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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-07-31

Study Completion Date

2014-09-30

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.

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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.

Conditions

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Asthma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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IPI-145

Capsules

Group Type ACTIVE_COMPARATOR

IPI-145, a PI3K Inhibitor

Intervention Type DRUG

Active drug

Placebo to match IPI-145

Intervention Type DRUG

Comparator

Placebo

Capsules

Group Type PLACEBO_COMPARATOR

IPI-145, a PI3K Inhibitor

Intervention Type DRUG

Active drug

Placebo to match IPI-145

Intervention Type DRUG

Comparator

Interventions

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IPI-145, a PI3K Inhibitor

Active drug

Intervention Type DRUG

Placebo to match IPI-145

Comparator

Intervention Type DRUG

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No