Study of Efficacy and Safety of LOU064 in Inadequately Controlled Asthma Patients

Exclusion Criteria

• •Patients who have had an asthma exacerbation requiring systemic corticosteroids, hospitalization, or emergency room visit within 6 weeks prior to screening or during the screening period.
• •Patients who have smoked or inhaled any substance other than asthma medications within the 6 month period prior to screening, or who have a smoking history of greater than 10 pack years (e.g. 10 pack years = 1 pack/day x 10 years or ½ pack/day x 20 years, etc.).
• •History of life-threatening asthma event such as significant hypercarbia (pCO2 \> 45 mmHg), endotracheal intubation, non-invasive positive pressure ventilation (NIPPV), respiratory arrest, or seizure as a result of asthma.
• •Patients with chronic lung diseases other than asthma, including (but not limited to) chronic obstructive pulmonary disease, clinically significant bronchiectasis, sarcoidosis, interstitial lung disease, cystic fibrosis, Churg-Strauss syndrome, allergic broncho-pulmonary aspergillosis, or clinically significant chronic lung diseases related to a history of tuberculosis or asbestosis.
• •History or current diagnosis of ECG abnormalities indicating significant risk of safety for subjects participating in the study such as:
• •* Concomitant clinically significant cardiac arrhythmias, e.g. sustained ventricular tachycardia, and clinically significant second or third degree AV block without a pacemaker
• •* History of familial long QT syndrome or known family history of Torsades de Pointes
• •* Resting heart rate (physical exam or 12 lead ECG) \< 50 bpm at screening
• •* Resting QTcF ≥ 450 msec (male) or ≥ 460 msec (female) at screening or inability to determine the QTcF interval
• •* Use of agents known to prolong the QT interval unless they can be permanently discontinued for the duration of study
• •At screening and/or run-in period, any severe, progressive or uncontrolled, acute or chronic, medical or psychiatric condition, or other factors such as abnormal vital signs, ECG or physical findings, or clinically relevant abnormal laboratory values, that in the judgment of the investigator may increase the risk associated with study participation/treatment or may interfere with interpretation of study results, and thus would make the patient inappropriate for entry into or continuing the study.
• •Major surgery within 8 weeks prior to screening or surgery planned prior to end of study.
• •History of live attenuated vaccine within 6 weeks prior to randomization or requirement to receive vaccinations at any time during the study.
• •Hematology parameters at screening:
• •* Hemoglobin: \< 10 g/dl
• •* Platelets: \< 100 000/mm3
• •* White blood cells: \< 3 000/mm3
• •* Neutrophils: \< 1 500/mm3
• •Significant bleeding risk or coagulation disorders.
• •History of gastrointestinal bleeding, e.g. in association with use of Nonsteroidal Anti-Inflammatory Drug (NSAID).
• •Requirement for anti-platelet or anticoagulant medication (e.g., warfarin, or clopidogrel or Novel Oral Anti-Coagulant (NOAC)) other than acetylsalicylic acid (up to 100 mg/d).
• •History or presence of thrombotic or thromboembolic event, or increased risk for thrombotic or thromboembolic event.