RecruitingPhase 3

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

A Multicenter, Open-Label, Long-term, Extension Study to Evaluate the Safety and Tolerability of Dazodalibep in Participants With Sjögren's Syndrome (SS)

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study looks at the long-term safety of dazodalibep and how well people can handle its side effects. It is for people with Sjögren's syndrome who finished one of two earlier dazodalibep studies.

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

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Give informed consent, meaning you agree to join after learning about the study, before any study activities.
  • Have been eligible for and received dazodalibep or placebo (a treatment with no study drug) in study HZNP-DAZ-301 or HZNP-DAZ-303, and finished that study through week 48.
  • Be able to get the first dose at the earlier study's week 48 visit or within 28 days after it.

Who can't join

  • Have a serious active infection on day 1, including an ongoing infection that needs antibiotics or medicine for a virus.
  • Plan to join another study involving an experimental drug or procedure, have other experimental procedures, or join research that only observes your health.
  • Have a health problem or change that the study doctors or sponsor believe could make treatment unsafe or make safety results hard to judge.
  • Plan surgery or a hospital stay that could make safety results hard to judge.
  • Plan to get a live vaccine, which contains a weakened germ, during the study.
  • Are pregnant, breastfeeding, or planning pregnancy during the study; or, if you can become pregnant, will not use the required birth control during treatment and for 12 weeks after the last dose.
  • Have a known sensitivity to any product or ingredient given with study doses.
  • Are unlikely to complete all required study visits or follow all required study steps.

Simplified for readability. The official criteria below are what the study team uses.

Official 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. * 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.

Study sites (31)

AZ

  • Arizona Arthritis & Rheumatology Associates - Avondale · Avondale, AZ 85392More trials in Avondale
  • Arizona Arthritis and Rheumatology Associates - Flagstaff - 399 S Malpais Ln · Flagstaff, AZ 86001-6269More trials in Flagstaff
  • Arizona Arthritis and Rheumatology Associates - Gilbert - 3645 S Rome St · Gilbert, AZ 85297-7336More trials in Gilbert
  • Arizona Arthritis and Rheumatology Associates - Glendale - 5681 W Beverly Ln · Glendale, AZ 85306-9800More trials in Glendale
  • Arizona Arthritis and Rheumatology Associates - Tucson - 2001 W Orange Grove Rd · Tucson, AZ 85704-1139More trials in Tucson

CA

CO

FL

MA

MI

MO

NC

NJ

OH

TN

TX

WA

WV