A Long-term Extension Study of Dazodalibep in Participants With Sjögren's Syndrome (SS) (NCT06747949) | Clinical Trial Compass
RecruitingPhase 3
A Long-term Extension Study of Dazodalibep in Participants With Sjögren's Syndrome (SS)
United States844 participantsStarted 2025-02-25
Plain-language summary
The primary objective of this study is to evaluate the long-term safety and tolerability of dazodalibep.
Who can participate
Age range18 Years
SexALL
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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 Investigat…
What they're measuring
1
Number of Participants with Treatment-emergent Adverse Events (TEAEs)