Pediatric Patients Aged 4 to 11 Years With APDS

PHASE3Active, not recruitingINTERVENTIONAL
Enrollment

15

Participants

Timeline

Start Date

February 1, 2023

Primary Completion Date

July 28, 2025

Study Completion Date

December 30, 2025

Conditions
APDS
Interventions
DRUG

Leniolisib

The doses selected range from 20 to 70 mg BID (resulting in total daily doses ranging from 40 to 140 mg per day) based on weight. The doses will be administered as (a combination of) 10 mg and 30 mg tablets

Trial Locations (7)

20814

National Institutes of Health, Bethesda

30322

Children's Healthcare of Atlanta, Atlanta

75015

Necker Hospital Paris, Paris

90095

University of California Los Angeles, Los Angeles

94305-5366

Stanford University, Standford

606-8507

Kyoto University Hospital, Kyoto

113-8519

Institute of Science Tokyo Hospital, Tokyo

Sponsors
All Listed Sponsors
collaborator

CMIC Co, Ltd. Japan

INDUSTRY

collaborator

Labcorp Central Laboratory

UNKNOWN

collaborator

Fortrea

INDUSTRY

collaborator

Aixial Group

INDUSTRY

lead

Pharming Technologies B.V.

INDUSTRY

NCT05438407 - Pediatric Patients Aged 4 to 11 Years With APDS | Biotech Hunter | Biotech Hunter