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Keep this study
Lead
SecuraBio
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.
Age
18–60
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible 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 be 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
Clareo Health | A Phase 2a, Efficacy and Safety Study of Duvelisib in Mild Asthmatic Subjects
