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Clinical Trials in the UK / NCT06245408
Active, not recruiting Phase 3

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

NCT06245408 · tracked via the Priya Life Science UK tracker
Sponsor
Amgen
Phase
Phase 3
Started
2024-04-08
Last updated
2026-01-08

Condition(s) studied

Sjögren's Syndrome (SS)

Investigational drug(s) / intervention(s)

DazodalibepPlacebo

Dazodalibep: IV infusion

Placebo: IV infusion

Study summary

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

Eligibility

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
Key Inclusion Criteria: 1. Diagnosed with SS by meeting the 2016 ACR/EULAR Classification Criteria 2. Have an ESSPRI score of ≥ 5 at screening. 3. Have an ESSDAI score of \< 5 at screening. 4. Positive for either anti-Ro autoantibodies or RF, or both at screening (as per the definition of the standard central laboratory test). 5. Residual salivary gland function as defined by whole stimulated salivary flow \> 0.1 mL/min. 6. Vaccinated against SARS-CoV-2 according to current local authority guidelines at least 2 weeks prior to screening unless participant refuses vaccination. 7. Meets all of the following tuberculosis (TB) criteria: 1. No history of latent or active TB prior to screening, except for latent TB with documented completion of locally appropriate treatment. 2. No signs or symptoms suggestive of active TB from medical history or physical examination. 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). 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. 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). Key Exclusion Criteria: 1. Individuals with medical history of confirmed deep venous thrombosis, pulmonary embolism, or arterial thromboembolism within 2 years of screening. 2. History or presence of concomitant polymyositis or dermatomyositis or systemic sclerosis. 3. Active malignancy or history of malignancy within the last 5 years, except as follows: 1. In situ carcinoma of the cervix treated with apparent success with curative therapy \> 12 months prior to screening; OR 2. Cutaneous basal cell carcinoma following presumed curative therapy. 4. Individuals who are pregnant or lactating or planning to become pregnant during the study. 5. Individuals with known history of severe allergy or reaction to any component of the IP formulation or to any other biologic therapy. 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. 7. Individuals who have a positive test for, or have been treated for, hepatitis B, hepatitis c or HIV infection. 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. 9. Individuals with: 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. 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.

Primary outcome measure(s)

Trial sites (194)

FacilityCityRegionStatus
Arizona Arthritis & Rheumatology Associates - Avondale Avondale Arizona
Arizona Research Clinic PLLC Chandler Arizona
Arizona Arthritis and Rheumatology Associates - Flagstaff - 399 S Malpais Ln Flagstaff Arizona
Arizona Arthritis and Rheumatology Associates - Gilbert - 3645 S Rome St Gilbert Arizona
Arizona Arthritis and Rheumatology Associates - Glendale - 5681 W Beverly Ln Glendale Arizona
Arizona Arthritis and Rheumatology Associates - Tucson - 2001 W Orange Grove Rd Tucson Arizona
Medvin Clinical Research - Covina Covina California
UCSD Altman Clinical and Translational Research Institute Building La Jolla California
Inland Rheumatology Clinical Trials Incorporated Upland California
Medvin Clinical Research Whittier California
Tekton Research, LLC - 2121 E Harmony Rd - PPDS Fort Collins Colorado
Bradenton Research Center Inc Bradenton Florida
Clinical Research of West Florida Inc - Clearwater Clearwater Florida
West Broward Rheumatology Associates, Inc. Tamarac Florida
BayCare Medical Group Primary Care and Rheumatology - Tampa Tampa Florida
University of Kansas Medical Center Kansas City Kansas
Tufts Medical Center - Rheumatology Research Office - PPDS Boston Massachusetts
Clinical Research Institute of Michigan, LLC-St. Claire Shores Saint Clair Shores Michigan
Kansas City Physician Partners-8350 N Saint Clair Ave Kansas City Missouri
Arthritis, Rheumatic & Bone Disease Associates - P Voorhees Township New Jersey
Albuquerque Center for Rheumatology Albuquerque New Mexico
NYU Langone Health - Joseph S. and Diane H. Steinberg Ambulatory Care Center Brooklyn New York
Arthritis and Osteoporosis Consultants of The Carolinas Charlotte North Carolina
Duke Early Phase Clinical Research Unit - PPDS Durham North Carolina
Onsite Clinical Solutions, LLC - Salisbury Salisbury North Carolina
Arthritis & Osteoporosis Center of Southwest Ohio - Miamisburg Miamisburg Ohio
University of Toledo Medical Center Toledo Ohio
STAT Research-600 Aviator Ct Vandalia Ohio
Low Country Rheumatology PA-Summerville Summerville South Carolina
Murfreesboro Medical Clinic Westlawn Murfreesboro Tennessee
Amarillo Center For Clinical Research Amarillo Texas
Accurate Clinical Management-Baytown Baytown Texas
Precision Comprehensive Clinical Research Solutions Grapevine Texas
R & H Clinical Research-777 S Fry Rd Katy Texas
Texas Arthritis & Rheumatology Associates Katy Texas
Valley Arthritis Center McAllen Texas
University of Texas - San Antonio - Health Science Center - PPDS San Antonio Texas
Advanced Rheumatology of Houston - The Woodlands The Woodlands Texas
DM Clinical Research - Migraine and COPD - PPDS Tomball Texas
Western Washington Medical Group Bothell Washington

+ 154 more sites — see the full list on the official registry below.

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 NCT06245408 on ClinicalTrials.gov ↗ ← All trials in the UK