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

NCT01653756 | Completed Phase 2

• 2 other identifiers: IPI-145-032012-001729-28
• Study Type: interventional
• Target: 50
• Locations: 2 countries
• Sites: 4

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.

Conditions

Asthma

Keywords

Asthma; Allergen Challenge

Outcome Measures

Primary Outcomes (1)

• Forced Expiratory Volume in one second (FEV1)

  Day 14

Secondary Outcomes (3)

• 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

• Number of Participants with Adverse Events as a Measure of Safety

  From signing of informed consent through 21 days following study drug administration

• Change in C-reactive Protein (CRP) levels

  Screening and/or Day 1 of each treatment period

Study Arms (2)

IPI-145

ACTIVE COMPARATOR

Capsules

Drug: IPI-145, a PI3K Inhibitor; Drug: Placebo to match IPI-145

Placebo

PLACEBO COMPARATOR

Capsules

Drug: IPI-145, a PI3K Inhibitor; Drug: Placebo to match IPI-145

Interventions

IPI-145, a PI3K Inhibitor DRUG

Active drug

IPI-145; Placebo

Placebo to match IPI-145 DRUG

Comparator

IPI-145; Placebo

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• SecuraBio: lead

Study Sites (4)

Investigational Site

Berlin, Germany

Location

Investigational Site

Großhansdorf, Germany

Location

Investigational Site

Wiesbaden, Germany

Location

Investigational Site

Harrow, United Kingdom

Location

MeSH Terms

Conditions

Asthma

Interventions

duvelisib

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• Hagop Youssoufian, MD

  Verastem, Inc.

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 19, 2012
• First Posted: July 31, 2012
• Study Start: July 1, 2012
• Primary Completion: August 1, 2014
• Study Completion: September 1, 2014
• Last Updated: March 17, 2021

Record last verified: 2021-03

Locations

DE (3); GB (1)