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An Open-label, Study to Assess Safety, Efficacy and Cellular Kinetics of YTB323 in Severe, Refractory Systemic Lupus Erythematosus

StatusCompleted
PhasePhase 1/2
Started
View on ClinicalTrials.gov ↗

Record History

  1. Trial completed Eligibility criteria expanded, about 23 words · Secondary endpoints: details revised at 4 of 15 entries Show 2 more changesShow less
    • Eligibility criteria expanded, about 23 words
    • Secondary endpoints: details revised at 4 of 15 entries
  2. 2 versions Re-verified since Jul 23, 2026, no change to tracked fieldsv25-v26
  3. Primary and study completion dates: Sep 9, 2026 to Sep 24, 2026v24
  4. 2 versions Re-verified since Feb 19, 2026, no change to tracked fieldsv22-v23
  5. Study sites: 12 to 10v21
Show 19 earlier versionsHide 19 earlier versions
  1. Site details revised at 1 of 12 sitesv20
  2. Re-verified, no change to tracked fieldsv19
  3. Primary and study completion dates: Sep 7, 2026 to Sep 9, 2026v18
  4. Study sites: 13 to 12v17
  5. Trial status: Recruiting to Active, Not Recruiting Enrollment target: estimated 24 to confirmed 21 · Primary and study completion dates: Oct 9, 2026 to Sep 7, 2026 · Study sites revised (13)v16 Show 3 more changesShow less
    • Enrollment target: estimated 24 to confirmed 21
    • Primary and study completion dates: Oct 9, 2026 to Sep 7, 2026
    • Study sites revised (13)

    See this version in full on ClinicalTrials.gov ↗

  6. Eligibility criteria expanded, about 8 words Site details revised at 1 of 13 sitesv15 Show 1 more changeShow less
    • Site details revised at 1 of 13 sites

    See this version in full on ClinicalTrials.gov ↗

  7. Study sites: 12 to 13v14
  8. Study sites: 10 to 12v13
  9. Study sites: 8 to 10v12
  10. Study sites: 7 to 8v11
  11. 2 versions Re-verified since Jan 23, 2024, no change to tracked fieldsv9-v10
  12. Enrollment target: 27 to 24v8
  13. Study sites: 6 to 7v7
  14. Study sites: 4 to 6v6
  15. Enrollment target: 12 to 27v5
  16. Study sites: 3 to 4v4
  17. Study sites: 2 to 3v3
  18. Study sites: 1 to 2 Primary and study completion dates: Mar 11, 2027 to Oct 9, 2026 · Eligibility criteria expanded, about 33 words · Secondary endpoints: 14 to 15 · 1 morev2 Show 4 more changesShow less
    • Primary and study completion dates: Mar 11, 2027 to Oct 9, 2026
    • Eligibility criteria expanded, about 33 words
    • Secondary endpoints: 14 to 15
    • Study title expanded, about 1 word

    See this version in full on ClinicalTrials.gov ↗

  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.
Novartis
555 trials monitored
See 31 trials at risk
Lupus (SLE)
651 trials monitored
See 25 trials at risk
The study is intended to assess safety, efficacy and cellular kinetics of YTB323 treatment in participants with severe refractory systemic lupus erythematosus.
Trial Details
NCT Number NCT05798117
Lead Sponsor Novartis Pharmaceuticals
Conditions Systemic Lupus Erythematosus, Lupus Nephritis
Enrollment 21 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov