ACTIVE_NOT_RECRUITING

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

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Conditions

Sjogren's SyndromeSjögren's Syndrome With Moderate-to-severe Systemic Disease Activity Study Phase: Phase 3European Alliance of Associations for Rheumatology Sjögren's Syndrome Disease Activity Index (ESSDAI)European Alliance of Associations for Rheumatology Sjögren's Syndrome Patient Reported Index (ESSPRI)European Alliance of Associations for Rheumatology (EULAR)

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Official Title

A Phase 3 Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Dazodalibep in Participants With Sjögren's Syndrome With Moderate-to-severe Systemic Disease Activity

Quick Facts

Study Start:2024-01-24
Study Completion:2026-08-19
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:ACTIVE_NOT_RECRUITING

Study ID

NCT06104124

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Diagnosed with Sjögren's syndrome (SS) by meeting the 2016 American College of Rheumatology (ACR)/European Alliance of Associations for Rheumatology (EULAR) Classification Criteria.
  2. * 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.
  3. * Positive for either anti-Ro autoantibodies or rheumatoid factor (RF), or both at screening (as per the central laboratory test).
  1. * Medical history of confirmed deep vein thrombosis, pulmonary embolism, or arterial thromboembolism within 2 years of screening.
  2. * 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.
  3. * 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.
  4. * 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.
  5. * Active TB or untreated (per local guidelines) latent TB
  6. * 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.
  7. * 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.
  8. * Last administration of experimental or investigational biologic or oral agents \< 6 months prior to screening.
  9. * 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.

Contacts and Locations

Principal Investigator

MD
STUDY_DIRECTOR
Amgen

Study Locations (Sites)

Arizona Arthritis & Rheumatology Associates - Avondale
Avondale, Arizona, 85392
United States
Arizona Research Clinic PLLC
Chandler, Arizona, 85225-2915
United States
Arizona Arthritis and Rheumatology Associates - Flagstaff - 399 S Malpais Ln
Flagstaff, Arizona, 86001-6299
United States
Arizona Arthritis and Rheumatology Associates - Gilbert - 3645 S Rome St
Gilbert, Arizona, 85297-7338
United States
Arizona Arthritis and Rheumatology Associates - Glendale - 5681 W Beverly Ln
Glendale, Arizona, 85306-9800
United States
Arizona Arthritis and Rheumatology Associates - Tucson - 2001 W Orange Grove Rd
Tucson, Arizona, 85704-1140
United States
UCSD Altman Clinical and Translational Research Institute Building
La Jolla, California, 92037-1337
United States
Inland Rheumatology Clinical Trials Incorporated
Upland, California, 91786-4951
United States
Tekton Research, LLC - 2121 E Harmony Rd - PPDS
Fort Collins, Colorado, 80528-3404
United States
Bradenton Research Center Inc
Bradenton, Florida, 34205-1704
United States
Clinical Research of West Florida Inc - Clearwater
Clearwater, Florida, 33765-2616
United States
University of Miami - Leonard M. Miller School of Medicine
Miami, Florida, 33136-1011
United States
Suncoast Clinical Research - ATLAS - New Port Richey - PPDS
New Port Richey, Florida, 34652-4020
United States
Millennium Research
Ormond Beach, Florida, 32174-1140
United States
West Broward Rheumatology Associates, Inc.
Tamarac, Florida, 33321-2956
United States
BayCare Medical Group
Tampa, Florida, 33614-7101
United States
Augusta University Medical Center-Augusta-1120 15th St
Augusta, Georgia, 30912-0004
United States
OrthoIllinois, LTD
Rockford, Illinois, 61114-4937
United States
University of Kansas Medical Center
Kansas City, Kansas, 66160-0001
United States
Massachusetts General Hospital
Boston, Massachusetts, 02114-2621
United States
Shores Rheumatology
Saint Clair Shores, Michigan, 48081-1274
United States
Kansas City Physician Partners-8350 N Saint Clair Ave
Kansas City, Missouri, 64151-5100
United States
Arthritis, Rheumatic & Bone Disease Associates - P
Voorhees, New Jersey, 08043-4509
United States
NYU Langone Health - Joseph S. and Diane H. Steinberg Ambulatory Care Center
Brooklyn, New York, 11201-5501
United States
Arthritis and Osteoporosis Consultants of The Carolinas
Charlotte, North Carolina, 28207
United States
Duke Early Phase Clinical Research Unit
Durham, North Carolina, 27710-0001
United States
Onsite Clinical Solutions, LLC - Salisbury
Salisbury, North Carolina, 28144
United States
Arthritis & Osteoporosis Center of Southwest Ohio - Miamisburg
Miamisburg, Ohio, 45342
United States
STAT Research-600 Aviator Ct
Vandalia, Ohio, 45377-9474
United States
Low Country Rheumatology PA-Summerville
Summerville, South Carolina, 29486-7887
United States
Murfreesboro Medical Clinic Westlawn
Murfreesboro, Tennessee, 37128
United States
Amarillo Center For Clinical Research - ClinEdge - PPDS
Amarillo, Texas, 79124-1601
United States
Tekton Research, LLC - W Gate Blvd - Austin - PPDS
Austin, Texas, 78745-1470
United States
Accurate Clinical Management-Baytown
Baytown, Texas, 77521
United States
Precision Comprehensive Clinical Research Solutions
Grapevine, Texas, 76051-3143
United States
Prolato Clinical Research Center
Houston, Texas, 77054-2853
United States
R & H Clinical Research-777 S Fry Rd
Katy, Texas, 77450
United States
Valley Arthritis Center
McAllen, Texas, 78501
United States
University of Texas - San Antonio - Health Science Center - PPDS
San Antonio, Texas, 78229-3901
United States
DM Clinical Research - Migraine and COPD - PPDS
Tomball, Texas, 77375
United States
Metrodora Institute
West Valley City, Utah, 84119
United States
Overlake Arthritis & Osteoporosis Center
Bellevue, Washington, 98004-3016
United States
Western Washington Medical Group, Bothell - Rheumatology
Bothell, Washington, 98021
United States
Rheumatology and Pulmonary Clinic
Beckley, West Virginia, 25801-2805
United States

Collaborators and Investigators

Sponsor: Amgen

  • MD, STUDY_DIRECTOR, Amgen

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-01-24
Study Completion Date2026-08-19

Study Record Updates

Study Start Date2024-01-24
Study Completion Date2026-08-19

Terms related to this study

Keywords Provided by Researchers

  • Sjögren's Syndrome With Moderate-to-severe Systemic Disease Activity Study Phase: Phase 3
  • European Alliance of Associations for Rheumatology Sjögren's Syndrome Disease Activity Index (ESSDAI)
  • European Alliance of Associations for Rheumatology Sjögren's Syndrome Patient Reported Index (ESSPRI)
  • European Alliance of Associations for Rheumatology (EULAR)

Additional Relevant MeSH Terms

  • Sjogren's Syndrome