Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Dupilumab SAR231893/REGN668 · 3 trials · 1 indication
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...
Dupilumab SAR231893 is an investigational drug being studied for allergic fungal rhinosinusitis, chronic rhinosinusitis with nasal polyps (CRSwNP), cold urticaria, atopic dermatitis, chronic spontaneous urticaria, and chronic obstructive pulmonary disease. It is in Phase 3 clinical development for these respiratory and inflammatory conditions.
Dupilumab SAR231893 is being developed by Sanofi, a biopharmaceutical company traded on the stock exchange under the ticker symbol SNY. The drug is currently in Phase 3 clinical trials for multiple indications including chronic rhinosinusitis with nasal polyps and chronic spontaneous urticaria.
Dupilumab SAR231893 is in Phase 3 clinical development. It has received FDA designations including Priority Review and Orphan Drug designation. The drug is investigational and not yet approved, with completed Phase 3 trials in chronic rhinosinusitis with nasal polyps and chronic spontaneous urticaria.
Dupilumab SAR231893 has completed three Phase 3 trials: NCT02898454 and NCT02912468 for chronic rhinosinusitis with nasal polyps, and NCT04180488 for chronic spontaneous urticaria. These trials enrolled a total of 1,874 participants across multiple countries including the United States, Japan, and European nations.
Yes, Dupilumab SAR231893 is also known as SAR231893. The drug is being developed by Sanofi and is in Phase 3 clinical trials for conditions such as chronic rhinosinusitis with nasal polyps and chronic spontaneous urticaria. It has received FDA Priority Review and Orphan Drug designations.