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

March 15, 2021 updated by: SecuraBio

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

50

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Berlin, Germany
        • Investigational Site
      • Grosshansdorf, Germany
        • Investigational Site
      • Wiesbaden, Germany
        • Investigational Site
  • United Kingdom
      • Harrow, United Kingdom
        • Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Triple

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Forced Expiratory Volume in one second (FEV1)
Time Frame: Day 14
Day 14

Secondary Outcome Measures

Outcome Measure
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
Time Frame: Day 14
Day 14
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
From signing of informed consent through 21 days following study drug administration
Change in C-reactive Protein (CRP) levels
Time Frame: Screening and/or Day 1 of each treatment period
Screening and/or Day 1 of each treatment period

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

SecuraBio

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2012

Primary Completion (Actual)

August 1, 2014

Study Completion (Actual)

September 1, 2014

Study Registration Dates

First Submitted

July 19, 2012

First Submitted That Met QC Criteria

July 26, 2012

First Posted (Estimate)

July 31, 2012

Study Record Updates

Last Update Posted (Actual)

March 17, 2021

Last Update Submitted That Met QC Criteria

March 15, 2021

Last Verified

March 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IPI-145-03
  • 2012-001729-28 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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