Efficacy and Safety Study in Mild Asthmatic Subjects Undergoing Allergen Challenge

• Conditions: Mild asthma with allergen challenge; MedDRA version: 16.1Level: LLTClassification code 10003561Term: Asthma, unspecifiedSystem Organ Class: 100000004855; Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]

• Registration Number: EUCTR2012-001729-28-DE
• Lead Sponsor: Infinity Pharmaceuticals, Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-05-18
• Last Update Posted: 19 October 2015

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 54

Inclusion Criteria

1. Male or female adults between 18 and 60 years of age
2. Body Mass Index (BMI) between 18 and 29.9 kg/m² at Screening
3. Written informed consent obtained from the subject prior to any study Screening procedures
4. Previously documented diagnosis of asthma for at least 6 months prior to Screening or a history of at least 6 months of episodic symptoms of airflow obstruction such as wheezing and/or chest tightness with other significant lung diseases ruled out (e.g., chronic obstructive pulmonary disease [COPD])
5. Forced expiratory volume in one second (FEV1) =70% of predicted value at Screening (based on American Thoracic Society [ATS]/ European Respiratory Society [ERS] standards
6. A positive skin prick test to test allergen [defined as the indurations of skin test wheal =2 mm larger in diameter than diameter of control wheal
7. Early-phase asthmatic response (EAR) of at least 20% and a late-phase asthmatic response (LAR) of at least 15% to inhaled allergen challenge [response defined as a decrease from pre-challenge in FEV1 on 2 consecutive occasions within 0 to <3 hours of last allergen challenge administered for EAR and within 3 to 10 hours for LAR]
8. a. Sexually active women, unless surgically sterile (confirmed by documentation) or at least 2 year post-menopausal (confirmed by FSH blood level at Screening), must have a negative serum pregnancy test result at Screening and agree to use two effective methods of contraception from the signing of informed consent through 21 days after the last dose of study drug
b. Sexually active men, unless surgically sterile, must agree to use an effective method of birth control from the signing of informed consent through 21 days after the last dose of study drug
9. Subject has the willingness and ability to complete all the study requirements, instructions, or study related restrictions through the final Safety Follow-up Phone Screen 21 days after last dose of study drug

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 54
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1. Any prior treatment with a phosphoinositide-3-kinase (PI3K) inhibitor other than IPI-145 in a previous clinical study
2. History of allergy or reaction to any component of the study drug formulation, such as excipients in the study drug capsule
3. Acute asthma exacerbations leading to hospitalization, emergency room visit, or unscheduled health care provider visit, within 6 weeks prior to Screening or any previous history of intubation or admission to an intensive care unit for asthma
4. Use of any medication for the treatment of asthma other than a short-acting ß2 agonist (as needed) within the 4 weeks prior to Screening and no significant changes in short-acting ß2 agonist use over the 6 weeks prior to Screening
5. Use if anti-IgE therapy (omalizumab) within 12 weeks prior to Screening
6. Currently receiving a cholinesterase inhibitor medication (including, but not limited to, donepezil, galantamine, rivastigmine, physostigmine, pyridostigmine, neostigmine, or edrophonium)
7. Currently receiving or expected to receive an acid-reducing agent including, but not limited to, proton pump inhibitors, H2-receptor blockers, and/or chronic antacid therapy
8. Upper or lower respiratory tract infections or acute illnesses or evidence of on-going clinically significant infection within the 4 weeks prior to Screening
9. Heart attack or stroke within the past 3 months, uncontrolled hypertension (systolic BP >200 or diastolic BP >100 mmHg), known aortic aneurysm, or any other cardiac condition in which induced bronchospasm may precipitate excessive cardiovascular stress, as judged by the Investigator
10. If undergoing concomitant allergy vaccination therapy (desensitization immunotherapy), <3 months of stable maintenance doses prior to the Baseline allergen challenge; any allergy concomitant vaccination therapy leading to desensitization to any of the allergens used in the allergen challenge
11. Participation in another clinical study within 30 days prior to study Screening or until completion of the final Safety Follow-up Visit
12. Blood donation (=500 mL) within 3 months before Screening
13. Any history of treatment with a leukocyte-depleting agent (eg, rituximab, alemtuzumab)
14. Positive laboratory test result for hepatitis B or C or HIV-1 or HIV-2 at Screening
15. A positive screen result for active or latent tuberculosis (verified by either PPD skin test or QuantiFERON-TB blood test at Screening)
16. History of significant systemic disease (e.g., cancer, coronary artery disease, seizure disorder) as judged by the Investigator
17. Currently pregnant or lactating
18. Smoking within 6 months prior to Screening or a smoking history of =10 pack-years
19. A positive screen for drug and/or alcohol abuse at Screening or reported use of illegal drugs or history of abuse of prescription drugs or alcohol within 1 year before Screening
20. Planned elective surgery from the time of Screening through the final Safety Follow-up Visit
21. Clinically significant abnormalities on safety laboratory tests, 12-lead ECG, vital signs, or physical examination or medical history at Screening, based on the medical judgment of the Investigator; specific safety laboratory values for exclusion include:
• Serum creatinine =2.0 mg/dL (177 µmol/L)
• ALT, AST, or total bilirubin >1.5 x ULN (if the subject has Gilbert’s disease, a total bilirubin value above 1.5 x ULN is acceptable if allowed by the Sponsor’s medical monitor)
• Hemoglobin <9 g/d

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified