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

RecruitingPhase 3

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

Who can join

Ages 18 and older · All sexes

Full eligibility 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.

About the study

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

What is being tested

Sponsor: Amgen · Participants: 844 · Started: Feb 25, 2025

Contact the study team

Official record on ClinicalTrials.gov — NCT06747949

Locations in the U.S.

ArizonaArizona Arthritis & Rheumatology Associates - Avondale, Avondale
Arizona Arthritis and Rheumatology Associates - Flagstaff - 399 S Malpais Ln, Flagstaff
Arizona Arthritis and Rheumatology Associates - Gilbert - 3645 S Rome St, Gilbert
Arizona Arthritis and Rheumatology Associates - Glendale - 5681 W Beverly Ln, Glendale
Arizona Arthritis and Rheumatology Associates - Tucson - 2001 W Orange Grove Rd, Tucson
CaliforniaSamy Metyas MD Inc, Covina
UCSD Altman Clinical and Translational Research Institute Building, La Jolla
ColoradoTekton Research, LLC - 2121 E Harmony Rd - PPDS, Fort Collins
FloridaBradenton Research Center Inc, Bradenton
Clinical Research of West Florida Inc - Clearwater, Clearwater
BayCare Medical Group Primary Care and Rheumatology - Tampa, Tampa
MassachusettsTufts University School of Dental Medicine, Boston
MichiganShores Rheumatology, Saint Clair Shores
MissouriKansas City Physician Partners-8350 N Saint Clair Ave, Kansas City
New JerseyArthritis, Rheumatic & Bone Disease Associates - Voorhees, Voorhees Township
North CarolinaArthritis and Osteoporosis Consultants of The Carolinas - Charlotte - 1918 Randolph Rd, Charlotte
Duke Early Phase Clinical Research Unit - PPDS, Durham
Onsite Clinical Solutions, LLC - Salisbury, Salisbury
OhioArthritis & Osteoporosis Center of Southwest Ohio - Miamisburg, Miamisburg
University of Toledo Medical Center, Toledo
STAT Research-600 Aviator Ct, Vandalia
TennesseeMurfreesboro Medical Clinic Westlawn, Murfreesboro
TexasAccurate Clinical Management-Baytown, Baytown
Precision Comprehensive Clinical Research Solutions, Colleyville
Houston Rheumatology & Arthritis Specialists - PLLC - PPDS, Katy
R & H Clinical Research-777 S Fry Rd, Katy
Biopharma Informatic - Ridge Road - PPDS, McAllen
Advanced Rheumatology of Houston, The Woodlands
DM Clinical Research - Migraine and COPD - PPDS, Tomball
WashingtonWestern Washington Medical Group, Bothell - Rheumatology, Bothell
West VirginiaRheumatology and Pulmonary Clinic, Beckley

Conditions

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.