Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
SAR440340 · 2 trials · 2 indications
Moderate exacerbations events were recorded by the investigator and defined as AECOPD that require either systemic corticosteroids (such as intramuscular, intravenous or oral) and/or antibiotics. Severe exacerbations events were defined as AECOPD requiring hospitalization, emergency medical care visit or resulting in death. Annualized event rate was the total number of exacerbations that occurred during the treatment period divided by the total number of participant-years treated.
An LOAC event during the 12-week treatment period was a deterioration of asthma defined as any of the following: a) 30 percent (%) or greater reduction from baseline in morning peak expiratory flow (PEF) on 2 consecutive days; b) greater than or equal to (\>=) 6 additional reliever puffs of salbutamol/albuterol or levosalbutamol/levalbuterol in a 24-hour period (compared to baseline) on 2 consecutive days; c) increase in inhaled corticosteroid (ICS) \>=4 times the last prescribed ICS dose (or \>=50% of the prescribed ICS dose at Baseline if background therapy withdrawal completed); d) required use of systemic (oral and/or parenteral) steroid treatment; e) required hospitalization or emergency room visit.
| Arm | Type | Description |
|---|---|---|
| Placebo | PLACEBO_COMPARATOR | Participants received placebo matched to SAR440340 administered as 2 subcutaneous (SC) injections every 2 weeks (Q2W). Participants were treated for a minimum of 24 weeks and up to a maximum of 52 weeks (last dose administered at Week 50, End of Treatment (EOT) visit occurred 2 weeks after last administration of IMP i.e., at Week 52). |
| SAR440340 | EXPERIMENTAL | Participants received SAR440340 300 milligrams (mg) administered as 2 SC injections Q2W. Participants were treated for a minimum of 24 weeks and up to a maximum of 52 weeks (last dose administered at Week 50, EOT visit occurred 2 weeks after last administration of IMP i.e., at Week 52). |
| Dupilumab | ACTIVE_COMPARATOR | Participants received 1 injection of dupilumab 300 mg along with 2 injections of SAR440340 placebo, SC Q2W for 12 weeks. |
| SAR440340 + Dupilumab | EXPERIMENTAL | Participants received 2 injections of SAR440340 300 mg along with 1 injection of dupilumab 300 mg, SC Q2W for 12 weeks. |
| Name | Type | Description |
|---|---|---|
| SAR440340 | DRUG | Pharmaceutical form: Solution for injection; Route of administration: SC |
| Placebo | DRUG | Pharmaceutical form: Solution for injection; Route of administration: SC |
| Any Inhaled Corticosteroids as prescribed by treating physician as standard of care | DRUG | Pharmaceutical form: Aerosol or Dry Powder inhaler Route of administration: Inhaled |
| Any Long Acting Beta Agonist as prescribed by treating physician as standard of care | DRUG | Pharmaceutical form: Aerosol or Dry Powder inhaler; Route of administration: Inhaled |
| Any Long Acting Muscarinic Agonist as prescribed by treating physician as standard of care | DRUG | Pharmaceutical form: Aerosol or Dry Powder inhaler; Route of administration: Inhaled |
| Any short-acting β agonist as prescribed by treating physician as standard of care | DRUG | Pharmaceutical form: Aerosol or Dry Powder inhaler; Route of administration: inhaled |
| Dupilumab | DRUG | Pharmaceutical form: Solution for Injection, Route of administration: SC |
| Fluticasone or Fluticasone/salmeterol combination | DRUG | Pharmaceutical form: Aerosol, dry powder, Route of administration: Inhaled |
| Placebo for SAR440340 | DRUG | Pharmaceutical form: Solution for Injection, Route of administration: SC |
| Placebo for dupilumab | DRUG | Pharmaceutical form: Solution for Injection, Route of administration: SC |
Inclusion criteria : * Participants with a diagnosis of chronic obstructive pulmonary disease (COPD) for at least 1 year (based on Global Initiative for Chronic Obstructive Lung Disease \[GOLD\] definition). * Participants with moderate-to-severe COPD (post-bronchodilator forced expiratory volume i...
SAR440340 is an investigational small molecule being studied for the treatment of moderate-to-severe asthma and moderate-to-severe chronic obstructive pulmonary disease (COPD). It is currently in Phase 2 clinical development and has not been approved by regulatory authorities.
SAR440340 is an anti-IL-33 monoclonal antibody, meaning it targets the interleukin-33 (IL-33) pathway. By binding to IL-33, it is designed to modulate inflammatory responses implicated in respiratory conditions like asthma and COPD.
SAR440340 is being developed by Sanofi, a global biopharmaceutical company listed on the stock exchange under the ticker symbol SNY. The company is conducting clinical trials to evaluate the drug's safety and efficacy in respiratory indications.
SAR440340 is in Phase 2 clinical development. Two Phase 2 trials have been completed, one in asthma and one in COPD. The drug is investigational and has not received FDA approval or any other regulatory approval.
SAR440340 has been studied in two completed Phase 2 trials: NCT03387852, which evaluated the drug alone and in combination with dupilumab in 296 participants with moderate-to-severe asthma, and NCT03546907, a proof-of-concept study in 343 participants with moderate-to-severe COPD.
Yes, SAR440340 is described as an anti-IL-33 monoclonal antibody in clinical trial documentation. This means it is designed to bind to and neutralize interleukin-33, a cytokine involved in inflammatory responses. The drug is being investigated for asthma and COPD.