Long-term evaluation of dazodalibep for Sjögren's Syndrome

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study aims to assess the long-term safety and tolerability of dazodalibep in participants who have previously completed a phase 3 study for Sjögren's Syndrome. Eligible participants must have received either dazodalibep or a placebo in earlier studies and are now being monitored for extended outcomes. The study will involve administering the treatment and observing participants over an extended period to gather data on its effects.

Why it matters

Who can join: the full rules

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.

Where it's running

• Arizona Arthritis & Rheumatology Associates - Avondale
  Avondale, Arizona, United States Recruiting
• Arizona Arthritis and Rheumatology Associates - Flagstaff - 399 S Malpais Ln
  Flagstaff, Arizona, United States Recruiting
• Arizona Arthritis and Rheumatology Associates - Gilbert - 3645 S Rome St
  Gilbert, Arizona, United States Recruiting
• Arizona Arthritis and Rheumatology Associates - Glendale - 5681 W Beverly Ln
  Glendale, Arizona, United States Recruiting
• Arizona Arthritis and Rheumatology Associates - Tucson - 2001 W Orange Grove Rd
  Tucson, Arizona, United States Recruiting
• Samy Metyas MD Inc
  Covina, California, United States Recruiting

+124 more sites. See ClinicalTrials.gov for the full list.

Study contacts

• Study coordinator: Amgen Call Center
• Email: medinfo@amgen.com
• Phone: 866-572-6436

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• See if small fiber neuropathy is common in people with primary Sjögren’s syndrome

  This study tests whether small fiber neuropathy is common in adults with primary Sjögren’s syndrome using a quick, non-invasive Sudoscan test.

  Recruiting Centre Hospitalier Universitaire, Amiens · Amiens · NCT07917442

• rhPRG4 (450 µg/mL) eye drops for Sjögren's-related dry eye

  This study will test whether rhPRG4 eye drops relieve symptoms and improve corneal staining in adults with Sjögren's-related dry eye compared with a placebo eye drop.

  Recruiting at 7 sites Phase 2 Lubris Bio Pty Ltd · Sydney, New South Wales and 6 other locations · NCT07118241

• Using PSMA and FAPI PET scans to map salivary gland function and inflammation in Sjögren's syndrome

  This study will test whether combining PSMA and FAPI PET scans can better show salivary gland function and inflammation in people with primary Sjögren's syndrome.

  Recruiting Peking Union Medical College Hospital · Beijing · NCT07324733

• Anti-CD19/BCMA U CAR-T cell therapy for relapsed or refractory autoimmune diseases

  This pilot will test whether anti-CD19/BCMA U CAR-T cells can help adults with relapsed or refractory autoimmune diseases such as SLE, systemic sclerosis, Sjögren's syndrome, and rheumatoid arthritis.

  Recruiting Early Phase 1 Changhai Hospital · Shanghai · NCT07246096

• Creating a clinical model for primary Sjögren's syndrome using both traditional Chinese and Western medicine

  This study is trying to combine traditional Chinese medicine with Western medicine to see if it can improve how we diagnose and manage primary Sjögren's syndrome in patients.

  Recruiting China-Japan Friendship Hospital · Beijing, Beijing Municipality · NCT06528197

• Impact of Sjögren's syndrome on quality of life and costs

  This study is trying to see how small fiber neuropathy affects the quality of life and costs for people with Sjögren's syndrome.

  Recruiting Assistance Publique - Hôpitaux de Paris · Paris · NCT03509064

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.