Approval Probability
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TEV-45779 · 1 trial · 1 indication
The severity of the itch was recorded by the participants twice daily in their eDiary, on a scale of 0 (none) to 3 (intense/severe). A weekly itch score (ISS7) was defined as the sum of the available daily itch severity scores in that week, divided by the number of days for which a daily itch severity score was available, multiplied by 7. The daily ISS was calculated as the average of the morning and evening scores. The possible range of the weekly score was therefore 0 (best score) to 21 (worst score) with higher scores indicating more severe itching. Least square (LS) mean and 95% confidence interval (CI) were calculated using analysis of covariance (ANCOVA) model. Multiple imputation performed both for the participants having missing ISS7 at week 12 and for participants using any disallowed concomitant medication.
The severity of the itch was recorded by the participants twice daily in their eDiary, on a scale of 0 (none) to 3 (intense/severe). A weekly itch score (ISS7) was defined as the sum of the available daily itch severity scores in that week, divided by the number of days for which a daily itch severity score was available, multiplied by 7. The daily ISS was calculated as the average of the morning and evening scores. The possible range of the weekly score was therefore 0 (best score) to 21 (worst score) with higher scores indicating more severe itching. LS mean and 90% CI were calculated using ANCOVA model. Multiple imputation performed for the participants having missing ISS7 at week 12.
| Arm | Type | Description |
|---|---|---|
| TEV-45779-300 mg Main Treatment period | EXPERIMENTAL | TEV-45779 (Omalizumab) injection 150 mg/mL pre-filled syringe administered twice (total dosage 300 mg) at week 0, 4, 8 |
| Xolair-300 mg Main Treatment Period | ACTIVE_COMPARATOR | XOLAIR (omalizumab) injection 150 mg/mL pre-filled syringe administered twice (total dosage 300 mg) at week 0, 4, 8 |
| TEV-45779-150 mg Main Treatment period | EXPERIMENTAL | TEV-45779 (Omalizumab) injection 150 mg/mL pre-filled syringe administered with one placebo injection at week 0, 4, 8 |
| Xolair-150 mg Main Treatment Period | ACTIVE_COMPARATOR | XOLAIR (omalizumab) injection 150 mg/mL pre-filled syringe administered with one placebo injection at week 0, 4, 8 |
| TEV-45779-300 mg Main / TEV45779-300 mg Transition Period | EXPERIMENTAL | TEV-45779 (Omalizumab) injection 150 mg/mL pre-filled syringe administered twice (total dosage 300 mg) at week 12,16,20 in patients that were randomized to TEV-45779-300 mg in the Main Treatment period. |
| Xolair-300 mg Main / TEV45779-300 mg Transition Period | EXPERIMENTAL | TEV-45779 (Omalizumab) injection 150 mg/mL pre-filled syringe administered twice (total dosage 300 mg) at week 12,16,20 in patients that were randomized to Xolair-300 mg in the main treatment period. |
| Xolair-300 mg Main / Xolair-300 mg Transition Period | ACTIVE_COMPARATOR | XOLAIR (omalizumab) injection 150 mg/mL pre-filled syringe administered twice (total dosage 300 mg) at week 12,16,20 in patients that were randomized to Xolair-300 mg in the main treatment period. |
| TEV-45779-150 mg Main / TEV-45779-150 mg Transition Period | EXPERIMENTAL | TEV-45779 (Omalizumab) injection 150 mg/mL pre-filled syringe administered with one placebo injection at week 12,16,20 in patients that were randomized to TEV-45779-150 mg in the main treatment period. |
| Xolair-150 mg Main / TEV-45779-150 mg Transition Period | EXPERIMENTAL | TEV-45779 (Omalizumab) injection 150 mg/mL pre-filled syringe administered with one placebo injection at week 12,16,20 in patients that were randomized to XOLAIR-150 mg in the main treatment period. |
| Xolair-150 mg Main / Xolair-150 mg Transition Period | ACTIVE_COMPARATOR | XOLAIR (omalizumab) injection 150 mg/mL pre-filled syringe administered with one placebo injection at week 12,16,20 in patients that were randomized to XOLAIR -150 mg in the main treatment period. |
| Name | Type | Description |
|---|---|---|
| TEV-45779 | COMBINATION_PRODUCT | TEV-45779 (Omalizumab) solution for injection 150 mg/mL prefilled syringe |
| XOLAIR® Injection | COMBINATION_PRODUCT | XOLAIR (omalizumab) injection is supplied as a single dose PFS. Each PFS of XOLAIR contains 150 mg of omalizumab in 1 mL of solution. |
Inclusion Criteria: * Diagnosis of CIU refractory to H1 antihistamines for ≥3 months Exclusion Criteria: * Chronic urticaria with clearly defined underlying etiology * Other skin disease associated with itch * Evidence of parasitic infection on stool evaluation for ova and parasites * History of ...
TEV-45779 is an investigational small molecule being developed for chronic urticaria, a skin condition characterized by recurrent hives. It is being studied in adults with chronic idiopathic urticaria, a form of the condition with no identifiable trigger. The drug is currently in Phase 3 clinical development.
TEV-45779 is a small molecule, but its specific molecular target has not been disclosed. It is being studied as a potential treatment for chronic urticaria, with a Phase 3 trial comparing it to omalizumab, an approved biologic for this condition. The mechanism of action is not publicly detailed.
TEV-45779 is being developed by Teva Pharmaceutical Industries Limited, a global pharmaceutical company traded on the NYSE under the ticker TEVA. The drug is currently in Phase 3 clinical development for chronic urticaria.
TEV-45779 is in Phase 3 clinical development. It is an investigational drug and has not been approved by regulatory authorities. A Phase 3 trial comparing it to omalizumab in adults with chronic idiopathic urticaria has been completed.
TEV-45779 has one completed Phase 3 trial, NCT04976192, which compared its efficacy and safety with omalizumab in adults with chronic idiopathic urticaria. The randomized, double-blind, active-controlled study enrolled 608 participants in the United States and has been completed.
No, TEV-45779 is not the same as omalizumab. TEV-45779 is a small molecule being developed by Teva, while omalizumab is an approved biologic antibody. They are being compared in a Phase 3 clinical trial for chronic idiopathic urticaria, but they are distinct drug products.