Den här översättningen är inte klar ännu. Den här sidan är just nu på engelska.

Gå till den engelska sidan

Cure My Disease

Don't miss your cure!

 Log in / Sign up

New biosimilar aims to tame stubborn hives at lower cost

NCT ID NCT04976192

Disease control Sponsor: Teva Pharmaceuticals USA Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

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.

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.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

608 people

The number who actually took part.

Started

Aug 2021

Finished

Apr 2024

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 75 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Diagnosis of CIU refractory to H1 antihistamines for ≥3 months Exclusion Criteria: * Chronic urticaria with clearly defined underlying etiology * Other skin disease associated with itch * Evidence of parasitic infection on stool evaluation for ova and parasites * History of anaphylactic shock * Hypersensitivity to omalizumab or any component of the formulation * Required background therapy with other than protocol-defined antihistamines * Any medical condition that could jeopardize or would compromise the patient's safety or ability to participate in this study

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Chronic idiopathic urticaria are added.

Vår säkerhetsrekommendation!

Genom att skicka in godkänner du våra Användarvillkor

Conditions

The condition(s) this trial relates to.

chronic idiopathic urticaria chronic urticaria

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Chronic urticaria

Contacts and locations

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

More trials for these conditions

Other studies related to the condition(s) this trial covers.