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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT04976192 | Study to Compare Efficacy and Safety of TEV-45779 With XOLAIR (Omalizumab) in Adults With Chronic Idiopathic Urticaria | PHASE3 | COMPLETED | 608 | — | — | Aug 30, 2021 | Apr 5, 2024 | Oct 7, 2025 | 9 | United States |
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 ...