What side effects are associated with this type of intervention?

The most common treatments for Chronic Urticaria, particularly those involving monoclonal antibodies like omalizumab, can have several side effects. These include local injection site reactions such as erythema, pain, or bruising. Other potential side effects are hypersensitivity reactions like rash, pruritus, and urticaria. Serious allergic reactions, although rare, can include severe urticaria and hypersensitivity vasculitis. Additionally, some patients may develop drug-neutralizing antibodies, which can increase the frequency of injection site reactions but generally do not affect the efficacy of the treatment.

What prior FDA approvals exist?

Omalizumab (XOLAIR) is an FDA-approved monoclonal antibody for the treatment of Chronic Idiopathic Urticaria (CIU) in patients who remain symptomatic despite H1 antihistamine treatment. It works by targeting and binding to IgE, thereby inhibiting its interaction with the IgE receptor on mast cells and basophils, which plays a crucial role in the allergic pathway. This mechanism helps reduce the severity and frequency of urticaria symptoms. Other treatments for CIU primarily include antihistamines and corticosteroids, but Omalizumab remains the key biologic therapy approved for this condition.

What other types of research exist?

Promising novel alternatives to TEV-45779 for Chronic Urticaria patients include: 1) Omalizumab (Xolair), a well-established monoclonal antibody targeting IgE, which has shown efficacy in patients with Chronic Idiopathic Urticaria (CIU) who are unresponsive to antihistamines. 2) Ligelizumab, another anti-IgE monoclonal antibody, which has demonstrated higher efficacy compared to omalizumab in clinical trials. 3) Dupilumab, an IL-4 receptor alpha antagonist, which has shown potential in treating various allergic conditions and is being investigated for CU. These alternatives offer different mechanisms of action and have shown promising results in clinical studies.

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Monoclonal Antibodies

TEV-45779 vs. Omalizumab for Chronic Urticaria

Phase 3

Waitlist Available

Research Sponsored by Teva Pharmaceuticals USA

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Must not have

Other skin disease associated with itch

Chronic urticaria with clearly defined underlying etiology

Timeline

Screening 3 weeks

Treatment Varies

Follow Up week 12 and week 40

Awards & highlights

Pivotal Trial

No Placebo-Only Group

Summary

This trial is testing a new drug, TEV-45779, against an existing drug, XOLAIR, in patients with chronic hives who don't respond to antihistamines. The drugs are injected periodically to help control the immune response causing the hives. XOLAIR is used to treat moderate to severe allergic asthma and chronic hives.

Who is the study for?

This trial is for adults with Chronic Idiopathic Urticaria (CIU), also known as chronic hives, who haven't found relief with standard antihistamine treatments. Participants should not have other skin conditions causing itch, a history of severe allergic reactions, or any health issues that could make the trial unsafe for them.

What is being tested?

The study aims to compare TEV-45779 and XOLAIR (Omalizumab) injections in their effectiveness and safety for treating chronic hives unresponsive to antihistamines. It will look at how the body processes these drugs and their effects on the immune system.

What are the potential side effects?

Possible side effects may include reactions at the injection site, headaches, fatigue, joint pain, and potential allergic responses. The exact side effects will be monitored throughout the study.

Eligibility Criteria

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have a skin condition that causes itching.

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I have long-term hives with a known cause.

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I am taking antihistamines not listed in the study protocol.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ week 12 and week 40

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~week 12 and week 40

This trial's timeline: 3 weeks for screening, Varies for treatment, and week 12 and week 40 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change from baseline in the ISS7 at Week 12 between TEV 45779 300 mg and XOLAIR 300 mg

Relative potency of TEV 45779 and XOLAIR

Secondary study objectives

Change from Week 12 in ISS7 at Week 24

Change from Week 12 in ISS7 at Week 40

Change from Week 12 in the UAS7 at Week 24

+23 more

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

10Treatment groups

Experimental Treatment

Active Control

Group I: Xolair-300 mg Main / TEV45779-300 mg Transition PeriodExperimental Treatment2 Interventions

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.

Group II: Xolair-150 mg Main / TEV-45779-150 mg Transition PeriodExperimental Treatment2 Interventions

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.

Group III: TEV-45779-300 mg Main Treatment periodExperimental Treatment1 Intervention

TEV-45779 (Omalizumab) injection 150 mg/mL pre-filled syringe administered twice (total dosage 300 mg) at week 0, 4, 8

Group IV: TEV-45779-300 mg Main / TEV45779-300 mg Transition PeriodExperimental Treatment1 Intervention

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.

Group V: TEV-45779-150 mg Main Treatment periodExperimental Treatment1 Intervention

TEV-45779 (Omalizumab) injection 150 mg/mL pre-filled syringe administered with one placebo injection at week 0, 4, 8

Group VI: TEV-45779-150 mg Main / TEV-45779-150 mg Transition PeriodExperimental Treatment1 Intervention

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.

Group VII: Xolair-300 mg Main / Xolair-300 mg Transition PeriodActive Control1 Intervention

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.

Group VIII: Xolair-150 mg Main / Xolair-150 mg Transition PeriodActive Control1 Intervention

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.

Group IX: Xolair-300 mg Main Treatment PeriodActive Control1 Intervention

XOLAIR (omalizumab) injection 150 mg/mL pre-filled syringe administered twice (total dosage 300 mg) at week 0, 4, 8

Group X: Xolair-150 mg Main Treatment PeriodActive Control1 Intervention

XOLAIR (omalizumab) injection 150 mg/mL pre-filled syringe administered with one placebo injection at week 0, 4, 8

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

TEV-45779

2021

Completed Phase 3

~610

XOLAIR® Injection

2021

Completed Phase 3

~610

0 / 3Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for Chronic Urticaria, particularly monoclonal antibodies like omalizumab, work by targeting and neutralizing IgE, a key antibody involved in allergic reactions. By binding to IgE, these treatments prevent it from attaching to mast cells and basophils, which are responsible for releasing histamine and other inflammatory mediators that cause the symptoms of urticaria. This mechanism is crucial for Chronic Urticaria patients as it helps reduce the frequency and severity of hives and itching, improving their quality of life and reducing the need for other medications like antihistamines and corticosteroids.

Symptomatic Dermographism: A Systematic Review of Treatment Options.