What is dazodalibep studying for Sjögren's Syndrome?

Dazodalibep is being studied to understand its long-term safety and tolerability in people with Sjögren's Syndrome. Researchers aim to monitor how participants respond to extended treatment to gather important safety information. The study is sponsored by Amgen and focuses on patients who completed earlier dazodalibep trials.

Who may be eligible for this Sjögren's Syndrome clinical trial?

Adults aged 18 years or older who have completed 48 weeks of dazodalibep or placebo treatment in previous phase 3 studies may be eligible. All genders can participate as long as they can receive the study dose and complete all visits. Participants must not have active infections or plans to receive live vaccines. Please review eligibility criteria for more details.

Is there any cost to participate in this Sjögren's Syndrome clinical trial?

Study-related care, including the study drug and all trial visits, is provided at no cost. However, personal travel expenses may vary and are not guaranteed to be covered. Participants should prepare for any costs related to getting to and from study visits.

Actively Recruiting

Phase 3

Age: 18Years +

All Genders

ID06747949

A Multicenter, Open-Label, Long-term Extension Study to Evaluate the Safety and Tolerability of Dazodalibep in Participants With Sjgrens Syndrome

Led by Amgen · Updated on 2026-04-28

844

Participants Needed

174

Research Sites

N/A

Total Duration

AI-Summary

What this Trial Is About

Researchers are evaluating the long-term safety and tolerability of dazodalibep in people with Sjgrens Syndrome. This phase 3 open-label study extends previous trials by continuing to monitor participants who completed 48 weeks of treatment with dazodalibep or placebo. The study is sponsored by Amgen and aims to better understand the safety profile of dazodalibep over an extended period. Participants who finished the initial 48-week trials HZNP-DAZ-301 or HZNP-DAZ-303 will receive an assigned dose of dazodalibep intravenously for an additional 132 weeks. This extension study involves a single treatment group receiving dazodalibep without placebo, focusing on ongoing treatment effects and participant safety. During the study, participants will be monitored for treatment-emergent adverse events for up to 152 weeks. Researchers will also measure the presence of anti-drug antibodies and plasma concentrations of dazodalibep for up to 132 weeks. Participants need to be available for all study visits and procedures, with safety assessments conducted regularly throughout the long-term extension period.

CONDITIONS

Brief Title

A Long-term Extension Study of Dazodalibep in Participants With Sjögren's Syndrome (SS)

Who Can Participate

Age: 18Years +

All Genders

Eligibility Criteria

You may qualify if you...

Participant has provided informed consent before any study activities.
Completed 48 weeks of dazodalibep or placebo treatment in phase 3 studies HZNP-DAZ-301 or HZNP-DAZ-303.
Eligible to receive Dose 1 of this long-term extension study within 28 days after Week 48 visit of prior studies.

You will not qualify if you...

Clinically significant active infection at Day 1, including ongoing or chronic infections requiring treatment.
Planned participation in another clinical study with investigational product or procedure during this study.
Any health condition or change during prior phase 3 studies that may affect safety assessment or risk-benefit.
Planned surgeries or hospitalizations that could interfere with safety evaluation.
Plans to receive live (attenuated) vaccines during the study.
Female participants of childbearing potential unwilling to use contraception during treatment and 12 weeks after last dose.
Pregnant or lactating females or planning pregnancy during the study.
Known sensitivity to any products administered during dosing.
Likely inability to complete all study visits or comply with procedures.
History or evidence of disorders posing safety risk or interfering with study evaluation.

Research Team

Amgen Call Center

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