A PHASE IIA, MULTICENTER, RANDOMIZED, PLACEBO-CONTROLLED, DOUBLE-BLIND STUDY TO EVALUATE THE EFFICACY, SAFETY, AND PHARMACOKINETICS OF MTP9579AIN PATIENTS WITH ASTHMA REQUIRING INHALED CORTICOSTEROIDS AND A SECOND CONTROLLER.
- Conditions
- -J45J45
- Registration Number
- PER-034-19
- Lead Sponsor
- GENENTECH, INC.,
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 6
-Signed Informed Consent Form
- Ability to comply with the study protocol, in the investigator´s judgment.
- Age 18 - 75 years, inclusive, at the time of signing the Informed Consent Form.
- Body mass index of 18-38 kg/m2 and weight ≥ 40 kg at screening.
- Documented physician-diagnosed asthma for at least 12 months prior to screening.
- Pre-bronchodilator FEV1 40%-80% predicted at screening
- Post-bronchodilator reversibility of FEV1 (liters) 12% and 200 mL at screening
- Treatment with asthma controller therapy (daily ICS [≥ 100 µg of fluticasone propionate or equivalent] and at least one additional controller therapy [LABA, LAMA, LTM/LTRA]) for ≥ 3 months prior to screening, with no changes within 4 weeks prior to screening or during the screening period and no anticipated changes in controller dosing regimens throughout the Study.
- ACQ-5 score ≥ 1.5 at screening.
- Documented history (e.g., medical report, pharmacy prescription assessed by investigator) of ≥ 1 asthma exacerbation within the 12 months prior to screening while on daily ICS maintenance therapy (same or higher dose as at screening).
- Demonstration of acceptable inhaler, peak flow meter, and spirometry techniques at screening.
- Demonstrated compliance with required use of the eDiary, as defined in the protocol.
- - For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraception, as defined in the protocol.
- For men: agreement to remain abstinent (refrain from heterosexual intercourse) or use a condom, and agreement to refrain from donating sperm, as defined in the protocol.
- History or evidence of vocal cord dysfunction, reactive airways dysfunction syndrome, hyperventilation associated with panic attacks, or other mimics of asthma.
- History or evidence of significant respiratory disease other than asthma, including occupational asthma, aspirin-sensitive asthma, asthma-chronic obstructive pulmonary disease (COPD) overlap syndrome, bronchiolitis, interstitial lung disease, or COPD.
- Current smoker, former smoker with smoking history of ˃ 10 pack-years, or unwilling to abstain from smoking from the time of consent through the completion of the study
- History or evidence of substance abuse that, in the investigator’s judgment, would affect the patient’s ability to participate in the study, pose a risk to patient safety, interfere with the conduct of the study, or have an impact on the study results.
- History or evidence of any clinically significant medical condition/disease (e.g., psychiatric, neurologic, cardiovascular, renal, hepatic, gastrointestinal, endocrine, autoimmune) or abnormalities in laboratory tests that, in the investigator´s judgment, precludes the patient’s safe participation and completion of the study, or interferes with the conduct and interpretation of the study.
- Hemoglobin A1c (HbA1c) ˃ 8.5% at screening or any other clinically significant finding that, in the opinion of the investigator, may define uncontrolled diabetes.
- Myocardial infarction, unstable angina pectoris, or stroke within 12 months prior to screening.
Any chronic heart failure exacerbation within 12 months prior to screening or at risk for heart failure exacerbation in the investigator’s opinion.
- History or presence of an abnormal ECG that is clinically significant in the investigator´s opinion, including complete left bundle branch block, second- or third degree atrioventricular heart block, or evidence of prior myocardial infarction.
- QT interval corrected through use of Fridericia´s formula (QTcF) ˃ 450 ms, if patient is male, or QTcF ˃ 470, if patient is female, demonstrated by at least two ECGs ˃30 minutes apart.
- Active malignancy or history of malignancy within 5 years of screening, except for appropriately treated non-melanoma skin carcinoma, cervical carcinoma in situ, breast ductal carcinoma in situ, or Stage I uterine cancer.
- Positive for hepatitis C virus (HCV) antibody at screening, unless HCV RNA ˂ 15 IU/mL (or undetectable) at screening and for 6 months if successfully completed HCV anti-viral treatment.
- Positive hepatitis B surface antigen (HBsAg) at screening, or:
Negative HBsAg and positive hepatitis B core antibody (HBcAb); with a positive hepatitis B virus (HBV) DNA test.
- Positive HIV antibody at screening
- Positive for TB during screening, defined as either a positive purified protein derivative (PPD) test (≥5 mm of induration 48-72 hours after injection) or a positive QuantiFERON®TB Gold (QFT-G) test during screening:
For patients with a history of bacille Calmette-Guerin (BCG) vaccination, the criteria for the QFT-G apply as defined in the protocol.
Patients with a positive PPD test or QFT-G are eligible if they meet all of the criteria defined in the protocol for these cases.
- Acute infection requiring either surgical intervention (e.g., drainage) or medical therapy (e.g., antibiotics) within 4 weeks prior to screening.
- Active para
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <br>Outcome name:As time from randomization to first asthma exacerbation (assessed by the investigator) or diary worsening during the 48-week double-blind treatment period.<br>Measure:Time to First CompEx event.<br>Timepoints:Week 2 and week 50.<br>
- Secondary Outcome Measures
Name Time Method <br>Outcome name:Asthma exacerbations assessed by the investigator<br>Measure:Rate of asthma exacerbations<br>Timepoints:During the 48-week double-blind treatment period<br>;<br>Outcome name:Evaluacion del investigador de las exacerbaciones del asma<br>Measure:Time to first asthma exacerbation<br>Timepoints:During the 48-week double-blind treatment period<br>;<br>Outcome name:Spirometry<br>Measure:Absolute and relative change from randomization in pre-bronchodilator forced expiratory volume in 1 second (FEV1; liters)<br>Timepoints:Week 50<br>;<br>Outcome name:Measurements of FeNO<br>Measure:Absolute and relative change from randomization in fractional exhaled nitric oxide (FeNO)<br>Timepoints:Week 50<br>