All > Chronic Spontaneous Urticaria

TEV-45779 for Chronic Hives

10006, Kissimmee, FL
Chronic Hives+9 More ConditionsTEV-45779 - CombinationProduct
Eligibility
18 - 75
All Sexes

Study Summary

This trial will compare two drugs to see which is more effective in treating people with hives who don't respond well to antihistamines.

Eligible Conditions
  • Chronic Hives
  • Chronic Idiopathic Urticaria
  • Chronic Urticaria

Treatment Effectiveness

Phase-Based Effectiveness

2 of 3
Phase 3
This is further along than 85% of similar trials

Similar Trials

1
Nucala
1
barzolvolimab
1
barzolvolimab

Study Objectives

2 Primary · 26 Secondary · Reporting Duration: week 12 and week 40

Baseline and week 12
Change from baseline in the ISS7 at Week 12 between TEV 45779 300 mg and XOLAIR 300 mg
Change from baseline in the UAS7 at Week 12
Change from baseline in the overall DLQI score at Week 12
Change from baseline in the physician's (in-clinic) assessment of UAS7 at Week 12
Change from baseline in the weekly number of wheals score at Week 12
Change from baseline in the weekly size of the largest wheals score at Week 12
Percentage of ISS7 MID responders at Week 12
Relative potency of TEV 45779 and XOLAIR
Baseline till week 12
Incidence of adverse event and withdrawals due to adverse events in the main period
Incidence of antidrug antibodies (ADAs) in the main treatment period
Time to MID response in ISS7 score by Week 12
Week 12
Change from baseline in the ISS7 at Week 12
week 12
Percentage of complete responders (UAS7=0) at Week 12
Percentage of patients with a UAS7 ≤6 at Week 12
Week 24
Change from Week 12 in ISS7 at Week 24
Change from Week 12 in the UAS7 at Week 24
Change from Week 12 in the overall DLQI score at Week 24
Change from Week 12 in the physician's (in-clinic) assessment of UAS7 at Week 24
Change from Week 12 in the weekly number of the largest wheals score at Week 24
Change from Week 12 in the weekly number of wheals score at Week 24
Percentage of angioedema-free days from Week 12 to Week 24
Week 40
Change from Week 12 in ISS7 at Week 40
Change from Week 12 in the overall DLQI score at Week 40
Change from Week 12 in the weekly number of the largest wheals score at Week 40
Change from Week 12 in the weekly number of wheals score at Week 40
Week 40
Incidence of adverse event in the transition and follow up period
Incidence of antidrug antibodies (ADAs) in the transition and follow up period
Week 12
Percentage of angioedema-free days from Week 4 to Week 12

Trial Safety

Phase-Based Safety

3 of 3
This is further along than 85% of similar trials

Similar Trials

1
Nucala
2
barzolvolimab
2
barzolvolimab

Awards & Highlights

No Placebo Group
All patients enrolled in this trial will receive the new treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

Trial Design

10 Treatment Groups

Xolair-300 mg Main / Xolair-300 mg Transition Period
1 of 10
Xolair-300 mg Main Treatment Period
1 of 10
Xolair-150 mg Main / Xolair-150 mg Transition Period
1 of 10
Xolair-150 mg Main Treatment Period
1 of 10
Xolair-150 mg Main / TEV-45779-150 mg Transition Period
1 of 10
TEV-45779-300 mg Main Treatment period
1 of 10
TEV-45779-150 mg Main / TEV-45779-150 mg Transition Period
1 of 10
Xolair-300 mg Main / TEV45779-300 mg Transition Period
1 of 10
TEV-45779-150 mg Main Treatment period
1 of 10
TEV-45779-300 mg Main / TEV45779-300 mg Transition Period
1 of 10

Active Control

Experimental Treatment

600 Total Participants · 10 Treatment Groups

Primary Treatment: TEV-45779 · No Placebo Group · Phase 3

Xolair-150 mg Main / TEV-45779-150 mg Transition PeriodExperimental Group · 2 Interventions: XOLAIR® Injection, TEV-45779 · Intervention Types: CombinationProduct, CombinationProduct
TEV-45779-300 mg Main Treatment period
CombinationProduct
Experimental Group · 1 Intervention: TEV-45779 · Intervention Types: CombinationProduct
TEV-45779-150 mg Main / TEV-45779-150 mg Transition Period
CombinationProduct
Experimental Group · 1 Intervention: TEV-45779 · Intervention Types: CombinationProduct
Xolair-300 mg Main / TEV45779-300 mg Transition PeriodExperimental Group · 2 Interventions: XOLAIR® Injection, TEV-45779 · Intervention Types: CombinationProduct, CombinationProduct
TEV-45779-150 mg Main Treatment period
CombinationProduct
Experimental Group · 1 Intervention: TEV-45779 · Intervention Types: CombinationProduct
TEV-45779-300 mg Main / TEV45779-300 mg Transition Period
CombinationProduct
Experimental Group · 1 Intervention: TEV-45779 · Intervention Types: CombinationProduct
Xolair-300 mg Main / Xolair-300 mg Transition Period
CombinationProduct
ActiveComparator Group · 1 Intervention: XOLAIR® Injection · Intervention Types: CombinationProduct
Xolair-300 mg Main Treatment Period
CombinationProduct
ActiveComparator Group · 1 Intervention: XOLAIR® Injection · Intervention Types: CombinationProduct
Xolair-150 mg Main / Xolair-150 mg Transition Period
CombinationProduct
ActiveComparator Group · 1 Intervention: XOLAIR® Injection · Intervention Types: CombinationProduct
Xolair-150 mg Main Treatment Period
CombinationProduct
ActiveComparator Group · 1 Intervention: XOLAIR® Injection · Intervention Types: CombinationProduct

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: week 12 and week 40

Who is running the clinical trial?

Teva Pharmaceuticals USALead Sponsor
229 Previous Clinical Trials
184,634 Total Patients Enrolled
Teva Pharmaceuticals Development, Inc.UNKNOWN
Teva Medical Expert, MDStudy DirectorTeva Pharmaceuticals Development, Inc.
87 Previous Clinical Trials
35,296 Total Patients Enrolled

Eligibility Criteria

Age 18 - 75 · All Participants · 1 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You have had chronic hives that have not responded to antihistamines for at least 3 months.

Who else is applying?

What state do they live in?
Utah100.0%
What site did they apply to?
10004100.0%
What portion of applicants met pre-screening criteria?
Met criteria100.0%
Why did patients apply to this trial?
  • "I’ve tried 5 different medications and still have symptoms."
What questions have other patients asked about this trial?
  • "Are there any medications that disqualify you? When does the study start? Are there multiple cohorts?"
How many prior treatments have patients received?
3+100.0%

How responsive is this trial?

Average response time
  • < 2 Days
Most responsive sites:
  1. 10004: < 48 hours
Typically responds via
Phone Call100.0%
References

Frequently Asked Questions

What is the intended sample size for this clinical trial?

"In order to have statistically significant results, this study requires 600 participants who meet the pre-determined inclusion criteria. There are many enrolling locations, including 10012 in Coral Gables, Florida and Site 101 in Clearwater, California." - Anonymous Online Contributor

Unverified Answer

Are people with the specific condition being sought currently able to enroll in this trial?

"Active recruitment is occurring for this clinical trial, as seen in the most recent data from clinicaltrials.gov. This study was first posted on 8/30/2021 and edited on 12/16/2021; it plans to enroll 600 patients from 10 different locations." - Anonymous Online Contributor

Unverified Answer

Does this research study include geriatric patients?

"This trial's age requirements are that potential participants must be between 18-75 years old." - Anonymous Online Contributor

Unverified Answer

Has the FDA greenlit TEV-45779 for public use?

"There is a fair amount of clinical data supporting TEV-45779's safety, as it has progressed to Phase 3 trials." - Anonymous Online Contributor

Unverified Answer

To what extent is this research being conducted in urban hospitals?

"A few of the 10 recruiting sites for this study include 10012 in Coral Gables, Florida, Site 101 in Clearwater, California, and 10008 in Bakersfield, Utah." - Anonymous Online Contributor

Unverified Answer

What has TEV-45779 been traditionally employed for?

"TEV-45779 is most frequently used to manage perennial aeroallergen reactivity. However, it can also provide symptomatic relief for patients with moderate asthma whose conditions are not well controlled by inhaled corticosteroids and histamine h1 antagonists." - Anonymous Online Contributor

Unverified Answer

Are there specific demographics that are being targeted for this experiment?

"The aim of this study is to test the efficacy of a new medication on chronic urticaria sufferers who fall between 18-75 years old. There are approximately 600 positions available." - Anonymous Online Contributor

Unverified Answer

Do you know if there has been any prior research on TEV-45779?

"The drug known as TEV-45779 was first studied a decade ago at London Chest Hospital. Out of the 102 completed clinical trials, 23 are still ongoing with many taking place in Coral Gables, Florida." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top