A Study of Nipocalimab in Adults With Primary Sjogren's Syndrome (pSS)
Sjogren's Syndrome
About this trial
This is an interventional other trial for Sjogren's Syndrome
Eligibility Criteria
Inclusion Criteria:
- Meets classification criteria for primary Sjogren's syndrome (pSS) by the 2016 American College of Rheumatology (ACR) / European League Against Rheumatism (EULAR) at the time of screening, and was diagnosed with pSS no less than 26 weeks prior to screening
- 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 that participants are up to date on all age-appropriate vaccinations prior to screening as per routine local medical guidelines. For study participants who received locally-approved (and including emergency use-authorized) coronavirus disease 2019 (COVID-19) vaccines recently prior to study entry, 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:
- Has any confirmed or suspected clinical immunodeficiency syndrome not related to treatment of his/her pSS or has a family history of congenital or hereditary immunodeficiency unless confirmed absent in the participant
- 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
Sites / Locations
- Anniston Medical Clinic
- Arizona Arthritis and Rheumatology Research, PLLC
- Arizona Arthritis & Rheumatology Research, PLLC
- St. Jude Heritage Medical Group
- Inland Rheumatology Clinical Trials, Inc.
- Colorado Arthritis Associates
- Denver Arthritis Clinic
- Rheumatology Associates Of South Florida
- Bay Area Arthritis and Osteoporosis
- Centre for Rheumatology, Immunology and Arthritis
- University of Florida Health Jacksonville
- Omega Research Consultants
- Clinical Investigation Specialists
- University of Iowa Hospitals and Clinics
- University of Kansas Medical Center
- St. Paul Rhuematology, P.A.
- North Mississippi Medical Clinics
- PMG Research of Salisbury
- Altoona Center For Clinical Research
- University of Pennsylvania
- Columbia Arthritis Center
- West Tennessee Research Institute
- Dr. Ramesh Gupta
- Austin Regional Clinic
- Trinity Clinical Research, LLC
- CHU de Grenoble - Hopital Albert Michallon
- Centre Hospitalier Le Mans
- Hopital Saint Joseph
- Hopital Pitie Salpetriere
- CHRU Hôpital de Hautepierre
- Charité Universitätsmedizin Berlin
- Universitätsklinikum Carl Gustav Carus Dresden
- Hamburger Rheuma Forschungszentrum II
- medius KLINIK KIRCHHEIM
- Uniklinik Köln
- Universitätsklinikum Tübingen
- Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia Presidio Spedali Civili
- P.O. Vittorio Emanuele Azienda Ospedaliero Universitaria 'Policlinico Vittorio Emanuele'
- IRCCS Ospedale San Raffaele
- Azienda Ospedaliero Universitaria Policlinico Paolo Giaccone
- Azienda Ospedaliera Universitaria Integrata Verona
- Tokyo Metropolitan Tama Medical Center
- Nagasaki University Hospital
- Hokkaido University Hospital
- St. Luke's International Hospital
- Nihon University Itabashi Hospital
- University of Tsukuba Hospital
- Medisch Centrum Leeuwarden
- Erasmus Medisch Centrum
- Nasz Lekarz Przychodnie Medyczne
- Szpital Uniwersytecki nr 2 im. dr. Jana Biziela w Bydgoszczy
- Zespołu Opieki Zdrowotnej w Końskich
- Malopolskie Badania Kliniczne Sp. z o.o.
- REUMED Zespol Poradni Specjalistycznych Filia nr 2
- Centrum Medyczne
- Medycyna Kliniczna
- Narodowy Instytut Geriatrii, Reumatologii i Rehabilitacji im. prof. dr hab. med. Eleonory Reicher
- Centrum Medyczne AMED Targowek
- Centrum Medyczne Oporow
- Instituto Portugues de Reumatologia
- ULSAM, EPE - Hospital Conde de Bertiandos
- Hosp. Reina Sofia
- Hosp. Univ. A Coruña
- Hosp. de Merida
- Corporacio Sanitari Parc Tauli
- Hosp. Clinico Univ. de Salamanca
- Hosp. Infanta Luisa
- Tri-Service General Hospital
- Chang Gung Memorial Hospital Linkou Branch
Arms of the Study
Arm 1
Arm 2
Arm 3
Placebo Comparator
Experimental
Experimental
Group 1: Placebo
Group 2: Nipocalimab Dose 1
Group 3: Nipocalimab Dose 2
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).
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).
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).