EMR700461-024: Phase IIb Long-Term Extension Study of Atacicept in SLE
Research type
Research Study
Full title
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)
IRAS ID
147713
Contact name
Professor Bhaskar Dasgupta
Contact email
Sponsor organisation
Merck KGaA
Eudract number
2013-002758-62
Research summary
This research study, sponsored by Merck KGaA, is a long-term extension trial in which participants will receive the study drug, atacicept 75 or 150mg, given as once weekly subcutaneous (SC - under the skin) injections. Eligible patients who complete the 24-week treatment period of EMR700461-023 (ADDRESS II core trial), and enter this long-term extension trial will have treatment assigned based on the dose received in the core trial.
Atacicept is being evaluated for the treatment of Systemic Lupus Erythematosus (SLE). SLE is a disease in which the immune system (the body’s system that fights infection) attacks its own cell and tissues, causing inflammation. It can damage organs in the body and it can affect almost any organ in the body. The main purpose of the study is to determine the long-term safety and tolerability of atacicept in SLE subjects.
The trial is composed of a treatment period of approximately 2 years duration and a safety follow-up period. The trial will be conducted on an outpatient basis and approximately 213 participants will take part globally.
REC name
London - London Bridge Research Ethics Committee
REC reference
14/LO/0437
Date of REC Opinion
9 May 2014
REC opinion
Further Information Favourable Opinion