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NCT06549114 · ClinicalTrials.gov registry record · Phase 2
Leniolisib for Immune Dysregulation in PIDs
A Phase 2 study of Primary Immunodeficiency Disorders (PIDs), sponsored by Pharming Technologies B.V..
- Active
- Registry status
- Phase 2
- Development phase
- 12
- Enrollment target
- 1
- Study location
NCT06549114: Active Phase 2 study of Primary Immunodeficiency Disorders (PIDs), sponsored by Pharming Technologies B.V..
NCT06549114 is a Phase 2 study of Primary Immunodeficiency Disorders (PIDs) that is active but no longer recruiting, 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 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06549114, a Phase 2 study of Primary Immunodeficiency Disorders (PIDs), is active but no longer recruiting, sponsored by Pharming Technologies B.V..
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 12 participants
- Enrollment target
- 1
- Study location
Study Summary
This study is an exploratory, non-randomized, open-label, within-patient dose escalation study. The primary objective is to assess safety and tolerability of leniolisib. Secondary objectives include assessments of PK/PD, and to explore clinical efficacy measures with administration of three different dose levels of leniolisib.
Primary Outcome
• To assess the number of AEs/SAEs and number of participants with AEs/SAEs
Conditions Studied
Interventions
- DRUG Leniolisib
Study Locations (1)
Maryland
- National Institute of Health - Bethesda
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 12 participants |
| Start Date | 2024-10-21 |
| Est. Completion | 2026-11 |
| Phase | Phase 2 |
What the registry record for NCT06549114 still lists
NCT06549114 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 Primary Immunodeficiency Disorders (PIDs) appearing as the primary indexed condition, and to 1 intervention - of which Leniolisib is the first listed.
NCT06549114 reports a single indexed study location in Maryland.
Frequently Asked Questions
What is clinical trial NCT06549114 about?
NCT06549114 is a clinical study titled "Leniolisib for Immune Dysregulation in PIDs". This study is an exploratory, non-randomized, open-label, within-patient dose escalation study. The primary objective is to assess safety and tolerability of leniolisib. Secondary objectives include assessments of PK/PD, and to explore clinical efficacy measures with administration of three differen...
What is the current status of trial NCT06549114?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 12 participants. The study started on 2024-10-21. Estimated completion is 2026-11.
What conditions does trial NCT06549114 study?
This clinical trial studies the following conditions: Primary Immunodeficiency Disorders (PIDs).
What interventions are being tested in trial NCT06549114?
The interventions under investigation include: Leniolisib (DRUG).
Who is sponsoring clinical trial NCT06549114?
This trial is sponsored by Pharming Technologies B.V., which has 11 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06549114 being conducted?
This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT06549114'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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