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NCT06897358 · ClinicalTrials.gov registry record · Phase 2
Leniolisib for Immune Dysregulation in CVID
A Phase 2 study of Common Variable Immunodeficiency (CVID), sponsored by Pharming Technologies B.V..
- Active
- Registry status
- Phase 2
- Development phase
- 20
- Enrollment target
- 7
- Study locations
NCT06897358: Active Phase 2 study of Common Variable Immunodeficiency (CVID), sponsored by Pharming Technologies B.V..
NCT06897358 is a Phase 2 study of Common Variable Immunodeficiency (CVID) that is active but no longer recruiting, run by Pharming Technologies B.V.. The registered enrollment target is 20 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (85% lower). The trial reports 7 study locations across 6 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06897358, a Phase 2 study of Common Variable Immunodeficiency (CVID), is active but no longer recruiting, sponsored by Pharming Technologies B.V..
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 20 participants
- Enrollment target
- 7
- Study locations
Study Summary
In this study, common variable immunodeficiency (CVID) patients will all receive the study drug, leniolisib, for a treatment period of 6 months. Participants will start on a lower dose of leniolisib, followed by a mid and then a higher dose level. The primary goal is to assess the safety and tolerability of leniolisib, and secondary goal is to assess the potential for leniolisib to provide benefits for patients.
Primary Outcome
To assess the number of AEs/SAEs and number of participants with AEs/SAEs
Conditions Studied
Interventions
- DRUG Leniolisib
Study Locations (7)
Other
- IIS La Fe - Valencia
- Leeds Teaching Hospital NHS Trust - Leeds
Colorado
- Children's Hospital Colorado - Aurora
Maryland
- National Institute of Health - Bethesda
Massachusetts
- Lahey Hospital & Medical Center - Burlington
New York
- Mount Sinai Hospital - New York
Texas
- Texas Children's Hospital - Houston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2025-02-12 |
| Est. Completion | 2026-10 |
| Phase | Phase 2 |
What the registry record for NCT06897358 still lists
NCT06897358 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 20 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (85% lower).
The record links to 1 condition, with Common Variable Immunodeficiency (CVID) appearing as the primary indexed condition, and to 1 intervention - of which Leniolisib is the first listed.
NCT06897358 lists 7 locations in 6 states (Other, Colorado, Maryland).
Frequently Asked Questions
What is clinical trial NCT06897358 about?
NCT06897358 is a clinical study titled "Leniolisib for Immune Dysregulation in CVID". In this study, common variable immunodeficiency (CVID) patients will all receive the study drug, leniolisib, for a treatment period of 6 months. Participants will start on a lower dose of leniolisib, followed by a mid and then a higher dose level. The primary goal is to assess the safety and tolerab...
What is the current status of trial NCT06897358?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 20 participants. The study started on 2025-02-12. Estimated completion is 2026-10.
What conditions does trial NCT06897358 study?
This clinical trial studies the following conditions: Common Variable Immunodeficiency (CVID).
What interventions are being tested in trial NCT06897358?
The interventions under investigation include: Leniolisib (DRUG).
Who is sponsoring clinical trial NCT06897358?
This trial is sponsored by Pharming Technologies B.V., which has 11 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06897358 being conducted?
This trial has 7 study locations across Colorado, Maryland, Massachusetts, New York, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Common Variable Immunodeficiency (CVID)
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.
Where NCT06897358's enrollment target sits among peer trials
20 1805th of 2000 higher than 107 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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