Testing Dazodalibep for sjögren's syndrome

Exclusion

• −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 InvestigatorPrincipal investigatorThe doctor or researcher responsible for running the study at a site.Read more →, 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 observationalObservational studyA study that watches what happens without assigning any treatment.Read more → research studies while participating in this study are excluded.
• −Any condition or change in health status observed or reported during the phase 3Phase 3A large study comparing a treatment against the current standard.Read more → SS studies (HZNP-DAZ-301, or HZNP-DAZ-303) that, in the opinion of the Investigator or the SponsorSponsorThe organisation responsible for the study overall.Read more →, 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.
• −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 protocolProtocolThe detailed plan a study must follow.Read more →-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.
• −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.