Clinical trial NCT04968912: A Study of Nipocalimab in Adults With Primary Sjogren's Syndrome (pSS)
Official title: A Randomized, Placebo-controlled, Double-blind, Multicenter Study to Assess the Efficacy and Safety of Nipocalimab in Adults With Primary Sjogren's Syndrome (pSS)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Sjogren's Syndrome
Lead sponsor: Janssen Research & Development, LLC
Sponsor class: INDUSTRY
First posted: 2021-07-20
Enrollment: 163
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief 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.

Detailed description: 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.

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

Primary outcomes:
measure: Change from Baseline in Clinical European League Against Rheumatism Sjogren's Syndrome Disease Activity Index (clinESSDAI) Score at Week 24
timeFrame: Baseline to Week 24
Secondary outcomes:
measure: Change from Baseline in European League Against Rheumatism (EULAR) Sjogren Syndrome Patient Reported Index (ESSPRI) Score at Week 24
timeFrame: Baseline to Week 24
measure: Improvement of Greater than or Equal to (>=) 4 Points from Baseline in ESSDAI Score (Minimal Clinically Important Improvement) at Week 24
timeFrame: Baseline to Week 24
measure: Improvement of >= 4 Points from Baseline in clinESSDAI Score (Minimal Clinically Important Improvement) at Week 24
timeFrame: Baseline to Week 24
measure: ESSPRI Response at Week 24
timeFrame: Week 24
measure: Disease Response as Assessed by Sjögren's Tool for Assessing Response (STAR) Composite Score at Week 24
timeFrame: Week 24
measure: Improvement in Disease Activity Level by >= 1 Level in at Least One clinESSDAI or ESSDAI Domain at Week 24
timeFrame: Week 24
measure: Improvement from Baseline in >= 3 of 5 Composite of Relevant Endpoints for Sjogren's Syndrome (CRESS) Categories at Week 24
timeFrame: Baseline to Week 24
measure: Percentage of Participants with Treatment-emergent Adverse Events (TEAEs)
timeFrame: Up to 30 weeks
measure: Percentage of Participants with Adverse Events of Special interests (AESIs)
timeFrame: Up to 36 weeks
measure: Percentage of Participants with Treatment-emergent Serious Adverse Events (SAEs)
timeFrame: Up to 30 weeks
measure: Percentage of Participants with TEAEs Leading to Treatment Discontinuation
timeFrame: Up to 30 weeks
measure: Percentage of Participants with Clinically Significant Abnormalities in Vital Signs
timeFrame: Up to 36 weeks
measure: Percentage of Participants with Clinically Significant Abnormalities in Laboratory Parameters
timeFrame: Up to 36 weeks
measure: Serum Concentration of Nipocalimab Over Time
timeFrame: Up to Week 30
measure: Number of Participants with Antibodies to Nipocalimab (Anti-drug Antibodies [ADAs] and Neutralizing Antibodies [NAbs])
timeFrame: Up to Week 36
measure: Number of Participants with Change from Baseline in Biomarkers
timeFrame: Baseline to Week 36
measure: Number of Participants with Change from Baseline in Autoantibodies
timeFrame: Baseline to Week 36
Other outcomes:
Locations:
city: Anniston
country: United States
facility: Anniston Medical Clinic
state: Alabama
city: Glendale
country: United States
facility: Arizona Arthritis and Rheumatology Research PLLC
state: Arizona
city: Mesa
country: United States
facility: Arizona Arthritis & Rheumatology Research, PLLC
state: Arizona
city: Fullerton
country: United States
facility: St. Jude Heritage Medical Group
state: California
city: Upland
country: United States
facility: Inland Rheumatology Clinical Trials, Inc.
state: California
city: Denver
country: United States
facility: Colorado Arthritis Associates
state: Colorado
city: Denver
country: United States
facility: Denver Arthritis Clinic
state: Colorado
city: Boca Raton
country: United States
facility: Rheumatology Associates Of South Florida
state: Florida
city: Brandon
country: United States
facility: Bay Area Arthritis and Osteoporosis
state: Florida
city: Fort Lauderdale
country: United States
facility: Centre for Rheumatology, Immunology and Arthritis
state: Florida
city: Jacksonville
country: United States
facility: University of Florida Health Jacksonville
state: Florida
city: Orlando
country: United States
facility: Omega Research Consultants
state: Florida
city: Gurnee
country: United States
facility: Clinical Investigation Specialists
state: Illinois
city: Iowa City
country: United States
facility: University of Iowa Hospitals and Clinics
state: Iowa
city: Kansas City
country: United States
facility: University of Kansas Medical Center
state: Kansas
city: Eagan
country: United States
facility: St. Paul Rheumatology P A
state: Minnesota
city: Tupelo
country: United States
facility: North Mississippi Medical Clinics
state: Mississippi
city: Salisbury
country: United States
facility: PMG Research of Salisbury
state: North Carolina
city: Duncansville
country: United States
facility: Altoona Center For Clinical Research
state: Pennsylvania
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
city: Columbia
country: United States
facility: Columbia Arthritis Center
state: South Carolina
city: Jackson
country: United States
facility: West Tennessee Research Institute
state: Tennessee
city: Memphis
country: United States
facility: Dr. Ramesh Gupta
state: Tennessee
city: Austin
country: United States
facility: Austin Regional Clinic
state: Texas
city: Carrollton
country: United States
facility: Trinity Clinical Research, LLC
state: Texas
city: La Tronche
country: France
facility: CHU de Grenoble Hopital Albert Michallon
city: le mans Cedex 9
country: France
facility: Centre Hospitalier Le Mans
city: Marseille Cedex 08
country: France
facility: Hopital Saint Joseph
city: Paris
country: France
facility: Hopital Pitie Salpetriere
city: Strasbourg Cedex
country: France
facility: CHRU Hôpital de Hautepierre
city: Berlin
country: Germany
facility: Charite Universitaetsmedizin Berlin
city: Dresden
country: Germany
facility: Universitatsklinikum Carl Gustav Carus Dresden
city: Hamburg
country: Germany
facility: Hamburger Rheuma Forschungszentrum II
city: Kirchheim unter Teck
country: Germany
facility: medius KLINIK KIRCHHEIM
city: Köln
country: Germany
facility: Uniklinik Köln
city: Tübingen
country: Germany
facility: Universitatsklinikum Tubingen
city: Brescia
country: Italy
facility: Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia Presidio Spedali Civili
city: Catania
country: Italy
facility: P.O. Vittorio Emanuele Azienda Ospedaliero Universitaria 'Policlinico Vittorio Emanuele'
city: Milano
country: Italy
facility: IRCCS Ospedale San Raffaele
city: Palermo
country: Italy
facility: Azienda Ospedaliero Universitaria Policlinico Paolo Giaccone
city: Verona
country: Italy
facility: Azienda Ospedaliera Universitaria Integrata Verona
city: Fuchu
country: Japan
facility: Tokyo Metropolitan Tama Medical Center
city: Nagasaki-shi
country: Japan
facility: Nagasaki University Hospital
city: Sapporo-shi
country: Japan
facility: Hokkaido University Hospital
city: Tokyo
country: Japan
facility: St. Luke's International Hospital
city: Tokyo
country: Japan
facility: Nihon University Itabashi Hospital
city: Tsukuba-Shi
country: Japan
facility: University of Tsukuba Hospital
city: Leeuwarden
country: Netherlands
facility: Medisch Centrum Leeuwarden
city: Rotterdam
country: Netherlands
facility: Erasmus Medisch Centrum
city: Bydgoszcz
country: Poland
facility: Nasz Lekarz Przychodnie Medyczne
city: Bydgoszcz
country: Poland
facility: Szpital Uniwersytecki nr 2 im dr Jana Biziela w Bydgoszczy
city: Konskie
country: Poland
facility: Zespolu Opieki Zdrowotnej w Konskich
city: Krakow
country: Poland
facility: Malopolskie Badania Kliniczne Sp z o o
city: Lublin
country: Poland
facility: REUMED Zespol Poradni Specjalistycznych Filia nr 2
city: Poznan
country: Poland
facility: Centrum Medyczne
city: Warsaw
country: Poland
facility: Medycyna Kliniczna
city: Warsaw
country: Poland
facility: Narodowy Instytut Geriatrii Reumatologii i Rehabilitacji im prof dr hab med Eleonory Reicher
city: Warszawa
country: Poland
facility: Centrum Medyczne AMED Targowek
city: Wroclaw
country: Poland
facility: Centrum Medyczne Oporow
city: Lisboa
country: Portugal
facility: Instituto Portugues de Reumatologia
city: Ponte de Lima
country: Portugal
facility: ULSAM, EPE - Hospital Conde de Bertiandos
city: Córdoba
country: Spain
facility: Hosp Reina Sofia
city: La Coruña
country: Spain
facility: Hosp Univ A Coruna
city: Merida
country: Spain
facility: Hosp. de Merida
city: Sabadell
country: Spain
facility: Corporacio Sanitari Parc Tauli
city: Salamanca
country: Spain
facility: Hosp Clinico Univ de Salamanca
city: Sevilla
country: Spain
facility: Hosp. Infanta Luisa
city: Taipei
country: Taiwan
facility: Tri-Service General Hospital
city: Taoyuan
country: Taiwan
facility: Chang Gung Memorial Hospital Linkou Branch
Study officials:
affiliation: Janssen Research & Development, LLC
name: Janssen Research & Development, LLC Clinical Trial
role: STUDY_DIRECTOR
References: