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New drug shows promise for teens with stubborn hives

NCT ID NCT03437278

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 tested a drug called ligelizumab in 49 teenagers aged 12 to 17 who had chronic hives (itchy welts) that didn't get better with standard allergy pills. The goal was to see if adding ligelizumab to their current treatment could reduce the number and severity of hives. Participants received either the study drug or a placebo, and their symptoms were tracked over several weeks.

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 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

49 people

The number who actually took part.

Started

Aug 2018

Finished

Feb 2021

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

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: * Parent or legal guardian's written informed consent and child's assent, if appropriate, must be obtained before any study related activity or assessment is performed. Of note, if the subject reaches age of consent (age as per local law) during the study, they will also need to sign the corresponding study ICF (Informed Consent Form) at the next study visit. * Male and female adolescent patients aged ≥ 12 to \<18 years at the time of screening. * Diagnosis of CSU refractory to approved doses of H1-antihistamines at the time of randomization, as defined by all of the following: * The presence of itch and hives for at least 6 consecutive weeks at any time prior to enrollment despite current use of non-sedating H1-antihistamines during this time period * UAS7 score (range 0 - 42) ≥ 16 and HSS7 (range 0 - 21) ≥ 8 during 7 days prior to randomization (Day 1) * In-clinic UAS ≥ 4 on at least one of the screening visit days or Day 1 or a medical record of the presence of hives (confirmed and documented by a physician); patients must have been on H1-antihistamines for treatment of CSU at the time of in-clinic UAS at screening visit and/or time of the medical record of hives (for at least 3 days prior to the in-clinic UAS or medical record) • Patients must have been on H1-antihistamines for treatment of CSU for at least the 3 consecutive days immediately prior to the first screening visit and must have documented current use on the day of the initial screening visit * CSU diagnosis for ≥ 6 months * Willing and able to complete a daily symptom e-Diary for the duration of the study and adhere to the study visit schedules. * Demonstration of compliance with the e-Diary: patients should not have had any missing e-Diary entries in the 7 days prior to randomization. Re-screening may be considered. Exclusion Criteria: * Clearly defined underlying etiology for chronic urticarias other than CSU. This includes the following: * Inducible urticaria: urticaria factitia, cold-, heat-, solar-, pressure-, delayed pressure-, aquagenic-, cholinergic-, or contact-urticaria * Diseases with possible symptoms of urticaria or angioedema such as urticarial vasculitis, erythema multiforme, cutaneous mastocytosis (urticaria pigmentosa), and hereditary or acquired angioedema (e.g., due to C1 inhibitor deficiency) * Any other skin disease associated with chronic itching that might confound the study evaluations and results (e.g. atopic dermatitis, bullous pemphigoid, dermatitis herpetiformis etc.) * Previous exposure to omalizumab * History of anaphylaxis

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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

    Rosario, Santa Fe Province, S2000BRH, Argentina

  • Novartis Investigative Site

    Bahía Blanca, B8000JRB, Argentina

  • Novartis Investigative Site

    Buenos Aires, C1125ABE, Argentina

  • Novartis Investigative Site

    Brussels, 1200, Belgium

  • Novartis Investigative Site

    Montreal, Quebec, H3H 1P3, Canada

  • Novartis Investigative Site

    Québec, Quebec, G1V 4W2, Canada

  • Novartis Investigative Site

    Berlin, 13353, Germany

  • Novartis Investigative Site

    Mainz, 55131, Germany

  • Novartis Investigative Site

    Budapest, HUN, 1037, Hungary

  • Novartis Investigative Site

    Nashik, Maharashtra, 422 101, India

  • Novartis Investigative Site

    New Delhi, National Capital Territory of Delhi, 110 060, India

  • Novartis Investigative Site

    Bikaner, Rajasthan, 334001, India

  • Novartis Investigative Site

    Saint Petersburg, 191015, Russia

  • Novartis Investigative Site

    Saint Petersburg, 191123, Russia

  • Novartis Investigative Site

    Smolensk, 214019, Russia

  • Novartis Investigative Site

    Barcelona, Barcelona, 08006, Spain

  • Novartis Investigative Site

    Esplugues de Llobregat, Barcelona, 08950, Spain

  • Novartis Investigative Site

    Taipei, Taiwan, 10002, Taiwan

  • Novartis Investigative Site

    Aydin, Turkey, 09100, Turkey (Türkiye)

  • Novartis Investigative Site

    Ankara, 06100, Turkey (Türkiye)

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