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A Randomized, Placebo-controlled, Double-blind, Multicenter Phase 3 Protocol to Assess the Efficacy and Safety of Nipocalimab in Adults with Moderate to Severe Sjogren's Disease (SjD) (DAFFODIL )

Nipocalimab in Moderate to Severe Sjogren's Disease (DAFFODIL)

Ohashi Hiroki

Janssen Pharmaceutical K.K.

5-2, Nishi-kanda 3-chome, Chiyoda-ku, Tokyo

DL-JANJP-JCO_TL_TSG_EMP@its.jnj.com

Medical Information Center

Janssen Pharmaceutical K.K.

5-2, Nishi-kanda 3-chome, Chiyoda-ku, Tokyo

+81-120-183-275

DL-JANJP-JCO_TL_TSG_EMP@its.jnj.com

Not Recruiting

Mar. 28, 2025

Interventional

randomized controlled trial

double blind

placebo control

parallel assignment

treatment purpose

- Medically stable on the basis of physical examination, medical history, vital signs, clinical laboratory tests, and 12-lead electrocardiogram (ECG) performed at screening
- Meets criteria for diagnosis of SjD by the 2016 American College of Rheumatology/European Alliance of Associations for Rheumatology (ACR/EULAR) classification criteria
- Seropositive for antibodies to Ro/SSAA (Ro60 and/or Ro52) at screening
- Total ClinESSDAI score greater than or equal to (>=) 5 at screening
- Participants of childbearing potential must have a negative highly sensitive serum (beta-hCG) pregnancy test at screening and a negative urine pregnancy test at Week 0 prior to randomization

- Has a history of severe, progressive and/or uncontrolled hepatic, gastrointestinal, renal, pulmonary,cardiovascular, psychiatric, neurological or musculoskeletal disorder, hypertension, and/or any other medical or uncontrolled autoimmune disorder or clinically significant abnormalities in screening laboratory
- Known allergies, hypersensitivity, or intolerance to nipocalimab or its excipients or excipients used in the placebo formulation
- Has any confirmed or suspected clinical immunodeficiency syndrome not related to treatment of his/her SjD or has a family history of congenital or hereditary immunodeficiency
- Has shown a previous severe immediate hypersensitivity reaction, such as anaphylaxis, to therapeutic proteins (for example [e.g.], monoclonal antibodies, intravenous immunoglobulin)
- Has any unstable or progressive manifestation of SjD that is likely to warrant escalation in therapy beyond permitted background medications

Both

Sjogrens Syndrome

Nipocalimab:Nipocalimab SC: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.

Placebo:Placebo SC: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.

Change from Baseline in Clinical European League Against Rheumatism Sjogren's Syndrome Disease Activity Index (ClinESSDAI) Score at Week 48: Baseline to 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.

-Improvement from Baseline in Minimal Clinically Important Improvement (MCII) in ClinESSDAI Score at Week 48: Baseline to Week 48: The ClinESSDAI is a validated tool used in clinical studies to measure the systemic disease activity in participants with Sjogren's syndrome.
-Improvement from Baseline in ClinESSDAI Score at Week 48 in Participants with High Immunoglobulin (IgG) Levels at Baseline: Baseline to Week 48: ClinESSDAI is a validated tool used in clinical studies to measure the systemic disease activity in participants with SjD.
-Change from Baseline in ClinESSDAI Score at Week 8: Baseline to Week 8: ClinESSDAI is a validated tool used in clinical studies to measure the systemic disease activity in participants with SjD.
-Change from Baseline in Stimulated Salivary Flow Rate at Week 48: Baseline to Week 48: Stimulated salivary flow is considered a reliable and objective method to evaluate glandular function in SjD patients.
-Change from Baseline in Sjogren's Symptoms Dryness Score at Week 48: Baseline to 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.
-Change from Baseline in Sjogren's Symptoms Joint Pain Score at Week 48: Baseline to 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.
-Change from Baseline in EULAR Sjogren's Syndrome Patient Reported Index (ESSPRI) Score At Week 48: Baseline to 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.
-Change from Baseline in Functional Assessment of Chronic Illness Therapy Fatigue (FACIT) Fatigue Score at Week 48: Baseline to Week48: 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.

Dec. 10, 2024

Yes

The data sharing policy of the Janssen Pharmaceutical Companies of Johnson and 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.

Argentina/Austria/Brazil/Bulgaria/China/Denmark/France/Germany/Hungary/Italy/Korea Republic Of/Mexico/Poland/Portugal/Romania/Spain/Taiwan Province Of China/United Kingdom Of Great Britain/United States Of America/Australia/Canada/Czechia/Hong Kong/Israel/Kingdom Of The Netherlands /Norway/Switzerland/Turkiye