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

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ClinicalTrials.gov Identifier: NCT04968912
Recruitment Status : Recruiting
First Posted : July 20, 2021
Last Update Posted : June 8, 2022
Sponsor:
Information provided by (Responsible Party):
Janssen Research & Development, LLC

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
Sjogren's Syndrome Other: Placebo Drug: Nipocalimab Drug: Standard of Care Treatment Phase 2

Expanded Access : An investigational treatment associated with this study is available outside the clinical trial.   More info ...

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.

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Study Type : Interventional  (Clinical Trial)
Estimated 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 : September 21, 2021
Estimated Primary Completion Date : October 2, 2023
Estimated Study Completion Date : December 1, 2023

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  1. Change from Baseline in Clinical European League Against Rheumatism Sjogren's Syndrome Disease Activity Index (clinESSDAI) Score at Week 24 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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. Sjogren's Syndrome Responder Index (SSRI) Response at Week 24 [ Time Frame: Week 24 ]
    SSRI response defined as >= 20% improvement from baseline in at least two of five domains (fatigue, oral dryness, ocular dryness, unstimulated whole salivary flow, erythrocyte sedimentation rate) at Week 24 will be reported.

  6. Improvement in Disease Activity Level by >= 1 Level in at Least One clinESSDAI or ESSDAI Domain at Week 24 [ Time Frame: 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 [ Time Frame: 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) [ Time Frame: 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) [ Time Frame: 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) [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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]) [ Time Frame: 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 [ Time Frame: Baseline to Week 36 ]
    Number of participants with change from baseline in biomarkers (C-reactive protein [CRP], erythrocyte sedimentation rate [ESR], total immunoglobulin [Ig]G, IgG1, IgG2, IgG3, IgG4) will be reported.

  17. Number of Participants with Change from Baseline in Autoantibodies [ Time Frame: 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04968912


Contacts
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Contact: Study Contact 844-434-4210 Participate-In-This-Study@its.jnj.com

Locations
Show Show 71 study locations
Sponsors and Collaborators
Janssen Research & Development, LLC
Investigators
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Study Director: Janssen Research & Development, LLC Clinical Trial Janssen Research & Development, LLC
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Responsible Party: Janssen Research & Development, LLC
ClinicalTrials.gov Identifier: NCT04968912    
Other Study ID Numbers: CR109062
2021-000665-32 ( EudraCT Number )
80202135SJS2001 ( Other Identifier: Janssen Research & Development, LLC )
First Posted: July 20, 2021    Key Record Dates
Last Update Posted: June 8, 2022
Last Verified: June 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
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
URL: https://www.janssen.com/clinical-trials/transparency

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Sjogren's Syndrome
Syndrome
Disease
Pathologic Processes
Arthritis, Rheumatoid
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Xerostomia
Salivary Gland Diseases
Mouth Diseases
Stomatognathic Diseases
Dry Eye Syndromes
Lacrimal Apparatus Diseases
Eye Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases