Last updated 23 days ago
Nipocalimab in Moderate to Severe Sjogren's Disease
600 patients around the world
Available in Argentina, United States, Mexico, Brazil
This clinical development program for nipocalimab in SjD includes 2 identical double
blind, placebo-controlled studies to evaluate the efficacy, safety, and tolerability of
nipocalimab in participants greater than or equal to (>=) 18 years of age with moderate
to severe SjD.
Janssen Research & Development, LLC
15Research sites
600Patients 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
- Medically stable on the basis of physical examination, medical history, vital signs, clinical laboratory tests, and 12-lead electrocardiogram (ECG) performed at screening.Meets criteria for diagnosis of SjD by the 2016 American College of Rheumatology/European Alliance of Associations for Rheumatology (ACR/EULAR) classification criteria.Seropositive for antibodies to Ro/SSA (Ro60 and/or Ro52) at screening.Total ClinESSDAI score greater than or equal to (>=) 5 at screening.Participants of childbearing potential must have a negative highly sensitive serum (beta-hCG) pregnancy test at screening and a negative urine pregnancy test at Week 0 prior to randomization.
- Has a history of severe, progressive and/or uncontrolled hepatic, gastrointestinal, renal, pulmonary, cardiovascular, psychiatric, neurological or musculoskeletal disorder, hypertension, and/or any other medical or uncontrolled autoimmune disorder or clinically significant abnormalities in screening laboratory.Known allergies, hypersensitivity, or intolerance to nipocalimab or its excipients or excipients used in the placebo formulation.Has any confirmed or suspected clinical immunodeficiency syndrome not related to treatment of his/her SjD or has a family history of congenital or hereditary immunodeficiency.Has shown a previous severe immediate hypersensitivity reaction, such as anaphylaxis, to therapeutic proteins (for example, monoclonal antibodies, intravenous immunoglobulin).Has any unstable or progressive manifestation of SjD that is likely to warrant escalation in therapy beyond permitted background medications.
Sites
Centro de Investigaciones Médicas Tucumán
Recruiting
Instituto Médico de Alta Complejidad San Isidro IMACSI
Recruiting
Consultorios Reumatológicos Pampa - CABA
Recruiting
Swiss Medical Center Barrio Parque - CABA
Recruiting
CIER - Centro de Investigación en Enfermedades Reumáticas
Recruiting
Centro Paulista de Investigação Clínica - CEPIC
Recruiting
Hospital De Base de São José do Rio Preto - CIP São José
Recruiting
CETI - Centro de Estudos em Terapias Inovadoras
Recruiting
Empresa Brasileira de Serviços Hospitalares- EBSERH
Recruiting
Cedoes - Pesquisa e Diagnóstico
Recruiting
StudyDAFFODIL
SponsorJanssen Research & Development, LLC
Study typeInterventional
Conditions
Sjogren's syndrome
Requirements
From 18 YearsAll Gender
Unique study IDclinicaltrials.gov
NCT06741969
