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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01653756
First Posted: July 31, 2012
Last Update Posted: August 1, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Verastem, Inc.
  Purpose
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: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (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
Active Comparator: IPI-145
Capsules
Drug: IPI-145, a PI3K Inhibitor
Active drug
Drug: Placebo to match IPI-145
Comparator
Placebo Comparator: Placebo
Capsules
Drug: IPI-145, a PI3K Inhibitor
Active drug
Drug: Placebo to match IPI-145
Comparator

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.
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01653756


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

Responsible Party: Verastem, Inc.
ClinicalTrials.gov Identifier: NCT01653756     History of Changes
Other Study ID Numbers: IPI-145-03
2012-001729-28 ( EudraCT Number )
First Submitted: July 19, 2012
First Posted: July 31, 2012
Last Update Posted: August 1, 2017
Last Verified: July 2017

Keywords provided by Verastem, Inc.:
Asthma
Allergen Challenge