Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT03782532 | Efficacy and Safety Study of Dupilumab in Patients With Persistent Asthma | PHASE3 | COMPLETED | 486 | — | — | Jan 25, 2019 | May 21, 2022 | Dec 28, 2022 | 67 | China, India |
| NCT03620747 | Continuation of TRAVERSE- LTS12551 Evaluating Dupilumab Safety in Patients With Asthma (Long-Term Follow-Up) | PHASE3 | COMPLETED | 393 | — | — | Aug 30, 2018 | Feb 18, 2022 | Mar 16, 2023 | 132 | United States, Argentina +8 |
| NCT02573233 | Evaluation of Dupilumab's Effects on Airway Inflammation in Patients With Asthma | PHASE2 | COMPLETED | 42 | — | — | Jan 27, 2016 | Jan 3, 2018 | Apr 4, 2022 | 16 | United States, Canada +4 |
Absolute change from baseline in pre-bronchodilator FEV1 at Week 12
An adverse event (AE) was defined as any untoward medical occurrence in a participant who received study drug and did not necessarily had to have a causal relationship with the treatment. TEAEs were the AEs that developed or worsened or became serious during the TEAE period (defined as the time from the first dose of the investigational medicinal product \[IMP\] up to 12 weeks after the last dose of the IMP).
An AE was defined as any untoward medical occurrence in a participant who received study drug and did not necessarily had to have a causal relationship with the treatment. TEAEs were the AEs that developed or worsened or became serious during the TEAE period (defined as the time from the first dose of the IMP up to 12 weeks after last dose of the IMP). TEAE event rate was defined as the number of TEAE events per 100 participant-years.
Inflammatory cells i.e. eosinophils were counted in the bronchial submucosa of biopsy thin sections using quantitative immunohistochemistry and reported as the number of cells per square millimeter.
Mucin was identified by staining with Alcian-blue periodic acid-Schiff and/or immunostaining for MUC5AC and then the mucin-positive area was measured and expressed per square millimeter.
Inflammatory cells i.e. mast cells were counted in the bronchial submucosa of biopsy thin sections using quantitative immunohistochemistry and reported as the number of cells per square millimeter.
Inflammatory cells i.e. mast cells were counted in the bronchial submucosa of biopsy thin sections using quantitative immunohistochemistry and reported as the number of cells per square millimeter.
T-Lymphocytes i.e. CD3 positive cells were counted in the bronchial submucosa of biopsy thin sections using quantitative immunohistochemistry and reported as the number of cells per square millimeter.
T-helper i.e. CD4 positive lymphocytes were counted in the bronchial submucosa of biopsy thin sections using quantitative immunohistochemistry and reported as the number of cells per square millimeter.
| Arm | Type | Description |
|---|---|---|
| Dupilumab | EXPERIMENTAL | For patients without oral corticosteroids (OCS) maintenance therapy, dose 1 of dupilumab administered once in 2 weeks (q2w) with loading dose of dupilumab, two times dose 1; for patients on OCS maintenance therapy, the dose will be dupilumab dose 2 q2w with loading dose 2 times dose 2 |
| Placebo for dupilumab | PLACEBO_COMPARATOR | For patients without OCS maintenance therapy, the patients will take placebo matching to dupilumab dose 1 q2w with loading dose; for patients on OCS maintenance therapy, the patients will take placebo matching to dupilumab dose 2 q2w with loading dose |
| Placebo | PLACEBO_COMPARATOR | Placebo (for dupilumab), 2 subcutaneous injections on Day 1 (Week 1) as a loading dose followed by a single injection q2w from Week 2 to Week 14, added to stable inhaled corticosteroid/ long-acting beta-agonist (ICS/LABA) therapy. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication. |
| Name | Type | Description |
|---|---|---|
| Dupilumab SAR231893 | DRUG | Pharmaceutical form: Solution Route of administration: Subcutaneous |
| Placebo | DRUG | Pharmaceutical form: Solution Route of administration: Subcutaneous |
| Asthma Controller Therapies (include prednisone/prednisolone) | DRUG | Pharmaceutical form: Aerosol, capsules, tablets, oral solution Route of administration: Inhalation, oral |
| Asthma Reliever Therapies | DRUG | Pharmaceutical form: Nebulized, aerosol Route of administration: Inhaled |
| Dupilumab SAR231893 (REGN668) | DRUG | Pharmaceutical form: prefilled syringes Route of administration: subcutaneous |
| Dupilumab SAR231893/REGN668 | DRUG | Pharmaceutical form:solution Route of administration: subcutaneous |
| fluticasone propionate and salmeterol | DRUG | Pharmaceutical form:inhalation aerosol, inhalation powder Route of administration: inhaled |
| budesonide and formoterol | DRUG | Pharmaceutical form:inhalation aerosol Route of administration: inhaled |
| mometasone furoate and formoterol | DRUG | Pharmaceutical form:inhalation aerosol Route of administration: inhaled |
Inclusion criteria : * Adults and adolescent patients (≥12 years of age) with a physician diagnosis of asthma for ≥12 months, based on the Global Initiative for Asthma 2017 Guidelines and the following criteria: * Patients requiring a third controller for their asthma will be considered eligible fo...