Clinical Trials in the UK / NCT06747949
Recruiting
Phase 3
A Long-term Extension Study of Dazodalibep in Participants With Sjögren's Syndrome (SS)
NCT06747949 · tracked via the Priya Life Science UK tracker
Condition(s) studied
Sjögren's Syndrome
Investigational drug(s) / intervention(s)
Dazodalibep: Dazodalibep will be given intravenously (IV).
Study summary
The primary objective of this study is to evaluate the long-term safety and tolerability of dazodalibep.
Eligibility
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.
Primary outcome measure(s)
- 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).
Trial sites (174)
| Facility | City | Region | Status |
|---|---|---|---|
| Arizona Arthritis & Rheumatology Associates - Avondale | Avondale | Arizona | Recruiting |
| Arizona Arthritis and Rheumatology Associates - Flagstaff - 399 S Malpais Ln | Flagstaff | Arizona | Recruiting |
| Arizona Arthritis and Rheumatology Associates - Gilbert - 3645 S Rome St | Gilbert | Arizona | Recruiting |
| Arizona Arthritis and Rheumatology Associates - Glendale - 5681 W Beverly Ln | Glendale | Arizona | Recruiting |
| Arizona Arthritis and Rheumatology Associates - Tucson - 2001 W Orange Grove Rd | Tucson | Arizona | Recruiting |
| Samy Metyas MD Inc | Covina | California | Recruiting |
| UCSD Altman Clinical and Translational Research Institute Building | La Jolla | California | Recruiting |
| Tekton Research, LLC - 2121 E Harmony Rd - PPDS | Fort Collins | Colorado | Recruiting |
| Bradenton Research Center Inc | Bradenton | Florida | Recruiting |
| Clinical Research of West Florida Inc - Clearwater | Clearwater | Florida | Recruiting |
| BayCare Medical Group Primary Care and Rheumatology - Tampa | Tampa | Florida | Recruiting |
| Tufts University School of Dental Medicine | Boston | Massachusetts | Recruiting |
| Shores Rheumatology | Saint Clair Shores | Michigan | Recruiting |
| Kansas City Physician Partners-8350 N Saint Clair Ave | Kansas City | Missouri | Recruiting |
| Arthritis, Rheumatic & Bone Disease Associates - Voorhees | Voorhees Township | New Jersey | Recruiting |
| Arthritis and Osteoporosis Consultants of The Carolinas - Charlotte - 1918 Randolph Rd | Charlotte | North Carolina | Recruiting |
| Duke Early Phase Clinical Research Unit - PPDS | Durham | North Carolina | Recruiting |
| Onsite Clinical Solutions, LLC - Salisbury | Salisbury | North Carolina | Recruiting |
| Arthritis & Osteoporosis Center of Southwest Ohio - Miamisburg | Miamisburg | Ohio | Recruiting |
| University of Toledo Medical Center | Toledo | Ohio | Recruiting |
| STAT Research-600 Aviator Ct | Vandalia | Ohio | Recruiting |
| Murfreesboro Medical Clinic Westlawn | Murfreesboro | Tennessee | Recruiting |
| Accurate Clinical Management-Baytown | Baytown | Texas | Recruiting |
| Precision Comprehensive Clinical Research Solutions | Colleyville | Texas | Recruiting |
| R & H Clinical Research-777 S Fry Rd | Katy | Texas | Recruiting |
| Houston Rheumatology & Arthritis Specialists - PLLC - PPDS | Katy | Texas | Recruiting |
| Biopharma Informatic - Ridge Road - PPDS | McAllen | Texas | Recruiting |
| Advanced Rheumatology of Houston | The Woodlands | Texas | Recruiting |
| DM Clinical Research - Migraine and COPD - PPDS | Tomball | Texas | Recruiting |
| Western Washington Medical Group, Bothell - Rheumatology | Bothell | Washington | Recruiting |
| Rheumatology and Pulmonary Clinic | Beckley | West Virginia | Recruiting |
| Consultorios Médicos Dr. Doreski - Fundacion Respirar - PPDS | Ciudad Autónoma de Buenos Aires | Buenos Aires | Recruiting |
| Instituto CER S.A. | Quilmes | Buenos Aires | Recruiting |
| Instituto de Investigaciones Clinicas Quilmes SRL | Quilmes | Buenos Aires | Recruiting |
| MR Medicina Reumatologica | San Fernando | Buenos Aires | Recruiting |
| DOM Centro de Reumatología | Buenos Aires | Ciudad Autónoma de BuenosAires | Recruiting |
| Centro de Investigaciones Reumatológicas | San Miguel de Tucumán | Tucumán Province | Recruiting |
| Centro Medico Privado de Reumatologia - PPDS | San Miguel de Tucumán | Tucumán Province | Recruiting |
| Clínica Mayo de U.M.C.B. S.R.L | San Miguel de Tucumán | Tucumán Province | Recruiting |
| Aprillus Asistencia e Investigacion - Terrada 89 | Buenos Aires | Argentina | Recruiting |
+ 134 more sites — see the full list on the official registry below.
More Amgen trials in the UK
Other trials for the same condition
Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT06747949 on ClinicalTrials.gov ↗ ← All trials in the UK