A Study of Nipocalimab in Adults With Primary Sjogren's Syndrome (pSS)
NCT ID: NCT04968912
Last Updated: 2025-11-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
163 participants
INTERVENTIONAL
2021-09-21
2023-11-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
OTHER
DOUBLE
Study Groups
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Group 1: Placebo
Participants will receive placebo intravenously (IV) every 2 weeks (q2w) through Week 22 along with standard of care treatments (\[including ophthalmic drops, artificial tears and saliva, punctum plugs, and secretagogues\], and/or one immunomodulator with or without low-dose glucocorticosteroids).
Placebo
Placebo infusion will be administered intravenously.
Standard of Care Treatment
Standard of care treatment including ophthalmic drops, artificial tears and saliva, punctum plugs, and secretagogues, and/or one immunomodulator with or without low-dose glucocorticosteroids will be administered topically/orally.
Group 2: Nipocalimab Dose 1
Participants will receive nipocalimab dose 1 IV q2w through Week 22 along with standard of care treatments (\[including ophthalmic drops, artificial tears and saliva, punctum plugs, and secretagogues\], and/or one immunomodulator with or without low-dose glucocorticosteroids).
Nipocalimab
Nipocalimab dose 1 and dose 2 infusions will be administered intravenously.
Standard of Care Treatment
Standard of care treatment including ophthalmic drops, artificial tears and saliva, punctum plugs, and secretagogues, and/or one immunomodulator with or without low-dose glucocorticosteroids will be administered topically/orally.
Group 3: Nipocalimab Dose 2
Participants will receive nipocalimab dose 2 IV q2w through Week 22 along with standard of care treatments (\[including ophthalmic drops, artificial tears and saliva, punctum plugs, and secretagogues\], and/or one immunomodulator with or without low-dose glucocorticosteroids).
Nipocalimab
Nipocalimab dose 1 and dose 2 infusions will be administered intravenously.
Standard of Care Treatment
Standard of care treatment including ophthalmic drops, artificial tears and saliva, punctum plugs, and secretagogues, and/or one immunomodulator with or without low-dose glucocorticosteroids will be administered topically/orally.
Interventions
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Placebo
Placebo infusion will be administered intravenously.
Nipocalimab
Nipocalimab dose 1 and dose 2 infusions will be administered intravenously.
Standard of Care Treatment
Standard of care treatment including ophthalmic drops, artificial tears and saliva, punctum plugs, and secretagogues, and/or one immunomodulator with or without low-dose glucocorticosteroids will be administered topically/orally.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* At screening is seropositive for antibodies to pSS-associated antigen A (Ro/Sjogren's syndrome-related antigen A \[SSA\])
* Total Clinical European League Against Rheumatism Sjogren's Syndrome Disease Activity Index (clinESSDAI) score greater than or equal to (\>=) 6
* At least one abnormal laboratory marker of pSS-related inflammatory disease activity, and at least low activity in one or more specified European League Against Rheumatism Sjogren's Syndrome Disease Activity Index (ESSDAI) domains
* It is recommended to be up to date on all age-appropriate vaccinations prior to screening per routine local medical guidelines. It is strongly recommended that participants will have completed a locally-approved (or emergency use-authorized) coronavirus disease 2019 (COVID-19) vaccination regimen at least 2 weeks prior to study related visits or procedures. Study participants should, follow applicable local vaccine labelling, guidelines, and standards-of-care for participants receiving immune-targeted therapy will be followed when determining an appropriate interval between vaccination and study enrollment
Exclusion Criteria
* Comorbidities (for example, asthma, chronic obstructive pulmonary disease) which have required 3 or more courses of systemic glucocorticoids within the previous 12 months
* Has any unstable or progressive manifestation of pSS that is likely to warrant escalation in therapy beyond permitted background medications and/or has severely active pSS
* Has received oral cyclophosphamide within 3 months or intravenous (IV) cyclophosphamide within 6 months prior to first administration of study intervention
* Has Sjogren's syndrome overlap syndromes where another confirmed autoimmune rheumatic or systemic inflammatory condition (for example, rheumatoid arthritis \[RA\], systemic lupus erythematosus \[SLE\], scleroderma, inflammatory bowel disease \[IBD\]) is the primary diagnosis or has clinical manifestations that, in the opinion of the investigator, or the sponsor or sponsor's representative, are likely to interfere with the investigator's ability to assess pSS manifestations
18 Years
75 Years
ALL
No
Sponsors
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Janssen Research & Development, LLC
INDUSTRY
Responsible Party
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Principal Investigators
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Janssen Research & Development, LLC Clinical Trial
Role: STUDY_DIRECTOR
Janssen Research & Development, LLC
Locations
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Anniston Medical Clinic
Anniston, Alabama, United States
Arizona Arthritis and Rheumatology Research PLLC
Glendale, Arizona, United States
Arizona Arthritis & Rheumatology Research, PLLC
Mesa, Arizona, United States
St. Jude Heritage Medical Group
Fullerton, California, United States
Inland Rheumatology Clinical Trials, Inc.
Upland, California, United States
Colorado Arthritis Associates
Denver, Colorado, United States
Denver Arthritis Clinic
Denver, Colorado, United States
Rheumatology Associates Of South Florida
Boca Raton, Florida, United States
Bay Area Arthritis and Osteoporosis
Brandon, Florida, United States
Centre for Rheumatology, Immunology and Arthritis
Fort Lauderdale, Florida, United States
University of Florida Health Jacksonville
Jacksonville, Florida, United States
Omega Research Consultants
Orlando, Florida, United States
Clinical Investigation Specialists
Gurnee, Illinois, United States
University of Iowa Hospitals and Clinics
Iowa City, Iowa, United States
University of Kansas Medical Center
Kansas City, Kansas, United States
St. Paul Rheumatology P A
Eagan, Minnesota, United States
North Mississippi Medical Clinics
Tupelo, Mississippi, United States
PMG Research of Salisbury
Salisbury, North Carolina, United States
Altoona Center For Clinical Research
Duncansville, Pennsylvania, United States
University of Pennsylvania
Philadelphia, Pennsylvania, United States
Columbia Arthritis Center
Columbia, South Carolina, United States
West Tennessee Research Institute
Jackson, Tennessee, United States
Dr. Ramesh Gupta
Memphis, Tennessee, United States
Austin Regional Clinic
Austin, Texas, United States
Trinity Clinical Research, LLC
Carrollton, Texas, United States
CHU de Grenoble Hopital Albert Michallon
La Tronche, , France
Centre Hospitalier Le Mans
Le Mans, , France
Hopital Saint Joseph
Marseille, , France
Hopital Pitie Salpetriere
Paris, , France
CHRU Hôpital de Hautepierre
Strasbourg, , France
Charite Universitaetsmedizin Berlin
Berlin, , Germany
Uniklinik Köln
Cologne, , Germany
Universitatsklinikum Carl Gustav Carus Dresden
Dresden, , Germany
Hamburger Rheuma Forschungszentrum II
Hamburg, , Germany
medius KLINIK KIRCHHEIM
Kirchheim unter Teck, , Germany
Universitatsklinikum Tubingen
Tübingen, , Germany
Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia Presidio Spedali Civili
Brescia, , Italy
P.O. Vittorio Emanuele Azienda Ospedaliero Universitaria 'Policlinico Vittorio Emanuele'
Catania, , Italy
IRCCS Ospedale San Raffaele
Milan, , Italy
Azienda Ospedaliero Universitaria Policlinico Paolo Giaccone
Palermo, , Italy
Azienda Ospedaliera Universitaria Integrata Verona
Verona, , Italy
Tokyo Metropolitan Tama Medical Center
Fuchū, , Japan
Nagasaki University Hospital
Nagasaki, , Japan
Hokkaido University Hospital
Sapporo, , Japan
St. Luke's International Hospital
Tokyo, , Japan
Nihon University Itabashi Hospital
Tokyo, , Japan
University of Tsukuba Hospital
Tsukuba, , Japan
Medisch Centrum Leeuwarden
Leeuwarden, , Netherlands
Erasmus Medisch Centrum
Rotterdam, , Netherlands
Nasz Lekarz Przychodnie Medyczne
Bydgoszcz, , Poland
Szpital Uniwersytecki nr 2 im dr Jana Biziela w Bydgoszczy
Bydgoszcz, , Poland
Zespolu Opieki Zdrowotnej w Konskich
Gmina Końskie, , Poland
Malopolskie Badania Kliniczne Sp z o o
Krakow, , Poland
REUMED Zespol Poradni Specjalistycznych Filia nr 2
Lublin, , Poland
Centrum Medyczne
Poznan, , Poland
Medycyna Kliniczna
Warsaw, , Poland
Narodowy Instytut Geriatrii Reumatologii i Rehabilitacji im prof dr hab med Eleonory Reicher
Warsaw, , Poland
Centrum Medyczne AMED Targowek
Warsaw, , Poland
Centrum Medyczne Oporow
Wroclaw, , Poland
Instituto Portugues de Reumatologia
Lisbon, , Portugal
ULSAM, EPE - Hospital Conde de Bertiandos
Ponte de Lima, , Portugal
Hosp Univ A Coruna
A Coruña, , Spain
Hosp Reina Sofia
Córdoba, , Spain
Hosp. de Merida
Mérida, , Spain
Corporacio Sanitari Parc Tauli
Sabadell, , Spain
Hosp Clinico Univ de Salamanca
Salamanca, , Spain
Hosp. Infanta Luisa
Seville, , Spain
Tri-Service General Hospital
Taipei, , Taiwan
Chang Gung Memorial Hospital Linkou Branch
Taoyuan District, , Taiwan
Countries
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Other Identifiers
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80202135SJS2001
Identifier Type: OTHER
Identifier Source: secondary_id
2021-000665-32
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
CR109062
Identifier Type: -
Identifier Source: org_study_id
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