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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT07309614 | A Study Assessing the Effect of Dupilumab on Inducing Clinical Remission in Asthma | PHASE3 | RECRUITING | 150 | — | — | Jan 29, 2026 | Jan 1, 2030 | Mar 4, 2026 | 5 | Australia, Canada +1 |
Win ratio comparing patients achieving clinical remission outcomes in dupilumab group vs placebo group, based on remission criteria. The unmatched paired testing will follow this hierarchy: 1. Study participant has not had a severe asthma attack between weeks 4 and 56 2. Number of asthma attacks between weeks 4 and 56 3. Improved or stable lung function (defined as a decline from parent study baseline in pre- or postbronchodilator FEV1 by no more than 5%) at Week 56 4. No more than medium-dose ICS maintenance therapy (as defined by GINA 2025) at Week 56 5. 5-item Asthma Control Questionnaire mean score \<1.5 at Week 56
| Arm | Type | Description |
|---|---|---|
| Placebo | PLACEBO_COMPARATOR | - |
| Dupilumab | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| Dupilumab Prefilled Syringe | DRUG | Dupilumab 400mg subcut x1 followed by 200mg subcut every 2 weeks |
| Placebo Injection | DRUG | Volume-matched placebo injected subcut every 2 weeks |
INCLUSION CRITERIA Study participants are eligible to be included in the study only if all of the following criteria apply: Age 1. Participant must be 18-\<80 years of age at the time of signing the informed consent. Type of participant and disease characteristics 2. Physician diagnosis of as...