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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT06040086 | Efficacy and Safety of Tozorakimab in Symptomatic Chronic Obstructive Pulmonary Disease With a History of Exacerbations | PHASE3 | ACTIVE NOT_RECRUITING | 1,454 | — | — | Sep 22, 2023 | May 22, 2026 | Mar 18, 2026 | 368 | United States, Argentina +27 |
| NCT05742802 | Long-term Efficacy and Safety of Tozorakimab in Participants With Chronic Obstructive Pulmonary Disease With a History of Exacerbations (PROSPERO). | PHASE3 | ACTIVE NOT_RECRUITING | 1,713 | — | — | Mar 6, 2023 | May 28, 2026 | Mar 13, 2026 | 335 | United States, Argentina +35 |
| NCT05158387 | Efficacy and Safety of Tozorakimab in Symptomatic Chronic Obstructive Pulmonary Disease With a History of Exacerbations. | PHASE3 | COMPLETED | 1,172 | — | — | Feb 7, 2022 | Mar 22, 2026 | Apr 16, 2026 | 212 | United States, Australia +18 |
| NCT05166889 | Efficacy and Safety of Tozorakimab in Symptomatic Chronic Obstructive Pulmonary Disease With a History of Exacerbations | PHASE3 | COMPLETED | 1,132 | — | — | Jan 3, 2022 | Mar 11, 2026 | Apr 16, 2026 | 212 | United States, Argentina +19 |
| NCT06897748 | A Study to Investigate Efficacy and Safety of Tozorakimab Injections Compared With Placebo in Adult Participants With Symptomatic Chronic Obstructive Pulmonary Disease (COPD) With a History of COPD Exacerbations and Elevated Eosinophils | PHASE2 | ACTIVE NOT_RECRUITING | 98 | — | — | Apr 12, 2025 | Apr 30, 2026 | Apr 8, 2026 | 12 | Russia |
| NCT04631016 | A Phase II, Randomized, Double-blind, Placebo-controlled Study to Assess MEDI3506 in Participants With COPD and Chronic Bronchitis | PHASE2 | COMPLETED | 137 | — | — | Dec 14, 2020 | Nov 13, 2023 | Feb 27, 2025 | 90 | United States, Australia +13 |
The primary endpoint will be assessed in the primary population (former smokers with symptomatic COPD and a history of exacerbations, on optimised treatment with maintenance inhaled therapy \[triple therapy, or dual therapy if triple is not considered appropriate\]).
The primary efficacy endpoint is the rate of severe COPD exacerbations.
The difference in mean change from baseline in FEV1
| Arm | Type | Description |
|---|---|---|
| Tozorakimab | EXPERIMENTAL | Dosing subcutaneously tozorakimab |
| Placebo | PLACEBO_COMPARATOR | Dosing subcutaneously with equivalent volume to tozorakimab |
| Tozorakimab Dose 1 | EXPERIMENTAL | Injection subcutaneously Tozorakimab via pre-filled syringe. |
| Tozorakimab Dose 2 | EXPERIMENTAL | Injection subcutaneously Tozorakimab via pre-filled syringe. |
| Name | Type | Description |
|---|---|---|
| Placebo | DRUG | Placebo administered subcutaneously, equivalent volume to tozorakimab throughout the study. |
| Tozorakimab | DRUG | Administered subcutaneously tozorakimab and placebo throughout the study. |
| Tozorakimab 1 | COMBINATION_PRODUCT | Participants randomised to either dose regimen in the predecessor studies will be assigned to a single Tozorakimab dose regimen in the PROSPERO study. |
| Tozorakimab 2 | COMBINATION_PRODUCT | Participants randomised to either dose regimen in the predecessor studies will be assigned to a single Tozorakimab dose regimen in the PROSPERO study. |
Inclusion Criteria: 1. Participant must be ≥ 40 years of age and capable of giving signed informed consent. 2. Documented diagnosis of COPD for at least one year prior to enrolment. 3. Post BD FEV1/FVC \< 0.70 and post-BD FEV1 \>20% of predicted normal value 4. Documented history of ≥ 2 moderate or...