A Study of Nipocalimab in Adults with Primary Sjogren's Syndrome (pSS)
Last Updated   May 4, 2023 - 00:00
OVERVIEW
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Gender
all -
Age
years -
Phase
phase 2The drug or treatment is given to a larger group of people to see if it is effective and to better understand its safety. -
Sites
sites -
Status
Recruiting
SUMMARY
The purpose of this study is to evaluate the efficacy and safety of nipocalimab in participants with primary Sjogren’s syndrome (pSS) versus placebo.
CONDITIONS
- Sjogren’s Syndrome
ELIGIBILITY
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
DETAILS
Sjogren’s syndrome is a chronic, progressive autoimmune disease of unclear etiology typically originating in exocrine glands and capable of affecting the function of almost any organ system in the body. Nipocalimab is a fully human aglycosylated immunoglobulin (Ig)G1 monoclonal antibody designed to selectively bind, saturate, and block the IgG binding site on the endogenous neonatal fragment crystallizable receptor (FcRn). Nipocalimab blocks the binding site for IgG on FcRn, leads directly to increased IgG catabolism and a decrease in circulating IgG antibody concentrations, including pathogenic IgG antibody concentrations, and directly inhibits inflammatory cellular responses to these pathogenic IgG. Therefore, Nipocalimab may successfully treat pSS and improve disease manifestations. The study will consist of Screening Period (less than or equal to [<=] 6 Weeks), Double-blind Treatment Period (24 Weeks), and a Follow-up Period (6 Weeks). Key safety assessments will include adverse events (AEs), serious adverse events (SAEs), adverse events of special interests (AESIs), clinical laboratory safety tests (hematology, chemistry, urinalysis, and lipid profile) and vital signs. The total duration of the study is up to 36 weeks.
LOCATIONS
Country (10) | City or Province (69) | Status |
United States | Anniston, AL Anniston Medical Clinic |
Recruiting
|
United States | Austin, TX Austin Regional Clinic |
Recruiting
|
United States | Boca Raton, FL Rheumatology Associates Of South Florida |
Recruiting
|
United States | Brandon, FL Bay Area Arthritis and Osteoporosis |
Recruiting
|
United States | Carrollton, TX Trinity Clinical Research, LLC |
Recruiting
|
United States | Columbia, SC Columbia Arthritis Center |
Completed
|
United States | Denver, CO Colorado Arthritis Associates |
Recruiting
|
United States | Denver, CO Denver Arthritis Clinic |
Recruiting
|
United States | Duncansville, PA Altoona Center For Clinical Research |
Recruiting
|
United States | Eagan, MN St. Paul Rhuematology, P.A. |
Recruiting
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United States | Fort Lauderdale, FL Centre for Rheumatology, Immunology and Arthritis |
Recruiting
|
United States | Fullerton, CA St. Jude Heritage Medical Group |
Recruiting
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United States | Glendale, AZ Arizona Arthritis and Rheumatology Research, PLLC |
Recruiting
|
United States | Gurnee, IL Clinical Investigation Specialists |
Recruiting
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United States | Iowa City, IA University of Iowa Hospitals and Clinics |
Recruiting
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United States | Jackson, TN West Tennessee Research Institute |
Recruiting
|
United States | Jacksonville, FL University of Florida Health Jacksonville |
Recruiting
|
United States | Kansas City, KS University of Kansas Medical Center |
Recruiting
|
United States | Memphis, TN Dr. Ramesh Gupta |
Recruiting
|
United States | Mesa, AZ Arizona Arthritis & Rheumatology Research, PLLC |
Recruiting
|
United States | Orlando, FL Omega Research Consultants |
Recruiting
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United States | Philadelphia, PA University of Pennsylvania |
Recruiting
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United States | Salisbury, NC PMG Research of Salisbury |
Recruiting
|
United States | Tupelo, MS North Mississippi Medical Clinics |
Recruiting
|
United States | Upland, CA Inland Rheumatology Clinical Trials, Inc. |
Recruiting
|
Taiwan | Taipei Tri-Service General Hospital |
Recruiting
|
Taiwan | Taoyuan Chang Gung Memorial Hospital Linkou Branch |
Recruiting
|
Spain | Córdoba HOSP. REINA SOFIA |
Recruiting
|
Spain | La Coruña HOSP. UNIV. A CORUÑA |
Recruiting
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Spain | Mérida, BJ HOSP. DE MERIDA |
Recruiting
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Spain | Sabadell, BA CORPORACIO SANITARI PARC TAULI |
Recruiting
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Spain | Salamanca, SL HOSP. CLINICO UNIV. DE SALAMANCA |
Recruiting
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Spain | Sevilla HOSP. INFANTA LUISA |
Recruiting
|
Portugal | Lisboa Instituto Portugues de Reumatologia |
Recruiting
|
Portugal | Ponte de Lima ULSAM, EPE - Hospital Conde de Bertiandos |
Recruiting
|
Poland | Bydgoszcz NASZ LEKARZ PRZYCHODNIE MEDYCZNE |
Recruiting
|
Poland | Bydgoszcz Szpital Uniwersytecki nr 2 im. dr. Jana Biziela w Bydgoszczy |
Recruiting
|
Poland | Końskie Zespołu Opieki Zdrowotnej w Końskich |
Recruiting
|
Poland | Krakow Malopolskie Badania Kliniczne Sp. z o.o. Sp. k. |
Recruiting
|
Poland | Lublin REUMED Zespol Poradni Specjalistycznych Filia nr 2 |
Recruiting
|
Poland | Poznan Centrum Medyczne |
Recruiting
|
Poland | Warsaw Medycyna Kliniczna |
Recruiting
|
Poland | Warsaw Narodowy Instytut Geriatrii, Reumatologii i Rehabilitacji im. prof. dr hab. med. Eleonory Reicher |
Recruiting
|
Poland | Warszawa Centrum Medyczne AMED Warszawa Targowek |
Recruiting
|
Poland | Wrocław Centrum Medyczne Oporow |
Recruiting
|
Netherlands | LEEUWARDEN, FR MEDISCH CENTRUM LEEUWARDEN |
Recruiting
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Netherlands | Rotterdam Erasmus Medisch Centrum |
Recruiting
|
Japan | Fuchu, 13 Tokyo Metropolitan Tama Medical Center |
Recruiting
|
Japan | Nagasaki-shi, 42 Nagasaki University Hospital |
Recruiting
|
Japan | Sapporo-shi, 01 Hokkaido University Hospital |
Recruiting
|
Japan | Tokyo, 13 Nihon University Itabashi Hospital |
Recruiting
|
Japan | Tokyo, 13 St. Luke's International Hospital |
Recruiting
|
Japan | Tsukuba-Shi, 08 University of Tsukuba Hospital |
Recruiting
|
Italy | Brescia Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia Presidio Spedali Civili |
Recruiting
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Italy | Catania P.O. Vittorio Emanuele Azienda Ospedaliero Universitaria 'Policlinico Vittorio Emanuele' |
Recruiting
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Italy | Milano IRCCS Ospedale San Raffaele |
Recruiting
|
Italy | Palermo Azienda Ospedaliero Universitaria Policlinico Paolo Giaccone |
Recruiting
|
Italy | Verona Azienda Ospedaliera Universitaria Integrata Verona |
Recruiting
|
Germany | Berlin, BE Charité Universitätsmedizin Berlin |
Recruiting
|
Germany | Dresden, SN Universitätsklinikum Carl Gustav Carus Dresden |
Recruiting
|
Germany | Hamburg, HH Hamburger Rheuma Forschungszentrum II |
Recruiting
|
Germany | Kirchheim unter Teck, BW medius KLINIK KIRCHHEIM |
Recruiting
|
Germany | Köln Uniklinik Köln |
Recruiting
|
Germany | Tübingen, BW Universitätsklinikum Tübingen |
Recruiting
|
France | La Tronche CHU de Grenoble - Hopital Albert Michallon |
Recruiting
|
France | Marseille Cedex 08 Hopital Saint Joseph |
Recruiting
|
France | Paris HOPITAL PITIE SALPETRIERE |
Recruiting
|
France | Strasbourg Cedex CHRU Hôpital de Hautepierre |
Recruiting
|
France | le mans Cedex 9 Centre Hospitalier Le Mans |
Recruiting
|
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Indicates < 10 sites in this region: click to zoom in.
Corresponds to individual site.