NCT01653756

A Phase 2a, Efficacy and Safety Study of Duvelisib in Mild Asthmatic Subjects

A Phase 2a, Randomized, Double-Blind, Placebo-Controlled, Multi-Dose, Cross-Over, Efficacy and Safety Study of Duvelisib in Mild Asthmatic Subjects Undergoing Allergen Challenge

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 50 (actual)
• Sponsor: SecuraBio · Industry
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to examine the effects of multi-dose regimens of IPI-145 on lung function in mild asthmatic subjects following allergen challenge.

Detailed description

This is a phase 2a, randomized, double-blind, placebo-controlled, multi-dose, 2-way cross-over study designed to examine the effect of IPI-145 on lung function and inflammatory indices in mild, allergen-reactive asthmatic subjects undergoing allergen challenge.

Conditions

• Asthma

Interventions

Type	Name	Description
DRUG	IPI-145, a PI3K Inhibitor	Active drug
DRUG	Placebo to match IPI-145	Comparator

Timeline

• Start date: 2012-07-01
• Primary completion: 2014-08-01
• Completion: 2014-09-01
• First posted: 2012-07-31
• Last updated: 2021-03-17

Locations

4 sites across 2 countries: Germany, United Kingdom