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

JRCT ID: jRCT2031210484

Registered date:14/12/2021

Basic Information

• Recruitment status: Not Recruiting
• Health condition(s) or Problem(s) studied: Sjogren's Syndrome
• Date of first enrollment: 30/03/2022
• Target sample size: 150
• Countries of recruitment: Germany,Japan,Spain,Japan,Italy,Japan,Netherlands,Japan,Poland,Japan,Portugal,Japan,United States Of America,Japan,France,Japan,Taiwan,Japan
• Study type: Interventional

Intervention(s)

Placebo
Placebo infusion will be administered intravenously.

Nipocalimab
Nipocalimab dose 1 and dose 2 infusions will be administered intravenously.

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(s)

Primary Outcome

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

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.

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.

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.

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.

Sjogren's Syndrome Responder Index (SSRI) Response at Week 24
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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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 sedimentation rate [ESR], total immunoglobulin [Ig]G, IgG1, IgG2, IgG3, IgG4) will be reported.

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.

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: <= 75age old
• Gender: Both

Include criteria

- Meets classification criteria for primary Sjogren's syndrome (pSS) by the 2016 American College of Rheumatology (ACR) / European League Against Rheumatism (EULAR) the time of screening, and was diagnosed with pSS no less than 26 weeks prior to screening
- At screening is seropositive for antibodies to pSSassociated
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.

Exclude 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

Related Information

• Primary Sponsor: Nishikawa Kazuko
• Secondary ID(s): NCT04968912