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NCT05693129 · ClinicalTrials.gov registry record · Phase 3
Pediatric Patients Aged 1 to 6 Years With APDS
A Phase 3 study of APDS, sponsored by Pharming Technologies B.V..
- Active
- Registry status
- Phase 3
- Development phase
- 16
- Enrollment target
- 9
- Study locations
NCT05693129 is a Phase 3 study of APDS that is active but no longer recruiting, run by Pharming Technologies B.V.. The registered enrollment target is 16 participants. The trial reports 9 study locations across 5 states.
The verdict
NCT05693129, a Phase 3 study of APDS, is active but no longer recruiting, sponsored by Pharming Technologies B.V..
- ACTIVE NOT RECRUITING
- Registry status
- Phase 3
- Development phase
- 16 participants
- Enrollment target
- 9
- Study locations
Study Summary
This is a 2-part, prospective, open-label, single arm, multicenter study to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PDx), and efficacy of leniolisib in at least 15 pediatric patients (aged 1 to 6 years) with activated phosphoinositide 3-kinase delta (PI3Kδ) syndrome (APDS)
Conditions Studied
Interventions
- DRUG Leniolisib
Study Locations (9)
Other
- Kyoto University Hospital - Kyoto
- Institute of Science Tokyo Hospital - Tokyo
- Hospital Pediátrico de Coimbra da ULS Coimbra UNIDADE LOCAL DE SAÚDE DE COIMBRA - Coimbra
- Hospital Universitario Virgen del Rocío - Seville
- Great Ormond Street Hospital - London
California
- University of California Los Angeles - Los Angeles
Maryland
- National Institutes of Health - Bethesda
Ohio
- Rainbow Childrens Hospital - Shaker Heights
Texas
- Texas Children's Hospital - Houston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 16 participants |
| Start Date | 2023-08-30 |
| Est. Completion | 2026-10-28 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05693129
The ClinicalTrials.gov registry entry for NCT05693129 describes a study currently listed as active not recruiting, categorized as Phase 3. The registered enrollment target is 16 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Pharming Technologies B.V., which has 11 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with APDS appearing as the primary indexed condition, and to 1 intervention - of which Leniolisib is the first listed.
NCT05693129 reports 9 study locations spanning 5 distinct geographic areas - top geographies include Other, California, Maryland.
Frequently Asked Questions
What is clinical trial NCT05693129 about?
NCT05693129 is a clinical study titled "Pediatric Patients Aged 1 to 6 Years With APDS". This is a 2-part, prospective, open-label, single arm, multicenter study to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PDx), and efficacy of leniolisib in at least 15 pediatric patients (aged 1 to 6 years) with activated phosphoinositide 3-kinase delta (PI3Kδ) syndro...
What is the current status of trial NCT05693129?
This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 16 participants. The study started on 2023-08-30. Estimated completion is 2026-10-28.
What conditions does trial NCT05693129 study?
This clinical trial studies the following conditions: APDS.
What interventions are being tested in trial NCT05693129?
The interventions under investigation include: Leniolisib (DRUG).
Who is sponsoring clinical trial NCT05693129?
This trial is sponsored by Pharming Technologies B.V., which has 11 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05693129 being conducted?
This trial has 9 study locations across California, Maryland, Ohio, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Related
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