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

A Randomized, Placebo-controlled, Double-blind, Multicenter Study to Assess the Efficacy and Safety of Nipocalimab in Adults With Primary Sjogren's Syndrome (pSS)

The purpose of this study is to evaluate the efficacy and safety of nipocalimab in participants with primary Sjogren's syndrome (pSS) versus placebo.

Study Overview

• Status: Completed
• Conditions: Sjogren's Syndrome
• Intervention / Treatment: Other: Placebo; Drug: Standard of Care Treatment; Drug: Nipocalimab

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.

• Study Type: Interventional
• Enrollment (Actual): 163
• Phase: Phase 2

Expanded Access

Temporarily not available outside the clinical trial. See expanded access record.

Contacts and Locations

Study Locations

• France
  • La Tronche, France, 38700
    • CHU de Grenoble Hopital Albert Michallon
  • Marseille Cedex 08, France, 13285
    • Hopital Saint Joseph
  • Paris, France, 75013
    • Hopital Pitie Salpetriere
  • Strasbourg Cedex, France, 67098
    • CHRU Hôpital de Hautepierre
  • le mans Cedex 9, France, 72037
    • Centre Hospitalier Le Mans
• Germany
  • Berlin, Germany, 10117
    • charite universitatsmedizin Berlin
  • Dresden, Germany, 01307
    • Universitätsklinikum Carl Gustav Carus Dresden
  • Hamburg, Germany, 20095
    • Hamburger Rheuma Forschungszentrum II
  • Kirchheim unter Teck, Germany, 73230
    • medius KLINIK KIRCHHEIM
  • Köln, Germany, 50923
    • Uniklinik Köln
  • Tübingen, Germany, 72076
    • Universitätsklinikum Tübingen
• Italy
  • Brescia, Italy, 25123
    • Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia Presidio Spedali Civili
  • Catania, Italy, 95100
    • P.O. Vittorio Emanuele Azienda Ospedaliero Universitaria 'Policlinico Vittorio Emanuele'
  • Milano, Italy, 20132
    • IRCCS Ospedale San Raffaele
  • Palermo, Italy, 90129
    • Azienda Ospedaliero Universitaria Policlinico Paolo Giaccone
  • Verona, Italy, 37126
    • Azienda Ospedaliera Universitaria Integrata Verona
• Japan
  • Fuchu, Japan, 183-8524
    • Tokyo Metropolitan Tama Medical Center
  • Nagasaki-shi, Japan, 852-8501
    • Nagasaki University Hospital
  • Sapporo-shi, Japan, 060-8648
    • Hokkaido University Hospital
  • Tokyo, Japan, 173-8610
    • Nihon University Itabashi Hospital
  • Tokyo, Japan, 104 8560
    • St. Luke's International Hospital
  • Tsukuba-Shi, Japan, 305-8520
    • University of Tsukuba Hospital
• Netherlands
  • Leeuwarden, Netherlands, 8934 AD
    • Medisch Centrum Leeuwarden
  • Rotterdam, Netherlands, 3015 GD
    • Erasmus Medisch Centrum
• Poland
  • Bydgoszcz, Poland, 85-168
    • Szpital Uniwersytecki nr 2 im dr Jana Biziela w Bydgoszczy
  • Bydgoszcz, Poland, 85-065
    • Nasz Lekarz Przychodnie Medyczne
  • Końskie, Poland, 26-200
    • Zespołu Opieki Zdrowotnej w Końskich
  • Krakow, Poland, 30 002
    • Malopolskie Badania Kliniczne Sp z o o
  • Lublin, Poland, 20-607
    • REUMED Zespol Poradni Specjalistycznych Filia nr 2
  • Poznan, Poland, 61-113
    • Centrum Medyczne
  • Warsaw, Poland, 00-874
    • Medycyna Kliniczna
  • Warsaw, Poland, 02-637
    • Narodowy Instytut Geriatrii Reumatologii i Rehabilitacji im prof dr hab med Eleonory Reicher
  • Warszawa, Poland, 03-291
    • Centrum Medyczne AMED Targowek
  • Wrocław, Poland, 52-415
    • Centrum Medyczne Oporow
• Portugal
  • Lisboa, Portugal, 1050-034
    • Instituto Portugues de Reumatologia
  • Ponte de Lima, Portugal, 4990-078
    • ULSAM, EPE - Hospital Conde de Bertiandos
• Spain
  • Córdoba, Spain, 14004
    • Hosp. Reina Sofia
  • La Coruña, Spain, 15006
    • Hosp. Univ. A Coruna
  • Mérida, Spain, 6800
    • Hosp. de Merida
  • Sabadell, Spain, 08208
    • Corporacio Sanitari Parc Tauli
  • Salamanca, Spain, 37007
    • Hosp. Clinico Univ. de Salamanca
  • Sevilla, Spain, 41010
    • Hosp. Infanta Luisa
• Taiwan
  • Taipei, Taiwan, 11490
    • Tri-Service General Hospital
  • Taoyuan, Taiwan, 333
    • Chang Gung Memorial Hospital Linkou Branch
• United States
  • Alabama
    • Anniston, Alabama, United States, 36207
      • Anniston Medical Clinic
  • Arizona
    • Glendale, Arizona, United States, 85306
      • Arizona Arthritis and Rheumatology Research PLLC
    • Mesa, Arizona, United States, 85210
      • Arizona Arthritis & Rheumatology Research, PLLC
  • California
    • Fullerton, California, United States, 92835
      • St. Jude Heritage Medical Group
    • Upland, California, United States, 91786
      • Inland Rheumatology Clinical Trials, Inc.
  • Colorado
    • Denver, Colorado, United States, 80230
      • Denver Arthritis Clinic
    • Denver, Colorado, United States, 80228
      • Colorado Arthritis Associates
  • Florida
    • Boca Raton, Florida, United States, 33486
      • Rheumatology Associates of South Florida
    • Brandon, Florida, United States, 33511
      • Bay Area Arthritis and Osteoporosis
    • Fort Lauderdale, Florida, United States, 33309
      • Centre for Rheumatology, Immunology and Arthritis
    • Jacksonville, Florida, United States, 32209
      • University of Florida Health Jacksonville
    • Orlando, Florida, United States, 32835
      • Omega Research Consultants
  • Illinois
    • Gurnee, Illinois, United States, 60031
      • Clinical Investigation Specialists
  • Iowa
    • Iowa City, Iowa, United States, 52242
      • University of Iowa Hospitals and Clinics
  • Kansas
    • Kansas City, Kansas, United States, 66160
      • University of Kansas Medical Center
  • Minnesota
    • Eagan, Minnesota, United States, 55121
      • St. Paul Rhuematology P A
  • Mississippi
    • Tupelo, Mississippi, United States, 38801
      • North Mississippi Medical Clinics
  • North Carolina
    • Salisbury, North Carolina, United States, 28144
      • PMG Research of Salisbury
  • Pennsylvania
    • Duncansville, Pennsylvania, United States, 16635
      • Altoona Center for Clinical Research
    • Philadelphia, Pennsylvania, United States, 19104
      • University of Pennsylvania
  • South Carolina
    • Columbia, South Carolina, United States, 29204
      • Columbia Arthritis Center
  • Tennessee
    • Jackson, Tennessee, United States, 38305
      • West Tennessee Research Institute
    • Memphis, Tennessee, United States, 38119
      • Dr. Ramesh Gupta
  • Texas
    • Austin, Texas, United States, 78731-3146
      • Austin Regional Clinic
    • Carrollton, Texas, United States, 75007
      • Trinity Clinical Research, LLC

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: 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).	Other: Placebo; Placebo infusion will be administered intravenously.; Drug: 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.
Experimental: 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).	Drug: 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.; Drug: Nipocalimab; Nipocalimab dose 1 and dose 2 infusions will be administered intravenously.; Other Names: JNJ-80202135; M281
Experimental: 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).	Drug: 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.; Drug: Nipocalimab; Nipocalimab dose 1 and dose 2 infusions will be administered intravenously.; Other Names: JNJ-80202135; M281

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from Baseline in Clinical European League Against Rheumatism Sjogren's Syndrome Disease Activity Index (clinESSDAI) Score at Week 24	The clinESSDAI is a validated tool used in clinical studies to measure the systemic disease activity in participants with primary Sjogren's syndrome. The clinESSDAI includes 11 domains divided into 3-4 activity levels, where zero represents no activity and low, medium, and high scores can vary in numerical value depending on the domain.	Baseline to Week 24

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from Baseline in European League Against Rheumatism (EULAR) Sjogren Syndrome Patient Reported Index (ESSPRI) Score at Week 24	The ESSPRI is a patient-reported assessment of the severity of dryness, fatigue, and pain associated with primary Sjogren's Syndrome. Participants are asked to rate the severity of dryness, fatigue and pain over the past 2 weeks on a numeric rating scale (NRS), ranging from 0 "no symptoms (dryness, fatigue or pain)" to 10 "maximal imaginable (dryness, fatigue, pain)". A global score, calculated as the mean of the 3 domain scores, ranges from 0 to 10, with higher scores reflecting greater (worse) symptom severity.	Baseline to Week 24
Improvement of Greater than or Equal to (>=) 4 Points from Baseline in ESSDAI Score (Minimal Clinically Important Improvement) at Week 24	The ESSDAI is a validated tool used in clinical studies to measure the systemic disease activity in participants with primary Sjogren's syndrome. The ESSDAI includes 11 to 12 domains divided into 3-4 activity levels, where zero represents no activity and low, medium, and high scores can vary in numerical value depending on the domain.	Baseline to Week 24
Improvement of >= 4 Points from Baseline in clinESSDAI Score (Minimal Clinically Important Improvement) at Week 24	The clinESSDAI is a validated tool used in clinical studies to measure the systemic disease activity in participants with Sjogren's syndrome. A minimal clinically important improvement in clinESSDAI is defined as a decrease of at least 4 points in the composite clinESSDAI score.	Baseline to Week 24
ESSPRI Response at Week 24	ESSPRI response defined as a decrease of one point or a decrease of >= 15 percent (%) from baseline (minimal clinically important improvement) at Week 24 will be reported.	Week 24
Disease Response as Assessed by Sjögren's Tool for Assessing Response (STAR) Composite Score at Week 24	Disease response by STAR of >= 5 at Week 24 will be reported. STAR is a composite tool that incorporates measures of disease activity (clinESSDAI), symptoms (ESSPRI), glandular function and systemic disease activity biomarkers to assess disease activity.	Week 24
Improvement in Disease Activity Level by >= 1 Level in at Least One clinESSDAI or ESSDAI Domain at Week 24	Improvement in disease activity level by >= 1 level in at least one clinESSDAI or ESSDAI domain (biological, hematological, cutaneous, constitutional, lymphadenopathy and lymphoma, and glandular) at Week 24 will be reported.	Week 24
Improvement from Baseline in >= 3 of 5 Composite of Relevant Endpoints for Sjogren's Syndrome (CRESS) Categories at Week 24	Improvement from baseline in >= 3 of 5 CRESS categories at week 24 will be reported. CRESS is a composite tool that incorporates measures of disease activity (clinESSDAI), symptoms (ESSPRI), glandular function and systemic inflammation to assess disease activity.	Baseline to Week 24
Percentage of Participants with Treatment-emergent Adverse Events (TEAEs)	An adverse event (AE) is any untoward medical occurrence in a clinical study participant administered a pharmaceutical (investigational or non investigational) product. An AE does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. TEAEs are defined as AEs with onset or worsening on or after date of first dose of study treatment.	Up to 30 weeks
Percentage of Participants with Adverse Events of Special interests (AESIs)	Percentage of participants with AESIs will be reported. Treatment-emergent adverse events associated with the following situations are considered as AESIs: severe infections, severe hypoalbuminemia or hypogammaglobulinemia.	Up to 36 weeks
Percentage of Participants with Treatment-emergent Serious Adverse Events (SAEs)	Treatment-emergent SAEs are defined as SAEs with onset or worsening on or after date of first dose of study treatment.	Up to 30 weeks
Percentage of Participants with TEAEs Leading to Treatment Discontinuation	Percentage of participants with TEAEs leading to treatment discontinuation will be reported. TEAEs are defined as AEs with onset or worsening on or after date of first dose of study treatment.	Up to 30 weeks
Percentage of Participants with Clinically Significant Abnormalities in Vital Signs	Percentage of participants with clinically significant abnormalities in vital signs (including temperature, pulse/heart rate, respiratory rate, and blood pressure) through end of study visit will be reported.	Up to 36 weeks
Percentage of Participants with Clinically Significant Abnormalities in Laboratory Parameters	Percentage of participants with clinically significant abnormalities in laboratory parameters (including hematology, blood chemistry, urinalysis, and blood coagulation) through end of study visit will be reported.	Up to 36 weeks
Serum Concentration of Nipocalimab Over Time	Serum concentrations of nipocalimab over time in participants receiving active study intervention will be reported.	Up to Week 30
Number of Participants with Antibodies to Nipocalimab (Anti-drug Antibodies [ADAs] and Neutralizing Antibodies [NAbs])	Number of participants with antibodies to nipocalimab (ADAs and NAbs) in participants receiving active study intervention will be reported.	Up to Week 36
Number of Participants with Change from Baseline in Biomarkers	Number of participants with change from baseline in biomarkers (C-reactive protein [CRP], erythrocyte, total immunoglobulin [Ig]G, IgG1, IgG2, IgG3, IgG4) will be reported.	Baseline to Week 36
Number of Participants with Change from Baseline in Autoantibodies	Number of participants with change from baseline in autoantibodies (anti-Sjogren's syndrome related antigen A (anti-Ro/SSA), anti-Sjogren's syndrome related antigen B (anti-La/SSB), rheumatoid factor [RF] and antinuclear antibody [ANA]) will be reported.	Baseline to Week 36

Collaborators and Investigators

• Sponsor: Janssen Research & Development, LLC
• Investigators: Study Director: Janssen Research & Development, LLC Clinical Trial, Janssen Research & Development, LLC

Study record dates

Study Major Dates

• Study Start (Actual): September 21, 2021
• Primary Completion (Actual): October 23, 2023
• Study Completion (Actual): November 30, 2023

Study Registration Dates

• First Submitted: July 9, 2021
• First Submitted That Met QC Criteria: July 9, 2021
• First Posted (Actual): July 20, 2021

Study Record Updates

• Last Update Posted (Actual): March 28, 2024
• Last Update Submitted That Met QC Criteria: March 27, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Immune System Diseases; Autoimmune Diseases; Eye Diseases; Disease; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Arthritis; Stomatognathic Diseases; Mouth Diseases; Lacrimal Apparatus Diseases; Arthritis, Rheumatoid; Xerostomia; Salivary Gland Diseases; Dry Eye Syndromes; Syndrome; Sjogren's Syndrome
• Other Study ID Numbers: CR109062; 2021-000665-32 (EudraCT Number); 80202135SJS2001 (Other Identifier: Janssen Research & Development, LLC)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The data sharing policy of the Janssen Pharmaceutical Companies of Johnson & Johnson is available at www.janssen.com/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale open Data Access (YODA) Project site at yoda.yale.edu

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No