HZNP-DAZ-303 (Sjogren's Syndrome)

Purpose of this Study

We are doing this study to find out if an experimental drug called dazodalibep (the study drug) can improve symptoms for people who have Sjogren's Syndrome.

Who Can Participate?

Eligibility

Adults ages 18+ who:
  • Are diagnosed with Sjogren's Syndrom
  • Are not using a biologic medication or steroid to manage symptoms
  • Do not have cancer or any chronic infection disease (e.g., HIV or Hepatitis C)
For more information, contact the study team at julianna.ethridge@duke.edu.

Age Range

18-110

Sex/Genders

Male (cisgender)
Female (cisgender)
Non-binary or gender fluid
Transgender male
Transgender female
Looking for Healthy Participants
No

What is Involved?

Description

If you choose to join this study, you will get a random assignment to 1 of 2 study groups. Depending on your assignment, you will either:
  • Get the study drug; OR
  • Get a placebo (inactive substance that has no drug in it)
You will have a 2-in-3 chance of being assigned to take the study drug and a 1-in-3 chance of being assigned to take a placebo. The study drug targets receptors on T cells (immune cells in the blood) to block the activation of B cells. This drug mechanism is meant to decrease the overactivity of the immune system that is present in Sjogren's Syndrome. The study drug and placebo are given as intravenous (IV) infusions. The infusions are once a month and participants will get the infusions in the study for up to 1 year.

Locations

Duke University Hospital

Visit Timing

Weekdays

Compensation

Yes

Spanish Materials Available

No

Study Details

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

Principal Investigator

Teresa
Tarrant

Protocol Number

PRO00115843

NCT ID

NCT06245408

Phase

III

Enrollment Status

Open to Enrollment
ClinicalTrials.gov