Status:
RECRUITING
A Long-term Extension Study of Dazodalibep in Participants With Sjögren's Syndrome (SS)
Lead Sponsor:
Amgen
Conditions:
Sjögren's Syndrome
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
The primary objective of this study is to evaluate the long-term safety and tolerability of dazodalibep.
Eligibility Criteria
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
- 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.
Key Trial Info
Start Date :
February 25 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 11 2029
Estimated Enrollment :
844 Patients enrolled
Trial Details
Trial ID
NCT06747949
Start Date
February 25 2025
End Date
December 11 2029
Last Update
February 12 2026
Active Locations (144)
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1
Arizona Arthritis & Rheumatology Associates - Avondale
Avondale, Arizona, United States, 85392
2
Arizona Arthritis and Rheumatology Associates - Flagstaff - 399 S Malpais Ln
Flagstaff, Arizona, United States, 86001-6269
3
Arizona Arthritis and Rheumatology Associates - Gilbert - 3645 S Rome St
Gilbert, Arizona, United States, 85297-7336
4
Arizona Arthritis and Rheumatology Associates - Glendale - 5681 W Beverly Ln
Glendale, Arizona, United States, 85306-9800