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ACTIVE NOT RECRUITING
NCT06741969
PHASE3

Nipocalimab in Moderate to Severe Sjogren's Disease

Sponsor: Janssen Research & Development, LLC

View on ClinicalTrials.gov

Summary

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).

Official title: 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)

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

655

Start Date

2024-12-04

Completion Date

2029-05-18

Last Updated

2026-11-03

Healthy Volunteers

No

Interventions

DRUG

Nipocalimab

Nipocalimab SC.

DRUG

Placebo

Placebo SC.

DRUG

Standard of care treatment

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

Locations (254)

Advanced Clinical Research Center

Chula Vista, California, United States

Arthritis & Osteoporosis Medical Center - La Palma

La Palma, California, United States

Providence Medical Foundation

Mission Viejo, California, United States

NovaMed Research

Monterey Park, California, United States

Medvin Clinical Research San Leandro

San Leandro, California, United States

Providence Saint John s Health Center

Santa Monica, California, United States

Solace Clinical Research California

Tustin, California, United States

Inland Rheumatology Clinical Trials Inc.

Upland, California, United States

Denver Arthritis Clinic

Denver, Colorado, United States

Clinical Research of West Florida Inc

Clearwater, Florida, United States

UF Health Rheumatology

Jacksonville, Florida, United States

Suncoast Clinical Research

New Port Richey, Florida, United States

Sarasota Arthritis Center

Sarasota, Florida, United States

BioResearch Partner

South Miami, Florida, United States

Immunology and Rheumatology Research Associates LLC

Suwanee, Georgia, United States

Clinical Investigation Specialists - Clinic of Robert Hozman

Skokie, Illinois, United States

Willow Rheumatology and Wellness PLLC

Willowbrook, Illinois, United States

University of Iowa Hospital and Clinics

Iowa City, Iowa, United States

University of Kansas Medical Center

Kansas City, Kansas, United States

Clinical Research Institute of Michigan, LLC

Saint Clair Shores, Michigan, United States

St. Paul Rheumatology P A

Eagan, Minnesota, United States

AARA Clinical Research- Kansas City Physicians Partners

Kansas City, Missouri, United States

Arthritis Rheumatic And Back Disease Associates

Voorhees Township, New Jersey, United States

NYU Langone Health - Clinical and Translational Science Institute

New York, New York, United States

Pioneer Clinical Research NY

New York, New York, United States

Joint and Muscle Research Institute

Charlotte, North Carolina, United States

Atrium Health SouthPark Rheumatology

Charlotte, North Carolina, United States

Onsite Clinical Solutions

Salisbury, North Carolina, United States

Wright State Physicians Health Center

Fairborn, Ohio, United States

OMRF Rheumatology Center of Excellence

Oklahoma City, Oklahoma, United States

Rheumatology Associates of Oklahoma

Oklahoma City, Oklahoma, United States

Altoona Center For Clinical Research

Duncansville, Pennsylvania, United States

Clinical Research Philadelphia

Philadelphia, Pennsylvania, United States

Low Country Rheumatology PA

Summerville, South Carolina, United States

West Tennessee Research Institute

Jackson, Tennessee, United States

AARA Clinical Research - Murfreesboro Medical Clinic

Murfreesboro, Tennessee, United States

Amarillo Medical Specialists LLP

Amarillo, Texas, United States

Texas Rheumatology Research Institute LLC

Plano, Texas, United States

Fort Bend Rheumatology Associates PLLC

Sugar Land, Texas, United States

Advanced Rheumatology of Houston

The Woodlands, Texas, United States

Alpine Research TC LLC

Layton, Utah, United States

Tidewater Clinical Research

Chesapeake, Virginia, United States

Overlake Arthritis and Osteoporosis Center

Bellevue, Washington, United States

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

Medizinische Universitaet Graz

Graz, Austria

SCRI CCCIT gem GmbH

Salzburg, Austria

LK Weinviertel Stockerau

Stockerau, Austria

Medizinische Universitaet Wien

Vienna, Austria

Wiener Gesundheitsverbund Klinik Hietzing

Vienna, Austria

Instituto D Or de Pesquisa e Ensino 1

Brasília, Brazil

Ceti - Centro de Estudos Em Terapias Inovadoras

Curitiba, Brazil

Hospital De Clinicas De Porto Alegre

Porto Alegre, Brazil

Hospital Moinhos de Vento

Porto Alegre, Brazil

LMK Servicos Medicos S S

Porto Alegre, Brazil

Hospital das Clinicas da Faculdade de Medicina de Ribeirao Preto

Ribeirão Preto, Brazil

SER - Servicos Especializados em Reumatologia da Bahia

Salvador, Brazil

IDOR - Regional Bahia

Salvador, Brazil

Funfarme Sjrp

São José do Rio Preto, Brazil

Hospital Samaritano de Sao Paulo

São Paulo, Brazil

CEPIC Centro Paulista de Investigacao Clinica e Servicos Medicos

São Paulo, Brazil

Hospital Das Clinicas Da Faculdade De Medicina Da USP

São Paulo, Brazil

CEDOES Centro de Pesquisa Clinica e Diagnostico do Espirito Santo Ltda

Vitória, Brazil

UMHAT Kaspela

Plovdiv, Bulgaria

Medical Center Artmed

Plovdiv, Bulgaria

Medical Center Teodora

Rousse, Bulgaria

Lyulin Multi Profile Hospital For Active Medical Treatment

Sofia, Bulgaria

Diagnostic-Consultative Center (DCC) Aleksandrovska

Sofia, Bulgaria

St Ivan Rilski University Multiprofile Hospital For Active Treatment

Sofia, Bulgaria

Military Medical Academy Multiprofile Hospital for Active Treatment Sofia

Sofia, Bulgaria

Diagnostic Consultative Center - DCC Equita EOOD

Varna, Bulgaria

MHAT 'St. Marina' EAD

Varna, Bulgaria

Dr Sabeen Anwar Medicine Professional Corporation

Windsor, Ontario, Canada

Hospital Regional de Rimouski

Rimouski, Quebec, Canada

Centre de Recherche Musculo Squelettique

Trois-Rivières, Quebec, Canada

Beiijing Friendship Hospital, Capital Medical University

Beijing, China

Peking University Third Hospital

Beijing, China

Xiangya Hospital Central South University

Changsha, China

Changzhou No 2 Peoples Hospital

Changzhou, China

West China Hospital Sichuan University

Chengdu, China

Dazhou Central Hospital

Dazhou, China

First Affiliated Hospital of Gannan Medical University

Ganzhou, China

Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University

Guangzhou, China

The Affiliated Hospital of Guizhou Medical University

Guiyang, China

The Second Affiliated Hospital of Zhejiang University College of Medicine

Hangzhou, China

Anhui Provincial Hospital

Hefei, China

Shandong Provincial Hospital

Jinan, China

Jinhua municipal central hospital

Jinhua, China

Linyi City People Hospital

Linyi, China

The First Affiliated Hospital of NanChang University

Nanchang, China

Affiliated Hospital of North Sichuan Medical College

Nanchong, China

Zhongda Hospital Southeast University

Nanjing, China

And 154 more locations on ClinicalTrials.gov