Atacicept 75 milligram (mg)drug
Atacicept 75 mg will be administered as subcutaneous injection once weekly for 24 weeks.
Atacicept 150 mgdrug
Atacicept 150 mg will be administered as subcutaneous injection once weekly for 24 weeks.
Placebodrug
Placebo matched to atacicept will be administered as subcutaneous injection once weekly for 24 weeks.