Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-25 @ 12:07 AM
Ignite Modification Date:
2025-12-25 @ 12:07 AM
NCT ID:
NCT06897358
Brief 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.
Detailed Description:
The study includes administration of increasing dose levels of leniolisib in approximately 20 CVID patients presenting with clinical manifestations of immune dysregulation at study entry. Enrollment will include both patients without and those with genetic drivers identified for their CVID.
All subjects participating will receive leniolisib film-coated tablets (FCTs) with a planned dose regimen consisting of a starting dose of 10 mg twice daily (BID) for 4 weeks, followed by a dose escalation to 30 mg BID for 4 weeks, and then 70 mg BID for an additional 16 weeks. Dose adjustments are allowed during treatment if deemed clinically necessary.
Subjects not continuing leniolisib treatment outside the current protocol will be followed up, with the EoS visit planned to occur approximately 28 days after last dose of leniolisib.
Study:
NCT06897358
Study Brief:
Protocol Section:
NCT06897358