Primary Sjögren's Syndrom
Conditions
Interventions
Arm 1: Participants will receive placebo intravenously (IV) every 2 weeks (q2w)
through Week 22 along with standard of care treatments
Arm 2: Participants will receive nipocalimab dose 1 IV q2w throu
Sponsors
Janssen-Cilag
Eligibility
Age
18 Years to 99 Years
Inclusion 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 [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
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 the sponsor's representative are likely to interfere with the investigator's ability to assess pSS manifestations
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Measure: Change from Baseline in Clinical European League Against Rheumatism Sjogren's Syndrome Disease Activity Index (clinESSDAI) Score at Week 24 TimeFrame: Baseline to Week 24 Description: 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
| Measure | Time frame |
|---|---|
| Measure: Change from Baseline in European League Against Rheumatism (EULAR) Sjogren Syndrome Patient Reported Index (ESSPRI) Score at Week 24 TimeFrame: Baseline to Week 24 Description: 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. Measure: Improvement of Greater than or Equal to (>=) 4 Points from Baseline in ESSDAI Score (Minimal Clinically Important Improvement) at Week 24 TimeFrame: Baseline to Week 24 Description: 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. Measure: Improvement of >= 4 Points from Baseline in clinESSDAI Score (Minimal Clinically Important Improvement) at Week 24 TimeFrame: Baseline to Week 24 Description: 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. Measure: ESSPRI Response at Week 24 TimeFrame: Week 24 Measure: Sjogren's Syndrome Responder Index (SSRI) Response at Week 24 TimeFrame: Week 24 Measure: Improvement in Disease Activity Level by >= 1 Level in at Least One clinESSDAI or ESSDAI Domain at Week 24 TimeFrame: Week 24 Descri | — |
Countries
Netherlands
Outcome results
None listed