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Long-term evaluation of dazodalibep for Sjögren's Syndrome

A Multicenter, Open-Label, Long-term, Extension Study to Evaluate the Safety and Tolerability of Dazodalibep in Participants With Sjögren's Syndrome (SS)

Phase 3 Interventional Amgen · NCT06747949

This study is testing how safe and well-tolerated the drug dazodalibep is for people with Sjögren's Syndrome who have already taken it in earlier trials.

Quick facts

PhasePhase 3
Study typeInterventional
Enrollment844 (estimated)
Ages18 Years and up
SexAll
SponsorAmgen Industry-sponsored
Locations174 sites (Avondale, Arizona and 173 other locations)
Trial IDNCT06747949 on ClinicalTrials.gov

What this trial studies

This study aims to assess the long-term safety and tolerability of dazodalibep in participants who have previously completed a phase 3 study for Sjögren's Syndrome. Eligible participants must have received either dazodalibep or a placebo in earlier studies and are now being monitored for extended outcomes. The study will involve administering the treatment and observing participants over an extended period to gather data on its effects.

Who should consider this trial

Good fit: Ideal candidates are individuals who have completed a prior phase 3 study involving dazodalibep for Sjögren's Syndrome.

Not a fit: Patients with clinically significant active infections or those participating in other clinical studies may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide valuable insights into the long-term management of Sjögren's Syndrome with dazodalibep.

How similar studies have performed: Other studies have shown promise with similar approaches, but this specific long-term evaluation is novel.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

Participants are eligible to be included in the study only if all the following criteria apply:

* 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 Criteria:

Participants are excluded from the study if any of the following criteria apply:

* 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.

Where this trial is running

Avondale, Arizona and 173 other locations

+124 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Sjögren's SyndromeCluster of differentiation 40DazodalibepAMG 611
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.