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

Amgen

Status and phase: Enrolling; Phase 3

Conditions: Sjögren's Syndrome

Treatments: Drug: Dazodalibep

Study type: Interventional

Funder types: Industry

Identifiers

NCT06747949

2024-517513-32-00 (Other Identifier)

20230050 (Other Identifier)

HZNP-DAZ-304

Details and patient eligibility

About

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

Enrollment: 844 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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, including laboratory studies performed on Week 44 of prior phase 3 study.
• 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.
• Male participants with a female partner of childbearing potential who are unwilling to practice sexual abstinence (refrain from heterosexual intercourse) or use contraception during treatment and for an additional 12 weeks after the last dose of investigational product.
• Male participants with a pregnant partner 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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844 participants in 2 patient groups

Dazodalibep/Dazodalibep

Experimental group

Description:

Participants who completed the 48-week dazodalibep treatment in trials HZNP-DAZ-301 or HZNP-DAZ-303 will continue with their assigned dose (1 or 2) for an additional 144 weeks.

Treatment:

Drug: Dazodalibep

Placebo/Dazodalibep

Experimental group

Description:

Participants who completed the 48-week placebo treatment in trials HZNP-DAZ-301 or HZNP-DAZ-303 will be randomized 1:1 to dazodalibep (dose 1 or 2) for an additional 144 weeks.

Treatment:

Drug: Dazodalibep