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

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.

Timeline

Start

2014-07-29

Primary completion

2016-04-05

Completion

2018-02-09

Publications

• Wallace DJ, Isenberg DA, Morand EF, Vazquez-Mateo C, Kao AH, Aydemir A, Pudota K, Ona V, Aranow C, Merrill JT. Safety and clinical activity of atacicept in the long-term extension of the phase 2b ADDRESS II study in systemic lupus erythematosus. Rheumatology (Oxford). 2021 Nov 3;60(11):5379-5389. doi: 10.1093/rheumatology/keab115.

Drugs

Indications