A Randomized, Placebo-controlled, Double-blind, Multicenter Phase 3 Protocol to Assess the Efficacy and Safety of Nipocalimab in Adults With Moderate to Severe Sjogren's Disease (SjD)

Activo, no reclutaFase 3ClinicalTrials.gov

ID: NCT06741969Tipo: INTERVENTIONALInicio: 4 de dic de 2024Fin estimado: 2 de ago de 2029

Traducción no disponible, mostrando original

Resumen

The purpose of this study is to evaluate the clinical efficacy and safety of nipocalimab in participants with moderate to severe Sjogren's disease (SjD).

Descripción detallada

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.

Elegibilidad

Edad mínima: 18 YearsSexo: ALL

Criterios de inclusión

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

Criterios de exclusión

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 \[e.g.\], monoclonal antibodies, intravenous immunoglobulin)
Has any unstable or progressive manifestation of SjD that is likely to warrant escalation in therapy beyond permitted background medications

Intervenciones

drug

Nipocalimab

Nipocalimab SC.

drug

Placebo

Placebo SC.

drug

Standard of care treatment

Protocol-defined topical and systemic standard of care background treatments.

Ubicaciones

Instituto Medico De Alta Complejidad (IMAC)

Buenos Aires, Argentina

Centro de Investigacion San Miguel CISM

Buenos Aires, Argentina

Mautalen Salud e Investigacion

CABA, Argentina

Centro Medico del Dr. Javier Gerardo Tartaglione

Cdad Autonoma de Buenos Aires, Argentina

Centro de Investigacion en Enfermedades Reumaticas CIER

Ciudad de Buenos Aires, Argentina

Centro Medico Barrio Parque. Swiss Medical Group

Ciudad de Buenos Aires, Argentina

Cosultorios Reumatologógicos Pampa

Ciudad de Buenos Aires, Argentina

Cer Instituto Medico

Quilmes, Argentina

MR Medicina Reumatologica

San Fernando, Argentina

Centro de Investigaciones Medicas Tucuman

San Miguel de Tucumán, Argentina

Patrocinadores

PrincipalJanssen Research & Development, LLC

Aviso: La información de este ensayo proviene de fuentes públicas y tiene carácter exclusivamente informativo. No constituye asesoramiento médico, regulatorio ni de ningún otro tipo. Las traducciones son automatizadas y no poseen validez oficial. Consultá siempre con un profesional de la salud. Ver Términos de Uso.

A Randomized, Placebo-controlled, Double-blind, Multicent... | EligiMed