Either you have JavaScript disabled or your browser does not support Javascript . To work properly, this page requires JavaScript to be enabled.
How to enable JavaScript in your browser?

An Open-label, Single Arm Study of the Safety, Pharmacokinetics, Pharmacodynamics, and Efficacy of Leniolisib in Pediatric Patients (Aged 1 to 6 Years) with APDS (Activated Phosphoinositide 3-Kinase Delta Syndrome) Followed by an Open-label Long-term Extension

Next Previous
Search
Trial Profile

An Open-label, Single Arm Study of the Safety, Pharmacokinetics, Pharmacodynamics, and Efficacy of Leniolisib in Pediatric Patients (Aged 1 to 6 Years) with APDS (Activated Phosphoinositide 3-Kinase Delta Syndrome) Followed by an Open-label Long-term Extension

Status: Recruiting
Phase of Trial: Phase III

Latest Information Update: 01 Feb 2025

Price :
$35 *
Note:
  • Adis is an information provider.
  • Final gross price and currency may vary according to local VAT and billing address.
  • Your purchase entitles you to full access to the information contained in our trial profile at the time of purchase.
  • A link to download a PDF version of the trial profile will be included in your email receipt.

At a glance

  • Drugs Leniolisib (Primary)
  • Indications Immunodeficiency disorders
  • Focus Adverse reactions; Registrational; Therapeutic Use
  • Sponsors Pharming Group NV

    • Most Recent Events

    • 17 Dec 2024 Planned End Date changed from 28 Nov 2025 to 28 Feb 2026.
    • 01 Aug 2024 According to Pharming Group NV media release, the Company anticipate completion of this trial in 2024.
    • 21 Nov 2023 According to a Pharming Group NV media release, company looking forward to generate the necessary supporting data from this trial to facilitate additional regulatory filings, thereby ensuring that patients from as broad an age range as possible can potentially benefit from this disease-modifying treatment.

You need to be a logged in or subscribed to view this content Request demo

If your organization or you do not have a subscription, try one of the following:
  • Contacting your organization’s admin about adding this content to your AdisInsight subscription
  • Buying a PDF version of any individual profile
  • Request a free trial
If your organization has a subscription, there are several access options, even while working remotely:
  • Working within your organization’s network
  • with username/password or try to via your institution
  • Persisted access using your organization’s identifier stored in your user browser for 90 days
Back to top