deltatrials
Active Not Recruiting PHASE3 INTERVENTIONAL 1-arm NCT05693129

Pediatric Patients Aged 1 to 6 Years With APDS

An Open-label, Single Arm Study of the Safety, Pharmacokinetics, Pharmacodynamics, and Efficacy of Leniolisib in Pediatric Patients (Aged 1 to 6 Years) With APDS (Activated Phosphoinositide 3-Kinase Delta Syndrome) Followed by an Open-label Long-term Extension

Sponsor: Aixial Group

Conditions APDS
Interventions Leniolisib
Updated 20 times since 2023 Last updated: Oct 27, 2025 Started: Aug 30, 2023 Primary completion: Jul 9, 2026 Completion: Oct 28, 2026
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

Listed as NCT05693129, this PHASE3 trial focuses on APDS and remains ongoing. Sponsored by Aixial Group, it has been updated 20 times since 2023, reflecting substantial change activity. This study adds to the evidence base for this therapeutic area through structured, versioned documentation.

Status Flow

~Feb 2023 – ~May 2023 · 3 months · monthly snapshot~May 2023 – ~Jun 2023 · 31 days · monthly snapshot~Jun 2023 – ~Jul 2023 · 30 days · monthly snapshot~Jul 2023 – ~Oct 2023 · 3 months · monthly snapshot~Oct 2023 – ~Nov 2023 · 31 days · monthly snapshot~Nov 2023 – ~Dec 2023 · 30 days · monthly snapshot~Dec 2023 – ~Jan 2024 · 31 days · monthly snapshot~Jan 2024 – ~Mar 2024 · 2 months · monthly snapshot~Mar 2024 – ~Apr 2024 · 31 days · monthly snapshot~Apr 2024 – ~Jul 2024 · 3 months · monthly snapshot~Jul 2024 – ~Aug 2024 · 31 days · monthly snapshot~Aug 2024 – ~Sep 2024 · 31 days · monthly snapshot~Sep 2024 – ~Jan 2025 · 4 months · monthly snapshot~Jan 2025 – ~Feb 2025 · 31 days · monthly snapshot~Feb 2025 – ~Apr 2025 · 59 days · monthly snapshot~Apr 2025 – ~May 2025 · 30 days · monthly snapshot~May 2025 – ~Aug 2025 · 3 months · monthly snapshot~Aug 2025 – ~Sep 2025 · 31 days · monthly snapshot~Sep 2025 – ~Nov 2025 · 2 months · monthly snapshot~Nov 2025 – present · 8 months · monthly snapshot

Change History

20 versions recorded

  1. Nov 2025 — Present [monthly]

    Active Not Recruiting PHASE3

  2. Sep 2025 — Nov 2025 [monthly]

    Active Not Recruiting PHASE3

  3. Aug 2025 — Sep 2025 [monthly]

    Active Not Recruiting PHASE3

  4. May 2025 — Aug 2025 [monthly]

    Active Not Recruiting PHASE3

    Status: Recruiting → Active Not Recruiting

  5. Apr 2025 — May 2025 [monthly]

    Recruiting PHASE3

▶ Show 15 earlier versions

  1. Feb 2025 — Apr 2025 [monthly]

    Recruiting PHASE3

  2. Jan 2025 — Feb 2025 [monthly]

    Recruiting PHASE3

  3. Sep 2024 — Jan 2025 [monthly]

    Recruiting PHASE3

  4. Aug 2024 — Sep 2024 [monthly]

    Recruiting PHASE3

  5. Jul 2024 — Aug 2024 [monthly]

    Recruiting PHASE3

  6. Apr 2024 — Jul 2024 [monthly]

    Recruiting PHASE3

  7. Mar 2024 — Apr 2024 [monthly]

    Recruiting PHASE3

  8. Jan 2024 — Mar 2024 [monthly]

    Recruiting PHASE3

  9. Dec 2023 — Jan 2024 [monthly]

    Recruiting PHASE3

  10. Nov 2023 — Dec 2023 [monthly]

    Recruiting PHASE3

    Status: Not Yet Recruiting → Recruiting

  11. Oct 2023 — Nov 2023 [monthly]

    Not Yet Recruiting PHASE3

  12. Jul 2023 — Oct 2023 [monthly]

    Not Yet Recruiting PHASE3

  13. Jun 2023 — Jul 2023 [monthly]

    Not Yet Recruiting PHASE3

  14. May 2023 — Jun 2023 [monthly]

    Not Yet Recruiting PHASE3

  15. Feb 2023 — May 2023 [monthly]

    Not Yet Recruiting PHASE3

    First recorded

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:
  • Aixial Group
  • CMIC Co, Ltd. Japan
  • Fortrea
  • Labcorp Central Laboratory
  • Pharming Technologies B.V.
Data source: Pharming Technologies B.V.

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

Study Locations