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.
- Chronic Hives
- Chronic Idiopathic Urticaria
- Chronic Urticaria
Treatment Effectiveness
Phase-Based Effectiveness
Study Objectives
2 Primary · 26 Secondary · Reporting Duration: week 12 and week 40
Trial Safety
Phase-Based Safety
Awards & Highlights
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
Trial Logistics
Trial Timeline
Who is running the clinical trial?
Eligibility Criteria
Age 18 - 75 · All Participants · 1 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:Who else is applying?
What state do they live in?
Utah | 100.0% |
What site did they apply to?
10004 | 100.0% |
What portion of applicants met pre-screening criteria?
Met criteria | 100.0% |
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:
- 10004: < 48 hours
Typically responds via
Phone Call | 100.0% |
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
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
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
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
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
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
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
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