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

Sponsor: Janssen Research & Development, LLC

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

TIPOLOGIA STUDIO

Interventistico

FASE

Fase 2

TRATTAMENTO

• Placebo
• Nipocalimab
• Standard of Care Treatment

OBIETTIVO PRIMARIO

• Misura: Change from Baseline in Clinical European League Against Rheumatism Sjogren's Syndrome Disease Activity Index (clinESSDAI) Score at Week 24
• Tempo: Baseline to Week 24
• Descrizione: 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.

OBIETTIVO SECONDARIO

• Misura: Change from Baseline in European League Against Rheumatism (EULAR) Sjogren Syndrome Patient Reported Index (ESSPRI) Score at Week 24
• Tempo: Baseline to Week 24
• Descrizione: 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.

• Misura: Improvement of Greater than or Equal to (>=) 4 Points from Baseline in ESSDAI Score (Minimal Clinically Important Improvement) at Week 24
• Tempo: Baseline to Week 24
• Descrizione: 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.

• Misura: Improvement of >= 4 Points from Baseline in clinESSDAI Score (Minimal Clinically Important Improvement) at Week 24
• Tempo: Baseline to Week 24
• Descrizione: 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.

• Misura: ESSPRI Response at Week 24
• Tempo: Week 24
• Descrizione: 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.

• Misura: Disease Response as Assessed by Sjögren's Tool for Assessing Response (STAR) Composite Score at Week 24
• Tempo: Week 24
• Descrizione: 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.

• Misura: Improvement in Disease Activity Level by >= 1 Level in at Least One clinESSDAI or ESSDAI Domain at Week 24
• Tempo: Week 24
• Descrizione: 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.

• Misura: Improvement from Baseline in >= 3 of 5 Composite of Relevant Endpoints for Sjogren's Syndrome (CRESS) Categories at Week 24
• Tempo: Baseline to Week 24
• Descrizione: 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.

• Misura: Percentage of Participants with Treatment-emergent Adverse Events (TEAEs)
• Tempo: Up to 30 weeks
• Descrizione: 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.

• Misura: Percentage of Participants with Adverse Events of Special interests (AESIs)
• Tempo: Up to 36 weeks
• Descrizione: 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.

• Misura: Percentage of Participants with Treatment-emergent Serious Adverse Events (SAEs)
• Tempo: Up to 30 weeks
• Descrizione: Treatment-emergent SAEs are defined as SAEs with onset or worsening on or after date of first dose of study treatment.

• Misura: Percentage of Participants with TEAEs Leading to Treatment Discontinuation
• Tempo: Up to 30 weeks
• Descrizione: 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.

• Misura: Percentage of Participants with Clinically Significant Abnormalities in Vital Signs
• Tempo: Up to 36 weeks
• Descrizione: 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.

• Misura: Percentage of Participants with Clinically Significant Abnormalities in Laboratory Parameters
• Tempo: Up to 36 weeks
• Descrizione: 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.

• Misura: Serum Concentration of Nipocalimab Over Time
• Tempo: Up to Week 30
• Descrizione: Serum concentrations of nipocalimab over time in participants receiving active study intervention will be reported.

• Misura: Number of Participants with Antibodies to Nipocalimab (Anti-drug Antibodies [ADAs] and Neutralizing Antibodies [NAbs])
• Tempo: Up to Week 36
• Descrizione: Number of participants with antibodies to nipocalimab (ADAs and NAbs) in participants receiving active study intervention will be reported.

• Misura: Number of Participants with Change from Baseline in Biomarkers
• Tempo: Baseline to Week 36
• Descrizione: 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.

• Misura: Number of Participants with Change from Baseline in Autoantibodies
• Tempo: Baseline to Week 36
• Descrizione: 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.

CRITERI DI ELIGIBILITA'

• Criteri di inclusione e esclusione

  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

SESSO

Tutti

ETA' MINIMA

Età Minima: 18 Years
Età Massima: 75 Years

LUOGO

Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia Presidio Spedali Civili
Brescia, 25123

P.O. Vittorio Emanuele Azienda Ospedaliero Universitaria 'Policlinico Vittorio Emanuele'
Catania, 95100

IRCCS Ospedale San Raffaele
Milano, 20132

Azienda Ospedaliero Universitaria Policlinico Paolo Giaccone
Palermo, 90129

Azienda Ospedaliero Universitaria Pisana
Pisa, 56126

Azienda Ospedaliero Universitaria S.Maria Della Misericordia
Udine, 33100

Azienda Ospedaliera Universitaria Integrata Verona
Verona, 37126