deltatrials
Completed PHASE3 INTERVENTIONAL 2-arm NCT04558918

Study of Efficacy and Safety of Twice Daily Oral LNP023 in Adult PNH Patients With Residual Anemia Despite Anti-C5 Antibody Treatment (APPLY-PNH)

A Randomized, Multicenter, Active-comparator Controlled, Open-label Trial to Evaluate Efficacy and Safety of Oral, Twice Daily LNP023 in Adult Patients With PNH and Residual Anemia, Despite Treatment With an Intravenous Anti-C5 Antibody.

Sponsor: Novartis Pharmaceuticals

Updated 25 times since 2020 Last updated: Oct 7, 2024 Started: Jan 25, 2021 Primary completion: Sep 26, 2022 Completion: Mar 6, 2023
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

A PHASE3 clinical study on Paroxysmal Nocturnal Hemoglobinuria (PNH), this trial is completed. The trial is conducted by Novartis Pharmaceuticals and has accumulated 25 data snapshots since 2021. Longitudinal tracking of this trial contributes to a broader understanding of treatment development timelines.

Status Flow

~Oct 2020 – ~Jan 2021 · 3 months · monthly snapshot~Jan 2021 – ~Mar 2021 · 59 days · monthly snapshot~Mar 2021 – ~Apr 2021 · 31 days · monthly snapshot~Apr 2021 – ~Jun 2021 · 2 months · monthly snapshot~Jun 2021 – ~Sep 2021 · 3 months · monthly snapshot~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 – ~Apr 2022 · 3 months · monthly snapshot~Apr 2022 – ~May 2022 · 30 days · monthly snapshot~May 2022 – ~Sep 2022 · 4 months · monthly snapshot~Sep 2022 – ~Oct 2022 · 30 days · monthly snapshot~Oct 2022 – ~Nov 2022 · 31 days · monthly snapshot~Nov 2022 – ~Dec 2022 · 30 days · monthly snapshot~Dec 2022 – ~Feb 2023 · 2 months · monthly snapshot~Feb 2023 – ~May 2023 · 3 months · monthly snapshot~May 2023 – ~Dec 2023 · 7 months · monthly snapshot~Dec 2023 – ~May 2024 · 5 months · monthly snapshot~May 2024 – ~Jul 2024 · 2 months · monthly snapshot~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshot~Sep 2024 – ~Oct 2024 · 30 days · monthly snapshot~Oct 2024 – ~Nov 2024 · 31 days · monthly snapshot~Nov 2024 – ~Sep 2025 · 10 months · monthly snapshot~Sep 2025 – present · 12 months · monthly snapshot

Change History

25 versions recorded
  1. Sep 2025 — Present [monthly]

    Completed PHASE3

  2. Nov 2024 — Sep 2025 [monthly]

    Completed PHASE3

  3. Oct 2024 — Nov 2024 [monthly]

    Completed PHASE3

  4. Sep 2024 — Oct 2024 [monthly]

    Completed PHASE3

  5. Jul 2024 — Sep 2024 [monthly]

    Completed PHASE3

Show 20 earlier versions
  1. May 2024 — Jul 2024 [monthly]

    Completed PHASE3

  2. Dec 2023 — May 2024 [monthly]

    Completed PHASE3

  3. May 2023 — Dec 2023 [monthly]

    Completed PHASE3

    Status: Active Not RecruitingCompleted

  4. Feb 2023 — May 2023 [monthly]

    Active Not Recruiting PHASE3

  5. Dec 2022 — Feb 2023 [monthly]

    Active Not Recruiting PHASE3

  6. Nov 2022 — Dec 2022 [monthly]

    Active Not Recruiting PHASE3

  7. Oct 2022 — Nov 2022 [monthly]

    Active Not Recruiting PHASE3

  8. Sep 2022 — Oct 2022 [monthly]

    Active Not Recruiting PHASE3

  9. May 2022 — Sep 2022 [monthly]

    Active Not Recruiting PHASE3

  10. Apr 2022 — May 2022 [monthly]

    Active Not Recruiting PHASE3

    Status: RecruitingActive Not Recruiting

  11. Jan 2022 — Apr 2022 [monthly]

    Recruiting PHASE3

  12. Dec 2021 — Jan 2022 [monthly]

    Recruiting PHASE3

  13. Nov 2021 — Dec 2021 [monthly]

    Recruiting PHASE3

  14. Oct 2021 — Nov 2021 [monthly]

    Recruiting PHASE3

  15. Sep 2021 — Oct 2021 [monthly]

    Recruiting PHASE3

  16. Jun 2021 — Sep 2021 [monthly]

    Recruiting PHASE3

  17. Apr 2021 — Jun 2021 [monthly]

    Recruiting PHASE3

  18. Mar 2021 — Apr 2021 [monthly]

    Recruiting PHASE3

    Status: Not Yet RecruitingRecruiting

  19. Jan 2021 — Mar 2021 [monthly]

    Not Yet Recruiting PHASE3

  20. Oct 2020 — Jan 2021 [monthly]

    Not Yet Recruiting PHASE3

    First recorded

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:
  • Novartis Pharmaceuticals
Data source: Novartis

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