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

Merck KGaA (EMD Serono)

Status and phase

Terminated

Phase 2

Conditions

Lupus Erythematosus, Systemic

Treatments

Drug: Atacicept 150 mg

Drug: Atacicept 75 mg

Study type

Interventional

Funder types

Industry

Identifiers

NCT02070978

700461-024

2013-002758-62 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment

253 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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