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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT07190222 | Efficacy, Safety, and Tolerability Study of Lunsekimig Compared With Placebo in Adult Participants With Inadequately Controlled Chronic Obstructive Pulmonary Disease (COPD), Characterized by an Eosinophilic Phenotype | PHASE3 | RECRUITING | 942 | — | — | Sep 17, 2025 | Jan 22, 2030 | May 27, 2026 | 206 | United States, Argentina +12 |
| NCT07190209 | Efficacy, Safety, and Tolerability Study of Lunsekimig Compared With Placebo in Adult Participants With Inadequately Controlled Chronic Obstructive Pulmonary Disease (COPD) Characterized by an Eosinophilic Phenotype | PHASE3 | RECRUITING | 942 | — | — | Sep 16, 2025 | Jan 22, 2030 | May 27, 2026 | 196 | United States, Argentina +9 |
The annualized moderate or severe COPD exacerbation rate up to 48 weeks treatment period compared to placebo
| Arm | Type | Description |
|---|---|---|
| Lunsekimig dose regimen A | EXPERIMENTAL | Participants will receive lunsekimig dose regimen A. |
| Lunsekimig dose regimen B | EXPERIMENTAL | Participants will receive lunsekimig dose regimen B. |
| Placebo | PLACEBO_COMPARATOR | Participants will receive lunsekimig-matching placebo. |
| Name | Type | Description |
|---|---|---|
| Lunsekimig | DRUG | Pharmaceutical form: solution for injection in prefilled syringe. Route of administration: Subcutaneous injection |
| Placebo | DRUG | Pharmaceutical form: solution for injection. Route of administration: Subcutaneous injection |
Inclusion Criteria: * Between 40 to 80 years of age * Physician diagnosed chronic obstructive pulmonary disease (COPD) ≥1 year * Post-bronchodilator forced expiratory volume in 1 second (post-BD FEV1) ≥ 20% and ≤ 70% of predicted value and FEV1/FVC (forced expiratory volume in 1 second /forced vita...