Activated PI3 kinase delta syndrome – European Clinical Trials Information Network https://clinicaltrials.eu Bridging Patients with Clinical Trials Sat, 13 Jun 2026 04:03:16 +0000 en-US hourly 1 https://wordpress.org/?v=7.0 https://clinicaltrials.eu/wp-content/uploads/2024/12/cropped-EU_icon-32x32.png Activated PI3 kinase delta syndrome – European Clinical Trials Information Network https://clinicaltrials.eu 32 32 Study on Leniolisib for Patients with Activated Phosphoinositide 3-Kinase Delta Syndrome and Impaired Liver Function https://clinicaltrials.eu/trial/study-on-leniolisib-for-patients-with-activated-phosphoinositide-3-kinase-delta-syndrome-and-impaired-liver-function/ Mon, 04 May 2026 07:51:00 +0000 https://clinicaltrials.eu/trial/study-on-leniolisib-for-patients-with-activated-phosphoinositide-3-kinase-delta-syndrome-and-impaired-liver-function/ This clinical trial is focused on studying a condition known as Activated Phosphoinositide 3-Kinase Delta Syndrome, which is a rare disorder affecting the immune system. The study will use a medication called CDZ173/Leniolisib, which is taken as a film-coated tablet. Leniolisib is a small molecule that works by inhibiting a specific part of the immune system, known as p110δ, to help manage the symptoms of this syndrome.

The purpose of the study is to understand how the body processes leniolisib in people with different liver functions. Participants will include those with impaired liver function and those with normal liver function. The study will involve taking a single dose of leniolisib and then monitoring how it is absorbed and processed in the body. This will help researchers learn more about the medication’s behavior in the bloodstream, which is referred to as its pharmacokinetics.

Participants will be divided into groups based on their liver function, and the study will follow a parallel-group design, meaning that all groups will be observed simultaneously. The study will not involve any placebo treatments. Throughout the study, participants will have regular check-ups and tests to monitor their health and the effects of the medication. This research aims to provide valuable information that could improve treatment options for those with Activated Phosphoinositide 3-Kinase Delta Syndrome.

]]> Study on the Effects of Leniolisib in Patients with Activated Phosphoinositide 3-Kinase Delta Syndrome https://clinicaltrials.eu/trial/study-on-the-effects-of-leniolisib-in-patients-with-activated-phosphoinositide-3-kinase-delta-syndrome/ Wed, 29 Apr 2026 15:05:51 +0000 https://clinicaltrials.eu/trial/study-on-the-effects-of-leniolisib-in-patients-with-activated-phosphoinositide-3-kinase-delta-syndrome/ This clinical trial is focused on studying a condition known as Activated Phosphoinositide 3-Kinase Delta Syndrome, a rare disorder that affects the immune system. The study will use a medication called CDZ173/Leniolisib, which is a small molecule designed to inhibit a specific part of the immune system. This medication is taken orally in the form of film-coated tablets or granules.

The purpose of the study is to compare how the body absorbs different doses of CDZ173/Leniolisib in healthy volunteers. Participants will receive single doses of the medication in various forms, including 10 mg, 30 mg, 40 mg, and 50 mg tablets, as well as 30 mg granules, and these will be compared to a 70 mg tablet. The study will also assess how well participants tolerate the medication after taking these single doses.

Throughout the study, participants will be monitored to ensure their safety and to observe any side effects that may occur. The trial aims to provide valuable information on the best way to administer CDZ173/Leniolisib for treating Activated Phosphoinositide 3-Kinase Delta Syndrome, helping to improve future treatment options for this condition.

]]> Study on the Effects of Leniolisib in Children Aged 1 to 6 with Activated PI3K Delta Syndrome (APDS) https://clinicaltrials.eu/trial/study-on-the-effects-of-leniolisib-in-children-aged-1-to-6-with-activated-pi3k-delta-syndrome-apds/ Wed, 29 Apr 2026 15:00:58 +0000 https://clinicaltrials.eu/trial/study-on-the-effects-of-leniolisib-in-children-aged-1-to-6-with-activated-pi3k-delta-syndrome-apds/ This clinical trial is focused on studying a rare condition known as Activated Phosphoinositide 3-Kinase Delta Syndrome (APDS), which affects the immune system. The study is testing a treatment called leniolisib, which is a medication designed to help manage this condition. The trial is specifically for young children aged 1 to 6 years who have been diagnosed with APDS. The purpose of the study is to evaluate the safety and effectiveness of leniolisib in these children.

Participants in the study will receive leniolisib, which comes in the form of film-coated granules that are taken orally. The study will be conducted in two parts. The first part will focus on assessing how well children tolerate the medication and its immediate effects. The second part will look at the long-term safety and tolerability of leniolisib. Throughout the study, various health checks will be performed, including monitoring vital signs, conducting physical examinations, and using imaging techniques like MRI or computed tomography (CT) to observe changes in the body.

The study aims to gather information on how leniolisib affects the body, including its impact on the immune system and any potential side effects. This will involve regular health assessments and laboratory tests to track changes in blood chemistry and other health indicators. The ultimate goal is to determine if leniolisib can provide a safe and effective treatment option for young children with APDS, potentially improving their quality of life by reducing symptoms and complications associated with the condition.

]]> Study of Leniolisib for Children Aged 4 to 11 with Activated PI3K Delta Syndrome https://clinicaltrials.eu/trial/study-of-leniolisib-for-children-aged-4-to-11-with-activated-pi3k-delta-syndrome/ Wed, 29 Apr 2026 14:58:47 +0000 https://clinicaltrials.eu/trial/study-of-leniolisib-for-children-aged-4-to-11-with-activated-pi3k-delta-syndrome/ This clinical trial is focused on studying a rare condition called Activated Phosphoinositide 3-Kinase Delta Syndrome (APDS), which affects the immune system. The study involves children aged 4 to 11 years who have this condition. The treatment being tested is a medication called Leniolisib, which is taken as a film-coated tablet. The purpose of the study is to evaluate the safety and effectiveness of Leniolisib in treating children with APDS.

The study is divided into two parts. In the first part, children will receive Leniolisib for a period of 12 weeks. During this time, researchers will monitor the children’s health to see how well they tolerate the medication and if it helps reduce symptoms of APDS. This includes checking for any side effects and changes in their health through regular medical tests. In the second part, the study will continue to observe the long-term safety of Leniolisib in these children.

Throughout the study, children will have regular check-ups, including physical exams and tests like magnetic resonance imaging (MRI) to assess changes in their condition. The study aims to provide valuable information on how Leniolisib can help manage APDS in young patients, potentially improving their quality of life by reducing symptoms and preventing complications associated with the syndrome.

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