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

NCT06990529 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2026-02-13

No results posted yet for this 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

  • PIDs Linked to PI3K

Interventions

DRUG

Leniolisib

All subjects will receive leniolisib film-coated tablets (FCTs) at the same dose they were receiving when they completed the preceding study (10, 30, or 70 mg twice daily \[BID\]).

Sponsors & Collaborators

  • Aixial Group

    collaborator INDUSTRY

  • Pharming Technologies B.V.

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
12 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-04-29
Primary Completion
2028-09-18
Completion
2029-04-13
FDA Drug
Yes

Countries

  • United States
  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06990529 on ClinicalTrials.gov