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Monoclonal Antibodies
TEV-45779 vs. Omalizumab for Chronic Urticaria
Phase 3
Waitlist Available
Research Sponsored by Teva Pharmaceuticals USA
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up week 12 and week 40
Awards & highlights
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.
Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
Possible side effects may include reactions at the injection site, headaches, fatigue, joint pain, and potential allergic responses. The exact side effects will be monitored throughout the study.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ week 12 and week 40
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 12 and week 40
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change from baseline in the ISS7 at Week 12 between TEV 45779 300 mg and XOLAIR 300 mg
Relative potency of TEV 45779 and XOLAIR
Secondary outcome measures
Change from Week 12 in ISS7 at Week 24
Change from Week 12 in ISS7 at Week 40
Change from Week 12 in the UAS7 at Week 24
+23 moreTrial Design
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 Location
Who is running the clinical trial?
Teva Pharmaceuticals Development, Inc.UNKNOWN
Teva Pharmaceuticals USALead Sponsor
230 Previous Clinical Trials
187,600 Total Patients Enrolled
Teva Medical Expert, MDStudy DirectorTeva Pharmaceuticals Development, Inc.
93 Previous Clinical Trials
38,171 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have signs of parasitic infection in your stool.My chronic hives haven't improved with allergy medication for over 3 months.You have had a severe allergic reaction called anaphylactic shock in the past.I have a skin condition that causes itching.I have long-term hives with a known cause.You are allergic to omalizumab or any of the ingredients in it.I am taking antihistamines not listed in the study protocol.
Research Study Groups:
This trial has the following groups:- Group 1: TEV-45779-300 mg Main / TEV45779-300 mg Transition Period
- Group 2: Xolair-300 mg Main / TEV45779-300 mg Transition Period
- Group 3: Xolair-300 mg Main / Xolair-300 mg Transition Period
- Group 4: TEV-45779-150 mg Main / TEV-45779-150 mg Transition Period
- Group 5: Xolair-150 mg Main / Xolair-150 mg Transition Period
- Group 6: Xolair-150 mg Main / TEV-45779-150 mg Transition Period
- Group 7: TEV-45779-300 mg Main Treatment period
- Group 8: Xolair-300 mg Main Treatment Period
- Group 9: TEV-45779-150 mg Main Treatment period
- Group 10: Xolair-150 mg Main Treatment Period
Awards:
This trial has 2 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Chronic Urticaria Patient Testimony for trial: Trial Name: NCT04976192 — Phase 3
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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."
Answered by AI
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."
Answered by AI
Does this research study include geriatric patients?
"This trial's age requirements are that potential participants must be between 18-75 years old."
Answered by AI
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."
Answered by AI
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."
Answered by AI
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."
Answered by AI
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."
Answered by AI
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."
Answered by AI
Who else is applying?
What state do they live in?
Utah
What site did they apply to?
10004
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
3+
Why did patients apply to this trial?
I’ve tried 5 different medications and still have symptoms.
PatientReceived no prior treatments
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?
PatientReceived 2+ prior treatments
How responsive is this trial?
Typically responds via
Phone Call
Most responsive sites:
- 10004: < 48 hours
Average response time
- < 2 Days
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