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A Safety and Efficacy Study of Dazodalibep in Participants With Sjögren's Syndrome (SS) With Moderate-to-Severe Symptom State
435 patients around the world
Available in Puerto Rico, Argentina
Acquired from Horizon in 2024.
Amgen
2Research sites
435Patients around the world
This study is for people with
Rare diseases
Sjogren's syndrome
Requirements for the patient
From 18 Years
All Gender
Medical requirements
- 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.No history of latent or active TB prior to screening, except for latent TB with documented completion of locally appropriate treatment.No signs or symptoms suggestive of active TB from medical history or physical examination.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.Negative Interferon Gamma Release Assay IGRA test result for TB at screen unless previously treated as per Inclusion Criterion.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.
- 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.In situ carcinoma of the cervix treated with apparent success with curative therapy > 12 months prior to screening.Cutaneous basal cell carcinoma following presumed curative therapy.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 a history ofmore 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.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.
Sites
Consultorios Médicos Dr. Doreski
Recruiting
GCM Medical Group
Recruiting
SponsorAmgen
Conditions
Sjogren's syndrome
Requirements
From 18 YearsAll Gender
Unique study IDclinicaltrials.gov
NCT06245408
