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Updated May 2026 · ClinicalTrials.gov

RECRUITINGPhase 3INTERVENTIONAL

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

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

A Long-term Extension Study of Dazodalibep in Participants With Sjögren's Syndrome (SS) (NCT06747949) is a Phase 3 interventional studying Sjögren's Syndrome, sponsored by Amgen. RECRUITING as of the most recent ClinicalTrials.gov update. Talk to your doctor before contacting the trial site.

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

The primary objective of this study is to evaluate the long-term safety and tolerability of dazodalibep.

What Stage of Research Is This?

Phase 3 trials confirm efficacy and safety in large patient groups (often 300–3,000+) and form the evidence base for an FDA approval submission. For Sjögren's Syndrome, Phase 3 studies typically randomize participants between the investigational treatment and either a placebo or current standard of care. A successful Phase 3 result is the threshold most treatments need to clear before regulatory approval.

This trial is currently recruiting participants. The sponsor has registered the study with ClinicalTrials.gov as actively enrolling, which means new applicants who meet the eligibility criteria can be considered for screening. Trial status can change between updates — confirm current recruiting status with the study contact before traveling for a screening visit.

A target enrollment of 844 participants makes this a sizable late-stage trial. Studies in this range typically have enough power to detect clinically meaningful differences from a comparator and to characterize less-common side effects.

Who May Be Eligible (Plain English)

Who May Qualify: Participants are eligible to be included in the study only if all the following criteria apply: - Participant has provided willing to sign a consent form 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). Who Should NOT Join This Trial: 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. ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

These are translations of the protocol\'s inclusion and exclusion criteria, simplified for patients and caregivers. The original clinical text appears below. Eligibility is ultimately confirmed by the trial site\'s screening process — this summary is a starting point for a conversation with your doctor, not a final determination.

Original Eligibility Criteria

View original clinical language
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.

Treatments Being Tested

DRUG

Dazodalibep

Dazodalibep will be given intravenously (IV).

Locations (20)

Trial sites listed on ClinicalTrials.gov for this study. Site activation status can vary — confirm with the specific site before traveling for a screening visit.

Arizona Arthritis & Rheumatology Associates - Avondale
Avondale, Arizona, United States
Arizona Arthritis and Rheumatology Associates - Flagstaff - 399 S Malpais Ln
Flagstaff, Arizona, United States
Arizona Arthritis and Rheumatology Associates - Gilbert - 3645 S Rome St
Gilbert, Arizona, United States
Arizona Arthritis and Rheumatology Associates - Glendale - 5681 W Beverly Ln
Glendale, Arizona, United States
Arizona Arthritis and Rheumatology Associates - Tucson - 2001 W Orange Grove Rd
Tucson, Arizona, United States
Samy Metyas MD Inc
Covina, California, United States
UCSD Altman Clinical and Translational Research Institute Building
La Jolla, California, United States
Tekton Research, LLC - 2121 E Harmony Rd - PPDS
Fort Collins, Colorado, United States
Bradenton Research Center Inc
Bradenton, Florida, United States
Clinical Research of West Florida Inc - Clearwater
Clearwater, Florida, United States
BayCare Medical Group Primary Care and Rheumatology - Tampa
Tampa, Florida, United States
Tufts University School of Dental Medicine
Boston, Massachusetts, United States
Shores Rheumatology
Saint Clair Shores, Michigan, United States
Kansas City Physician Partners-8350 N Saint Clair Ave
Kansas City, Missouri, United States
Arthritis, Rheumatic & Bone Disease Associates - Voorhees
Voorhees Township, New Jersey, United States
Arthritis and Osteoporosis Consultants of The Carolinas - Charlotte - 1918 Randolph Rd
Charlotte, North Carolina, United States
Duke Early Phase Clinical Research Unit - PPDS
Durham, North Carolina, United States
Onsite Clinical Solutions, LLC - Salisbury
Salisbury, North Carolina, United States
Arthritis & Osteoporosis Center of Southwest Ohio - Miamisburg
Miamisburg, Ohio, United States
University of Toledo Medical Center
Toledo, Ohio, United States

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT06747949), the sponsor (Amgen), and the key eligibility criteria — to your next appointment. Your doctor can review the inclusion and exclusion criteria against your medical history, lab values, and current treatments to assess whether you are likely to qualify. They can also help you weigh whether trial participation makes sense alongside your existing care plan.

Useful questions to walk through together: What does the trial protocol require beyond standard care? How long is the active treatment phase, and how long is follow-up? Are there study visits at sites I can reach? Who pays for the trial-specific procedures, and who pays for standard-of-care portions? See our 25 questions to ask about clinical trials guide for a more complete checklist.

Authoritative Sources

The official record for this trial lives on ClinicalTrials.gov — the federal registry maintained by the National Library of Medicine at NIH. For background on how this trial fits into the FDA approval pathway, see the FDA drug approval process. For oncology-specific guidance for patients considering trials, the National Cancer Institute publishes patient-oriented overviews. International trial registries are aggregated by the WHO ICTRP.

Frequently Asked Questions

What is the NCT06747949 clinical trial studying?

The primary objective of this study is to evaluate the long-term safety and tolerability of dazodalibep. The full protocol is registered on ClinicalTrials.gov and includes the primary outcome measures, eligibility criteria, and study endpoints.

Who can participate in NCT06747949?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

How do I contact the trial site for NCT06747949?

Contact information registered with ClinicalTrials.gov is shown in the sidebar of this page. Before reaching out, confirm with your treating physician that this trial is appropriate for your situation. The trial site will then walk you through the screening process to determine final eligibility.

Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

How This Page Is Built

Every field on this page is pulled directly from the ClinicalTrials.gov API v2 — no estimates, no proxies. The plain-English eligibility translation is generated from the original protocol text and reviewed for fidelity to the underlying clinical criteria. The original clinical text remains visible in the collapsible section above so users and clinicians can verify the translation. Read the full methodology for the data pipeline and known limitations.

Source: ClinicalTrials.gov API v2 record for NCT06747949. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT06747949. Data: ClinicalTrials.gov."

Medical disclaimer: This page is informational, not medical advice. Talk to your doctor about whether a clinical trial is right for you.

Last updated 2026-05-08 · Data from ClinicalTrials.gov.