NCT02070978

Long-term Safety and Tolerability of Atacicept (Long-term Follow-Up of Participant Who Participated in ADDRESS II)

A Phase IIb, Multi-Center, Long-Term Extension Trial to Evaluate the Safety and Tolerability of Atacicept in Subjects With Systemic Lupus Erythematosus (SLE) Who Completed Protocol EMR-700461-023 (ADDRESS II)

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 253 (actual)
• Sponsor: EMD Serono · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a multicenter, double-blind, Phase 2b, long-term extension (LTE) to the ADDRESS II core trial (EMR 700461-023) (NCT01972568), to evaluate long-term safety and tolerability of atacicept in participants with systemic lupus erythematosus (SLE). Participants who completed the 24-week core study ADDRESS II core study (NCT01972568) and thus not met any of the discontinuation criteria were invited to enter this long-term extension (LTE) study NCT02070978.

Conditions

• Lupus Erythematosus, Systemic

Interventions

Type	Name	Description
DRUG	Atacicept 75 mg	Participants who received atacicept 75 milligram (mg) as once-weekly subcutaneous injection in the core study ADDRESS II continued to receive this dose during this LTE study. Participants in this reporting arm received the medication up to a maximum of 143.7 weeks.
DRUG	Atacicept 150 mg	Participants who received placebo in the core study ADDRESS II switched to receive atacicept 150 mg as once-weekly subcutaneous injection for up to a maximum of 97.7 weeks during this LTE study.
DRUG	Atacicept 150 mg	Participants who received atacicept 150 mg in core study ADDRESS II continued to receive atacicept 150 mg as once-weekly subcutaneous injection during this LTE study up to a maximum of 97.9 weeks.

Timeline

• Start date: 2014-07-29
• Primary completion: 2016-04-05
• Completion: 2018-02-09
• First posted: 2014-02-25
• Last updated: 2019-03-21
• Results posted: 2019-03-21

Locations

84 sites across 17 countries: United States, Argentina, Brazil, Bulgaria, Chile, Czechia, Germany, Italy, Mexico, Peru, Philippines, Poland, Russia, South Africa, South Korea, Spain, United Kingdom