A Study to Evaluate the Efficacy and Safety of Abiprubart in Participants with Sjögren’s Disease
Research type
Research Study
Full title
A Phase 2, Multicenter, Randomized, Double-blind, Placebo-controlled, Dose-ranging Study to Evaluate the Efficacy and Safety of Abiprubart in Participants with Sjögren’s Disease
IRAS ID
1010305
Contact name
Eric Jenkins
Contact email
Sponsor organisation
Kiniksa Pharmaceuticals, GmbH
Eudract number
2024-512986-15
ISRCTN Number
N/A
Clinicaltrials.gov Identifier
Research summary
Sjögren’s Disease is an autoimmune disease that happens when the immune system damages the part of the body that produces fluids like tears and spit (saliva). Currently there is no cure for Sjögren’s Disease, the treatments that are available help to reduce symptoms. There is a need for new, safer and more effective treatments to be developed for the treatment of Sjögren’s Disease. Kiniksa Pharmaceuticals, GmbH (the Sponsor) are running a study to Evaluate the Efficacy and Safety of Abiprubart in Participants with Sjögren’s Disease. Abiprubart is the study medication being investigated in this research study. The aim of this clinical research study is to test the effectiveness and safety of abiprubart compared to placebo (dummy substance) in the treatment of patients with Sjögren’s Disease. Participants are expected to be in this study for about 14 months. Prior to undergoing any study procedures participants must sign an informed consent form . The main research study has 4 periods, the screening period to see if you are eligible to join the trial, the Double-blind Treatment period, the Active Treatment Extension Period and the safety follow-up period. Double- blind is when neither the doctor or participant know what treatment they are receiving. The treatment will be administered via a subcutaneous (under the skin) injection. The participants will be informed how they can administer the treatment at home. This study is expected to include 200 participants aged between 18 and 81years old. Study participants will visit the study site at the %me points specified in the main informed consent form. Participants will also undergo procedures such as blood and urine tests, ECGs, and a physical examination throughout the study. In addition to the main research study, there are 3 optional sub-studies: Ocular Staining, Salivary Gland Ultrasound and Salivary Gland Biopsies. Participants can take part in the main research study without having to join the sub-studies.
REC name
East of England - Cambridge East Research Ethics Committee
REC reference
24/EE/0215
Date of REC Opinion
22 Oct 2024
REC opinion
Further Information Favourable Opinion