A Study of Nipocalimab in Adults with Primary Sjogren's Syndrome (pSS)

Last Updated   September 29, 2022 - 00:00

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OVERVIEW

  • Gender
    all
  • Age
    18 - 75 years
  • Phase
    phase 2
    The drug or treatment is given to a larger group of people to see if it is effective and to better understand its safety.
  • Sites
    80 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

Locations in:
United States, Taiwan, Spain, Portugal, Poland, Netherlands, Japan, Italy, Germany, France
Country (10) City or Province (80) Status
United States Ann Arbor, MI University of Michigan
Withdrawn
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
Not yet recruiting
United States Carrollton, TX Trinity Clinical Research, LLC
Recruiting
United States Columbia, SC Columbia Arthritis Center
Recruiting
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
United States Fort Lauderdale, FL Centre for Rheumatology, Immunology and Arthritis
Recruiting
United States Fullerton, CA St. Jude Heritage Medical Group
Recruiting
United States Glendale, AZ Arizona Arthritis and Rheumatology Research, PLLC
Recruiting
United States Gurnee, IL Clinical Investigation Specialists
Recruiting
United States Iowa City, IA University of Iowa Hospitals and Clinics
Not yet recruiting
United States Jackson, TN West Tennessee Research Institute
Recruiting
United States Jacksonville, FL University of Florida
Recruiting
United States Kansas City, KS University of Kansas Medical Center
Not yet 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
United States Philadelphia, PA University of Pennsylvania
Not yet recruiting
United States Salisbury, NC PMG Research of Salisbury
Recruiting
United States Spokane, WA Arthritis Northwest PLLC
Withdrawn
United States Tupelo, MS North Mississippi Medical Clinics
Recruiting
United States Upland, CA Inland Rheumatology Clinical Trials, Inc.
Recruiting
United States West Reading, PA Reading Hospital
Withdrawn
Taiwan Taipei Tri-Service General Hospital
Recruiting
Taiwan Taoyuan Chang Gung Memorial Hospital Linkou Branch
Recruiting
Spain Barcelona, BA HOSP. DE LA SANTA CREU I SANT PAU
Withdrawn
Spain Córdoba HOSP. REINA SOFIA
Not yet recruiting
Spain La Coruña HOSP. UNIV. A CORUÑA
Recruiting
Spain Madrid, MD HOSP. UNIV. 12 DE OCTUBRE
Withdrawn
Spain Mérida, BJ HOSP. DE MERIDA
Recruiting
Spain Sabadell, BA CORPORACIO SANITARI PARC TAULI
Recruiting
Spain Salamanca, SL HOSP. CLINICO UNIV. DE SALAMANCA
Recruiting
Spain Sevilla HOSP. INFANTA LUISA
Recruiting
Portugal Lisboa Instituto Portugues de Reumatologia
Recruiting
Portugal Ponte de Lima ULSAM, EPE - Hospital Conde de Bertiandos
Recruiting
Portugal Vila Nova de Gaia Centro Hospitalar de Vila Nova de Gaia/Espinho, E.P.E.
Withdrawn
Poland Bydgoszcz NASZ LEKARZ PRZYCHODNIE MEDYCZNE
Recruiting
Poland Bydgoszcz Szpital Uniwersytecki nr 2 im. dr. Jana Biziela w Bydgoszczy
Recruiting
Poland Elblag Centrum Kliniczno Badawcze J. Brzezicki, B. Gornikiewicz-Brzezicka Lekarze Spolka Partnerska
Withdrawn
Poland Końskie Zespołu Opieki Zdrowotnej w Końskich
Not yet recruiting
Poland Krakow Malopolskie Badania Kliniczne Sp. z o.o. Sp. k.
Not yet 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
Not yet recruiting
Poland Warszawa Centrum Medyczne AMED Warszawa Targowek
Recruiting
Poland Wrocław Centrum Medyczne Oporow
Recruiting
Netherlands LEEUWARDEN, FR MEDISCH CENTRUM LEEUWARDEN
Recruiting
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
Italy Catania P.O. Vittorio Emanuele Azienda Ospedaliero Universitaria 'Policlinico Vittorio Emanuele'
Recruiting
Italy Milano IRCCS Ospedale San Raffaele
Recruiting
Italy Palermo Azienda Ospedaliero Universitaria Policlinico Paolo Giaccone
Recruiting
Italy Pisa Azienda Ospedaliero Universitaria Pisana
Not yet recruiting
Italy Udine Azienda Ospedaliero Universitaria S.Maria Della Misericordia
Not yet recruiting
Italy Verona Azienda Ospedaliera Universitaria Integrata Verona
Recruiting
Germany Berlin, BE Charité Universitätsmedizin Berlin
Not yet 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 München Klinikum der Universität München
Withdrawn
Germany Tübingen, BW Universitätsklinikum Tübingen
Recruiting
France La Tronche CHU de Grenoble - Hôpital Albert Michallon
Recruiting
France Marseille Cedex 08 Hopital Saint Joseph
Recruiting
France Montivilliers Centre Hospitalier du Havre
Withdrawn
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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50

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10

Indicates 10+ sites in this region: click to zoom in.

5

Indicates < 10 sites in this region: click to zoom in.

Corresponds to individual site.

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