Advanced Rheumatology of Houston | Houston, TX
Status and phase
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About
Primary Objective:
To evaluate the effect of dazodalibep on patient-reported symptoms of SS in participants with moderate-to-severe symptom state
Secondary Objectives:
Full description
Acquired from Horizon in 2024.
Enrollment
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Inclusion and exclusion criteria
Key Inclusion Criteria:
Diagnosed with SS by meeting the 2016 ACR/EULAR Classification Criteria
Have an ESSPRI score of ≥ 5 at screening.
Have an ESSDAI score of < 5 at screening.
Positive for either anti-Ro autoantibodies or RF, or both at screening (as per the definition of the standard central laboratory test).
Residual salivary gland function as defined by whole stimulated salivary flow > 0.1 mL/min.
Vaccinated against SARS-CoV-2 according to current local authority guidelines at least 2 weeks prior to screening unless participant refuses vaccination.
Meets all of the following tuberculosis (TB) criteria:
Key Exclusion Criteria:
Individuals with medical history of confirmed deep venous thrombosis, pulmonary embolism, or arterial thromboembolism within 2 years of screening.
History or presence of concomitant polymyositis or dermatomyositis or systemic sclerosis.
Active malignancy or history of malignancy within the last 5 years, except as follows:
Individuals who are pregnant or lactating or planning to become pregnant during the study.
Individuals with known history of severe allergy or reaction to any component of the IP formulation or to any other biologic therapy.
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.
Individuals who have a positive test for, or have been treated for, hepatitis B, hepatitis c or HIV infection.
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.
Individuals with:
Primary purpose
Allocation
Interventional model
Masking
435 participants in 3 patient groups, including a placebo group
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Central trial contact
Amgen Call Center
Data sourced from clinicaltrials.gov
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