608 Participants Needed

TEV-45779 vs. Omalizumab for Chronic Urticaria

Recruiting at 9 trial locations
MT
Overseen ByMD Teva U.S. Medical Information
Age: 18+
Sex: Any
Trial Phase: Phase 3
Sponsor: Teva Pharmaceuticals USA
Must be taking: H1 antihistamines
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Pivotal Trial (Near Approval)This treatment is in the last trial phase before FDA approval
Prior Safety DataThis treatment has passed at least one previous human trial

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but it mentions that participants should not require background therapy with medications other than the specified antihistamines.

What data supports the effectiveness of the drug Omalizumab for treating chronic urticaria?

Omalizumab (Xolair) has been shown to significantly reduce itching, hives, and improve quality of life in patients with chronic spontaneous urticaria who do not respond to antihistamines, according to well-controlled clinical trials. It is generally well tolerated, with most side effects being mild or moderate.12345

Is Omalizumab (Xolair) safe for use in humans?

Omalizumab (Xolair) is generally considered safe for use in humans, with most side effects being mild or moderate, such as headaches and upper respiratory infections. Rarely, it may cause serious allergic reactions like anaphylaxis, but this is uncommon.12678

How does the drug TEV-45779 differ from Omalizumab for treating chronic urticaria?

The research does not provide specific information about TEV-45779, but Omalizumab is unique because it is a monoclonal antibody that targets IgE (a type of antibody involved in allergic reactions) to reduce symptoms of chronic urticaria, and it is administered as an injection every four weeks.12379

Research Team

TM

Teva Medical Expert, MD

Principal Investigator

Teva Pharmaceuticals Development, Inc.

Eligibility Criteria

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.

Inclusion Criteria

My chronic hives haven't improved with allergy medication for over 3 months.

Exclusion Criteria

You have signs of parasitic infection in your stool.
Any medical condition that could jeopardize or would compromise the patient's safety or ability to participate in this study
You have had a severe allergic reaction called anaphylactic shock in the past.
See 4 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2 weeks

Main Treatment

Participants receive either TEV-45779 or XOLAIR at doses of 300 mg or 150 mg every 4 weeks for 12 weeks

12 weeks
3 visits (in-person)

Transition Treatment

Participants continue with their assigned treatment or switch to TEV-45779 for an additional 12 weeks

12 weeks
3 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

16 weeks

Treatment Details

Interventions

  • TEV-45779
  • XOLAIR (Omalizumab)
Trial OverviewThe 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.
Participant Groups
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

Find a Clinic Near You

Who Is Running the Clinical Trial?

Teva Pharmaceuticals USA

Lead Sponsor

Trials
232
Recruited
189,000+

Dr. Eric A. Hughes

Teva Pharmaceuticals USA

Chief Medical Officer since 2022

MD and PhD from Yale School of Medicine

Richard Francis profile image

Richard Francis

Teva Pharmaceuticals USA

Chief Executive Officer since 2023

BSc in Biochemistry from Imperial College London

Teva Pharmaceuticals Development, Inc.

Collaborator

Trials
1
Recruited
610+

Findings from Research

In a study of 11 patients with chronic spontaneous urticaria, 9 achieved complete resolution of symptoms after treatment with omalizumab, with an average time to remission of 9.3 weeks.
Omalizumab was found to be safe, as no side effects were reported during the treatment, indicating its potential as an effective option for patients unresponsive to other therapies.
Omalizumab for urticaria treatment in clinical practice: a case series.Lesiak, A., Bednarski, IA., Maćkowska, A., et al.[2022]
Omalizumab is an effective add-on therapy for patients with chronic spontaneous urticaria, significantly reducing itching and hives severity, and improving quality of life compared to placebo in well-controlled trials lasting 12 to 24 weeks.
The treatment is generally well tolerated, with adverse events similar in frequency and severity to those experienced by placebo recipients, primarily involving mild to moderate headaches and upper respiratory infections.
Omalizumab: a review of its use in patients with chronic spontaneous urticaria.McCormack, PL.[2021]
A study involving 6038 patients showed that nearly all individuals starting treatment with omalizumab had previously used multiple asthma medications, indicating that they were likely experiencing severe asthma symptoms despite existing treatments.
A significant number of new omalizumab users had recent asthma-related emergency room visits (up to 36% in Medicaid) or hospitalizations, highlighting the need for effective management in patients with moderate to severe persistent allergic asthma.
Concomitant asthma medication use in patients receiving omalizumab: results from three large insurance claims databases.Lafeuille, MH., Duh, MS., Zhang, J., et al.[2015]

References

Omalizumab for urticaria treatment in clinical practice: a case series. [2022]
Omalizumab: a review of its use in patients with chronic spontaneous urticaria. [2021]
Concomitant asthma medication use in patients receiving omalizumab: results from three large insurance claims databases. [2015]
Omalizumab Drug Survival in Chronic Urticaria: A Retrospective Multicentric French Study. [2023]
Safety and tolerability of omalizumab. [2023]
Omalizumab for the Treatment of Chronic Idiopathic Urticaria: Systematic Review of the Literature. [2018]
Evaluation of IgE Antibodies to Omalizumab (Xolair®) and Their Potential Correlation to Anaphylaxis. [2018]
Safety and tolerability of omalizumab (Xolair), a recombinant humanized monoclonal anti-IgE antibody. [2022]
Omalizumab in the treatment of chronic urticaria. [2022]