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A Study of Nipocalimab in Children Aged 2 to Less Than 18 Years With Generalized Myasthenia Gravis

StatusRecruiting
PhasePhase 2/3
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 12 months later Jun 26, 2026 → Jun 30, 2027
See other at-risk trials from Johnson & Johnson

Record History

  1. Primary completion pushed from Jun 26, 2026 to Jun 30, 2027v48
  2. Site details revised at 1 of 19 sitesv47
  3. Re-verified, no change to tracked fieldsv46
  4. Completion date: Jun 26, 2026 to Jul 2, 2029v45
  5. Site details revised at 1 of 19 sitesv44
Show 42 earlier versionsHide 42 earlier versions
  1. 2 versions Re-verified since Oct 9, 2025, no change to tracked fieldsv42-v43
  2. Primary completion date: Jun 30, 2026 to Jun 26, 2026 Completion date: Dec 31, 2026 to Jun 26, 2026 · Site details revised at 1 of 19 sitesv41 Show 2 more changesShow less
    • Completion date: Dec 31, 2026 to Jun 26, 2026
    • Site details revised at 1 of 19 sites
  3. 3 versions Re-verified since May 22, 2025, no change to tracked fieldsv38-v40
  4. Primary completion date: Mar 19, 2025 to Jun 30, 2026v37
  5. Completion date: Dec 30, 2025 to Dec 31, 2026 Eligibility criteria expanded, about 63 wordsv36 Show 1 more changeShow less
    • Eligibility criteria expanded, about 63 words

    See this version in full on ClinicalTrials.gov ↗

  6. Re-verified, no change to tracked fieldsv35
  7. Primary endpoints revised (14) Site details revised at 1 of 19 sites · Eligibility criteria expanded, about 2 wordsv34 Show 2 more changesShow less
    • Site details revised at 1 of 19 sites
    • Eligibility criteria expanded, about 2 words

    See this version in full on ClinicalTrials.gov ↗

  8. Study sites: 18 to 19v33
  9. 5 versions Re-verified since Jun 18, 2024, no change to tracked fieldsv28-v32
  10. Study sites: 17 to 18v27
  11. Eligibility criteria expanded, about 9 words Site details revised at 2 of 17 sitesv26 Show 1 more changeShow less
    • Site details revised at 2 of 17 sites

    See this version in full on ClinicalTrials.gov ↗

  12. Study sites: 16 to 17v25
  13. Study sites: 15 to 16v24
  14. Re-verified, no change to tracked fieldsv23
  15. Study sites: 14 to 15v22
  16. 3 versions Re-verified since Aug 15, 2023, no change to tracked fieldsv19-v21
  17. Completion date: Dec 31, 2025 to Dec 30, 2025v18
  18. Primary completion date: Dec 31, 2025 to Mar 19, 2025v17
  19. Study sites: 13 to 14v16
  20. Re-verified, no change to tracked fieldsv15
  21. Primary completion date: Mar 19, 2025 to Dec 31, 2025 Study sites: 25 to 13v14 Show 1 more changeShow less
    • Study sites: 25 to 13
  22. Site details revised at 1 of 25 sitesv13
  23. Re-verified, no change to tracked fieldsv12
  24. Site details revised at 1 of 25 sitesv11
  25. Site details revised at 1 of 25 sitesv10
  26. Study sites: 24 to 25v9
  27. Study sites: 22 to 24v8
  28. Eligibility criteria expanded, about 8 words Secondary endpoints: 7 to 9 · Site details revised at 3 of 22 sitesv7 Show 2 more changesShow less
    • Secondary endpoints: 7 to 9
    • Site details revised at 3 of 22 sites

    See this version in full on ClinicalTrials.gov ↗

  29. Study sites: 21 to 22v6
  30. Start date changed from estimate of Jul 29, 2022 to Jul 20, 2022 Site details revised at 1 of 21 sitesv5 Show 1 more changeShow less
    • Site details revised at 1 of 21 sites
  31. Site details revised at 1 of 21 sitesv4
  32. Trial status: Not Yet Recruiting to Recruiting Start date: Mar 31, 2022 to Jul 29, 2022 · Study sites: 18 to 21 · Completion date: Mar 19, 2025 to Dec 31, 2025v3 Show 3 more changesShow less
    • Start date: Mar 31, 2022 to Jul 29, 2022
    • Study sites: 18 to 21
    • Completion date: Mar 19, 2025 to Dec 31, 2025
  33. Start date: Mar 21, 2022 to Mar 31, 2022v2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
The purpose of this study is to determine the effect of nipocalimab on total serum immunoglobulin G (IgG) in pediatric participants 2 to less than (\<) 18 years of age (globally) and 8 to \<18 years of age (for Unites Stated (US) sites only), the safety and tolerability of treatment with nipocalimab in children and adolescents and to evaluate the pharmacokinetics (PK) of nipocalimab in children and adolescents with generalized myasthenia gravis (gMG) who have an insufficient clinical response to ongoing, stable standard-of-care therapy.
Trial Details
NCT Number NCT05265273
Lead Sponsor Janssen Research & Development, LLC
Conditions Myasthenia Gravis
Enrollment 12 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov