Recruiting

Phase 3

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

Sponsor:

Amgen

Code:

NCT06747949

Conditions

Sjögren's Syndrome

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Dazodalibep

Study Details

Brief summary:

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

Conditions

Sjögren's Syndrome

Study ID

NCT06747949

Start date

Feb 25, 2025

Status verified date

Apr, 2026

Completion date

Dec 11, 2029

Anticipated

Primary completion date

Dec 11, 2029

Anticipated

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

844 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Dazodalibep

Participants who completed the 48-week dazodalibep or placebo treatment in trials HZNP-DAZ-301 or HZNP-DAZ-303 will receive assigned dose Dose A of dazodalibep for an additional 132 weeks.

Interventions

Dazodalibep

Dazodalibep will be given intravenously (IV).

Primary outcome measure

Number of Participants with Treatment-emergent Adverse Events (TEAEs) [ Time Frame: Up to 152 weeks ]

Central Contacts and Locations

Central contacts

Amgen Call Center

866-572-6436 medinfo@amgen.com

Locations

Arizona Arthritis & Rheumatology Associates - Avondale

Recruiting

Avondale, Arizona, United States, 85392

Arizona Arthritis and Rheumatology Associates - Flagstaff - 399 S Malpais Ln

Recruiting

Flagstaff, Arizona, United States, 86001-6269

Arizona Arthritis and Rheumatology Associates - Gilbert - 3645 S Rome St

Recruiting

Gilbert, Arizona, United States, 85297-7336

Arizona Arthritis and Rheumatology Associates - Glendale - 5681 W Beverly Ln

Recruiting

Glendale, Arizona, United States, 85306-9800

Arizona Arthritis and Rheumatology Associates - Tucson - 2001 W Orange Grove Rd

Recruiting

Tucson, Arizona, United States, 85704-1139

Samy Metyas MD Inc

Recruiting

Covina, California, United States, 91723

UCSD Altman Clinical and Translational Research Institute Building

Recruiting

La Jolla, California, United States, 92037-1337

Tekton Research, LLC - 2121 E Harmony Rd - PPDS

Recruiting

Fort Collins, Colorado, United States, 80528-3400

Bradenton Research Center Inc

Recruiting

Bradenton, Florida, United States, 34205-1704

Clinical Research of West Florida Inc - Clearwater

Recruiting

Clearwater, Florida, United States, 33765-2616

BayCare Medical Group Primary Care and Rheumatology - Tampa

Recruiting

Tampa, Florida, United States, 33614-7101

Tufts University School of Dental Medicine

Recruiting

Boston, Massachusetts, United States, 02111-1527

Shores Rheumatology

Recruiting

Saint Clair Shores, Michigan, United States, 48081-1274

Kansas City Physician Partners-8350 N Saint Clair Ave

Recruiting

Kansas City, Missouri, United States, 64151

Arthritis, Rheumatic & Bone Disease Associates - Voorhees

Recruiting

Voorhees Township, New Jersey, United States, 08043-4501

Arthritis and Osteoporosis Consultants of The Carolinas - Charlotte - 1918 Randolph Rd

Recruiting

Charlotte, North Carolina, United States, 28207-1100

Duke Early Phase Clinical Research Unit - PPDS

Recruiting

Durham, North Carolina, United States, 27710-0001

Onsite Clinical Solutions, LLC - Salisbury

Recruiting

Salisbury, North Carolina, United States, 28144

Arthritis & Osteoporosis Center of Southwest Ohio - Miamisburg

Recruiting

Miamisburg, Ohio, United States, 45342-3585

University of Toledo Medical Center

Recruiting

Toledo, Ohio, United States, 43614-2595

STAT Research-600 Aviator Ct

Recruiting

Vandalia, Ohio, United States, 45377-9474

Murfreesboro Medical Clinic Westlawn

Recruiting

Murfreesboro, Tennessee, United States, 37128

Accurate Clinical Management-Baytown

Recruiting

Baytown, Texas, United States, 77521-2279

Precision Comprehensive Clinical Research Solutions

Recruiting

Colleyville, Texas, United States, 76034-5913

R & H Clinical Research-777 S Fry Rd

Recruiting

Katy, Texas, United States, 77450-2297

Houston Rheumatology & Arthritis Specialists - PLLC - PPDS

Recruiting

Katy, Texas, United States, 77494-1341

Biopharma Informatic - Ridge Road - PPDS

Recruiting

McAllen, Texas, United States, 78503-1527

Advanced Rheumatology of Houston

Recruiting

The Woodlands, Texas, United States, 77382-2935

DM Clinical Research - Migraine and COPD - PPDS

Recruiting

Tomball, Texas, United States, 77375

Western Washington Medical Group, Bothell - Rheumatology

Recruiting

Bothell, Washington, United States, 98021

Rheumatology and Pulmonary Clinic

Recruiting

Beckley, West Virginia, United States, 25801-2805

Clinique de Rhumatologie Du Centre Du Quebec

Recruiting

Trois-Rivières, Quebec, Canada, G8Z 1Y2

More Information

Sponsor

Amgen

Last update posted

Apr 28, 2026

Last verified

Apr, 2026

Keywords

Cluster of differentiation 40 (CD40)
Dazodalibep
AMG 611

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Amgen on 2026-04-28.