A Phase 3 interventional study of Nipocalimab and Placebo in Sjogrens Syndrome, sponsored by Janssen Research & Development, LLC. Active, not recruiting at 254 sites in 28 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-25.
Sponsored by Janssen Research & Development, LLC · Phase 3, Interventional, and Treatment
The purpose of this study is to evaluate the clinical efficacy and safety of nipocalimab in participants with moderate to severe Sjogren's disease (SjD).
This clinical development program for nipocalimab in SjD includes 2 identical double blind, placebo-controlled studies to evaluate the efficacy, safety, and tolerability of nipocalimab in participants greater than or equal to (>=) 18 years of age with moderate to severe SjD.
371 studies on the registry are indexed under Sjogren's Syndrome; 104 are open to participants now.
This study's enrollment of 655 is above the median of 50 across 244 interventional studies indexed under Sjogren's Syndrome.
Browse Sjogren's Syndrome studies →Janssen Research & Development, LLC is the lead sponsor of 912 studies on the registry; 76 are open to participants now.
Of its 278 completed or terminated interventional studies of FDA-regulated products, 131 (47%) have results posted.
Counted across the registry records on this site, refreshed daily.
Inclusion Criteria:-
Exclusion Criteria:
Participants will receive nipocalimab subcutaneously (SC) along with standard of care treatments. At the Week 48 visit, eligible participants from both studies will have the option to enter an open-label long-term extension (OLE) phase, where they will continue to receive nipocalimab until Week 143 or until the study intervention is discontinued and participants opt to withdraw from the study.
Drug: Nipocalimab · Drug: Standard of care treatment
Participants will receive placebo subcutaneously along with standard of care treatments. At the Week 48 visit, eligible participants from both studies will have the option to enter an OLE phase, where they will receive nipocalimab until Week 143 or until the study intervention is discontinued and participants opt to withdraw from the study.
Drug: Placebo · Drug: Standard of care treatment
Nipocalimab SC.
Also known as: JNJ-80202135, JNJ-86507083, M281
Placebo SC.
Protocol-defined topical and systemic standard of care background treatments.
Change from Baseline in Clinical European League Against Rheumatism Sjogren's Syndrome Disease Activity Index (ClinESSDAI) Score at Week 48
ClinESSDAI is a validated tool used in clinical studies to measure the systemic disease activity in participants with SjD. 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 being measured. A higher score represents worse disease symptoms.
Time frame: Baseline to Week 48
Improvement from Baseline in Minimal Clinically Important Improvement (MCII) in ClinESSDAI Score at Week 48
The ClinESSDAI is a validated tool used in clinical studies to measure the systemic disease activity in participants with Sjogren's syndrome.
Time frame: Baseline to Week 48
Improvement from Baseline in ClinESSDAI Score at Week 48 in Participants with High Immunoglobulin (IgG) Levels at Baseline
ClinESSDAI is a validated tool used in clinical studies to measure the systemic disease activity in participants with SjD.
Time frame: Baseline to Week 48
Change from Baseline in ClinESSDAI Score at Week 8
ClinESSDAI is a validated tool used in clinical studies to measure the systemic disease activity in participants with SjD.
Time frame: Baseline to Week 8
Change from Baseline in Stimulated Salivary Flow Rate at Week 48
Stimulated salivary flow is considered a reliable and objective method to evaluate glandular function in SjD patients.
Time frame: Baseline to Week 48
Change from Baseline in Sjogren's Symptoms Dryness Score at Week 48
Participants will be asked to report the worst severity of their dryness symptoms on a 0 to 10 numeric rating scale (NRS), with score 0 indicating "No \[specific symptom\]" and score 10 indicating "Severe \[specific symptom\]". Higher scores reflect greater symptom severity. Change from baseline in Sjogren's Symptoms dryness score at Week 48 for US, US reference regions, and other non-US regions will be reported.
Time frame: Baseline to Week 48
Change from Baseline in Sjogren's Symptoms Joint Pain Score at Week 48
Participants will be asked to report the worst severity of their joint pain symptoms on a 0 to 10 numeric rating scale (NRS), with score 0 indicating "No \[specific symptom\]" and score 10 indicating "Severe \[specific symptom\]". Higher scores reflect greater symptom severity. Change from baseline in Sjogren's Symptoms joint pain score at Week 48 for US, US reference regions, and other non-US regions will be reported.
Time frame: Baseline to Week 48
Change from Baseline in EULAR Sjogren's Syndrome Patient Reported Index (ESSPRI) Score At Week 48
ESSPRI is a participant-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 on a 0 to 10 NRS, with score 0 indicating "No \[specific symptom\]" and score 10 indicating "Severe \[specific symptom\]". 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. Change from baseline in Sjogren's Symptoms score at Week 48 for EU, UK \& EU reference regions will be reported.
Time frame: Baseline to Week 48
Change from Baseline in Functional Assessment of Chronic Illness Therapy Fatigue (FACIT) Fatigue Score at Week 48
FACIT-Fatigue version 4.0 is a 13-item questionnaire that assesses participant-reported fatigue and its impact upon daily activities and function over the past 7 days. Participants will be asked to answer each question using a 5-point Likert scale (0=Not at all; 1=A little bit; 2=Somewhat; 3=Quite a bit; and 4=Very much). FACIT-Fatigue has a total score range from 0 to 52, with 0 being the worst possible score and 52 the best.
Time frame: Baseline to Week 48
Showing the first 100 of 254 sites across 28 countries.
Plan to share: Yes — The data sharing policy of Johnson \& Johnson Innovative Medicine is available at www.innovativemedicine.jnj.com/our-innovation/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
No publications or documents are linked to this record.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is active, not recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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