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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT04751487 | Study to Assess the Efficacy, Safety, and Tolerability of SAR440340/REGN3500/Itepekimab in Chronic Obstructive Pulmonary Disease (COPD) | PHASE3 | COMPLETED | 1,239 | — | — | Feb 12, 2021 | Aug 28, 2025 | Apr 15, 2026 | 297 | United States, Argentina +28 |
| NCT04701983 | Study to Assess the Efficacy, Safety, and Tolerability of SAR440340/REGN3500/Itepekimab in Chronic Obstructive Pulmonary Disease (COPD) | PHASE3 | COMPLETED | 1,127 | — | — | Dec 16, 2020 | Aug 27, 2025 | Apr 15, 2026 | 248 | United States, Argentina +19 |
| NCT05326412 | Mechanistic Study of the Effect of Itepekimab on Airway Inflammation in Patients With COPD | PHASE2 | COMPLETED | 49 | — | — | May 19, 2022 | Jul 25, 2025 | Mar 11, 2026 | 28 | United States, Belgium +5 |
Annualized rate of moderate or severe acute exacerbation of COPD (AECOPD) over the placebo-controlled treatment period.
Annualized rate of moderate or severe AECOPD over the placebo-controlled treatment period
As measured by RNA sequencing, in former and current smokers with COPD
As measured by RNA sequencing, in former and current smokers with COPD
As measured by RNA sequencing, in former and current smokers with COPD
| Arm | Type | Description |
|---|---|---|
| Itepekimab Q2W in former smokers | EXPERIMENTAL | Subcutaneous (SC) administration of Itepekimab every 2 weeks (Q2W) for up to 52 weeks |
| Itepekimab Q4W in former smokers | EXPERIMENTAL | SC administration of Itepekimab every 4 weeks (Q4W) for up to 52 weeks, with alternating SC administration of matching placebo at the 2-week interval between active IMP |
| Placebo in former smokers | PLACEBO_COMPARATOR | SC administration of matching placebo Q2W for up to 52 weeks |
| Itepekimab Q2W in current smokers | EXPERIMENTAL | SC administration of Itepekimab every 2 weeks (Q2W) for 52 weeks |
| Placebo in current smokers | PLACEBO_COMPARATOR | SC administration of matching placebo Q2W for 52 weeks |
| Itepekimab Q2W | EXPERIMENTAL | Subcutaneous (SC) administration of Itepekimab every 2 weeks (Q2W) for up to 52 weeks |
| Itepekimab Q4W | EXPERIMENTAL | SC administration of Itepekimab every 4 weeks (Q4W) for up to 52 weeks, with alternating SC administration of matching placebo at the 2-week interval between active IMP |
| Placebo | PLACEBO_COMPARATOR | SC administration of matching placebo Q2W for up to 52 weeks |
| Itepekimab | EXPERIMENTAL | This arm includes participants from 2 populations: Part A-former smokers and Part B-current smokers. Subcutaneous (SC) administration of Itepekimab every 2 weeks (Q2W) for 12 weeks |
| Name | Type | Description |
|---|---|---|
| Itepekimab SAR440340 | DRUG | Pharmaceutical form: solution for injection in pre-filled syringe Route of administration: subcutaneous |
| Placebo | DRUG | Pharmaceutical form: solution for injection in pre-filled syringe Route of administration: subcutaneous |
Inclusion criteria : * Participant must be 40 to 85 years of age inclusive. * Physician diagnosis of COPD for at least 1 year (based on Global Initiative for Chronic Obstructive Lung Disease \[GOLD\] definition). * Smoking history of ≥10 pack-years: * For former smokers: participants who report ...