Health Condition 1: J459- Other and unspecified asthma
Conditions
Interventions
Intervention1: Dupilumab: Dose formulation: A 150 mg/mL dupilumab solution in a prefilled syringe to deliver 300 mg in a 2 mL injection.
Unit dose strength(s) 150 mg/mL
Route of Administration: SC in
Sponsors
Sanofi Healthcare India Private Limited
Eligibility
Inclusion criteria
Inclusion criteria: Participant must be at least 18 (or the legal age of consent in the jurisdiction in which the study is taking place) years of age inclusive, at the time of signing the informed consent. Patients with a physician diagnosis of asthma (according to GINA 2021) for >=12 months Treatment with medium to high dose ICS (>=250 mcg of fluticasone propionate twice daily or equipotent ICS daily dosage to a maximum of 2000 mcg/day of fluticasone propionate or equivalent) in combination with a second controller (eg, LABA, LTRA) with a stable dose >=1 month prior to Visit 1. Patients requiring a third controller for their asthma will be considered eligible for this study, and should be on stable dose of the third controller for >=1 month prior to Visit 1. Pre-bronchodilator forced expiratory volume (FEV1) Asthma Control Questionnaire 5-question version (ACQ-5) score >=1.5 at Visits 1 and 2, prior to randomization. Bronchodilator reversibility (>=12% and 200 mL improvement in FEV1 post SABA administration) during the screening period, prior to randomization, unless reversibility test meeting the inclusion criteria was done within 12 months prior to Visit 1. FeNO >=35 ppb at Visit 2, prior to randomization. Up to 550 patients can be enrolled with FeNO Note: FeNO values greater than 35ppb measured within 3 days (72h) prior to V2 will be accepted for eligibility. Female Contraceptive use by female should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies. a) Female participants A female participant is eligible to participate if she is not pregnant or breastfeeding, and at least one of the following conditions applies: Is a woman of nonchildbearing potential (WONCBP) as defined in Appendix 4 Contraceptive and barrier guidance (Section 10.4 of Protocol). OR - Is a WOCBP and agrees to use a contraceptive method that is highly effective, with a failure rate of A WOCBP must have a negative highly sensitive serum (Appendix 2) Capable of giving signed informed consent as described in Appendix 1 (Section 10.1) of the protocol which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol. In countries where legal age of majority is above 18 years, a specific ICF must also be signed by the participantâ??s legally authorized representative
Exclusion criteria
Exclusion criteria: History or clinical evidence of COPD including Asthma-COPD Overlap Syndrome (ACOS) or any other significant lung disease (eg, emphysema, lung fibrosis, sarcoidosis, interstitial lung disease, pulmonary hypertension, bronchiectasis, Churg-Strauss Syndrome). Severe asthma exacerbation requiring treatment with SCS in the past month before V1 or during the screening period. Current acute bronchospasm or status asthmaticus Diagnosed pulmonary (other than asthma) or systemic disease associated with elevated peripheral eosinophil counts. Patients with active tuberculosis (TB ) or non-tuberculous mycobacterial infection, or a history of incompletely treated TB will be excluded from the study unless it is well documented by a specialist that the participant has been adequately treated and can now start treatment with a biologic agent, in the medical judgment of the Investigator and/or infectious disease specialist. Tuberculosis testing will be performed on a country by country basis, according to local guidelines if required by regulatory authorities or ethics boards, or if TB is suspected by the investigator. Known or suspected immunodeficiency, including history of invasive opportunistic infections (eg, histoplasmosis, listeriosis, coccidioidomycosis, pneumocystosis, and aspergillosis) despite infection resolution, or otherwise recurrent infections of abnormal frequency or prolonged duration suggesting an immune-compromised status, as judged by the Investigator. Active malignancy or history of malignancy within 5 years before Visit 1 (screening visit),except completely treated in situ carcinoma of the cervix and completely treated and resolved non metastatic squamous or basal cell carcinoma of the skin. Active chronic or acute infection requiring treatment with systemic antibiotics, antivirals, antifungals or receiving only symptomatic treatment (eg, influenza or COVID-19) within 2 weeks before the screening visit (Visit 1) or during the screening period. History of human immunodeficiency virus (HIV) infection or positive HIV 1/2 serology at Visit 1 (screening visit). Diagnosed with, suspected of, or at high risk of endoparasites infection, and/or use of antiparasitic drugs within 2 weeks before Visit 1 (screening visit) or during the screening and run-in period
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Rate of change from Week 8 to Week 52 on post-Bronchodilator FEV1 slopeTimepoint: Week 8 to Week 52 | — |
Secondary
| Measure | Time frame |
|---|---|
| To evaluate the long-term effect of dupilumab on preventing or slowing the rate of lung function decline by Week 52 (year 1) compared to placebo in total population To evaluate the long-term effect of dupilumab on preventing or slowing the rate of lung function decline by Week 104 (year 2) compared to placebo in FeNO population. To evaluate the effect of dupilumab in improving lung function parameters, exacerbations, asthma control and biomarker levels at Week 52 compared to placebo in FeNO and Total populations. To evaluate the long-term effect of dupilumab on improving lung function parameters, exacerbations, asthma control and biomarker levels at Week 104 compared to placebo in FeNO and Total populations. To evaluate the long-term effect of dupilumab in improving quality of life at Week 52 and 104 compared to placebo in FeNO and Total populations.Timepoint: Week 52 | — |
Countries
Belgium, Brazil, Bulgaria, Canada, Czech Republic, Greece, Hungary, India, Ireland, Mexico, Oman, Poland, Portugal, Republic of Korea, Romania, Russian Federation, Saudi Arabia, Slovakia, South Africa, Taiwan, Ukraine, United Arab Emirates, United Kingdom, United States of America
Contacts
Public ContactSwapnil Sonje
Sanofi Healthcare India Private Limited
Outcome results
None listed