Phase 3 study
Recruiting Phase 3
This trial at a glance
Where this trial is running
| Site | City | State or country | Status at this site |
|---|---|---|---|
| The Queen Elizabeth Hospital | Woodville South | SA | Recruiting |
voxsanity.com.au · trial sites from public registries · registry record synced 11 October 2026 · not medical advice
Who can join
The official eligibility criteria
Registry text, reproduced exactly. These are the words the trial's sponsor published on ClinicalTrials.gov. They have not been edited, shortened or rewritten, and they are written for researchers rather than for patients.
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.
Dates on the record
Results, publications and the official record
- No results are posted on the official record yet.
- No publications are listed on the official record yet.
- Official record and contacts on ClinicalTrials.gov – contact details for each site are kept there, and are not copied onto this page.
Sources and dates
- ClinicalTrials.gov – the record this page reformats
- ClinicalTrials.gov processing date: 28 April 2026.
- This page last checked by Voxsanity: 11 October 2026.
Voxsanity reformats data from public registries into this layout. It does not edit, interpret or add to what the registry published.
Not medical advice.
Individual trial records are refreshed on a rolling basis rather than all at once, so a record may be up to several weeks old. Each trial page and trial card shows the date its own record was last synced. Where a record has lagged, its status, sites and enrolment can differ from the current registry state in either direction, so check the registry link on the trial page before acting on them.
Letter for your doctor
A one-page summary of this trial to print or email to your GP. It carries the registry's own record of the trial and its eligibility criteria, and nothing Voxsanity has written about whether it suits you.