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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT06114238 | Pharmacokinetic Study to Compare Itepekimab Exposure When Administered With an Autoinjector Versus Prefilled Syringe | PHASE1 | COMPLETED | 90 | — | — | Sep 16, 2021 | Mar 8, 2022 | Sep 19, 2024 | 1 | United States |
Maximum plasma concentration of itepekimab
AUClast: Area under the plasma concentration versus time curve calculated using the trapezoidal method from time zero to the real time tlast
AUC: Area under the plasma concentration versus time curve extrapolated to infinity
| Arm | Type | Description |
|---|---|---|
| Cohort 1 | EXPERIMENTAL | Itepekimab administered via AI |
| Cohort 2 | ACTIVE_COMPARATOR | Itepekimab administered via PFS |
| Name | Type | Description |
|---|---|---|
| Itepekimab AI | DRUG | Pharmaceutical form:Solution for injection; Route of administration: Subcutaneous AI |
| Itepekimab PFS | DRUG | Pharmaceutical form:Solution for injection; Route of administration: Subcutaneous PFS |
Inclusion Criteria: • Having given written informed consent prior to undertaking any study-related procedure. Exclusion Criteria: Participants are excluded from the study if any of the following criteria apply: • Any participant who, in the judgment of the Investigator, is likely to be noncompli...