A Study to Evaluate the Efficacy and Safety of Dazodalibep in Participants With Sjögren's Syndrome (SS) With Moderate-to-severe Systemic Disease Activity

Purpose

Primary Objective: To evaluate the effect of dazodalibep on systemic manifestations of Sjögren's Syndrome (SS) in participants with moderate-to-severe systemic disease activity. Secondary Objectives: 1. To evaluate the effect of dazodalibep on patient reported outcomes (PROs) in participants with SS. 2. To evaluate the safety and tolerability of dazodalibep in participants with SS

Condition

  • Sjogren's Syndrome

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Diagnosed with Sjögren's syndrome (SS) by meeting the 2016 American College of Rheumatology (ACR)/European Alliance of Associations for Rheumatology (EULAR) Classification Criteria. - Have an European Alliance of Associations for Rheumatology Sjögren's Syndrome Disease Activity Index (ESSDAI) score of >= 5 despite symptomatic or local therapy at screening. - Positive for either anti-Ro autoantibodies or rheumatoid factor (RF), or both at screening (as per the central laboratory test).

Exclusion Criteria

  • Medical history of confirmed deep vein thrombosis, pulmonary embolism, or arterial thromboembolism within 2 years of screening. - Active malignancy or history of malignancy within the last 5 years, except in situ carcinoma of cervix treated with apparent success with curative therapy > 12 months prior to screening OR cutaneous basal cell carcinoma following presumed curative therapy. - Individuals with any severe or life-threatening cardiovascular (including vasculitis), respiratory, endocrine, gastrointestinal, hematological, psychiatric, or systemic disorder or any other condition that would place the individual at unacceptable risk of complications, interfere with evaluation of the IP, or confound the interpretation of participant safety or study results. - Individuals who have a positive test for hepatitis B, hepatitis C, or HIV infection. A positive test for hepatitis B at screening is defined as: (1) positive for HBsAg OR (2) positive for either HBcAb or HBsAb and HBV DNA detected above the LLOQ by reflex testing by the central laboratory at screening. - Active TB or untreated (per local guidelines) latent TB - Individuals with a history of more than one episode of herpes zoster and/or any opportunistic infection in the last 12 months, and active infection requiring systemic treatment at the time of screening or through randomization, or history of more than 2 infections requiring intravenous (IV) antibiotics within 12 months prior to screening. - Individuals who have received a live (attenuated) vaccine within the 4 weeks prior to randomization or plan to receive a live vaccine during their participation in the study. - Last administration of experimental or investigational biologic or oral agents < 6 months prior to screening. - Individuals who have had previous treatment with any biologic B-cell-depleting therapy (eg, rituximab, ocrelizumab, inebilizumab, ofatumumab, or ianalumab) within 12 months or other B-cell-targeting therapy (eg, belimumab) < 3 months prior to screening.

Study Design

Phase
Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Dazodalibep Dose 1 		Participants will be administered dose 1 of dazodalibep by intravenous (IV) infusion.
  • Drug: Dazodalibep
    IV infusion
    Other names:
    • VIB 4920
    • MEDI 4920
Experimental
Dazodalibep Dose 2 		Participants will be administered dose 2 of dazodalibep by IV infusion.
  • Drug: Dazodalibep
    IV infusion
    Other names:
    • VIB 4920
    • MEDI 4920
Placebo Comparator
Placebo 		Participants will be administered placebo by IV infusion.
  • Drug: Placebo
    IV infusion

Recruiting Locations

Arizona Arthritis & Rheumatology Associates - Avondale
Avondale, Arizona 85392

Arizona Research Clinic PLLC
Chandler, Arizona 85225-2915

Arizona Arthritis and Rheumatology Associates - Flagstaff - 399 S Malpais Ln
Flagstaff, Arizona 86001-6299

Arizona Arthritis and Rheumatology Associates - Gilbert - 3645 S Rome St
Gilbert, Arizona 85297-7338

Arizona Arthritis and Rheumatology Associates - Glendale - 5681 W Beverly Ln
Glendale, Arizona 85306-9800

Arizona Arthritis and Rheumatology Associates - Tucson - 2001 W Orange Grove Rd
Tucson, Arizona 85704-1140

UCSD Altman Clinical and Translational Research Institute Building
La Jolla, California 92037-1337

Inland Rheumatology Clinical Trials Incorporated
Upland, California 91786-4951

Tekton Research, LLC - 2121 E Harmony Rd - PPDS
Fort Collins, Colorado 80528-3404

Bradenton Research Center Inc
Bradenton, Florida 34205-1704

Clinical Research of West Florida Inc - Clearwater
Clearwater, Florida 33765-2616

Life Arc Research
Coral Gables, Florida 33134-4552

University of Miami - Leonard M. Miller School of Medicine
Miami, Florida 33136-1011

Suncoast Clinical Research - ATLAS - New Port Richey - PPDS
New Port Richey, Florida 34652-4020

Millennium Research
Ormond Beach, Florida 32174-1140

West Broward Rheumatology Associates, Inc.
Tamarac, Florida 33321-2956

BayCare Medical Group
Tampa, Florida 33614-7101

Augusta University Medical Center-Augusta-1120 15th St
Augusta, Georgia 30912-0004

OrthoIllinois, LTD
Rockford, Illinois 61114-4937

University of Kansas Medical Center
Kansas City, Kansas 66160-0001

Shores Rheumatology
Saint Clair Shores, Michigan 48081-1274

Kansas City Physician Partners-8350 N Saint Clair Ave
Kansas City, Missouri 64151-5100

Kirk Kerkorian School of Medicine UNLV
Las Vegas, Nevada 89102

Arthritis, Rheumatic & Bone Disease Associates - P
Voorhees, New Jersey 08043-4509

NYU Langone Health - Joseph S. and Diane H. Steinberg Ambulatory Care Center
Brooklyn, New York 11201-5501

Arthritis and Osteoporosis Consultants of The Carolinas
Charlotte, North Carolina 28207

Duke Early Phase Clinical Research Unit
Durham, North Carolina 27710-0001

Onsite Clinical Solutions, LLC - Salisbury
Salisbury, North Carolina 28144

Arthritis & Osteoporosis Center of Southwest Ohio - Miamisburg
Miamisburg, Ohio 45342

University of Toledo Medical Center
Toledo, Ohio 43614-2595

STAT Research-600 Aviator Ct
Vandalia, Ohio 45377-9474

Low Country Rheumatology PA-Summerville
Summerville, South Carolina 29486-7887

West Tennessee Research Institute
Jackson, Tennessee 38305-2883

Murfreesboro Medical Clinic Westlawn
Murfreesboro, Tennessee 37128

Amarillo Center For Clinical Research - ClinEdge - PPDS
Amarillo, Texas 79124-1601

Tekton Research, LLC - W Gate Blvd - Austin - PPDS
Austin, Texas 78745-1470

Accurate Clinical Management-Baytown
Baytown, Texas 77521

Precision Comprehensive Clinical Research Solutions
Grapevine, Texas 76051-3143

Prolato Clinical Research Center
Houston, Texas 77054-2853

R & H Clinical Research-777 S Fry Rd
Katy, Texas 77450

Valley Arthritis Center
McAllen, Texas 78501

University of Texas - San Antonio - Health Science Center - PPDS
San Antonio, Texas 78229-3901

DM Clinical Research - Migraine and COPD - PPDS
Tomball, Texas 77375

Metrodora Institute
West Valley City, Utah 84119

Overlake Arthritis & Osteoporosis Center
Bellevue, Washington 98004-3016

Western Washington Medical Group, Bothell - Rheumatology
Bothell, Washington 98021

Rheumatology and Pulmonary Clinic
Beckley, West Virginia 25801-2805

GCM Medical Group, PSC -62 Calle Jose Marti
San Juan, Puerto Rico 00917

More Details

NCT ID
NCT06104124
Status
Recruiting
Sponsor
Amgen

Study Contact

Amgen Call Center
866-572-6436
medinfo@amgen.com

Detailed Description

Acquired from Horizon in 2024.

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ResearchMatch is funded in part by the National Institutes of Health (NIH) Clinical and Translational Science Award (CTSA) program, led by the NIH’s National Center for Advancing Translational Sciences (NCATS), grants UL1TR000445 and 1U54RR032646-01, and grant U24TR001579 from NCATS and the National Library of Medicine. The content of this website is solely the responsibility of ResearchMatch and Vanderbilt University and does not necessarily represent the official views of the NIH, NCATS, or NLM.

Vanderbilt University Medical Center