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DAFFODILNCT06741969

Nipocalimab in Moderate to Severe Sjogren's Disease

StatusActive, Not Recruiting
PhasePhase 3
Primary completion (estimated)
Track this trial

Free. We email you which fields changed when ClinicalTrials.gov updates this record.

Record History

All 31 versions: 27 with changes below, 4 re-verified with no change. See every version on ClinicalTrials.gov ↗

  1. Primary completion moved earlier from Jan 1, 2028 to Feb 4, 2027
  2. Study sites revised (254)
  3. Eligibility criteria expanded, about 10 words Show 4 more changesShow less
    • Primary endpoints: details revised at 1 of 1 entry
    • Secondary endpoints: details revised at 5 of 8 entries
    • Study description revised
    • Site details revised at 7 of 254 sites
  4. Study sites revised (254)v28
  5. Study sites revised (254)v26
  6. Site details revised at 1 of 254 sitesv25
  7. Study completion moved earlier from Aug 2, 2029 to May 18, 2029v24
  8. Study sites revised (254)v23
  9. Trial status: Recruiting to Active, Not Recruiting
    • Enrollment target: estimated 600 to confirmed 655
    • Site details revised at 254 of 254 sites
    v22
  10. Study sites: 245 to 254v21
  11. Study sites: 240 to 245v20
  12. Study sites: 227 to 240v19
  13. Study sites: 217 to 227v18
  14. Study sites: 197 to 217v17
  15. Study sites: 179 to 197
    • Study completion date: Apr 17, 2030 to Aug 2, 2029
    v16
  16. Study sites: 152 to 179
    • Study completion date: Jun 29, 2030 to Apr 17, 2030
    v15
  17. Study sites: 122 to 152v14
  18. Study sites: 96 to 122v12
  19. Eligibility criteria revised
    • Study sites: 77 to 96
    v11
  20. Study sites: 59 to 77
    • Study completion date: May 29, 2030 to Jun 29, 2030
    v10
  21. Study sites: 56 to 59v9
  22. Study sites: 44 to 56v8
  23. Study sites: 38 to 44v7
  24. Study sites: 20 to 38v6
  25. Study sites: 7 to 20v4
  26. Eligibility criteria expanded, about 3 words
    • Study sites: 3 to 7
    • Secondary endpoints revised (8)
    v2
  27. Study First Submitted
  • Notable: the plan changed
  • Minor: routine updates

Endpoints

Primary

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

Secondary (8)

Improvement from Baseline in Minimal Clinically Important Improvement (MCII) in ClinESSDAI Score at Week 48
Improvement from Baseline in ClinESSDAI Score at Week 48 in Participants with High Immunoglobulin (IgG) Levels at Baseline
Change from Baseline in ClinESSDAI Score at Week 8
Change from Baseline in Stimulated Salivary Flow Rate at Week 48
Change from Baseline in Sjogren's Symptoms Dryness Score at Week 48
Show 3 moreShow less
Change from Baseline in Sjogren's Symptoms Joint Pain Score at Week 48
Change from Baseline in EULAR Sjogren's Syndrome Patient Reported Index (ESSPRI) Score At Week 48
Change from Baseline in Functional Assessment of Chronic Illness Therapy Fatigue (FACIT) Fatigue Score at Week 48

Arms and interventions

NipocalimabExperimental

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.

PlaceboPlacebo comparator

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.

Drugs: Nipocalimab, Placebo, Standard of care treatment

Sites

254 sites in 28 countries

United States 43, China 30, Poland 14, Brazil 13, Japan 12, Germany 11, Argentina 10, Italy 10, Bulgaria 9, France 8, Israel 8, Mexico 8, South Korea 8, Spain 8, United Kingdom 8, Hungary 7, Romania 7, Taiwan 7, Turkey (Türkiye) 6, Austria 5, Czechia 5, Portugal 4, Canada 3, Denmark 3, Hong Kong 2, Norway 2, Switzerland 2, Netherlands 1