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New hope for teens with stubborn hives: xolair shows promise

NCT ID NCT06053801

Symptom relief Sponsor: Novartis Pharmaceuticals 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 study looked at whether Xolair (omalizumab) is safe and works for Chinese teenagers with chronic spontaneous urticaria (long-term hives and itching) that doesn't get better with standard antihistamines. 55 teens took part, receiving Xolair for 12 weeks, followed by 4 weeks of safety check-ups. The main goal was to track side effects and see how well the drug reduced itching.

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.

Participants

55 people

The number who actually took part.

Started

Feb 2024

Finished

Aug 2025

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.

Who is studied

Chinese pediatric patients aged between 12 to less than 18 years and diagnosed with Chronic Spontaneous Urticaria.

Ages

12 to 17 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: The patient should meet all of the following criteria: 1. Diagnosed with CSU refractory to H1-AH at approved doses as defined by all of the following: * The presence of itch and hives for ≥ 6 consecutive weeks at any time prior to enrollment despite current use of second-generation H1-AH (at locally approved doses) * UAS7 score (range 0-42) ≥ 16 and ISS7 (range 0-21) ≥ 8 as captured in the UPDD during the 7 days prior to treatment initiation with Xolair® 2. Willing and able to complete a daily symptom Diary (UPDD) for the duration of the study, and having no more than 3 missing diary entries in the screening period. 3. Planned to receive Xolair® treatment according to the approved label in China at the time of screening. Exclusion Criteria: The patient should not meet any of the following criteria: 1. Use of other investigational drugs for CSU treatment within 5 half-lives, or within 30 days (for small molecules) prior to screening or until the expected pharmacodynamic effect has returned to baseline (for biologics), whichever is longer. 2. History of hypersensitivity to any of the anti-IgE drugs or their excipients or to drugs of similar classes (i.e. to murine, chimeric, or human antibodies). 3. Any other skin disease associated with chronic itching that might influence, in the investigators opinion, the study evaluations and results. (e.g. atopic dermatitis, bullous pemphigoid, dermatitis herpetiformis, senile pruritus, etc.) Other protocol-defined inclusion/exclusion criteria may apply at the end.

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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 spontaneous urticaria

Contacts and locations

Locations

  • Novartis Investigative Site

    Fuzhou, Fujian, 350025, China

  • Novartis Investigative Site

    Guangzhou, Guangdong, 510091, China

  • Novartis Investigative Site

    Changsha, Hunan, 410008, China

  • Novartis Investigative Site

    Nantong, Jiangsu, 226000, China

  • Novartis Investigative Site

    Dalian, Liaoning, 116000, China

  • Novartis Investigative Site

    Hangzhou, Zhejiang, 310001, China

  • Novartis Investigative Site

    Hangzhou, Zhejiang, 310006, China

  • Novartis Investigative Site

    Wenzhou, Zhejiang, 325000, China

  • Novartis Investigative Site

    Beijing, 100069, China

  • Novartis Investigative Site

    Shanghai, 200443, China

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