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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT06673329 | Brodalumab in the Treatment of Immune-Related Adverse Events | PHASE1 | RECRUITING | 11 | — | — | Mar 11, 2025 | Nov 1, 2026 | May 14, 2025 | 1 | United States |
The number of adverse events of each grade that occur and the number of adverse events attributed to brodalumab, as per the Common Terminology Criteria for Adverse Events version 5 (CTCAE v5).
The percentage of patients whose primary irAE severity decreased by \>1 grade per CTCAE criteria from study completion to treatment discontinuation.
| Arm | Type | Description |
|---|---|---|
| brodalumab to treat irAEs in patient with solid tumors | EXPERIMENTAL | Brodalumab 210 mg subcutaneous injection on weeks 0, 1, 2 followed by administration every 2 weeks until week 24 |
| Name | Type | Description |
|---|---|---|
| Brodalumab | DRUG | Brodalumab 210 mg subcutaneous injection |
| CT scan | RADIATION | CT scans within 4 weeks of starting brodalumab and every 3 months during the study for tumor assessment |
Inclusion Criteria: * Ability to provide written informed consent by subject or guardian * Individuals \>18 years of age * Diagnosis of an irAE clinically suspected to be IL-17 mediated * Intent-to-treat or prior treatment with systemic steroids for irAE management * Histology-proven primary advanc...