EMR700461-023: Phase IIb Study of Atacicept in SLE
Research type
Research Study
Full title
A Phase IIb, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Multidose, 24-Week Study to Evaluate the Efficacy and Safety of Atacicept in Subjects With Systemic Lupus Erythematosus (SLE)
IRAS ID
144232
Contact name
Professor Bhaskar Dasgupta
Contact email
Sponsor organisation
Merck KGaA
Eudract number
2013-002773-21
Clinicaltrials.gov Identifier
Research summary
This research study, sponsored by Merck KGaA, is testing the investigational drug atacicept. 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 this research study is to test two different doses of atacicept to see how well it works to treat SLE compared to placebo. Some additional purposes of the study are to assess side effects of atacicept, to see if atacicept will reduce the need for people with SLE to use corticosteroids, to see the effect it has on the activity of the disease, to assess if it helps people with SLE have a better quality of life and to measure the amount of atacicept in the blood, and see how the body responds to atacicept.
Approximately 279 people will participate in the study globally. Eligible participants will be randomly assigned to one of two treatment groups in a ratio of 2:1, with 2 people receiving study drug for every one person receiving placebo. A placebo is a ‘dummy treatment’, which looks like atacicept but does not contain the active ingredient that is thought to have an effect on SLE.
Participants will receive treatment for up to 24 weeks. This will be followed by a safety follow-up period. Subjects who complete the full 24 weeks of treatment, have the option to go into a long term extension study where they will be able to receive study treatment for a longer period of time. All patients in the long-term extension study will receive active atacicept even if they were on placebo in this study.
REC name
London - London Bridge Research Ethics Committee
REC reference
14/LO/0081
Date of REC Opinion
3 Mar 2014
REC opinion
Further Information Favourable Opinion