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

Status:	Terminated
Conditions:	Lupus
Therapuetic Areas:	Immunology / Infectious Diseases
Healthy:	No
Age Range:	18 - Any
Updated:	3/23/2019
Start Date:	July 29, 2014
End Date:	February 9, 2018

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)

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.

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

We found this trial at

sites

East Bay Rheumatology Medical Group, Inc.

San Leandro, California 94578

Phone: 510-357-1303

from

San Leandro, CA