Sjögren's Syndrome
Conditions
Keywords
Cluster of differentiation 40 (CD40), Dazodalibep, AMG 611
Brief summary
The primary objective of this study is to evaluate the long-term safety and tolerability of dazodalibep.
Interventions
DRUGDazodalibep
Dazodalibep will be given intravenously (IV).
Sponsors
Amgen
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants with Treatment-emergent Adverse Events (TEAEs) | Up to 152 weeks | Includes treatment emergent serious adverse events (TESAEs) and adverse events of special interest (AESIs). |
Secondary
| Measure | Time frame |
|---|---|
| Number of Participants with Anti-drug Antibodies (ADAs) During the Study | Up to 132 weeks |
| Plasma Concentration of Dazodalibep | Up to 132 weeks |
Countries
Argentina, Australia, Belgium, Brazil, Canada, Chile, Croatia, France, Germany, Greece, Hungary, Israel, Italy, Japan, Mexico, New Zealand, Peru, Poland, Portugal, Serbia, Slovenia, South Korea, Spain, Taiwan, United Kingdom, United States
Contacts
CONTACTAmgen Call Center
STUDY_DIRECTORMD
Amgen
Outcome results
None listed