Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Tozorakimab · 10 trials · 5 indications
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.
To evaluate the effect of tozorakimab versus placebo as an add on to Standard of Care (SoC) in participants with viral lung infection requiring supplemental oxygen on the prevention of death or progression to IMV/ECMO.
The difference in mean change from baseline in FEV1
The rate ratio of severe asthma exacerbations will be assessed in the participants with uncontrolled moderate-to-severe asthma and ≥ 1 severe exacerbation within 12 months prior to screening.
To compare the PK exposure following single SC administration of tozorakimab using AI and APFS devices in healthy participants.
To compare the PK exposure following single SC administration of tozorakimab using AI and APFS devices in healthy participants.
To compare the PK exposure following single SC administration of tozorakimab using AI and APFS devices in healthy participants.
To evaluate the relative bioavailability of two different dosage forms of tozorakimab (test and reference).
To evaluate the relative bioavailability of two different dosage forms of tozorakimab (test and reference).
To evaluate the relative bioavailability of two different dosage forms of tozorakimab (test and reference).
| 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. |
| Treatment A: Tozorakimab (Test) | EXPERIMENTAL | Participants will receive a single SC dose of tozorakimab via AI device. |
| Treatment B: Tozorakimab (Reference) | ACTIVE_COMPARATOR | Participants will receive a single SC dose of tozorakimab via APFS device with the same container closure as the AI. |
| Tozorakimab Dosage form A (Test) | EXPERIMENTAL | Participants will receive a single dose of Tozorakimab Dosage form A via subcutaneous (SC) injection. |
| Tozorakimab Dosage form B (Reference) | EXPERIMENTAL | Participants will receive a single dose of Tozorakimab Dosage form B via SC injection. |
| 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. |
| Autoinjector (AI) Device | DEVICE | AI device will be used to administer single SC dose of tozorakimab on Day 1. |
| Accessorised Prefilled Syringe (APFS) Device | DEVICE | APFS device will be used to administer single SC dose of tozorakimab on Day 1. |
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...