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

• Status: Completed
• Trial end date: 2014-09-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Infinity Pharmaceuticals, Inc.; SecuraBio

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