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NCT06990529 · ClinicalTrials.gov registry record · Phase 2
Long-term Safety and Efficacy of Leniolisib in PIDs With Immune Dysregulation
A Phase 2 study of PIDs Linked to PI3K, sponsored by Pharming Technologies B.V..
- Recruiting
- Registry status
- Phase 2
- Development phase
- 12
- Enrollment target
- 4
- Study locations
NCT06990529 is a Phase 2 study of PIDs Linked to PI3K that is actively recruiting participants, run by Pharming Technologies B.V.. The registered enrollment target is 12 participants. The trial reports 4 study locations across 4 states.
The verdict
NCT06990529, a Phase 2 study of PIDs Linked to PI3K, is actively recruiting participants, sponsored by Pharming Technologies B.V..
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 12 participants
- Enrollment target
- 4
- Study locations
Study Summary
This is an open-label extension (OLE) study to extend treatment to patients with primary immunodeficiency (PID) disorders linked to phosphoinositide 3-kinase delta signaling who participated in a prior study of leniolisib, LE 7201. The primary objective is to assess long-term safety and tolerability of leniolisib. Secondary and exploratory objectives include various efficacy and immunophenotyping measures for leniolisib.
Conditions Studied
Interventions
- DRUG Leniolisib
Study Locations (4)
Maryland
- National Institute of Health - Bethesda
Massachusetts
- Lahey Hospital & Medical Center - Burlington
New York
- Mount Sinai Hospital - New York
Other
- IIS La Fe - Valencia
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 12 participants |
| Start Date | 2025-04-29 |
| Est. Completion | 2029-04-13 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06990529
The ClinicalTrials.gov registry entry for NCT06990529 describes a study currently listed as recruiting, categorized as Phase 2. The registered enrollment target is 12 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 PIDs Linked to PI3K appearing as the primary indexed condition, and to 1 intervention - of which Leniolisib is the first listed.
NCT06990529 reports 4 study locations spanning 4 distinct geographic areas - top geographies include Maryland, Massachusetts, New York.
Frequently Asked Questions
What is clinical trial NCT06990529 about?
NCT06990529 is a clinical study titled "Long-term Safety and Efficacy of Leniolisib in PIDs With Immune Dysregulation". This is an open-label extension (OLE) study to extend treatment to patients with primary immunodeficiency (PID) disorders linked to phosphoinositide 3-kinase delta signaling who participated in a prior study of leniolisib, LE 7201. The primary objective is to assess long-term safety and tolerability...
What is the current status of trial NCT06990529?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 12 participants. The study started on 2025-04-29. Estimated completion is 2029-04-13.
What conditions does trial NCT06990529 study?
This clinical trial studies the following conditions: PIDs Linked to PI3K.
What interventions are being tested in trial NCT06990529?
The interventions under investigation include: Leniolisib (DRUG).
Who is sponsoring clinical trial NCT06990529?
This trial is sponsored by Pharming Technologies B.V., which has 11 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06990529 being conducted?
This trial has 4 study locations across Maryland, Massachusetts, New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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