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

Sponsor
Janssen Research & Development, LLC (Industry)
Overall Status
Recruiting
CT.gov ID
NCT04968912
Collaborator
(none)
150
Enrollment
78
Locations
3
Arms
26.3
Anticipated Duration (Months)
1.9
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
Phase 2

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 Design

Study Type:
Interventional
Anticipated Enrollment :
150 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Other
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)
Actual Study Start Date :
Sep 21, 2021
Anticipated Primary Completion Date :
Oct 2, 2023
Anticipated Study Completion Date :
Dec 1, 2023

Arms and Interventions

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: Nipocalimab
Nipocalimab dose 1 and dose 2 infusions will be administered intravenously.
Other Names:
  • JNJ-80202135
  • M281

    • 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 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: Nipocalimab
    Nipocalimab dose 1 and dose 2 infusions will be administered intravenously.
    Other Names:
  • JNJ-80202135
  • M281

    • 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.

    Outcome Measures

    Primary Outcome Measures

    1. Change from Baseline in Clinical European League Against Rheumatism Sjogren's Syndrome Disease Activity Index (clinESSDAI) Score at Week 24 [Baseline to 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.

    Secondary Outcome Measures

    1. Change from Baseline in European League Against Rheumatism (EULAR) Sjogren Syndrome Patient Reported Index (ESSPRI) Score at Week 24 [Baseline to 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.

    2. Improvement of Greater than or Equal to (>=) 4 Points from Baseline in ESSDAI Score (Minimal Clinically Important Improvement) at Week 24 [Baseline to 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.

    3. Improvement of >= 4 Points from Baseline in clinESSDAI Score (Minimal Clinically Important Improvement) at Week 24 [Baseline to 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.

    4. ESSPRI Response at Week 24 [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.

    5. Disease Response as Assessed by Sjögren's Tool for Assessing Response (STAR) Composite Score at Week 24 [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.

    6. Improvement in Disease Activity Level by >= 1 Level in at Least One clinESSDAI or ESSDAI Domain at Week 24 [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.

    7. Improvement from Baseline in >= 3 of 5 Composite of Relevant Endpoints for Sjogren's Syndrome (CRESS) Categories at Week 24 [Baseline to 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.

    8. Percentage of Participants with Treatment-emergent Adverse Events (TEAEs) [Up to 30 weeks]

      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.

    9. Percentage of Participants with Adverse Events of Special interests (AESIs) [Up to 36 weeks]

      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.

    10. Percentage of Participants with Treatment-emergent Serious Adverse Events (SAEs) [Up to 30 weeks]

      Treatment-emergent SAEs are defined as SAEs with onset or worsening on or after date of first dose of study treatment.

    11. Percentage of Participants with TEAEs Leading to Treatment Discontinuation [Up to 30 weeks]

      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.

    12. Percentage of Participants with Clinically Significant Abnormalities in Vital Signs [Up to 36 weeks]

      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.

    13. Percentage of Participants with Clinically Significant Abnormalities in Laboratory Parameters [Up to 36 weeks]

      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.

    14. Serum Concentration of Nipocalimab Over Time [Up to Week 30]

      Serum concentrations of nipocalimab over time in participants receiving active study intervention will be reported.

    15. Number of Participants with Antibodies to Nipocalimab (Anti-drug Antibodies [ADAs] and Neutralizing Antibodies [NAbs]) [Up to Week 36]

      Number of participants with antibodies to nipocalimab (ADAs and NAbs) in participants receiving active study intervention will be reported.

    16. Number of Participants with Change from Baseline in Biomarkers [Baseline to Week 36]

      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.

    17. Number of Participants with Change from Baseline in Autoantibodies [Baseline to Week 36]

      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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 75 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Anniston Medical Clinic Anniston Alabama United States 36207
    2 Arizona Arthritis and Rheumatology Research, PLLC Glendale Arizona United States 85306
    3 Arizona Arthritis & Rheumatology Research, PLLC Mesa Arizona United States 85210
    4 St. Jude Heritage Medical Group Fullerton California United States 92835
    5 Inland Rheumatology Clinical Trials, Inc. Upland California United States 91786
    6 Colorado Arthritis Associates Denver Colorado United States 80228
    7 Denver Arthritis Clinic Denver Colorado United States 80230
    8 Rheumatology Associates Of South Florida Boca Raton Florida United States 33486
    9 Centre for Rheumatology, Immunology and Arthritis Fort Lauderdale Florida United States 33309
    10 University of Florida Jacksonville Florida United States 32209
    11 Omega Research Consultants Orlando Florida United States 32835
    12 Clinical Investigation Specialists Gurnee Illinois United States 60031
    13 University of Iowa Hospitals and Clinics Iowa City Iowa United States 52242
    14 University of Kansas Medical Center Kansas City Kansas United States 66160
    15 University of Michigan Ann Arbor Michigan United States 48105
    16 St. Paul Rhuematology, P.A. Eagan Minnesota United States 55121
    17 North Mississippi Medical Clinics Tupelo Mississippi United States 38801
    18 PMG Research of Salisbury Salisbury North Carolina United States 28144
    19 Altoona Center For Clinical Research Duncansville Pennsylvania United States 16635
    20 University of Pennsylvania Philadelphia Pennsylvania United States 19104
    21 Reading Hospital West Reading Pennsylvania United States 19611
    22 Columbia Arthritis Center Columbia South Carolina United States 29204
    23 West Tennessee Research Institute Jackson Tennessee United States 38305
    24 Dr. Ramesh Gupta Memphis Tennessee United States 38119
    25 Austin Regional Clinic Austin Texas United States 78731-3146
    26 Trinity Clinical Research, LLC Carrollton Texas United States 75007
    27 Arthritis Northwest PLLC Spokane Washington United States 99204
    28 CHU de Grenoble - Hôpital Albert Michallon La Tronche France 38700
    29 Centre Hospitalier Le Mans le mans Cedex 9 France 72037
    30 Hopital Saint Joseph Marseille Cedex 08 France 13285
    31 Centre Hospitalier du Havre Montivilliers France 76290
    32 Hopital Pitie Salpetriere Paris France 75013
    33 CHRU Hôpital de Hautepierre Strasbourg Cedex France 67098
    34 Charité Universitätsmedizin Berlin Berlin Germany 10117
    35 Universitätsklinikum Carl Gustav Carus Dresden Dresden Germany 01307
    36 Hamburger Rheuma Forschungszentrum II Hamburg Germany 20095
    37 medius KLINIK KIRCHHEIM Kirchheim unter Teck Germany 73230
    38 Uniklinik Köln Köln Germany 50923
    39 Klinikum der Universität München München Germany 80336
    40 Universitätsklinikum Tübingen Tübingen Germany 72076
    41 Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia Presidio Spedali Civili Brescia Italy 25123
    42 P.O. Vittorio Emanuele Azienda Ospedaliero Universitaria 'Policlinico Vittorio Emanuele' Catania Italy 95100
    43 IRCCS Ospedale San Raffaele Milano Italy 20132
    44 Azienda Ospedaliero Universitaria Policlinico Paolo Giaccone Palermo Italy 90129
    45 Azienda Ospedaliero Universitaria Pisana Pisa Italy 56126
    46 Azienda Ospedaliero Universitaria S.Maria Della Misericordia Udine Italy 33100
    47 Azienda Ospedaliera Universitaria Integrata Verona Verona Italy 37126
    48 Tokyo Metropolitan Tama Medical Center Fuchu Japan 183-8524
    49 Nagasaki University Hospital Nagasaki-shi Japan 852-8501
    50 Hokkaido University Hospital Sapporo-shi Japan 060-8648
    51 St. Luke's International Hospital Tokyo Japan 104-8560
    52 Nihon University Itabashi Hospital Tokyo Japan 173-8610
    53 University of Tsukuba Hospital Tsukuba-Shi Japan 305-8520
    54 Medisch Centrum Leeuwarden Leeuwarden Netherlands 8934 AD
    55 Erasmus Medisch Centrum Rotterdam Netherlands 3015 GD
    56 Nasz Lekarz Przychodnie Medyczne Bydgoszcz Poland 85-065
    57 Szpital Uniwersytecki nr 2 im. dr. Jana Biziela w Bydgoszczy Bydgoszcz Poland 85-168
    58 Centrum Kliniczno Badawcze J. Brzezicki, B. Gornikiewicz-Brzezicka Lekarze Spolka Partnerska Elblag Poland 82-300
    59 Malopolskie Badania Kliniczne Sp. z o.o. Sp. k. Krakow Poland 30-002
    60 REUMED Zespol Poradni Specjalistycznych Filia nr 2 Lublin Poland 20-607
    61 Centrum Medyczne Poznan Poland 61-113
    62 Medycyna Kliniczna Warsaw Poland 00-874
    63 Narodowy Instytut Geriatrii, Reumatologii i Rehabilitacji im. prof. dr hab. med. Eleonory Reicher Warsaw Poland O2-637
    64 Centrum Medyczne AMED Warszawa Targowek Warszawa Poland 03-291
    65 Centrum Medyczne Oporow Wrocław Poland 52-415
    66 Instituto Portugues de Reumatologia Lisboa Portugal 1050-034
    67 ULSAM, EPE - Hospital Conde de Bertiandos Ponte de Lima Portugal 4990-078
    68 Centro Hospitalar de Vila Nova de Gaia/Espinho, E.P.E. Vila Nova de Gaia Portugal 4434-502
    69 Hosp. de La Santa Creu I Sant Pau Barcelona Spain 08025
    70 Hosp. Reina Sofia Córdoba Spain 14004
    71 Hosp. Univ. A Coruña La Coruña Spain 15006
    72 Hosp. Univ. 12 de Octubre Madrid Spain 28041
    73 Hosp. de Merida Mérida Spain 6800
    74 Corporacio Sanitari Parc Tauli Sabadell Spain 08208
    75 Hosp. Clinico Univ. de Salamanca Salamanca Spain 37007
    76 Hosp. Infanta Luisa Sevilla Spain 41010
    77 Tri-Service General Hospital Taipei Taiwan 11490
    78 Chang Gung Memorial Hospital Linkou Branch Taoyuan Taiwan 333

    Sponsors and Collaborators

    • Janssen Research & Development, LLC

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Janssen Research & Development, LLC
    ClinicalTrials.gov Identifier:
    NCT04968912
    Other Study ID Numbers:
    • CR109062
    • 2021-000665-32
    • 80202135SJS2001
    First Posted:
    Jul 20, 2021
    Last Update Posted:
    Aug 22, 2022
    Last Verified:
    Aug 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Sjogren's Syndrome
    Syndrome

    Study Results

    No Results Posted as of Aug 22, 2022