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

• Status: Terminated
• Trial end date: 2018-02-09
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: EMD Serono

Criteria

Inclusion Criteria:

• Participants who had completed the 24-week treatment period of study EMR-700461-023 (ADDRESS II core trial)

• Women of childbearing potential who had a negative pregnancy test

• Other protocol defined inclusion criteria were applied

Exclusion Criteria:

• Active neurological symptoms of SLE that were deemed severe or progressive

• Diagnosis of any demyelinating disease, such as, but not restricted to, multiple sclerosis (MS) or optic neuritis

• Pregnancy

• Active clinically significant viral, bacterial, or fungal infection, or any major episode of infection that in the investigator's opinion makes the participants unsuitable to continued participation in the study

• Other protocol defined exclusion criteria were applied