Registered outcomes27

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

1 to 20 of 27

List	Outcome	Time frame	Description
Primary	Number of Participants with Treatment-emergent adverse events (TEAEs), Serious Adverse Events (SAEs) , and Adverse Events (AEs)	From Baseline to the end of 20 weeks of Treatment	• To assess the number of AEs/SAEs and number of participants with AEs/SAEs
Secondary	To assess the PK of leniolisib in PID disorders linked to PI3K	From Baseline to the end of 20 weeks of Treatment	• PK parameters for leniolisib defined by Cmax
Secondary	To assess the PK of leniolisib in PID disorders linked to PI3K	From Baseline to the end of 20 weeks of Treatment	• PK parameters for leniolisib defined by Tmax
Secondary	To assess the PK of leniolisib in PID disorders linked to PI3K	From Baseline to the end of 20 weeks of Treatment	• PK parameters for leniolisib defined by t1/2
Secondary	To assess the PK of leniolisib in PID disorders linked to PI3K	From Baseline to the end of 20 weeks of Treatment	• PK parameters for leniolisib defined by AUC (0-t)
Secondary	To assess the impact of leniolisib on lymphocyte PI3K/AKT/mTOR pathway activity in PID disorders linked to PI3K	From Baseline to the end of 20 weeks of Treatment	• Percent change in pAKT and/or pS6 in B cells and/or T cells, under resting and stimulated conditions, at different dose levels of leniolisib relative to baseline pAKT/pS6 levels, as feasible
Secondary	To assess the impact of leniolisib on hemoglobin counts in PID disorders linked to PI3K	From Baseline to the end of 20 weeks of Treatment	• Hemoglobin over time
Secondary	To assess the impact of leniolisib on platelet counts in PID disorders linked to PI3K	From Baseline to the end of 20 weeks of Treatment	• Platelet count over time
Secondary	To assess the impact of leniolisib on absolute neutrophil counts in PID disorders linked to PI3K	From Baseline to the end of 20 weeks of Treatment	• Absolute neutrophil count over time
Secondary	To assess the clinical efficacy of leniolisib on PID-related ILD in PID disorders linked to PI3K	From Baseline to the end of 20 weeks of Treatment	• Change in CT evidence of GLILD or other PID-related ILD evaluated using Hartmann scoring methodology
Secondary	To assess the clinical efficacy of leniolisib on PFTs in PID disorders linked to PI3K	From Baseline to the end of 20 weeks of Treatment	• Change in forced expiratory volume 1 (FEV1)
Secondary	To assess the clinical efficacy of leniolisib on PFTs in PID disorders linked to PI3K	From Baseline to the end of 20 weeks of Treatment	• Change in forced vital capacity (FVC)
Secondary	To assess the clinical efficacy of leniolisib on PFTs in PID disorders linked to PI3K	From Baseline to the end of 20 weeks of Treatment	• Change in total lung capacity (TLC)
Secondary	To assess the clinical efficacy of leniolisib on PFTs in PID disorders linked to PI3K	From Baseline to the end of 20 weeks of Treatment	• Change in diffusing capacity (DLCO)
Secondary	To assess the clinical efficacy of leniolisib on lymphoproliferation in PID disorders linked to PI3K	From Baseline to the end of 20 weeks of Treatment	* Percent change from baseline in lymphadenopathy measured as the sum of product of diameters (SPD) in the index lesions selected per the Cheson methodology * Percent change from baseline in lymphadenopathy measured as SPD of measurable non-index lesions selected as per the Cheson methodology
Secondary	To assess the clinical efficacy of leniolisib on splenomegaly in PID disorders linked to PI3K	From Baseline to the end of 20 weeks of Treatment	• Percent change from baseline in splenomegaly measured by three-dimensional (3D) volume and bi-dimensional (2D) size of spleen
Secondary	To assess the impact of leniolisib on white blood cell counts in PID disorders linked to PI3K	From Baseline to the end of 20 weeks of Treatment	• White blood cell count over time
Secondary	To assess the impact of leniolisib on white blood cell counts in PID disorders linked to PI3K	From Baseline to the end of 20 weeks of Treatment	• Absolute monocyte count over time
Secondary	To assess the impact of leniolisib on white blood cell counts in PID disorders linked to PI3K	From Baseline to the end of 20 weeks of Treatment	• Absolute lymphocyte count over time
Secondary	To assess the impact of leniolisib on white blood cell counts in PID disorders linked to PI3K	From Baseline to the end of 20 weeks of Treatment	• Absolute eosinophil count over time

Source ClinicalTrials.govtrials-2026-11-12-0.5.0

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

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Registered outcomes27

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