A Phase 2a, Efficacy and Safety Study of Duvelisib in Mild Asthmatic Subjects
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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 or disease
Drug: IPI-145, a PI3K InhibitorDrug: Placebo to match IPI-145
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.
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Ages Eligible for Study:
18 Years to 60 Years (Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
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
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