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RECRUITING Phase 2

Long-term Safety and Efficacy of Leniolisib in PIDs With Immune Dysregulation

NCT06990529 · View on ClinicalTrials.gov ↗

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

FieldValue
Enrollment Target 12 participants
Start Date 2025-04-29
Est. Completion 2029-04-13
Phase Phase 2

Sponsor

Pharming Technologies B.V.

5 total trials

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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. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. 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 5 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT06990529 reports 4 study locations spanning 4 distinct geographic areas — top geographies include Maryland, Massachusetts, New York. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT06990529?

The interventions under investigation include: Leniolisib (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT06990529?

This trial is sponsored by Pharming Technologies B.V., which has 5 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial