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

This study has been completed.
Information provided by (Responsible Party):
Verastem, Inc. Identifier:
First received: July 19, 2012
Last updated: February 21, 2017
Last verified: April 2015
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.

Condition Intervention Phase
Asthma Drug: IPI-145, a PI3K Inhibitor Drug: Placebo to match IPI-145 Phase 2

Study Type: Interventional
Study Design: Intervention Model: Crossover Assignment
Masking: Participant, Care Provider, Investigator
Primary Purpose: Treatment
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

Further study details as provided by Verastem, Inc.:

Primary Outcome Measures:
  • Forced Expiratory Volume in one second (FEV1) [ Time Frame: Day 14 ]

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 [ Time Frame: 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 ]
  • Change in C-reactive Protein (CRP) levels [ Time Frame: Screening and/or Day 1 of each treatment period ]

Enrollment: 50
Study Start Date: July 2012
Study Completion Date: September 2014
Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: IPI-145/Placebo
Drug: IPI-145, a PI3K Inhibitor
Active drug
Drug: Placebo to match IPI-145

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.

Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
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Please refer to this study by its identifier: NCT01653756

Investigational Site
Berlin, Germany
Investigational Site
Grosshansdorf, Germany
Investigational Site
Wiesbaden, Germany
United Kingdom
Investigational Site
Harrow, United Kingdom
Sponsors and Collaborators
Verastem, Inc.
Study Chair: Hagop Youssoufian, MD Verastem, Inc.
  More Information

Responsible Party: Verastem, Inc. Identifier: NCT01653756     History of Changes
Other Study ID Numbers: IPI-145-03
2012-001729-28 ( EudraCT Number )
Study First Received: July 19, 2012
Last Updated: February 21, 2017

Keywords provided by Verastem, Inc.:
Allergen Challenge processed this record on June 27, 2017