Mild asthma with allergen challenge MedDRA version: 20.0 Level: LLT Classification code 10003561 Term: Asthma, unspecified System Organ Class: 100000004855
Conditions
Interventions
Product Name: IPI-145
Product Code: IPI-145
Pharmaceutical Form: Powder for oral solution
INN or Proposed INN: Not available yet
CAS Num
Sponsors
Infinity Pharmaceuticals, Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Male or female adults between 18 and 60 years of age 2. Body Mass Index (BMI) between 18 and 32 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 as at least 15% to inhaled allergen challenge [response defined as a decrease from pre-challenge in FEV1 on 2 consecutive occasions within 0 to =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Any prior treatment with a phosphoinositide-3-kinase (PI3K) inhibitor 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 or oral solution (See Section 7.1) 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. Upper or lower respiratory tract infections or acute illnesses or evidence of on-going clinically significant infection within the 4 weeks prior to Screening 7. 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 8. Participation in another clinical study within 90 days prior to study Screening or until completion of the final Safety Follow-up Visit 9. Blood donation (=500 mL) within 3 months before Screening 10. Any history of treatment with a leukocyte-depleting agent (eg, rituximab, alemtuzumab) 11. Positive laboratory test result for hepatitis B or C or HIV-1 or HIV-2 at Screening 12. A positive screen result for active or latent tuberculosis (verified by either PPD skin test or Quantiferon blood test at Screening) 13. History of significant systemic disease (e.g., cancer, coronary artery disease, seizure disorder) as judged by the Investigator 14. Currently pregnant or lactating 15. Smoking within 6 months prior to Screening or a smoking history of =10 pack-years 16. 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 17. Planned elective surgery from the time of Screening through the final Safety Follow-up Visit 18. Clinically significant abnormalities on safety laboratory tests, 12-lead ECG, vital signs, or physical examination at Screening, based on the medical judgment of the Investigator 19. Vulnerable subjects (i.e., those subjects imprisoned or lawfully kept in an institution) 20. Subject is an employee or direct relative of an employee of the contract research organization (CRO) or Infinity Pharmaceuticals Inc.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Examine the effects of multi-dose regimens of different dose strengths of IPI-145 on lung function in asthmatic subjects following allergen challenge; Secondary Objective: • Examine the effects of multi-dose regimens of different dose strengths of IPI-145 on airway hyperresponsiveness (AHR) in mild asthmatic subjects following allergen challenge • Investigate the safety profile of IPI 145 in mild asthmatic subjects • Characterize the pharmacokinetic (PK) profile of IPI-145 in mild asthmatic subjects • Exploratory objective: Examine the effects of multi-dose regimens of different dose strengths of IPI-145 on indices of inflammation in mild asthmatic subjects following allergen challenge using induced sputum ; Primary end point(s): Maximal decrease from pre-allergen challenge in forced expiratory volume in one second (FEV1) following allergen challenge (including early asthmatic response [EAR] and late asthmatic response [LAR]) ; Timepoint(s) of evaluation of this end point: Lung function, inflammatory indices, and other efficacy endpoints will be assessed before and after each allergen challenge of each treatment period | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • Area under the curve (AUC) of FEV1 following allergen challenge • White blood cell (WBC) count and differential cell count in induced sputum specimen obtained after allergen challenge • Levels of cytokines and inflammatory mediators in induced sputum specimen obtained after allergen challenge • Provocative concentration of methacholine inducing a 20% fall in FEV1 (PC20) following allergen challenge • Concentration of inhaled nitric oxide (NO) after allergen challenge • Change in C-reactive Protein (CRP) levels over the course of the study • Adverse events (AEs) and safety laboratory findings. • PK Parameters including maximum concentration (Cmax), AUC, terminal elimination half-life (T1/2), time to maximum concentration (Tmax) • Exploratory endpoint: PEFR following allergen challenge " ; Timepoint(s) of evaluation of this end point: On the morning of Day 14 of both TP 1 (TP 1 Day 14) and TP 2 (TP 2 Day 14) subjects will be admitted to the clinic prior to taking their morning dose. At this visit, subjects will undergo an allergen challenge; spirometry and other efficacy endpoints will be assessed, and serial blood samples will be collected for PK. Subjects will be confined overnight for safety observation. On Day 15 additional efficacy endpoints will be evaluated in both treatment periods | — |
Countries
Germany, United Kingdom
Contacts
Public ContactIPI-145-03 Trial Information
Infinity Pharmaceuticals, Inc.
Outcome results
None listed