Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Experimental: Tezepelumab · 4 trials · 3 indications
The total nasal polyp score (NPS) is the sum of the right and left nostril scores (maximum of 8), as evaluated by nasal endoscopy. Higher scores indicate greater symptom severity. The left and right score will be based on a central read with a scale from 0 to 4. Each nasal endoscopy is evaluated by two independent physician reviewers.
The NCS is captured by one item in the NPSD (nasal polyps symptom diary) asking participants to rate the severity of their worst NC over the past 24 hours using the following response options: 0 - None; 1 - Mild; 2 - Moderate; 3 - Severe. Baseline will be the mean of daily responses from Day -13 to Day 0. Bi-weekly (14-day) mean NCS will be calculated if at least 8 days in each 14-day period has evaluable data; otherwise the bi-weekly mean is set to missing.
The annual exacerbation rate is based on exacerbations reported by the investigator in the eCRF over 52 weeks
The annual exacerbation rate is based on unadjudicated exacerbations reported by the investigator in the eCRF. The analysis is based on the primary population (Full Analysis Set)
The annual exacerbation rate is based on unadjudicated exacerbations reported by the investigator in the eCRF. This analysis is based on subjects with baseline eosinophils \< 300 cells/uL
To investigate the pharmacokinetics of single subcutaneous dose of tezepelumab in healthy Chinese subjects
To investigate the pharmacokinetics of single subcutaneous dose of tezepelumab in healthy Chinese subjects
To investigate the pharmacokinetics of single subcutaneous dose of tezepelumab in healthy Chinese subjects
To investigate the pharmacokinetics of single subcutaneous dose of tezepelumab in healthy Chinese subjects
To investigate the pharmacokinetics of single subcutaneous dose of tezepelumab in healthy Chinese subjects
To investigate the pharmacokinetics of single subcutaneous dose of tezepelumab in healthy Chinese subjects
To investigate the pharmacokinetics of single subcutaneous dose of tezepelumab in healthy Chinese subjects
| Arm | Type | Description |
|---|---|---|
| Tezepelumab | EXPERIMENTAL | Tezepelumab subcutaneous injection in an accessorized pre-filled syringe every 4 weeks (Q4W) added to background mometasone furoate (MFNS) or equivalent intranasal corticosteroid (INCS). |
| Placebo | PLACEBO_COMPARATOR | Placebo subcutaneous injection in an accessorized pre-filled syringe Q4W added to background MFNS or equivalent INCS. |
| Tezepelumab: Low dose | EXPERIMENTAL | Tezepelumab: Tezepelumab single dose subcutaneously injection. |
| Tezepelumab: Medium dose | EXPERIMENTAL | Tezepelumab: Tezepelumab single dose subcutaneously injection. |
| Tezepelumab: High dose | EXPERIMENTAL | Tezepelumab: Tezepelumab single dose subcutaneously injection. |
| Name | Type | Description |
|---|---|---|
| Experimental: Tezepelumab | BIOLOGICAL | Tezepelumab subcutaneous injection |
| Placebo | OTHER | Placebo subcutaneous injection |
| Mometasone furoate or equivalent intranasal corticosteroid | DRUG | Background MFNS or equivalent INCS at stable dose |
Inclusion Criteria: 1. Participants with physician-diagnosed CRSwNP for at least 12 months prior to Visit 1 that have: 1. Severity consistent with need for surgery as defined by total NPS ≥ 5 (≥ 2 for each nostril) at screening, as determined by the central reader 2. Nasal Congestion Score (...
Tezepelumab is an investigational monoclonal antibody being studied for severe uncontrolled asthma and chronic rhinosinusitis with nasal polyps. It has been evaluated in Phase 3 clinical trials for these conditions, as well as in a Phase 1 study in healthy subjects. It is not yet approved and remains in clinical development.
Tezepelumab is being developed by AstraZeneca PLC, a biopharmaceutical company traded on the NASDAQ under the ticker symbol AZN. The company has sponsored multiple clinical trials evaluating the drug for respiratory conditions including severe asthma and chronic rhinosinusitis with nasal polyps.
Tezepelumab has completed Phase 3 clinical trials for severe uncontrolled asthma and chronic rhinosinusitis with nasal polyps, as well as a Phase 1 study in healthy subjects. All trials listed are completed, and the drug remains investigational, meaning it has not received regulatory approval.
Tezepelumab has been studied in several completed trials, including NCT03347279 and NCT03927157 for severe uncontrolled asthma, NCT04851964 for chronic rhinosinusitis with nasal polyps, and NCT04362410, a Phase 1 pharmacokinetic study in healthy Chinese subjects. These trials enrolled a total of 1,466 participants.
Tezepelumab is a distinct monoclonal antibody targeting a different pathway than other asthma biologics. It is being developed by AstraZeneca for severe uncontrolled asthma and nasal polyps. No alternative names for Tezepelumab have been disclosed in the available clinical trial information.