TEV-45779 vs. Omalizumab for Chronic Urticaria

Recruiting at 9 trial locations

Overseen By MD Teva U.S. Medical Information

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Teva Pharmaceuticals USA

Must be taking: H1 antihistamines

Must not be taking: Omalizumab

Disqualifiers: Chronic urticaria, Skin disease, Anaphylactic history, others

No Placebo Group All 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 Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 6

608 Participants Needed

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. ^{1 2 3 4 5}

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. ^{1 2 6 7 8}

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. ^{1 2 3 7 9}

Research Team

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.

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 Overview 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.

Participant Groups

Group I: Xolair-300 mg Main / TEV45779-300 mg Transition Period Experimental Treatment 2 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 Period Experimental Treatment 2 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 period Experimental Treatment 1 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 Period Experimental Treatment 1 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 period Experimental Treatment 1 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 Period Experimental Treatment 1 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 Period Active Control 1 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 Period Active Control 1 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 Period Active Control 1 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 Period Active Control 1 Intervention

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

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

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Concomitant asthma medication use in patients receiving omalizumab: results from three large insurance claims databases. Lafeuille, MH., Duh, MS., Zhang, J., et al.[2015]

In a study of 878 French patients with chronic urticaria, omalizumab (OMA) showed a longer drug survival rate compared to previous studies, with 50% of patients still on treatment 2.4 years after starting.

The main reason for discontinuing OMA was achieving well-controlled disease in 50% of patients, but many were able to restart treatment, indicating its effectiveness in managing chronic urticaria.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Omalizumab Drug Survival in Chronic Urticaria: A Retrospective Multicentric French Study. Litovsky, J., Hacard, F., Tétart, F., et al.[2023]

Omalizumab has a favorable safety profile, with a low incidence of anaphylaxis (0.14%) in treated patients, comparable to control patients (0.07%), and no measurable anti-omalizumab antibodies were found in treated individuals.

The drug has been shown to be effective for patients with moderate-to-severe allergic asthma, and clinical data do not indicate an increased risk of serious side effects like malignant neoplasia or thrombocytopenia, even after long-term use of up to 4 years.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety and tolerability of omalizumab. Corren, J., Casale, TB., Lanier, B., et al.[2023]

Omalizumab, a monoclonal antibody used to treat IgE-mediated diseases, has a low incidence of anaphylaxis, reported in only 0.1% of asthma patients during clinical trials and estimated at 0.2% in post-marketing studies.

A post-marketing study found no correlation between anaphylaxis or skin test reactions and the presence of IgE antibodies to omalizumab, suggesting that the risk of anaphylaxis may not be related to the drug's immunogenicity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of IgE Antibodies to Omalizumab (Xolair®) and Their Potential Correlation to Anaphylaxis. Baker, DL., Nakamura, GR., Lowman, HB., et al.[2018]

Omalizumab (Xolair) is an effective treatment for moderate-to-severe persistent asthma in patients aged 12 and older who have a positive reaction to allergens and whose symptoms are not well controlled by inhaled corticosteroids, based on data from over 5,243 patients in 12 clinical trials.

The safety profile of omalizumab is comparable to that of placebo or standard therapy, indicating it is a well-tolerated option for managing IgE-mediated asthma.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety and tolerability of omalizumab (Xolair), a recombinant humanized monoclonal anti-IgE antibody. Deniz, YM., Gupta, N.[2022]

References

1. Poland pubmed.ncbi.nlm.nih.gov

Omalizumab for urticaria treatment in clinical practice: a case series. [2022]

2. New Zealand pubmed.ncbi.nlm.nih.gov

Omalizumab: a review of its use in patients with chronic spontaneous urticaria. [2021]

3. England pubmed.ncbi.nlm.nih.gov

Concomitant asthma medication use in patients receiving omalizumab: results from three large insurance claims databases. [2015]

4. United States pubmed.ncbi.nlm.nih.gov

Omalizumab Drug Survival in Chronic Urticaria: A Retrospective Multicentric French Study. [2023]

5. England pubmed.ncbi.nlm.nih.gov

Safety and tolerability of omalizumab. [2023]

6. United States pubmed.ncbi.nlm.nih.gov

Omalizumab for the Treatment of Chronic Idiopathic Urticaria: Systematic Review of the Literature. [2018]

7. United States pubmed.ncbi.nlm.nih.gov

Evaluation of IgE Antibodies to Omalizumab (Xolair®) and Their Potential Correlation to Anaphylaxis. [2018]

8. United States pubmed.ncbi.nlm.nih.gov

Safety and tolerability of omalizumab (Xolair), a recombinant humanized monoclonal anti-IgE antibody. [2022]

9. Spain pubmed.ncbi.nlm.nih.gov

Omalizumab in the treatment of chronic urticaria. [2022]