Health Condition 1: J454- Moderate persistent asthma Health Condition 2: J455- Severe persistent asthma
Conditions
Interventions
Intervention1: BP11 (Omalizumab) single-dose pre-filled syringe for subcutaneous injection.
Dosage Form & Strength: Pre-Filled Syringe for Subcutaneous Injection containing Omalizumab 75mg/0.5ml and15
Sponsors
CuraTeQ Biologics Private Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1.Adult male or female patients of age 18 to 65 years (both inclusive) 2.Patient with the diagnosis of moderate to severe persistent asthma >1 year duration who, meets the following criteria: - Patients with a positive prick skin test to at least one perennial allergen (e.g. dust mite, animal dander, cockroaches), within the past 1 year or at screening. - Patients with total serum IgE level 76 to 700 IU/mL. - Patients demonstrating 12% increase in FEV1 or 200mL of absolute value of FEV1 over baseline value within 20-30 minutes of taking up to 4 puffs of (SABA) documented within the past year or at screening or at baseline prior to randomization. - Patients with FEV1 - Multiple documented severe asthma exacerbations despite daily high dose ICS plus LABA (long acting inhaled ß2-agonist). 3.The screening laboratory tests must meet the following criteria: •Hemoglobin =9.0 g/dL. •WBC =3.5 x 109/L. •Neutrophils =1.5 x 109/L. •Platelets =100 x 109/L. •Serum transaminase =2.5 times the upper limit of normal •Alkaline phosphatase levels =2.5 times the upper limit of normal •Serum creatinine =150 µmol/L (=1.7mg/dL) 4.Men and women of childbearing potential must agree to use adequate birth control measures and continue such precautions for 6 months after receiving the last injection. 5.Patients who are able to understand the risks involved, comply with study and follow-up procedures and willing to provide written informed consent for participation.
Exclusion criteria
Exclusion criteria: 1.Any Clinically significant abnormal laboratory investigations or physical examination findings which may pose risk to the patients as assessed by investigator at screening visit. 2.Prior Hospitalization or an emergency visit for asthma within the 4 weeks before the screening Visit. 3.Patient with history of near fatal or life-threatening (including intubation) asthma within the past year prior to screening visit. 4.Patients with a history of allergic reactions attributed to compounds of similar chemical or biologic composition to Omalizumab or its any excipients. History of illicit drug use within one year prior to randomization. 5.Prior use of Omalizumab (or any biological treatment of Allergic Asthma) 6.Known history of systemic (injectable or oral) corticosteroid medication use within 1 month of the Screening Visit. 7.Significant, non-reversible, active pulmonary disease (e.g., chronic obstructive pulmonary disease (COPD), cystic fibrosis, bronchiectasis, tuberculosis etc.). 8.Subject has a smoking history equivalent to 10 pack years (i.e., at least 1 pack of 20 cigarettes/day for 10 years or 10 packs/day for 1 year, etc.). 9.Current smoker or smoking history within 12 months prior to the Screening Visit. 10.Any of the following concurrent severe and/or uncontrolled medical conditions which could compromise participation in the study: Uncontrolled high blood pressure, history of labile hypertension, or history of poor compliance with an antihypertensive regimen; Unstable angina; New York Heart Association (NYHA) greater than/equal to grade 2 congestive heart failure. 11.Myocardial infarction within 6 months of study enrollment; History of stroke within 6 months of study enrollment; Unstable symptomatic arrhythmia requiring medication (Patients with chronic atrial arrhythmia, i.e., atrial fibrillation or paroxysmal supraventricular tachycardia are eligible); Clinically significant peripheral vascular disease; Uncontrolled diabetes; Serious active or uncontrolled Infection 12.History of other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or that might affect the interpretation of the results of the study or render the subject at high risk from treatment complications. 13.Inability to comply with study and/or follow-up procedures. 14.Subjects with HIV, HBsAg, HCV test positive. 15.History or presence of any form of cancer within the 10 years prior to randomization. 16.Current signs or symptoms of significant, progressive or uncontrolled renal, hepatic, hematologic, gastrointestinal, endocrine, pulmonary, cardiac, neurologic or cerebral disease that renders the subject incapable of participating in the study 17.History of serious infection, which caused hospitalization within 6 months prior to randomization or other severe or chronic infection (such as sepsis, abscess or opportunistic infections, invasive fungal infection such as histoplasmosis, or a history of recurrent herpes zoster or other chronic or recurrent infection) or a past diagnosis without sufficient documentation of complete resolution following treatment. 18.Pre-ex
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of subjects with clinically significant asthma exacerbation.Timepoint: Week 16 | — |
Secondary
| Measure | Time frame |
|---|---|
| Compare Pharmacokinetic & Pharmacodynamic parametersTimepoint: As per pre-specified timepoints in the protocol;Incidence & Titres of Anti-Omalizumab Antibodies between both groupsTimepoint: Baseline, Week 4, Week 16 & 24;Mean change in pulmonary function tests measured by FEV1 & FEV1/FVC from baselineTimepoint: Week 8, 12, 16;Mean change in total asthma symptom score.Timepoint: Week 8, 12, 16 & 24;Number of asthma exacerbationsTimepoint: Week 8, 16 & 24;Overall proportions of responders with meaningful Asthma Quality of Life Questionnaire (AQLQ) improvements.Timepoint: Week 16 & 24;Proportion of patients with Reductions in inhaled corticosteroids dosesTimepoint: Week 8, 12, 16 & 24;Proportion of subjects with clinically significant asthma exacerbation.Timepoint: Week 8, 24;Reductions in doses of inhaled corticosteroids.Timepoint: Week 8, 12, 16, & 24;Time to first asthma exacerbation.Timepoint: Week 16 & 24;Treatment Emergent Adverse Events (TEAEs) evaluated on the basis of changes in clinical signs & symptoms and changes in safety laboratory values.Timepoint: Baseline to Week 26 | — |
Countries
India
Contacts
Public ContactMr Kartik Sahni
CuraTeQ Biologics Private Ltd.
Outcome results
None listed