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New treatment option for Sjögren's Syndrome
Official title A Long-term Extension Study of Dazodalibep in Participants With Sjögren's Syndrome (SS)
ClinicalTrials.gov ID: NCT06747949
What this study is testing
What is Dazodalibep?
Dazodalibep is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for sjögren's syndrome.
Also referred to as AMG 611.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The primary objective of this study is to evaluate the long-term safety and tolerability of dazodalibep.
- Phase 3: a large, late-stage study
- You might receive a placebo (an inactive treatment) instead of the study drug.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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...
- 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...
You likely can't join if
- 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...
- Planned participation in another clinical study with an IP or procedure during the LTE study. Other investigational procedures and participation in...
- 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...
- Planned surgeries or hospitalizations that, in the opinion of the Investigator or the Sponsor, would interfere with evaluation and interpretation of...
- Individuals who plan to receive live (attenuated) vaccine during the LTE study.
See the full eligibility 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).
- 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...
- 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...
- 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...
The study team makes the final eligibility decision.
Where it's taking place
- Avondale, Arizona, United States
- Flagstaff, Arizona, United States
- Gilbert, Arizona, United States
- Glendale, Arizona, United States
- Tucson, Arizona, United States
- Covina, California, United States
- La Jolla, California, United States
- Fort Collins, Colorado, United States
- Bradenton, Florida, United States
- Clearwater, Florida, United States
- Tampa, Florida, United States
- Boston, Massachusetts, United States
- Saint Clair Shores, Michigan, United States
- Kansas City, Missouri, United States
- Voorhees Township, New Jersey, United States
- Charlotte, North Carolina, United States
- Durham, North Carolina, United States
- Salisbury, North Carolina, United States
- Miamisburg, Ohio, United States
- Toledo, Ohio, United States
+ 124 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Avondale, Arizona, United States; Flagstaff, Arizona, United States; Gilbert, Arizona, United States; Glendale, Arizona, United States; Tucson, Arizona, United States; Covina, California, United States and 138 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.