NCT00624338

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

A Randomised, Double-blind, Placebo Controlled, Multicentre Prospective Dose-finding Phase II/III Study With Atacicept Given Subcutaneously to Subjects Having Recently Experienced a Flare of Systemic Lupus Erythematosus (SLE)

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 461 (actual)
• Sponsor: EMD Serono · Industry
• Sex: All
• Age: 16 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Lupus Erythematosus, Systemic

Interventions

Type	Name	Description
DRUG	Atacicept 75 mg	75 milligram (mg) atacicept injection will be administered subcutaneously twice weekly during initial loading period for 4 weeks followed by once weekly during maintenance period for subsequent 48 weeks.
DRUG	Atacicept 150 mg	150 mg atacicept injection will be administered subcutaneously twice weekly during initial loading period for 4 weeks followed by once weekly during maintenance period for subsequent 48 weeks.
OTHER	Placebo Comparator	Placebo matched to atacicept injection will be administered subcutaneously twice weekly during initial loading period for 4 weeks followed by once weekly during maintenance period for subsequent 48 weeks.

Timeline

• Start date: 2008-01-01
• Primary completion: 2012-04-01
• Completion: 2012-10-01
• First posted: 2008-02-27
• Last updated: 2016-03-14
• Results posted: 2016-03-14

Locations

113 sites across 29 countries: United States, Argentina, Australia, Austria, Bulgaria, Croatia, Czechia, France, Germany, Greece, India, Israel, Latvia, Lebanon, Lithuania, Malaysia, Mexico, Netherlands, Philippines, Poland, Russia, Serbia, South Africa, South Korea, Spain, Switzerland, Taiwan, Ukraine, United Kingdom