Clinical trial NCT06741969: Nipocalimab in Moderate to Severe Sjogren's Disease
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)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Sjogrens Syndrome
Keywords: Sjogrens Disease
Lead sponsor: Janssen Research & Development, LLC
Sponsor class: INDUSTRY
First posted: 2024-12-19
Enrollment: 600
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants will be randomly assigned to one of the 2 identical studies (conducted under this single protocol) to make a total of 300 participants in each study. Participants in each study will be randomly assigned to one of the arms nipocalimab or placebo respectively.
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Change from Baseline in Clinical European League Against Rheumatism Sjogren's Syndrome Disease Activity Index (ClinESSDAI) Score at Week 48
timeFrame: Baseline to Week 48
Secondary outcomes:
measure: Improvement from Baseline in Minimal Clinically Important Improvement (MCII) in ClinESSDAI Score at Week 48
timeFrame: Baseline to Week 48
measure: Improvement from Baseline in ClinESSDAI Score at Week 48 in Participants with High Immunoglobulin (IgG) Levels at Baseline
timeFrame: Baseline to Week 48
measure: Change from Baseline in ClinESSDAI Score at Week 8
timeFrame: Baseline to Week 8
measure: Change from Baseline in Stimulated Salivary Flow Rate at Week 48
timeFrame: Baseline to Week 48
measure: Change from Baseline in Sjogren's Symptoms Dryness Score at Week 48
timeFrame: Baseline to Week 48
measure: Change from Baseline in Sjogren's Symptoms Joint Pain Score at Week 48
timeFrame: Baseline to Week 48
measure: Change from Baseline in EULAR Sjogren's Syndrome Patient Reported Index (ESSPRI) Score At Week 48
timeFrame: Baseline to Week 48
measure: Change from Baseline in Functional Assessment of Chronic Illness Therapy Fatigue (FACIT) Fatigue Score at Week 48
timeFrame: Baseline to Week 48
Other outcomes:
Locations:
city: Fullerton
country: United States
facility: Providence Medical Foundation
state: California
city: Santa Monica
country: United States
facility: Providence Saint John s Health Center
state: California
city: Upland
country: United States
facility: Inland Rheumatology Clinical Trials Inc.
state: California
city: Denver
country: United States
facility: Denver Arthritis Clinic
state: Colorado
city: Clearwater
country: United States
facility: Clinical Research of West Florida Inc
state: Florida
city: New Port Richey
country: United States
facility: Suncoast Clinical Research
state: Florida
city: Sarasota
country: United States
facility: Sarasota Arthritis Center
state: Florida
city: South Miami
country: United States
facility: BioResearch Partner
state: Florida
city: Skokie
country: United States
facility: Clinical Investigation Specialists - Clinic of Robert Hozman
state: Illinois
city: Eagan
country: United States
facility: St. Paul Rheumatology P A
state: Minnesota
city: Charlotte
country: United States
facility: Atrium Health SouthPark Rheumatology
state: North Carolina
city: Salisbury
country: United States
facility: Onsite Clinical Solutions
state: North Carolina
city: Fairborn
country: United States
facility: Wright State Physicians Health Center
state: Ohio
city: Duncansville
country: United States
facility: Altoona Center For Clinical Research
state: Pennsylvania
city: Jackson
country: United States
facility: West Tennessee Research Institute
state: Tennessee
city: Bellevue
country: United States
facility: Overlake Arthritis and Osteoporosis Center
state: Washington
city: Buenos Aires
country: Argentina
facility: Instituto Medico De Alta Complejidad (IMAC)
city: Ciudad de Buenos Aires
country: Argentina
facility: Centro de Investigacion en Enfermedades Reumaticas CIER
city: Ciudad de Buenos Aires
country: Argentina
facility: Centro Medico Barrio Parque. Swiss Medical Group
city: Ciudad de Buenos Aires
country: Argentina
facility: Cosultorios Reumatologógicos Pampa
city: San Miguel De Tucuman
country: Argentina
facility: Centro de Investigaciones Medicas Tucuman
city: Curitiba
country: Brazil
facility: Ceti - Centro de Estudos Em Terapias Inovadoras
city: Porto Alegre
country: Brazil
facility: LMK Servicos Medicos S S
city: Salvador
country: Brazil
facility: SER - Servicos Especializados em Reumatologia da Bahia
city: Sao Jose do Rio Preto
country: Brazil
facility: Fundacao Faculdade Regional de Medicina de Sao Jose do Rio Preto Hospital de Base
city: Sao Paulo
country: Brazil
facility: EBSERH Empresa de Servicos Hospitalares Hospital Samaritano
city: Vitoria
country: Brazil
facility: CEDOES Centro de Pesquisa Clinica e Diagnostico do Espirito Santo Ltda
city: Chengdu
country: China
facility: West China Hospital Sichuan University
city: Chuo ku
country: Japan
facility: St. Luke's International Hospital
city: Fuchu
country: Japan
facility: Tokyo Metropolitan Tama Medical Center
city: Fukuoka
country: Japan
facility: National Hospital Organization Kyushu Medical Center
city: Kawachi Nagano
country: Japan
facility: National Hospital Organization Osaka Minami Medical Center
city: Naha
country: Japan
facility: Shinkenko Clinic
city: Okayama
country: Japan
facility: Okayama City General Medical Center Okayama City Hospital
city: Sapporo
country: Japan
facility: Hokkaido University Hospital
city: Sasebo
country: Japan
facility: Sasebo Chuo Hospital
city: Sendai
country: Japan
facility: Tohoku Medical And Pharmaceutical University Hospital
city: Shimotsuga Gun
country: Japan
facility: Dokkyo Medical University Hospital
city: Sumida ku
country: Japan
facility: Tokyo Metropolitan Bokutoh Hospital
city: Tokyo
country: Japan
facility: Nihon University Itabashi Hospital
city: Gwangju
country: Korea, Republic of
facility: Chonnam National University Hospital
city: Seoul
country: Korea, Republic of
facility: Hanyang University Medical Center
city: Seoul
country: Korea, Republic of
facility: Konkuk University Medical Center
city: Seoul
country: Korea, Republic of
facility: The Catholic University of Korea Seoul St Mary s Hospital
city: Suwon si
country: Korea, Republic of
facility: Ajou University Hospital
city: Culiacan
country: Mexico
facility: Centro de Investigacion de Tratamientos Innovadores de Sinaloa
city: Guadalajara
country: Mexico
facility: Clinica de Investigacion en Reumatologia y Obesidad
city: Merida
country: Mexico
facility: Medical Care & Research SA de CV
city: Mexico
country: Mexico
facility: CITER Centro de Investigacion y Tratamiento de las Enfermedades Reumaticas S A de C V
city: Queretaro
country: Mexico
facility: SMIQ S de R L de C V
city: Hsinchu City
country: Taiwan
facility: NTU Biomedical Park Hospital
city: Kaohsiung City
country: Taiwan
facility: Kaohsiung Chang Gung Memorial Hospital
city: Taipei
country: Taiwan
facility: Taipei Veterans General Hospital
city: Taoyuan
country: Taiwan
facility: Linkou Chang Gung Memorial Hospital
city: Doncaster
country: United Kingdom
facility: Doncaster Royal Infirmary
city: Greater London
country: United Kingdom
facility: Barts Health NHS Trust
city: Liverpool
country: United Kingdom
facility: University Hospital Aintree
city: Peterborough
country: United Kingdom
facility: Peterborough City Hospital
city: Swindon
country: United Kingdom
facility: Great Western Hospital
Study officials:
affiliation: Janssen Research & Development, LLC
name: Janssen Research & Development, LLC Clinical Trial
role: STUDY_DIRECTOR
References: