Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Itepekimab AI · 1 trial · 1 indication
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...
Itepekimab AI is an investigational monoclonal antibody developed by Sanofi for Chronic Obstructive Pulmonary Disease. It is in Phase 1 clinical development. The AI designation refers to an autoinjector presentation of itepekimab being studied for administration. It has been evaluated in a single completed Phase 1 trial.
Itepekimab AI is being developed for Chronic Obstructive Pulmonary Disease, a respiratory condition. The clinical program to date has focused on pharmacokinetic evaluation of the autoinjector presentation rather than on efficacy outcomes. It remains investigational and has not been approved for any use.
Itepekimab AI targets interleukin-33, or IL-33, and acts as an inhibitor of that target. IL-33 is a cytokine involved in airway inflammation, which is relevant to the respiratory indication being studied. The monoclonal antibody is designed to bind and inhibit IL-33 activity.
Itepekimab AI is developed by Sanofi, which trades under the ticker SNY. Sanofi is the sponsor of the clinical program evaluating the autoinjector presentation of itepekimab in Chronic Obstructive Pulmonary Disease.
Itepekimab AI is in Phase 1 clinical development. It is investigational and has not been approved by the FDA or any other regulatory authority. The Phase 1 program has completed one trial, and no active trials are currently listed.
Itepekimab AI has been studied in one completed Phase 1 trial, NCT06114238, titled a pharmacokinetic study comparing itepekimab exposure when administered with an autoinjector versus a prefilled syringe. The trial enrolled 90 participants in the United States, including healthy volunteers, and used an active-controlled design.