TEV-45779 vs. Omalizumab for Chronic Urticaria
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.12345
Is Omalizumab (Xolair) safe for use in humans?
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.12379
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
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Main Treatment
Participants receive either TEV-45779 or XOLAIR at doses of 300 mg or 150 mg every 4 weeks for 12 weeks
Transition Treatment
Participants continue with their assigned treatment or switch to TEV-45779 for an additional 12 weeks
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- TEV-45779
- XOLAIR (Omalizumab)
Find a Clinic Near You
Who Is Running the Clinical Trial?
Teva Pharmaceuticals USA
Lead Sponsor
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