CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 5 enrolled
Drug / intervention
Nemiralisibdrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02593539
NCT02593539Phase 2Completed
CompareCT.gov

An Open-label, Single Arm Study to Investigate the Safety, Pharmacokinetics and Pharmacodynamics of Repeat Doses of Inhaled Nemiralisib in Patients With APDS/PASLI

GlaxoSmithKline·interventional·Posted Nov 2, 2015·Updated Jun 18, 2021

In Brief

A Phase 2 clinical trial evaluating Nemiralisib for Activated PI3K-delta Syndrome. Completed, enrolled 5 participants across 1 site.

Detailed Summary

This is an open-label study conducted to investigate safety, pharmacokinetics and pharmacodynamics of repeat doses of inhaled nemiralisib (NEMI) in participants with activated phosphoinositide 3-kinase (PI3K) delta syndrome /p110 delta-activating mutation causing senescent T Cells, lymphadenopathy and immunodeficiency (APDS/PASLI)

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsActivated PI3K-delta Syndrome
CountriesUnited Kingdom
Collaborators--

Timeline

Phase 2CompletedFinished
20162017201820192020202120222023202420252026
First PostedNov 2, 2015
Enrollment StartJul 22, 2016
Primary CompletionJun 4, 2020
TodayJul 2, 2026
Enrollment to primary: 3.9 yearsPosted 10.7 years ago

Interventions

Nemiralisibdrug

Participants will be administered nemiralisib