Phase 3 Dazodalibep in patients with Moderate-to-Severe SS Symptom State
Research type
Research Study
Full title
A Phase 3 Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Dazodalibep in Participants With Sjögren’s Syndrome With Moderate-to-Severe Symptom State
IRAS ID
1008841
Contact name
Ilias Alevizos
Contact email
Sponsor organisation
Horizon Therapeutics Ireland DAC
Eudract number
2023-503923-24
Clinicaltrials.gov Identifier
Research summary
The purpose of this study is to evaluate the effectiveness, safety, and tolerability of a research medicine (study drug) called dazodalibep (also known as VIB4920) in participants with Sjogren's Syndrome (SS).
The main purposes of the study are:
• To evaluate the effect of dazodalibep on the symptoms and quality of life.
• To evaluate the safety of dazodalibep and assess how well it is tolerated.
• To see how dazodalibep is absorbed by the body and how levels change over time.
• To determine the effects of dazodalibep on the body’s immune system by measuring antibodies typical of SS and specialised white blood cells. Antibodies are proteins made by the body’s immune (defence) system to fight infection by binding other proteins and molecules.
• To determine if the body makes antibodies that attach to dazodalibep.
• To evaluate the biological effects of dazodalibep by measuring biomarkers, which may be seen in the blood or saliva and can be tested to see the effect of treatment. A biomarker is a substance in the body that can be measured and used to tell doctors and scientists something about the health of a person.
Dazodalibep is being developed as a potential treatment for SS, which causes the body’s immune system to attack itself. The immune system helps the body fight off infections. When the body’s immune system attacks itself, this can cause what is called an “autoimmune disease”. Dazodalibep is designed to target the immune system cells responsible for these attacks.REC name
North East - Newcastle & North Tyneside 1 Research Ethics Committee
REC reference
24/NE/0058
Date of REC Opinion
28 May 2024
REC opinion
Further Information Favourable Opinion