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

RecruitingPhase 3Ages 18 Years - anyAllAmgen
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In plain words

What the trial is, and whether it could suit you

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

Sign in to get the eligibility rules as simple questions to take to your doctor.

📋 Eligibility rules (as published)
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.
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What it tests

  • Dazodalibep
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Where

174 sites
Arizona Arthritis & Rheumatology Associates - Avondale
Avondale, United States
Arizona Arthritis and Rheumatology Associates - Flagstaff - 399 S Malpais Ln
Flagstaff, United States
Arizona Arthritis and Rheumatology Associates - Gilbert - 3645 S Rome St
Gilbert, United States
Arizona Arthritis and Rheumatology Associates - Glendale - 5681 W Beverly Ln
Glendale, United States
Arizona Arthritis and Rheumatology Associates - Tucson - 2001 W Orange Grove Rd
Tucson, United States
Samy Metyas MD Inc
Covina, United States
UCSD Altman Clinical and Translational Research Institute Building
La Jolla, United States
Tekton Research, LLC - 2121 E Harmony Rd - PPDS
Fort Collins, United States

…and 166 more on ClinicalTrials.gov.

🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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