A Long-term Extension Study of Dazodalibep in Participants with SS
Research type
Research Study
Full title
A Multicenter, Long-term, Randomized, Extension Study to Evaluate the Safety and Tolerability of Dazodalibep in Participants with Sjögren’s Syndrome (SS)
IRAS ID
1011386
Contact name
Angeliki Giannelou
Contact email
Sponsor organisation
Amgen Inc.
Research summary
This is a multicenter, randomised, long-term extension (LTE) study to evaluate the safety and tolerability of dazodalibep in eligible participants who have completed the treatment period of one of the phase 3 Sjögren’s Syndrome (SS) clinical studies (HZNP-DAZ-301, or HZNP-DAZ-303).
SS is a chronic autoimmune disease which affects the salivary glands and tear glands. In autoimmune diseases, the body’s own immune system attacks the body my mistake.
The primary objective of this study is to: To evaluate the long-term safety and tolerability of dazodalibep.The study drug, dazodalibep, is an immune modulator, it works by switching off the immune responses by inactivating immune cells, this makes it a beneficial drug for autoimmune diseases like SS.
In this study 844 adult participants will be recruited. The study involves 40 visits, and the duration is 152 weeks. The study will involve physical examinations, vital signs, electrocardiogram (ECG), urine and blood samples as well as questionnaires.
REC name
North East - Newcastle & North Tyneside 1 Research Ethics Committee
REC reference
25/NE/0023
Date of REC Opinion
5 Mar 2025
REC opinion
Further Information Favourable Opinion