deltatrials
Completed PHASE2 INTERVENTIONAL 3-arm NCT04968912

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

A Randomized, Placebo-controlled, Double-blind, Multicenter Study to Assess the Efficacy and Safety of Nipocalimab in Adults With Primary Sjogren's Syndrome (pSS)

Sponsor: Janssen Research & Development, LLC

Conditions Sjogren's Syndrome
Interventions Nipocalimab Placebo Standard of Care Treatment
Updated 37 times since 2021 Last updated: Nov 3, 2025 Started: Sep 21, 2021 Primary completion: Oct 23, 2023 Completion: Nov 30, 2023
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

This PHASE2 trial investigates Sjogren's Syndrome and is currently completed. Janssen Research & Development, LLC leads this study, which shows 37 recorded versions since 2021 — indicating substantial longitudinal coverage. The change history captured here reflects the iterative nature of clinical trial conduct.

Status Flow

~Sep 2021 – ~Oct 2021 · 30 days · monthly snapshot~Oct 2021 – ~Nov 2021 · 31 days · monthly snapshot~Nov 2021 – ~Dec 2021 · 30 days · monthly snapshot~Dec 2021 – ~Jan 2022 · 31 days · monthly snapshot~Jan 2022 – ~Feb 2022 · 31 days · monthly snapshot~Feb 2022 – ~Apr 2022 · 59 days · monthly snapshot~Apr 2022 – ~May 2022 · 30 days · monthly snapshot~May 2022 – ~Jun 2022 · 31 days · monthly snapshot~Jun 2022 – ~Jul 2022 · 30 days · monthly snapshot~Jul 2022 – ~Sep 2022 · 2 months · monthly snapshot~Sep 2022 – ~Nov 2022 · 2 months · monthly snapshot~Nov 2022 – ~Dec 2022 · 30 days · monthly snapshot~Dec 2022 – ~Jan 2023 · 31 days · monthly snapshot~Jan 2023 – ~Feb 2023 · 31 days · monthly snapshot~Feb 2023 – ~Mar 2023 · 28 days · monthly snapshot~Mar 2023 – ~Apr 2023 · 31 days · monthly snapshot~Apr 2023 – ~May 2023 · 30 days · monthly snapshot~May 2023 – ~Jun 2023 · 31 days · monthly snapshot~Jun 2023 – ~Jul 2023 · 30 days · monthly snapshot~Jul 2023 – ~Aug 2023 · 31 days · monthly snapshot~Aug 2023 – ~Sep 2023 · 31 days · monthly snapshot~Sep 2023 – ~Oct 2023 · 30 days · monthly snapshot~Oct 2023 – ~Nov 2023 · 31 days · monthly snapshot~Nov 2023 – ~Jan 2024 · 2 months · monthly snapshot~Jan 2024 – ~Apr 2024 · 3 months · monthly snapshot~Apr 2024 – ~Jul 2024 · 3 months · monthly snapshot~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshot~Sep 2024 – ~Nov 2024 · 2 months · monthly snapshot~Nov 2024 – ~Jan 2025 · 2 months · monthly snapshot~Jan 2025 – ~Feb 2025 · 31 days · monthly snapshot~Feb 2025 – ~Mar 2025 · 28 days · monthly snapshot~Mar 2025 – ~Apr 2025 · 31 days · monthly snapshot~Apr 2025 – ~May 2025 · 30 days · monthly snapshot~May 2025 – ~Sep 2025 · 4 months · monthly snapshot~Sep 2025 – ~Nov 2025 · 2 months · monthly snapshot~Nov 2025 – ~Dec 2025 · 30 days · monthly snapshot~Dec 2025 – present · 9 months · monthly snapshot

Change History

37 versions recorded

  1. Dec 2025 — Present [monthly]

    Completed PHASE2

  2. Nov 2025 — Dec 2025 [monthly]

    Completed PHASE2

  3. Sep 2025 — Nov 2025 [monthly]

    Completed PHASE2

  4. May 2025 — Sep 2025 [monthly]

    Completed PHASE2

  5. Apr 2025 — May 2025 [monthly]

    Completed PHASE2

▶ Show 32 earlier versions

  1. Mar 2025 — Apr 2025 [monthly]

    Completed PHASE2

  2. Feb 2025 — Mar 2025 [monthly]

    Completed PHASE2

  3. Jan 2025 — Feb 2025 [monthly]

    Completed PHASE2

  4. Nov 2024 — Jan 2025 [monthly]

    Completed PHASE2

  5. Sep 2024 — Nov 2024 [monthly]

    Completed PHASE2

  6. Jul 2024 — Sep 2024 [monthly]

    Completed PHASE2

  7. Apr 2024 — Jul 2024 [monthly]

    Completed PHASE2

    Status: Active Not Recruiting → Completed

  8. Jan 2024 — Apr 2024 [monthly]

    Active Not Recruiting PHASE2

  9. Nov 2023 — Jan 2024 [monthly]

    Active Not Recruiting PHASE2

  10. Oct 2023 — Nov 2023 [monthly]

    Active Not Recruiting PHASE2

  11. Sep 2023 — Oct 2023 [monthly]

    Active Not Recruiting PHASE2

  12. Aug 2023 — Sep 2023 [monthly]

    Active Not Recruiting PHASE2

  13. Jul 2023 — Aug 2023 [monthly]

    Active Not Recruiting PHASE2

    Status: Recruiting → Active Not Recruiting

  14. Jun 2023 — Jul 2023 [monthly]

    Recruiting PHASE2

  15. May 2023 — Jun 2023 [monthly]

    Recruiting PHASE2

  16. Apr 2023 — May 2023 [monthly]

    Recruiting PHASE2

  17. Mar 2023 — Apr 2023 [monthly]

    Recruiting PHASE2

  18. Feb 2023 — Mar 2023 [monthly]

    Recruiting PHASE2

  19. Jan 2023 — Feb 2023 [monthly]

    Recruiting PHASE2

  20. Dec 2022 — Jan 2023 [monthly]

    Recruiting PHASE2

  21. Nov 2022 — Dec 2022 [monthly]

    Recruiting PHASE2

  22. Sep 2022 — Nov 2022 [monthly]

    Recruiting PHASE2

  23. Jul 2022 — Sep 2022 [monthly]

    Recruiting PHASE2

  24. Jun 2022 — Jul 2022 [monthly]

    Recruiting PHASE2

  25. May 2022 — Jun 2022 [monthly]

    Recruiting PHASE2

  26. Apr 2022 — May 2022 [monthly]

    Recruiting PHASE2

  27. Feb 2022 — Apr 2022 [monthly]

    Recruiting PHASE2

  28. Jan 2022 — Feb 2022 [monthly]

    Recruiting PHASE2

  29. Dec 2021 — Jan 2022 [monthly]

    Recruiting PHASE2

  30. Nov 2021 — Dec 2021 [monthly]

    Recruiting PHASE2

  31. Oct 2021 — Nov 2021 [monthly]

    Recruiting PHASE2

    Status: Not Yet Recruiting → Recruiting

  32. Sep 2021 — Oct 2021 [monthly]

    Not Yet Recruiting PHASE2

    First recorded

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:
  • Janssen Research & Development, LLC
Data source: Janssen Research & Development, LLC

For direct contact, visit the study record on ClinicalTrials.gov .

Study Locations

A Coruña, Spain , Anniston, United States , Austin, United States , Berlin, Germany , Boca Raton, United States , Brandon, United States , Brescia, Italy , Bydgoszcz, Poland , Carrollton, United States , Catania, Italy and 54 more locations