Nipocalimab in Moderate to Severe Sjogren's Disease
- Conditions
- Sjogrens Syndrome
- Interventions
- Registration Number
- NCT06741969
- Lead Sponsor
- Janssen Research & Development, LLC
- Brief 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).
- Detailed Description
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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 600
- 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 [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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Nipocalimab Standard of care treatment Participants will receive nipocalimab subcutaneously (SC) along with standard of care treatments. At the Week 48 visit, eligible participants from both studies will have the option to enter an open-label long-term extension (OLE) phase, where they will continue to receive nipocalimab until Week 143 or until the study intervention is discontinued and participants opt to withdraw from the study. Placebo Placebo Participants will receive placebo subcutaneously along with standard of care treatments. At the Week 48 visit, eligible participants from both studies will have the option to enter an OLE phase, where they will receive nipocalimab until Week 143 or until the study intervention is discontinued and participants opt to withdraw from the study. Placebo Standard of care treatment Participants will receive placebo subcutaneously along with standard of care treatments. At the Week 48 visit, eligible participants from both studies will have the option to enter an OLE phase, where they will receive nipocalimab until Week 143 or until the study intervention is discontinued and participants opt to withdraw from the study. Nipocalimab Nipocalimab Participants will receive nipocalimab subcutaneously (SC) along with standard of care treatments. At the Week 48 visit, eligible participants from both studies will have the option to enter an open-label long-term extension (OLE) phase, where they will continue to receive nipocalimab until Week 143 or until the study intervention is discontinued and participants opt to withdraw from the study.
- Primary Outcome Measures
Name Time Method Change from Baseline in Clinical European League Against Rheumatism Sjogren's Syndrome Disease Activity Index (ClinESSDAI) Score at Week 48 Baseline to Week 48 ClinESSDAI is a validated tool used in clinical studies to measure the systemic disease activity in participants with SjD. The ClinESSDAI includes 11 domains divided into 3-4 activity levels, where zero represents no activity and low, medium, and high scores can vary in numerical value depending on the domain being measured. A higher score represents worse disease symptoms.
- Secondary Outcome Measures
Name Time Method Improvement from Baseline in Minimal Clinically Important Improvement (MCII) in ClinESSDAI Score at Week 48 Baseline to Week 48 The ClinESSDAI is a validated tool used in clinical studies to measure the systemic disease activity in participants with Sjogren's syndrome.
Improvement from Baseline in ClinESSDAI Score at Week 48 in Participants with High Immunoglobulin (IgG) Levels at Baseline Baseline to Week 48 ClinESSDAI is a validated tool used in clinical studies to measure the systemic disease activity in participants with SjD.
Change from Baseline in ClinESSDAI Score at Week 8 Baseline to Week 8 ClinESSDAI is a validated tool used in clinical studies to measure the systemic disease activity in participants with SjD.
Change from Baseline in Stimulated Salivary Flow Rate at Week 48 Baseline to Week 48 Stimulated salivary flow is considered a reliable and objective method to evaluate glandular function in SjD patients.
Change from Baseline in Sjogren's Symptoms Dryness Score at Week 48 Baseline to Week 48 Participants will be asked to report the worst severity of their dryness symptoms on a 0 to 10 numeric rating scale (NRS), with score 0 indicating "No \[specific symptom\]" and score 10 indicating "Severe \[specific symptom\]". Higher scores reflect greater symptom severity. Change from baseline in Sjogren's Symptoms dryness score at Week 48 for US, US reference regions, and other non-US regions will be reported.
Change from Baseline in Sjogren's Symptoms Joint Pain Score at Week 48 Baseline to Week 48 Participants will be asked to report the worst severity of their joint pain symptoms on a 0 to 10 numeric rating scale (NRS), with score 0 indicating "No \[specific symptom\]" and score 10 indicating "Severe \[specific symptom\]". Higher scores reflect greater symptom severity. Change from baseline in Sjogren's Symptoms joint pain score at Week 48 for US, US reference regions, and other non-US regions will be reported.
Change from Baseline in EULAR Sjogren's Syndrome Patient Reported Index (ESSPRI) Score At Week 48 Baseline to Week 48 ESSPRI is a participant-reported assessment of the severity of dryness, fatigue, and pain associated with primary Sjogren's Syndrome. Participants are asked to rate the severity of dryness, fatigue, and pain on a 0 to 10 NRS, with score 0 indicating "No \[specific symptom\]" and score 10 indicating "Severe \[specific symptom\]". A global score, calculated as the mean of the 3 domain scores, ranges from 0 to 10, with higher scores reflecting greater (worse) symptom severity. Change from baseline in Sjogren's Symptoms score at Week 48 for EU, UK \& EU reference regions will be reported.
Change from Baseline in Functional Assessment of Chronic Illness Therapy Fatigue (FACIT) Fatigue Score at Week 48 Baseline to Week 48 FACIT-Fatigue version 4.0 is a 13-item questionnaire that assesses participant-reported fatigue and its impact upon daily activities and function over the past 7 days. Participants will be asked to answer each question using a 5-point Likert scale (0=Not at all; 1=A little bit; 2=Somewhat; 3=Quite a bit; and 4=Very much). FACIT-Fatigue has a total score range from 0 to 52, with 0 being the worst possible score and 52 the best.
Related Research Topics
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Trial Locations
- Locations (56)
NTU Biomedical Park Hospital
🇨🇳Hsinchu City, Taiwan
University Hospital Aintree
🇬🇧Liverpool, United Kingdom
Peterborough City Hospital
🇬🇧Peterborough, United Kingdom
Great Western Hospital
🇬🇧Swindon, United Kingdom
Tokyo Metropolitan Bokutoh Hospital
🇯🇵Sumida ku, Japan
Hanyang University Medical Center
🇰🇷Seoul, Korea, Republic of
Ajou University Hospital
🇰🇷Suwon si, Korea, Republic of
Clinica de Investigacion en Reumatologia y Obesidad
🇲🇽Guadalajara, Mexico
Atrium Health SouthPark Rheumatology
🇺🇸Charlotte, North Carolina, United States
Wright State Physicians Health Center
🇺🇸Fairborn, Ohio, United States
Overlake Arthritis and Osteoporosis Center
🇺🇸Bellevue, Washington, United States
Centro Medico Barrio Parque. Swiss Medical Group
🇦🇷Ciudad de Buenos Aires, Argentina
Cosultorios Reumatologógicos Pampa
🇦🇷Ciudad de Buenos Aires, Argentina
Ceti - Centro de Estudos Em Terapias Inovadoras
🇧🇷Curitiba, Brazil
EBSERH Empresa de Servicos Hospitalares Hospital Samaritano
🇧🇷Sao Paulo, Brazil
CEPIC Centro Paulista de Investigacao Clinica e Servicos Medicos
🇧🇷Sao Paulo, Brazil
CEDOES Centro de Pesquisa Clinica e Diagnostico do Espirito Santo Ltda
🇧🇷Vitoria, Brazil
Dokkyo Medical University Hospital
🇯🇵Shimotsuga Gun, Japan
Konkuk University Medical Center
🇰🇷Seoul, Korea, Republic of
Barts Health NHS Trust
🇬🇧Greater London, United Kingdom
Providence Medical Foundation
🇺🇸Fullerton, 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
Suncoast Clinical Research
🇺🇸New Port Richey, Florida, United States
Sarasota Arthritis Center
🇺🇸Sarasota, Florida, United States
Onsite Clinical Solutions
🇺🇸Salisbury, North Carolina, United States
Altoona Center For Clinical Research
🇺🇸Duncansville, Pennsylvania, United States
Fundacao Faculdade Regional de Medicina de Sao Jose do Rio Preto Hospital de Base
🇧🇷Sao Jose do Rio Preto, Brazil
Shinkenko Clinic
🇯🇵Naha, Japan
Centro de Investigacion de Tratamientos Innovadores de Sinaloa
🇲🇽Culiacan, Mexico
CITER Centro de Investigacion y Tratamiento de las Enfermedades Reumaticas S A de C V
🇲🇽Mexico, Mexico
Doncaster Royal Infirmary
🇬🇧Doncaster, United Kingdom
BioResearch Partner
🇺🇸South Miami, Florida, United States
Clinical Investigation Specialists - Clinic of Robert Hozman
🇺🇸Skokie, Illinois, United States
St. Paul Rheumatology P A
🇺🇸Eagan, Minnesota, United States
West Tennessee Research Institute
🇺🇸Jackson, Tennessee, United States
Instituto Medico De Alta Complejidad (IMAC)
🇦🇷Buenos Aires, Argentina
Centro de Investigacion en Enfermedades Reumaticas CIER
🇦🇷Ciudad de Buenos Aires, Argentina
Sasebo Chuo Hospital
🇯🇵Sasebo, Japan
National Hospital Organization Kyushu Medical Center
🇯🇵Fukuoka, Japan
Chonnam National University Hospital
🇰🇷Gwangju, Korea, Republic of
The Catholic University of Korea Seoul St Mary s Hospital
🇰🇷Seoul, Korea, Republic of
Kaohsiung Chang Gung Memorial Hospital
🇨🇳Kaohsiung City, Taiwan
Centro de Investigaciones Medicas Tucuman
🇦🇷San Miguel De Tucuman, Argentina
St. Luke's International Hospital
🇯🇵Chuo ku, Japan
Tokyo Metropolitan Tama Medical Center
🇯🇵Fuchu, Japan
National Hospital Organization Osaka Minami Medical Center
🇯🇵Kawachi Nagano, Japan
Tohoku Medical And Pharmaceutical University Hospital
🇯🇵Sendai, Japan
SMIQ S de R L de C V
🇲🇽Queretaro, Mexico
Okayama City General Medical Center Okayama City Hospital
🇯🇵Okayama, Japan
Hokkaido University Hospital
🇯🇵Sapporo, Japan
Nihon University Itabashi Hospital
🇯🇵Tokyo, Japan
Medical Care & Research SA de CV
🇲🇽Merida, Mexico
Linkou Chang Gung Memorial Hospital
🇨🇳Taoyuan, Taiwan
Taipei Veterans General Hospital
🇨🇳Taipei, Taiwan