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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT03387852 | Evaluation of SAR440340 and as Combination Therapy With Dupilumab in Moderate-to-Severe Asthma Participants | PHASE2 | COMPLETED | 296 | — | — | Mar 12, 2018 | Aug 7, 2019 | Jun 14, 2022 | 71 | United States, Argentina +6 |
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 |
|---|---|---|
| SAR440340 | EXPERIMENTAL | Participants received 2 injections of SAR440340 300 milligram (mg) along with 1 injection of dupilumab placebo, subcutaneous (SC) once every 2 weeks (Q2W) for 12 weeks. |
| 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. |
| Placebo | PLACEBO_COMPARATOR | Participants received 2 SC injections of SAR440340 placebo along with 1 SC injection of dupilumab placebo Q2W for 12 weeks. |
| Name | Type | Description |
|---|---|---|
| SAR440340 | DRUG | Pharmaceutical form: Solution for Injection, Route of administration: SC |
| 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 : * Adult participants with a physician diagnosis of asthma for at least 12 months based on the Global Initiative for Asthma (GINA) 2017 Guidelines. * Participants with existing treatment with medium to high dose ICS (greater than or equal to \[\>=\] 250 microgram (mcg) of flutic...