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

Phase 2

Completed

• Conditions: Asthma
• Interventions: Drug: IPI-145, a PI3K Inhibitor; Drug: Placebo to match IPI-145

• Registration Number: NCT01653756
• Lead Sponsor: SecuraBio

Brief 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.

Study Timeline

• Study Start: 2012-07
• Study First Submitted: 2012-07-19
• Study First Submitted QC: 2012-07-26
• Study First Posted: 2012-07-31
• Primary Completion: 2014-08
• Study Completion: 2014-09
• Status Verified: 2021-03
• Last Update Submitted: 2021-03-15
• Last Update Posted: 2021-03-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• Male or female adults between 18 and 60 years of age
• Diagnosis of asthma (mild) for at least 6 months prior to Screening
• Forced expiratory volume in one second (FEV1) ≥70% of predicted value at Screening
• A positive skin prick test to test allergen

Exclusion Criteria

• Any prior treatment with a phosphoinositide-3-kinase (PI3K) inhibitor other than IPI-145 in a previous clinical study
• Acute asthma exacerbations within 6 weeks prior to Screening
• Use of any medication for the treatment of asthma other than a short-acting β2 agonist (as needed) within the 4 weeks prior to Screening
• Participation in another clinical study within minimum of 30 days prior to study Screening
• A positive screen result for active or latent tuberculosis
• A history of cardiovascular disease
• The concomitant use of acid-reducing agents and cholinesterase inhibiting medication
• Inadequate hepatic function defined by Aspartate Aminotransferase (AST) and/or Alanine Aminotransferase (ALT) greater than 1.5 times greater limit of normal (ULN)
• Inadequate renal function defined by serum creatinine greater than 2.0 milligrams/dL

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
IPI-145	Placebo to match IPI-145	Capsules
IPI-145	IPI-145, a PI3K Inhibitor	Capsules
Placebo	IPI-145, a PI3K Inhibitor	Capsules
Placebo	Placebo to match IPI-145	Capsules

Primary Outcome Measures

Name	Time	Method
Forced Expiratory Volume in one second (FEV1)	Day 14

Secondary Outcome Measures

Name	Time	Method
Maximum concentration (Cmax), Area Under the Curve, and terminal elimination half-life (T1/2) pre-dose and up to 12 hours post dose	Day 14
Number of Participants with Adverse Events as a Measure of Safety	From signing of informed consent through 21 days following study drug administration
Change in C-reactive Protein (CRP) levels	Screening and/or Day 1 of each treatment period

Trial Locations

Locations (1)

Investigational Site; 🇬🇧 Harrow, United Kingdom