New biosimilar aims to tame stubborn hives at lower cost
NCT ID NCT04976192
First seen Nov 01, 2025 · Last updated Jun 19, 2026 · Updated 30 times
Summary
This completed Phase 3 trial tested whether TEV-45779, a biosimilar of the drug omalizumab (XOLAIR), works as well as the original for people with chronic hives that don't improve with antihistamines. 608 participants received either the biosimilar or XOLAIR. The main goal was to compare changes in itch severity over 12 weeks. The study aims to show that the biosimilar is a safe and effective alternative.
Disclaimer
Read more
Show less
This is a summary of
the original study
.
Summaries may miss details or leave out important information. Before applying or accepting participation, make sure you have read and understood the full study. Curemydisease.com takes no responsibility whatsoever for anything missed, misunderstood, or acted upon as a result of our summary — we know it does not capture everything.
This is a summary of the original study . Summaries may miss details or leave out important information. Before applying or accepting participation, make sure you have read and understood the full study. Curemydisease.com takes no responsibility whatsoever for anything missed, misunderstood, or acted upon as a result of our summary — we know it does not capture everything.
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for CHRONIC URTICARIA are added.
By submitting, you agree to our Terms of use
Contacts and locations
Show contact details
Enter your email to view the contact information for this study.
By submitting, you agree to our Terms of use
Locations
-
10004
Salt Lake City, Utah, 84117, United States
-
10005
Miami, Florida, 33014, United States
-
10006
Kissimmee, Florida, 34744, United States
-
10007
Troy, Michigan, 48084, United States
-
10008
Bakersfield, California, 93301, United States
-
10009
Tampa, Florida, 33613, United States
-
10012
Coral Gables, Florida, 33134, United States
-
10014
Maitland, Florida, 32751, United States
-
Site 10001
Clearwater, Florida, 33765, United States
What this could mean
Our plain-language read of the trial. This is informational only — not medical advice or a prediction.
Active substance
omalizumab (biosimilar TEV-45779)
What this could lead to
If successful, this could offer a more affordable alternative to XOLAIR for controlling chronic hives.
What could go wrong
This is a biosimilar comparison study, not a new treatment. The main risk is that TEV-45779 may not work as well as XOLAIR, or may have different side effects.
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.