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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
Sponsor
Amgen
Phase
Phase 3
Started
2025-02-25
Last updated
2026-04-28

Condition(s) studied

Sjögren's Syndrome

Investigational drug(s) / intervention(s)

Dazodalibep

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

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
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)

Trial sites (174)

FacilityCityRegionStatus
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