This study is for people aged 12 to 75 who have primary immunodeficiency (PID) disorders linked to PI3K (phosphoinositide 3-kinase delta signaling) and have already participated in a previous leniolisib study (LE 7201). It aims to understand the long-term safety and how well leniolisib (a drug that targets PI3K and MTOR pathways) works. All participants will continue to receive leniolisib film-coated tablets at the same dose they were taking before. The main goal is to see how safe leniolisib is over about three years. This study is currently unclear on its recruitment status, but it plans to enroll 12 participants.

Study design

This is an open-label extension study, meaning both you and your doctor will know you are receiving leniolisib. It is designed for approximately 12 participants who have already been in a leniolisib study.

What's involved

You would continue receiving leniolisib at your current dose for approximately three years. You must be able to communicate with the investigator and understand the study requirements.

Compensation

Not stated in the trial record.

Follow-up

The primary endpoint assesses safety and tolerability from baseline to approximately 3 years of treatment.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.