Last updated 15 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

22Research 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

Investigaciones Reumatológicas y Osteológicas IRO

Recruiting

Jose E Uriburu 1170 Primer Piso, CABA, Buenos Aires

Clínica Adventista Belgrano - CABA - Buenos Aires

Recruiting

Estomba 1710, CABA, Buenos Aires

Santa Casa de Misericórdia de Belo Horizonte

Recruiting

Avenida Francisco Sales, 1111 - 1º Andar - Pesquisa Clínica - Santa Efigênia - Belo Horizonte/MG - CEP 30150-221

Hospital de Clínicas de Porto Alegre

Recruiting

Santa Cecília, Porto Alegre - RS, 90450-190, Brazil

SER - Serviços Especializados em Reumatologia da Bahia

Recruiting

Rua Conde Filho, 117 - Graça, Salvador - BA, 40150-150

Clinical Research Chile SpA

Recruiting

Beauchef 683, Valdivia, Los Ríos

Complejo Asistencial Hospital Dr. Sótero del Río

Recruiting

Av. Concha y Toro 3459, Puente Alto, 8150215, Región Metropolitana

BIOCINETIC SpA

Recruiting

Serafín Zamora 190, Torre B, piso 4, Oficina 14. Clínica Vespucio, La Florida

Clinstile S.A de C.V.

Recruiting

Durango 325, Roma Norte, Ciudad de México

Oaxaca Site Management Organization S.C.

Recruiting

Humboldt 302, ruta Independencia, Colonia Centro, Oaxaca de Juárez, Oaxaca. México. CP 68000

SponsorHorizon Therapeutics Ireland DAC

Conditions

Sjogren's syndrome

Requirements

From 18 YearsAll Gender

Unique study IDclinicaltrials.gov

NCT06104124