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Study of Efficacy and Safety of LNP023 in Participants With Active Lupus Nephritis Class III-IV, +/- V

StatusTerminated
PhasePhase 2
Started
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Record History

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  1. Trial terminated Sponsor's reason: The decision to conclude the study after Part 1 LPLV is based on strategic considerations by the Sponsor.
    • Trial sites reduced: 103 → 74 locations
    • Final enrollment: 81 participants (planned 240)
    • Study completion date changed from estimate of Sep 28, 2028 to Oct 1, 2026
  2. Eligibility criteria revised
    • Secondary endpoints: details revised at 1 of 7 entries
    • Site details revised at 17 of 103 sites
    • Publications: details revised at 1 of 1 entry
  3. Site details revised at 5 of 103 sitesv23
  4. Site details revised at 5 of 103 sitesv22
  5. Site details revised at 2 of 103 sitesv21
Show 19 earlier versionsHide 19 earlier versions
  1. Primary completion date changed from estimate of Mar 30, 2026 to Mar 19, 2026
    • Site contacts updated at 2 of 103 sites
    v20
  2. Site details revised at 15 of 103 sitesv19
  3. Site details revised at 5 of 103 sitesv18
  4. Primary completion date: Sep 30, 2025 to Mar 30, 2026
    • Study sites: 104 to 103
    v17
  5. Site details revised at 22 of 104 sitesv16
  6. Study sites: 102 to 104v15
  7. Site details revised at 8 of 102 sitesv14
  8. Primary completion date: Oct 24, 2024 to Sep 30, 2025
    • Study sites: 39 to 102
    • Study completion date: Mar 13, 2028 to Sep 28, 2028
    • Eligibility criteria revised
    v13
  9. Re-verified, no change to tracked fieldsv12
  10. Study sites: 31 to 39v11
  11. Study sites: 26 to 31v10
  12. Study sites: 19 to 26v9
  13. Study sites: 18 to 19v8
  14. Study sites: 17 to 18v7
  15. Study sites: 14 to 17v6
  16. Study sites: 10 to 14v5
  17. Study sites: 8 to 10v4
  18. Study sites: 3 to 8
    • Start date changed from estimate of Aug 1, 2022 to Aug 10, 2022
    v3
  19. Trial status: Not Yet Recruiting to Recruiting
    • Start date: May 2, 2022 to Aug 1, 2022
    • Study sites: 0 to 3
    v2
  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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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 34 trials at risk
Lupus (SLE)
666 trials monitored
See 25 trials at risk
The overall purpose of this two-part study is to evaluate the efficacy, safety and tolerability of iptacopan (LNP023) in addition to standard of care treatment.
Trial Details
NCT Number NCT05268289
Lead Sponsor Novartis Pharmaceuticals
Conditions
(from sponsor)		 Lupus Nephritis
Related terms Lupus Erythematosus, Systemic, Lupus Nephritis, Proteinuria
Enrollment 81 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov