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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Asthma

Intervention / Treatment
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* Drug: IPI-145, a PI3K Inhibitor
* Drug: Placebo to match IPI-145


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: IPI-145<br>Capsules | Drug: IPI-145, a PI3K Inhibitor<br>* Active drug<br>Drug: Placebo to match IPI-145<br>* Comparator<br>|
| Placebo Comparator: Placebo<br>Capsules | Drug: IPI-145, a PI3K Inhibitor<br>* Active drug<br>Drug: Placebo to match IPI-145<br>* Comparator<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Forced Expiratory Volume in one second (FEV1) |  | Day 14 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Allergen Challenge, Asthma