Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT05438407 · ClinicalTrials.gov registry record · Phase 3
Pediatric Patients Aged 4 to 11 Years With APDS
A Phase 3 study of APDS, sponsored by Pharming Technologies B.V..
- Active
- Registry status
- Phase 3
- Development phase
- 15
- Enrollment target
- 7
- Study locations
NCT05438407 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 15 participants. The trial reports 7 study locations across 4 states.
The verdict
NCT05438407, 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
- 15 participants
- Enrollment target
- 7
- 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 4 to 11 years) with activated phosphoinositide 3-kinase delta (PI3Kδ) syndrome (APDS).
Conditions Studied
Interventions
- DRUG Leniolisib
Study Locations (7)
Other
- Necker Hospital Paris - Paris
- Kyoto University Hospital - Kyoto
- Institute of Science Tokyo Hospital - Tokyo
California
- University of California Los Angeles - Los Angeles
- Stanford University - Standford
Georgia
- Children's Healthcare of Atlanta - Atlanta
Maryland
- National Institutes of Health - Bethesda
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 15 participants |
| Start Date | 2023-02-01 |
| Est. Completion | 2025-12-30 |
| Phase | Phase 3 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05438407
The ClinicalTrials.gov registry entry for NCT05438407 describes a study currently listed as active not recruiting, categorized as Phase 3. The registered enrollment target is 15 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.
NCT05438407 reports 7 study locations spanning 4 distinct geographic areas - top geographies include Other, California, Georgia.
Frequently Asked Questions
What is clinical trial NCT05438407 about?
NCT05438407 is a clinical study titled "Pediatric Patients Aged 4 to 11 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 4 to 11 years) with activated phosphoinositide 3-kinase delta (PI3Kδ) syndr...
What is the current status of trial NCT05438407?
This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 15 participants. The study started on 2023-02-01. Estimated completion is 2025-12-30.
What conditions does trial NCT05438407 study?
This clinical trial studies the following conditions: APDS.
What interventions are being tested in trial NCT05438407?
The interventions under investigation include: Leniolisib (DRUG).
Who is sponsoring clinical trial NCT05438407?
This trial is sponsored by Pharming Technologies B.V., which has 11 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05438407 being conducted?
This trial has 7 study locations across California, Georgia, Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for APDS
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.