Clinical trial NCT01653756: A Phase 2a, Efficacy and Safety Study of Duvelisib in Mild Asthmatic Subjects
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Asthma
Keywords: Asthma
Allergen Challenge
Lead sponsor: SecuraBio
Sponsor class: INDUSTRY
First posted: 2012-07-31
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Forced Expiratory Volume in one second (FEV1)
timeFrame: Day 14
Secondary outcomes:
measure: Maximum concentration (Cmax), Area Under the Curve, and terminal elimination half-life (T1/2) pre-dose and up to 12 hours post dose
timeFrame: Day 14
measure: Number of Participants with Adverse Events as a Measure of Safety
timeFrame: From signing of informed consent through 21 days following study drug administration
measure: Change in C-reactive Protein (CRP) levels
timeFrame: Screening and/or Day 1 of each treatment period
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Investigational Site
city: Grosshansdorf
country: Germany
facility: Investigational Site
city: Wiesbaden
country: Germany
facility: Investigational Site
city: Harrow
country: United Kingdom
facility: Investigational Site
Study officials:
affiliation: Verastem, Inc.
name: Hagop Youssoufian, MD
role: STUDY_CHAIR
References: