TEV-45779 vs. Omalizumab for Chronic Urticaria

No longer 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment, TEV-45779, against XOLAIR (Omalizumab) for individuals with chronic hives, also known as chronic urticaria, that do not improve with standard allergy medications like H1 antihistamines. The trial evaluates the effectiveness, safety, and bodily impact of TEV-45779 compared to XOLAIR. Individuals who continue to experience hives after using H1 antihistamines for at least three months may be suitable candidates for this study. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants a chance to contribute to potentially groundbreaking treatment advancements.

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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Studies have shown that TEV-45779 is generally safe, with side effects similar to those of Xolair, a well-known treatment. The FDA has already approved Xolair for other uses, indicating its safety for humans. Most reported side effects are mild or moderate, such as headaches and minor breathing issues. This suggests TEV-45779 is likely well-tolerated, as ongoing research aims to match Xolair's safety profile. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about TEV-45779 because it offers a potential new option for treating chronic urticaria, a condition that causes itchy hives and swelling. Unlike the standard treatment, which often relies on Xolair (omalizumab), TEV-45779 could provide a different formulation or dosing schedule that might improve patient outcomes. Additionally, TEV-45779 maintains the known benefits of omalizumab but may offer better convenience or efficacy, which can be particularly appealing for individuals whose symptoms are not fully managed by current options. This could mean more effective relief for those living with persistent hives.

What evidence suggests that this trial's treatments could be effective for chronic urticaria?

Research has shown that omalizumab, a treatment for chronic hives, has helped many patients. One study found that 9 out of 11 patients with chronic spontaneous hives experienced complete symptom relief after using omalizumab. This suggests its effectiveness in relieving symptoms for similar conditions. In this trial, researchers are testing a new treatment, TEV-45779, to determine if it can offer the same benefits as omalizumab. Participants will receive either TEV-45779 or omalizumab, with both treatments aiming to help people with chronic hives reduce or eliminate their symptoms. ^{1 4 5 6 7}

Who Is on the Research Team?

Teva Medical Expert, MD

Principal Investigator

Teva Pharmaceuticals Development, Inc.

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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 (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]

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]

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, 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]

Citations

1. trial.medpath.com trial.medpath.com/clinical-trial/f68b9b1a514ef2a1/nct04976192-study-tev-45779-xolair-urticaria

Study to Compare Efficacy and Safety of TEV-45779 With ... The purpose of the study is to compare the efficacy, pharmacokinetics, pharmacodynamics, safety, tolerability, and immunogenicity of TEV-45779 ...

2. ctv.veeva.com ctv.veeva.com/study/study-to-compare-efficacy-and-safety-of-tev-45779-with-xolair-omalizumab-in-adults-with-chronic-id

Study to Compare Efficacy and Safety of TEV-45779 With ... The purpose of the study is to compare the efficacy, pharmacokinetics, pharmacodynamics, safety, tolerability, and immunogenicity of TEV-45779 compared to ...

3. cdn.clinicaltrials.gov cdn.clinicaltrials.gov/large-docs/92/NCT04976192/SAP_001.pdf

Statistical Analysis Plan This is a multicenter, randomized, double-blind study to demonstrate similar efficacy and safety of. TEV-45779 compared to XOLAIR administered ...

4. withpower.com withpower.com/trial/phase-3-chronic-urticaria-7-2021-181f1

TEV-45779 vs. Omalizumab for Chronic Urticaria In a study of 11 patients with chronic spontaneous urticaria, 9 achieved complete resolution of symptoms after treatment with omalizumab, with an average time ...

5. cdek.pharmacy.purdue.edu cdek.pharmacy.purdue.edu/trial/NCT04976192/

Trial | NCT04976192 The purpose of the study is to compare the efficacy, pharmacokinetics, pharmacodynamics, safety, tolerability, and immunogenicity of TEV-45779 compared to ...

6. go.drugbank.com go.drugbank.com/drugs/DB00043/clinical_trials?conditions=DBCOND0037544&phase=3&purpose=treatment&status=completed

Omalizumab Completed Phase 3 Trials for Chronic ... Study to Compare Efficacy and Safety of TEV-45779 With XOLAIR (Omalizumab) in Adults With Chronic Idiopathic Urticaria. Omalizumab (DB00043) ...

7. clinicaltrialsregister.eu clinicaltrialsregister.eu/ctr-search/trial/2021-001796-17/CZ

Clinical Trials Register ... Urticaria/Chronic Spontaneous Urticaria That ... To compare the safety and tolerability between TEV 45779 and XOLAIR -throughout the study