Phase 3 study to evaluate efficacy and safety of Dazodalibep in patients with Sjogren's syndrome
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 Systemic Disease Activity.
IRAS ID
1007822
Contact name
Ilias Alevizos
Contact email
Sponsor organisation
Horizon Therapeutics Ireland DAC
Eudract number
2023-503904-10
Clinicaltrials.gov Identifier
Research summary
This is a phase 3 research study to evaluate the effectiveness, safety, and tolerability of a research medicine (study drug) called dazodalibep (also known as VIB4920) in participants with Sjorgren's syndrome (SS). This study will compare dazodalibep to a placebo (a dummy treatment). The main purposes of the study are:
• To evaluate the effectiveness of dazodalibep
• To evaluate the effects of dazodalibep on the signs and symptoms of SS
• 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 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 react to dazodalibep.
• To measure 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.
This study will have approximately 510 participants, both men and women over 18 years of age. About 340 participants will receive dazodalibep and 170 participants will receive placebo. The participation in this study will last for approximately 5 years. The study will include up to a 4-week screening period, a 48-week treatment period, and an 8-week follow-up period.REC name
North East - Newcastle & North Tyneside 1 Research Ethics Committee
REC reference
24/NE/0010
Date of REC Opinion
8 Feb 2024
REC opinion
Further Information Favourable Opinion