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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: Recruiting Phase 2 study of PIDs Linked to PI3K, sponsored by Pharming Technologies B.V..
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, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (91% lower). The trial reports 4 study locations across 4 states. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Adverse events (AEs)
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 |
What NCT06990529 shows while recruiting
NCT06990529 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 12 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (91% lower).
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 a single indexed study location in 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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT06990529's enrollment target sits among peer trials
12 1948th of 2000 higher than 34 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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