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

Asthma Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01653756
• Other study ID #: IPI-145-03
• Secondary ID: 2012-001729-28
• Status: Completed
• Phase: Phase 2
• Start date: July 2012
• Est. completion date: September 2014

Study information

• Verified date: March 2021
• Source: SecuraBio
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: September 2014
• Est. primary completion date: August 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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 ß2 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

Related Conditions & MeSH terms

• Asthma

Intervention

Drug:
• IPI-145, a PI3K Inhibitor
Active drug
• Placebo to match IPI-145
Comparator

Locations

Country	Name	City	State
Germany	Investigational Site	Berlin
Germany	Investigational Site	Grosshansdorf
Germany	Investigational Site	Wiesbaden
United Kingdom	Investigational Site	Harrow

Sponsors (1)

Lead Sponsor	Collaborator
SecuraBio

Countries where clinical trial is conducted

Germany,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Forced Expiratory Volume in one second (FEV1)		Day 14
Secondary	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
Secondary	Number of Participants with Adverse Events as a Measure of Safety		From signing of informed consent through 21 days following study drug administration
Secondary	Change in C-reactive Protein (CRP) levels		Screening and/or Day 1 of each treatment period