Teva Pharmaceuticals USA
The purpose of the study is to compare the efficacy, pharmacokinetics, pharmacodynamics, safety, tolerability, and immunogenicity of TEV-45779 compared to XOLAIR in patients with Urticaria (CIU)/Chronic Spontaneous Urticaria (CSU) who remain symptomatic on H1 antihistamine treatment.
Chronic Urticaria
TEV-45779
XOLAIR® Injection
Phase 3
This is a multicenter, randomized, double-blind study to demonstrate similar efficacy and safety of TEV-45779 compared to XOLAIR administered sc at doses of 300 mg or 150 mg every 4 weeks for 24 weeks (6 treatments) in patients with Chronic Idiopathic Urticaria (CIU)/Chronic Spontaneous Urticaria (CSU) who remain symptomatic despite antihistamine (H1) treatment. This study will consist of a screening period (up to 2 weeks), a 24-week treatment period consisting of a 12-week double-blind main treatment period and a 12-week double-blind transition period, which is followed by a 16-week follow-up period. The total duration of the study is up to 42 weeks. At baseline, patients will be randomized in a 2:2:1:1 ratio to receive the first 3 treatments of TEV-45779 300 mg, XOLAIR 300 mg, TEV-45779 150 mg or XOLAIR 150 mg (main treatment period). At Week 12, prior to receiving their fourth dose of study medication, patients in the XOLAIR 300 mg and the XOLAIR 150 mg treatment groups will be randomized 1:1 to receive 3 additional doses of XOLAIR (at the same dose level as prior to randomization, or switch to 3 doses of TEV-45779 (transition period) at the same dose level as prior to randomization. All patients in the TEV-45779 groups will continue to receive TEV-45779 at the same dose levels.}}
| Study Type : | Interventional |
| Estimated Enrollment : | 608 participants |
| Masking : | Quadruple |
| Primary Purpose : | Treatment |
| Official Title : | Study to Evaluate the Efficacy, Safety, Tolerability, and Immunogenicity of TEV-45779 Compared to XOLAIR (Omalizumab) in Patients With Chronic Idiopathic/Spontaneous Urticaria Who Remain Symptomatic Despite Antihistamine (H1) Treatment. |
| Actual Study Start Date : | August 30, 2021 |
| Estimated Primary Completion Date : | September 19, 2023 |
| Estimated Study Completion Date : | April 5, 2024 |
| Arm | Intervention/treatment |
|---|---|
|
Experimental: TEV-45779-300 mg Main Treatment period TEV-45779 (Omalizumab) injection 150 mg/mL pre-filled syringe administered twice (total dosage 300 mg) at week 0, 4, 8 |
Combination Product: TEV-45779 |
|
Active Comparator: Xolair-300 mg Main Treatment Period XOLAIR (omalizumab) injection 150 mg/mL pre-filled syringe administered twice (total dosage 300 mg) at week 0, 4, 8 |
Combination Product: XOLAIR® Injection |
|
Experimental: TEV-45779-150 mg Main Treatment period TEV-45779 (Omalizumab) injection 150 mg/mL pre-filled syringe administered with one placebo injection at week 0, 4, 8 |
Combination Product: TEV-45779 |
|
Active Comparator: Xolair-150 mg Main Treatment Period XOLAIR (omalizumab) injection 150 mg/mL pre-filled syringe administered with one placebo injection at week 0, 4, 8 |
Combination Product: XOLAIR® Injection |
|
Experimental: TEV-45779-300 mg Main / TEV45779-300 mg Transition 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 TEV-45779-300 mg in the Main Treatment period. |
Combination Product: TEV-45779 |
|
Experimental: Xolair-300 mg Main / TEV45779-300 mg Transition 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. |
Combination Product: TEV-45779 |
|
Active Comparator: Xolair-300 mg Main / Xolair-300 mg Transition 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. |
Combination Product: XOLAIR® Injection |
|
Experimental: TEV-45779-150 mg Main / TEV-45779-150 mg Transition 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. |
Combination Product: XOLAIR® Injection |
|
Experimental: Xolair-150 mg Main / TEV-45779-150 mg Transition 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. |
Combination Product: TEV-45779 |
|
Active Comparator: Xolair-150 mg Main / Xolair-150 mg Transition 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. |
Combination Product: TEV-45779 |
| Ages Eligible for Study: | 18 Years to 75 Years |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.
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10008
Bakersfield, California, United States, 93301
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Site 10001
Clearwater, florida, United States, 33765
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10012
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10006
Kissimmee, florida, United States, 34744
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10014
Maitland, florida, United States, 32751
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10005
Miami, florida, United States, 33014
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10009
Tampa, florida, United States, 33613
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10007
Troy, road cancer, United States, 48084
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10004
Salt Lake City, Utah, United States, 84117