Long-term Safety and Efficacy of Leniolisib in PIDs With Immune Dysregulation

PHASE2RecruitingINTERVENTIONAL
Enrollment

12

Participants

Timeline

Start Date

April 29, 2025

Primary Completion Date

September 18, 2028

Study Completion Date

April 13, 2029

Conditions
PIDs Linked to PI3K
Interventions
DRUG

Leniolisib

All subjects will receive leniolisib film-coated tablets (FCTs) at the same dose they were receiving when they completed the preceding study (10, 30, or 70 mg twice daily \[BID\]).

Trial Locations (1)

20892

RECRUITING

National Institute of Health, Bethesda

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Aixial Group

INDUSTRY

lead

Pharming Technologies B.V.

INDUSTRY