A study of SAR113244 treatment in patients with lupus.
Research type
Research Study
Full title
A randomised, double-blind, placebo-controlled study of safety, tolerability and pharmacokinetics of repeated ascending subcutaneous doses of SAR113244 and pharmacodynamics of single dose of SAR113244 in male and female lupus patients.
IRAS ID
164649
Contact name
Mohammed Inaam-ul Haq
Contact email
Sponsor organisation
Sanofi-Aventis Recherche & Développement
Eudract number
2014-001690-13
Duration of Study in the UK
0 years, 11 months, 0 days
Research summary
SLE (systemic lupus erythematosus) is an autoimmune disease in which the defence cells (lymphocytes) of the participant make proteins (antibodies) that attack different organs of the body. The immune system normally makes antibodies to protect the body against “foreign invaders” such as viruses, bacteria, and other germs. Lupus can affect almost any organ system of the body including kidneys, muscles, and brain; resulting in rashes, joint pains, fatigue, less stamina in performing usual daily activities and, overall, a decreased quality of life. Rarely, lupus may be life-threatening.
The study drug, SAR113244, is a biologically engineered protein designed for subcutaneous injection (needle under the skin) that has been developed to target overactive immune cells that cause lupus. SAR113244 differs from drugs available until now in its mode of action (how the drug works) and may possibly improve the medical care of participants who do not respond to or cannot tolerate the currently available drugs for the treatment of SLE.
The purpose of this study is to evaluate the possible risks and the activity of the study drug compared to placebo (a substance without active medication) in the treatment of patients with SLE. The study contains 2 parts: TDR11407 & PDY14076. Each participant will only participate in one of these parts. In TDR11407, the study drug or placebo will be given at 2 administrations separated by 4 weeks at doses of 250 mg or 500 mg and, possibly at 800 mg. In PDY14076, the study drug will be given one time, at the dose of 800mg.
Participants will be randomly (by chance-similar to a flip of a coin) assigned to receive either SAR113244 or placebo.
This is a multicentre study which will take place across Europe. It is anticipated that approximately 50 participants will be recruited worldwide.
REC name
Yorkshire & The Humber - Leeds East Research Ethics Committee
REC reference
15/YH/0019
Date of REC Opinion
20 Mar 2015
REC opinion
Further Information Favourable Opinion