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| ID | Type | Description | Link |
|---|---|---|---|
| 2012-001729-28 | EudraCT Number |
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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.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| IPI-145 | Active Comparator | Capsules |
|
| Placebo | Placebo Comparator | Capsules |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| IPI-145, a PI3K Inhibitor | Drug | Active drug |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Forced Expiratory Volume in one second (FEV1) | Day 14 |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum concentration (Cmax), Area Under the Curve, and terminal elimination half-life (T1/2) pre-dose and up to 12 hours post dose | Day 14 | |
| Number of Participants with Adverse Events as a Measure of Safety | From signing of informed consent through 21 days following study drug administration |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Hagop Youssoufian, MD | Verastem, Inc. | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Investigational Site | Berlin | Germany | ||||
| Investigational Site |
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| ID | Term |
|---|---|
| D001249 | Asthma |
| ID | Term |
|---|---|
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
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| ID | Term |
|---|---|
| C586691 | duvelisib |
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| Placebo to match IPI-145 |
| Drug |
Comparator |
|
| Change in C-reactive Protein (CRP) levels | Screening and/or Day 1 of each treatment period |
| Großhansdorf |
| Germany |
| Investigational Site | Wiesbaden | Germany |
| Investigational Site | Harrow | United Kingdom |
| D012130 |
| Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |