Last updated 31 days ago
A Study to Evaluate the Efficacy and Safety of Dazodalibep in Participants With Sjögren's Syndrome (SS) With Moderate-to-severe Systemic Disease Activity
621 patients around the world
Available in Chile, Argentina, Puerto Rico, Peru, Brazil, Mexico
Acquired from Horizon in 2024.
Horizon Therapeutics Ireland DAC
36Research sites
621Patients 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 Sjögren's syndrome (SS) by meeting the 2016 American College of Rheumatology (ACR)/European Alliance of Associations for Rheumatology (EULAR) Classification Criteria.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.Positive for either anti-Ro autoantibodies or rheumatoid factor (RF), or both at screening (as per the central laboratory test).
- Medical history of confirmed deep vein thrombosis, pulmonary embolism, or arterial thromboembolism within 2 years of screening.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.Individuals with any severe or life-threatening cardiovascular (including vasculitis).
Sites
Instituto de Investigaciones Clínicas Quilmes
Recruiting
Instituto Médico de la Fundación Estudios Clínicos - Rosario
Recruiting
Centro Polivalente de Asistencia e Investigación Clínica - CER San Juan
Recruiting
DOM Centro de Reumatología - CABA
Recruiting
Clínica Mayo de UMCB SRL
Recruiting
Centro Médico Arsema
Recruiting
Investigaciones Reumatológicas y Osteológicas IRO
Recruiting
Centro de Investigaciones Médicas Tucumán
Recruiting
Sanatorio Allende (Nueva Córdoba)
Recruiting
Centro Médico Framingham
Recruiting
StudyOasiz
SponsorHorizon Therapeutics Ireland DAC
Study typeInterventional
Conditions
Sjogren's syndrome
Requirements
From 18 YearsAll Gender
Unique study IDclinicaltrials.gov
NCT06104124
