Safety & efficacy of AMG557/MEDI5872 in Sjogren's syndrome
Research type
Research Study
Full title
A Phase 2a, Randomized, Placebo-controlled, Proof of Mechanism Study to Evaluate the Safety and Efficacy of AMG 557/MEDI5872 in Subjects with Primary Sjogren’s Syndrome
IRAS ID
167304
Contact name
Joelle Blakaitis
Contact email
Sponsor organisation
MedImmune
Eudract number
2014-003896-41
Duration of Study in the UK
1 years, 7 months, 30 days
Research summary
Sjogren's Syndrome(SS) is an autoimmune disease (the body fighting against its own tissues and cells) characterized by chronic inflammation (the body's effort to protect itself) of glands that secrete fluids. It mainly affects the salivary and lacrimal glands leading to a dry mouth and dry eyes. Primary Sjogren's syndrome (pSS) develops by itself and not as a result of another autoimmune condition such as rheumatoid arthritis. There is no known cure for this disease nor a specific treatment to permanently restore gland function.
The aim of this study is to evaluate the effect of study drug compared to placebo in reducing the objective measures (that are measured using clinical patient questionnaires) of disease activity in patients with pSS. Additional objectives are:
-To assess the effect of study drug on peripheral blood and salivary gland biomarkers (substances in blood that indicates the presence or severity of disease) in pSS patients
-To assess the safety and tolerability of multiple subcutaneous doses of study drug in pSS patients
-To assess the effect of study drug in reducing subjective measures (that are measured by perception of a person) of disease activity.Exploratory objectives are:
-To assess the effect of study drug on clinical and laboratory components of pSS.
-To assess the effect of study drug on specific subjective symptoms of pSS
-To evaluate the pharmacokinetics (what the body does to the drug), immunogenicity (ability of the body to induce immune response) and pharmacodynamics (what the drug does to the body)REC name
London - Brent Research Ethics Committee
REC reference
15/LO/0090
Date of REC Opinion
4 Feb 2015
REC opinion
Favourable Opinion