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

Secura Bio

Status and phase: Completed; Phase 2

Conditions: Asthma

Treatments: Drug: IPI-145, a PI3K Inhibitor; Drug: Placebo to match IPI-145

Study type: Interventional

Funder types: Industry

Identifiers

NCT01653756

2012-001729-28 (EudraCT Number)

IPI-145-03

Details and patient eligibility

About

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.

Full 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.

Enrollment: 50 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

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50 participants in 2 patient groups, including a placebo group

IPI-145

Active Comparator group

Description:

Capsules

Treatment:

Drug: Placebo to match IPI-145

Drug: IPI-145, a PI3K Inhibitor

Placebo

Placebo Comparator group

Description:

Capsules

Treatment:

Drug: Placebo to match IPI-145

Drug: IPI-145, a PI3K Inhibitor