Clinical Trials Now Underway
A global phase 3 trial for Leniolisib for people with APDS is currently underway.
Open-label designed study
Estimated Enrollment: 42 Participants
This study is designed to provide long-term CDZ173 treatment, a selective PI3Kδ inhibitor, to the patients with genetically activated PI3Kδ, i.e., patients with APDS/PASLI who participated in the CCDZ173X2201 study or who were treated previously with PI3Kδ inhibitors other than CDZ173. The study is open-label designed to establish the long-term safety, tolerability, efficacy and pharmacokinetics of CDZ173 in the target population.
Time Frame: 3 years 3 months
All safety parameters (including AEs, physical exam, vital signs, ECG, safety laboratory (hematology, blood chemistry, urinalysis)).
Phase 3: Program Resources
View Phase 3 Trial information
If you are a physician and would like more information, or are interested in participating in clinical trials, click below.
Learn more at http://www.clinicaltrials.gov
To learn more contact Medical Information via the email below.
The safety and efficacy of Leniolisib has not been established. There is no guarantee that it will receive health authority approval or become commercially available in any country for the use being investigated.