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Long-term Dazodalibep Study for Sjögren's Syndrome

This study is looking at the long-term safety of dazodalibep, a drug given intravenously (through a vein), for people with Sjögren's Syndrome (an autoimmune disease causing dryness). You can join if you are 18 or older, have Sjögren's Syndrome, and have already completed a previous Phase 3 study of dazodalibep. The main goal is to see how many participants experience side effects over a long period, up to 152 weeks. The study is currently recruiting 844 participants, but its exact status is unclear.

Study design
This is an interventional study, meaning participants will receive a specific treatment. It plans to enroll 844 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for treatment-emergent adverse events (side effects) for up to 152 weeks.

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NCT06747949

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

Recruiting
PHASE3Ages 18+InterventionalTreatment
Amgen
~844 participants
Updated 2026-04-28 on ClinicalTrials.gov
What's tested:Dazodalibep

At a glance

Recruiting sites
174 of 174 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Number of Participants with Treatment-emergent Adverse Events (TEAEs)
Measured over Up to 152 weeks

Conditions

Sjögren's Syndrome

Explore related trials

Sjogren Syndrome

Where it's being run

174 sites across 89 states
Poland14
Texas7
Argentina7
Arizona5
France5
Masovian Voivodeship5
Serbia5
Buenos Aires4

Study leadership

  • MD · STUDY_DIRECTOR · Amgen

Who to contact

Amgen Call Center
[email protected]
866-572-6436
Email the study team

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Eligibility criteria

Inclusion

Participant has provided informed consent before initiation of any study specific activities/procedures.
Must have been eligible to receive and have received IP (dazodalibep or placebo) and completed the study (through Week 48) in one of the phase 3 SS dazodalibep studies (HZNP-DAZ-301, or HZNP-DAZ-303).
Must be able to receive Dose 1 of this LTE study at the Week 48 Visit (+28 days) for the prior pivotal phase 3 SS dazodalibep studies (HZNP DAZ-301, or HZNP DAZ-303).

Exclusion

Clinically significant active infection at Day 1, in the opinion of the Investigator, including ongoing and chronic infection requiring antibiotics or antiviral medication.
Planned participation in another clinical study with an IP or procedure during the LTE study. Other investigational procedures and participation in observational research studies while participating in this study are excluded.
Any condition or change in health status observed or reported during the phase 3 SS studies (HZNP-DAZ-301, or HZNP-DAZ-303) that, in the opinion of the Investigator or the Sponsor, would interfere with evaluation and interpretation of participant safety or alter the risk-benefit associated with IP administration.
Planned surgeries or hospitalizations that, in the opinion of the Investigator or the Sponsor, would interfere with evaluation and interpretation of participant safety.
Individuals who plan to receive live (attenuated) vaccine during the LTE study.
Female participants of childbearing potential unwilling to use protocol-specified method of contraception during treatment and for an additional 12 weeks after the last dose of investigational product.
Female participants who are pregnant or lactating or planning to become pregnant during the study.
Participant has known sensitivity to any of the products or components to be administered during dosing.
Participant likely to not be available to complete all protocol-required study visits or procedures, and/or to comply with all required study procedures to the best of the participant and investigator's knowledge.
History or evidence of any other clinically significant disorder, condition, or disease that, in the opinion of the investigator or Amgen physician, if consulted, would pose a risk to participant safety or interfere with the study evaluation.

What this trial measures

  • Number of Participants with Treatment-emergent Adverse Events (TEAEs)Up to 152 weeks

    Includes treatment emergent serious adverse events (TESAEs) and adverse events of special interest (AESIs).