ACTIVE_NOT_RECRUITING

A Safety and Efficacy Study of Dazodalibep in Participants With Sjögren's Syndrome (SS) With Moderate-to-Severe Symptom State

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Conditions

Sjögren's Syndrome (SS)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)

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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 patient-reported symptoms of SS in participants with moderate-to-severe symptom state Secondary Objectives: 1. To evaluate the effect of dazodalibep on patient-reported outcomes (PROs) in participants with SS. 2. To evaluate the effect of dazodalibep on measures of systemic activity, PROs, and salivary flow in participants with SS 3. To evaluate the safety and tolerability of multiple doses 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 Symptom State (HZNP-DAZ-303)

Quick Facts

Study Start:2024-04-08
Study Completion:2026-12-17
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:ACTIVE_NOT_RECRUITING

Study ID

NCT06245408

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. 1. Diagnosed with SS by meeting the 2016 ACR/EULAR Classification Criteria
  2. 2. Have an ESSPRI score of ≥ 5 at screening.
  3. 3. Have an ESSDAI score of \< 5 at screening.
  4. 4. Positive for either anti-Ro autoantibodies or RF, or both at screening (as per the definition of the standard central laboratory test).
  5. 5. Residual salivary gland function as defined by whole stimulated salivary flow \> 0.1 mL/min.
  6. 6. Vaccinated against SARS-CoV-2 according to current local authority guidelines at least 2 weeks prior to screening unless participant refuses vaccination.
  7. 7. Meets all of the following tuberculosis (TB) criteria:
  8. 1. No history of latent or active TB prior to screening, except for latent TB with documented completion of locally appropriate treatment.
  9. 2. No signs or symptoms suggestive of active TB from medical history or physical examination.
  10. 3. No recent (≤ 12 weeks of screening) close contact with a person with active TB (close contact is defined as ≥ 4 hours/week OR living in the same household OR in a house where a person with active TB is a frequent visitor).
  11. 4. Negative Interferon Gamma Release Assay (IGRA) test result for TB at screen unless previously treated as per Inclusion Criterion. Participants with an indeterminate test result can repeat the test, but if the repeat test is also indeterminate, they are excluded.
  12. 5. A chest radiograph (obtained during the screening period or any time within 12 weeks prior to screening) with no evidence of current active TB or other infection, or prior TB, malignancy, or clinically significant abnormalities suggesting an active process (unless due to SS).
  1. 1. Individuals with medical history of confirmed deep venous thrombosis, pulmonary embolism, or arterial thromboembolism within 2 years of screening.
  2. 2. History or presence of concomitant polymyositis or dermatomyositis or systemic sclerosis.
  3. 3. Active malignancy or history of malignancy within the last 5 years, except as follows:
  4. 1. In situ carcinoma of the cervix treated with apparent success with curative therapy \> 12 months prior to screening; OR
  5. 2. Cutaneous basal cell carcinoma following presumed curative therapy.
  6. 4. Individuals who are pregnant or lactating or planning to become pregnant during the study.
  7. 5. Individuals with known history of severe allergy or reaction to any component of the IP formulation or to any other biologic therapy.
  8. 6. Individuals with any severe cardiovascular, respiratory, endocrine, gastrointestinal, hematological, neurological, psychiatric, or systemic disorder or any other condition that, in the opinion of the Investigator, 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.
  9. 7. Individuals who have a positive test for, or have been treated for, hepatitis B, hepatitis c or HIV infection.
  10. 8. Individuals with a positive test for SARS-CoV-2 on the day of randomization or symptoms suggestive of SARS-CoV-2 at randomization or significant exposure to coronavirus disease 2019 (COVID-19) within 10 calendar days prior to randomization.
  11. 9. Individuals with:
  12. 1. A history of more than one episode of herpes zoster and/or opportunistic infections in the last 12 months, with the exception of non-invasive herpes simplex at any site, oral candidiasis, vaginal candidiasis, or cutaneous fungal infections, which are permitted within the prior 12 months unless of unusual severity.
  13. 2. Active infection requiring systemic treatment at the time of screening or through randomization, or history of more than 2 infections requiring IV antibiotics within 12 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
Medvin Clinical Research - Covina
Covina, California, 91723
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
Medvin Clinical Research
Whittier, California, 90602
United States
Tekton Research, LLC - 2121 E Harmony Rd - PPDS
Fort Collins, Colorado, 80528-3400
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
West Broward Rheumatology Associates, Inc.
Tamarac, Florida, 33321-2956
United States
BayCare Medical Group Primary Care and Rheumatology - Tampa
Tampa, Florida, 33614-7101
United States
University of Kansas Medical Center
Kansas City, Kansas, 66160-8500
United States
Tufts Medical Center - Rheumatology Research Office - PPDS
Boston, Massachusetts, 02111-1552
United States
Clinical Research Institute of Michigan, LLC-St. Claire Shores
Saint Clair Shores, Michigan, 48081
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 Township, New Jersey, 08043-4509
United States
Albuquerque Center for Rheumatology
Albuquerque, New Mexico, 87102-1710
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, 28207-1100
United States
Duke Early Phase Clinical Research Unit - PPDS
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, 45342-3585
United States
University of Toledo Medical Center
Toledo, Ohio, 43614-2595
United States
STAT Research-600 Aviator Ct
Vandalia, Ohio, 45377-9474
United States
Low Country Rheumatology PA-Summerville
Summerville, South Carolina, 29486
United States
Murfreesboro Medical Clinic Westlawn
Murfreesboro, Tennessee, 37128
United States
Amarillo Center For Clinical Research
Amarillo, Texas, 79124-1601
United States
Accurate Clinical Management-Baytown
Baytown, Texas, 77521
United States
Precision Comprehensive Clinical Research Solutions
Grapevine, Texas, 76051-3143
United States
R & H Clinical Research-777 S Fry Rd
Katy, Texas, 77450-2297
United States
Texas Arthritis & Rheumatology Associates
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
Advanced Rheumatology of Houston - The Woodlands
The Woodlands, Texas, 77382
United States
DM Clinical Research - Migraine and COPD - PPDS
Tomball, Texas, 77375
United States
Western Washington Medical Group
Bothell, Washington, 98021-4418
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 Date2024-04-08
Study Completion Date2026-12-17

Study Record Updates

Study Start Date2024-04-08
Study Completion Date2026-12-17

Terms related to this study

Keywords Provided by Researchers

  • 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

  • Sjögren's Syndrome (SS)