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

Primary Purpose

Asthma

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
IPI-145, a PI3K Inhibitor
Placebo to match IPI-145
Sponsored by
SecuraBio
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Asthma focused on measuring Asthma, Allergen Challenge

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Investigational Site
  • Investigational Site
  • Investigational Site
  • Investigational Site

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

IPI-145

Placebo

Arm Description

Capsules

Capsules

Outcomes

Primary Outcome Measures

Forced Expiratory Volume in one second (FEV1)

Secondary Outcome Measures

Maximum concentration (Cmax), Area Under the Curve, and terminal elimination half-life (T1/2) pre-dose and up to 12 hours post dose
Number of Participants with Adverse Events as a Measure of Safety
Change in C-reactive Protein (CRP) levels

Full Information

First Posted
July 19, 2012
Last Updated
March 15, 2021
Sponsor
SecuraBio
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1. Study Identification

Unique Protocol Identification Number
NCT01653756
Brief Title
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

2. Study Status

Record Verification Date
March 2021
Overall Recruitment Status
Completed
Study Start Date
July 2012 (undefined)
Primary Completion Date
August 2014 (Actual)
Study Completion Date
September 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
SecuraBio

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asthma
Keywords
Asthma, Allergen Challenge

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
IPI-145
Arm Type
Active Comparator
Arm Description
Capsules
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Capsules
Intervention Type
Drug
Intervention Name(s)
IPI-145, a PI3K Inhibitor
Intervention Description
Active drug
Intervention Type
Drug
Intervention Name(s)
Placebo to match IPI-145
Intervention Description
Comparator
Primary Outcome Measure Information:
Title
Forced Expiratory Volume in one second (FEV1)
Time Frame
Day 14
Secondary Outcome Measure Information:
Title
Maximum concentration (Cmax), Area Under the Curve, and terminal elimination half-life (T1/2) pre-dose and up to 12 hours post dose
Time Frame
Day 14
Title
Number of Participants with Adverse Events as a Measure of Safety
Time Frame
From signing of informed consent through 21 days following study drug administration
Title
Change in C-reactive Protein (CRP) levels
Time Frame
Screening and/or Day 1 of each treatment period

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hagop Youssoufian, MD
Organizational Affiliation
Verastem, Inc.
Official's Role
Study Chair
Facility Information:
Facility Name
Investigational Site
City
Berlin
Country
Germany
Facility Name
Investigational Site
City
Grosshansdorf
Country
Germany
Facility Name
Investigational Site
City
Wiesbaden
Country
Germany
Facility Name
Investigational Site
City
Harrow
Country
United Kingdom

12. IPD Sharing Statement

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

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