Phase 3 Clinical Trial Now Enrolling
A global (phase 3) trial for leniolisib for people with APDS is actively recruiting patients.
Open-label designed study
Estimated Enrolment: 42 Participants
The primary objective of the clinical trial is to evaluate the long term safety an tolerability of CDZ173 in patients with APDS/PASLI
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 a Phase 3 Trial information Sheet
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
Contact Pharming Medical Information to learn about the Pharming sponsored Study.
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.
2. Singh A, Joshi V, Jindal AK, Mathew B, Rawat A. An updated review on activated PI3 kinase delta syndrome (APDS). Genes Dis. 2019;7(1):67-74. Published 2019 Oct 14. oi:10.1016/j.gendis.2019.09.015
3. Coulter TI, Chandra A, Bacon CM, et al. Clinical spectrum and features of activated phosphoinositide 3-kinase δ syndrome: A large patient cohort study. J Allergy Clin Immunol. 2017;139(2):597-606.e4.