Long-term study of dazodalibep in people with Sjögren's syndrome

Trial details

Who runs it

Amgen

Trial code

NCT06747949EU 2024-517513-32-00

Record updated

28 April 2026

Original description

The primary objective of this study is to evaluate the long-term safety and tolerability of dazodalibep.Read full original descriptionShow less

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

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

Inclusion: 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: 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; Clinically significant active infection at Day 1, in the opinion of the Investigator, including ongoing and chronic infection requiring antibiotics or antiviral medication; 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; 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; Participants are excluded from the study if any of the following criteria apply:; 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; Planned surgeries or hospitalizations that, in the opinion of the Investigator or the Sponsor, would interfere with evaluation and interpretation of participant safety; 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.

ClinicalTrials.gov NCT06747949 · EU CTIS 2024-517513-32-00