Study to Compare Efficacy and Safety of TEV-45779 With XOLAIR (Omalizumab) in Adults With Chronic Idiopathic Urticaria
Chronic Urticaria
About this trial
This is an interventional treatment trial for Chronic Urticaria
Eligibility Criteria
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 anaphylactic shock
- Hypersensitivity to omalizumab or any component of the formulation
- Required background therapy with other than protocol-defined antihistamines
- Any medical condition that could jeopardize or would compromise the patient's safety or ability to participate in this study
Sites / Locations
- 10008
- Site 10001
- 10012
- 10006
- 10014
- 10005
- 10009
- 10007
- 10004
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm 6
Arm 7
Arm 8
Arm 9
Arm 10
Experimental
Active Comparator
Experimental
Active Comparator
Experimental
Experimental
Active Comparator
Experimental
Experimental
Active Comparator
TEV-45779-300 mg Main Treatment period
Xolair-300 mg Main Treatment Period
TEV-45779-150 mg Main Treatment period
Xolair-150 mg Main Treatment Period
TEV-45779-300 mg Main / TEV45779-300 mg Transition Period
Xolair-300 mg Main / TEV45779-300 mg Transition Period
Xolair-300 mg Main / Xolair-300 mg Transition Period
TEV-45779-150 mg Main / TEV-45779-150 mg Transition Period
Xolair-150 mg Main / TEV-45779-150 mg Transition Period
Xolair-150 mg Main / Xolair-150 mg Transition Period
TEV-45779 (Omalizumab) injection 150 mg/mL pre-filled syringe administered twice (total dosage 300 mg) at week 0, 4, 8
XOLAIR (omalizumab) injection 150 mg/mL pre-filled syringe administered twice (total dosage 300 mg) at week 0, 4, 8
TEV-45779 (Omalizumab) injection 150 mg/mL pre-filled syringe administered with one placebo injection at week 0, 4, 8
XOLAIR (omalizumab) injection 150 mg/mL pre-filled syringe administered with one placebo injection at week 0, 4, 8
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.
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 (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 (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.
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 (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.