Clinical trial NCT06747949: A Long-term Extension Study of Dazodalibep in Participants With Sjögren's Syndrome (SS)
Official title: A Multicenter, Long-term, Randomized, Extension Study to Evaluate the Safety and Tolerability of Dazodalibep in Participants With SS
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Sjögren's Syndrome
Keywords: Cluster of differentiation 40 (CD40)
Dazodalibep
AMG 611
Lead sponsor: Amgen
Sponsor class: INDUSTRY
First posted: 2024-12-24
Enrollment: 844
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility criteria: 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

Primary outcomes:
measure: Number of Participants with Treatment-emergent Adverse Events (TEAEs)
timeFrame: Up to 152 weeks
Secondary outcomes:
measure: Number of Participants with Anti-drug Antibodies (ADAs) During the Study
timeFrame: Up to 152 weeks
measure: Plasma Concentration of Dazodalibep
timeFrame: Up to 152 weeks
Other outcomes:
Locations:
city: Gilbert
country: United States
facility: Arizona Arthritis and Rheumatology Associates - Gilbert - 3645 S Rome St
state: Arizona
city: Bradenton
country: United States
facility: Bradenton Research Center Inc
state: Florida
city: Clearwater
country: United States
facility: Clinical Research of West Florida Inc - Clearwater
state: Florida
city: Saint Clair Shores
country: United States
facility: Shores Rheumatology
state: Michigan
city: Voorhees
country: United States
facility: Arthritis, Rheumatic & Bone Disease Associates - P
state: New Jersey
city: Katy
country: United States
facility: R & H Clinical Research-777 S Fry Rd
state: Texas
city: Tomball
country: United States
facility: DM Clinical Research - Migraine and COPD - PPDS
state: Texas
city: Hamburg
country: Germany
facility: MVZ Rheuma
Study officials:
affiliation: Amgen
name: MD
role: STUDY_DIRECTOR
References: