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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT07363642 | Phase 3b Study in Patients With Severe Asthma Treated With Tezepelumab | PHASE3 | RECRUITING | 400 | — | — | Jan 28, 2026 | Mar 31, 2029 | May 26, 2026 | 76 | China |
| NCT06473779 | Open-label Study to Assess Reduction of Background Asthma Medication While Sustaining Asthma Control and Clinical Remission With Tezepelumab in Patients 12-80yrs With Severe Asthma. | PHASE3 | ACTIVE NOT_RECRUITING | 326 | — | — | Sep 30, 2024 | Jun 25, 2027 | Mar 12, 2026 | 70 | United States, Argentina +10 |
Main Endpoints: Proportion of patients with at least one controller medication category reduction at the end of reduction phase (week 36) while sustaining asthma control * discontinuation of LTRA, or * discontinuation of LAMA, or * discontinuation of theophylline, or * Reduce inhale therapy to MD ICS/LABA, or * Reduce inhale therapy to LD ICS/LABA
Proportion of patients who reduced their SYMBICORT® daily maintenance dose without the loss of asthma control at the end of the step-down phase to either: Outside of the US: * Medium-dose maintenance and reliever therapy, or * Low-dose maintenance and reliever therapy, or * SYMBICORT® anti-inflammatory reliever only In the US: * Medium-dose SYMBICORT® and AIRSUPRA®,or * Low-dose SYMBICORT® and AIRSUPRA®, or * AIRSUPRA® only
| Arm | Type | Description |
|---|---|---|
| Tezepelumab | EXPERIMENTAL | Severe asthma taking medium-high dose ICS/LABA with up to one additional controller will be enrolled into this single arm treatment |
| Group 1 - Asthma Control or Low Biomarkers - Step-down of ICS | EXPERIMENTAL | Asthma Control or Low Biomarkers - Step-down of ICS. Only patients with asthma control or low biomarkers at Week 24 will be randomized into Group 1 or 2 |
| Group 2 - Asthma Control or Low Biomarkers - No Step-down of ICS | EXPERIMENTAL | Asthma Control or Low Biomarkers - No Step-down of ICS. Only patients with asthma control or low biomarkers at Week 24 will be randomized into Group 1 or 2 |
| Group 3 - No Asthma Control or Low Biomarkers - No Step-down of ICS | EXPERIMENTAL | No Asthma Control or Low Biomarkers - No Step-down of ICS |
| Name | Type | Description |
|---|---|---|
| Tezepelumab | DRUG | Severe asthma taking medium-high dose ICS/LABA with up to one additional controller will be enrolled into this single arm treatment |
| Budesonide/formoterol | COMBINATION_PRODUCT | AxMP. Oral inhalation. High-dose: 160 μg/4.5 μg per inhalation; Medium and Low-dose: 80 μg/4.5 μg per inhalation |
| Albuterol/budesonide (AIRSUPRA®) | COMBINATION_PRODUCT | AxMP. Oral inhalation. Reliever only. Unit dose strengths 90 μg/80 μg per inhalation In US only. |
| Mannitol | COMBINATION_PRODUCT | NIMP. Oral nebulization. Unit dose strengths: Graduated doses of 0 mg, 5 mg, 10 mg, 20 mg and 40 mg capsules |
| Salbutamol | COMBINATION_PRODUCT | AxMP. Used outside the US only. Oral inhalation. Unit dose strengths: 100 μg per inhalation |
Inclusion Criteria: 1．Provision of informed consent prior to any study-specific procedures. Written informed consent, and assent when applicable for study participation must be obtained prior to any study related procedures being performed (local regulations are to be followed in determining the as...