Phase IIa study of Anti-IL-7 receptor-αMab GSK2618960 in pSS treatment
Research type
Research Study
Full title
A two part Phase IIa Study, to Evaluate the Safety and Tolerability, Pharmacokinetics, Proof of Mechanism and Potential for Efficacy of an Anti-IL-7 Receptor-α Monoclonal Antibody (GSK2618960) in the Treatment of Primary Sjögren’s Syndrome.
IRAS ID
219574
Contact name
Natasha Jordan
Contact email
Sponsor organisation
GlaxoSmithKline
Eudract number
2016-004258-14
Duration of Study in the UK
2 years, 9 months, 19 days
Research summary
Primary Sjögren’s Syndrome (pSS) is an autoimmune disease presenting with dry mouth, dry eyes, fatigue and systemic manifestations. There are no approved therapies for pSS. GlaxoSmithKline (GSK) is investigating interleukin-7 (IL-7) as a new therapeutic target in pSS. GSK2618960 is an antibody that blocks IL-7 receptor.
GSK2618960 was safely administered in healthy individuals as a single dose injection directly into veins (intravenous [IV]) in an earlier study conducted by GSK. In that study healthy participants developed anti-drug antibodies (ADA) to GSK2618960 that were not associated with any safety events. This study 201579 is the first time repeat doses of GSK2618960 IV will be given to patients. Methotrexate and folic acid tablets will be given together with GSK2618960 to reduce the risk of developing ADA against GSK2618960. The main purpose of the study is to look at the safety of GSK2618960, how long the body takes to get rid of the drug, how the drug works in the body and if it impacts disease pathology.
The study consists of 2 parts. Part 1 is a safety cohort enrolling 4 participants, dosed sequentially (2 followed by 2) and will be conducted at Clinical Unit Cambridge, UK (a MHRA accredited research unit) with adequate safety and compliance facilities. Each participant will receive 4 infusions of GSK2618960. Part 2 involving approximately 18 participants will be conducted in University Medical Centre, Utrecht in the Netherlands. In Part 2, enrolled participants will receive either GSK2618960 or placebo (a dummy medicine containing no active ingredients). Part 2 will start only after all safety information from part 1 is assessed.
Study participants will not experience clinical benefit as a result of treatment in this study. However, it will provide important data on potential of clinical application of IL-7 inhibition in pSS. The study is sponsored by GSK.REC name
North East - Tyne & Wear South Research Ethics Committee
REC reference
17/NE/0024
Date of REC Opinion
21 Feb 2017
REC opinion
Further Information Favourable Opinion