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Could fewer shots control hives just as well? new trial aims to find out

NCT ID NCT05916937

Disease control Sponsor: Simon Francis Thomsen Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jun 26, 2026 · Updated 1 time

Summary

This study looks at whether people with chronic spontaneous urticaria (long-term hives) who are well-controlled on omalizumab every 4 weeks can switch to every 6 weeks without losing control. Forty adults will be randomly assigned to continue standard dosing or extend their injection interval. The main goal is to see if disease control stays the same after 36 weeks.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
omalizumab
What this could lead to
If successful, this could allow patients with well-controlled chronic hives to receive fewer injections while still keeping symptoms under control.
What could go wrong
This is a small, early-phase trial with only 40 participants, so results may not apply to everyone. Extending the interval might lead to a return of hives in some patients.

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 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

About 40 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jan 2024

Expected to finish

Dec 2025

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

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

Ages

18 years and older

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: * A diagnosis of CSU according to the EAACI/GA2LEN/EDF/WAO guidelines. * Age ≥ 18 years. * Omalizumab-naïve prior to initiating treatment with omalizumab. * Background treatment with four antihistamines daily. * Candidate for omalizumab treatment according to Danish guidelines. Exclusion Criteria: * Pregnant or breastfeeding women. * Planned pregnancy within the next 6 months. * Weight ≥ 100 kilograms. * Presence of any other active skin disease or condition that may interfere with the assessment of CSU, such as atopic dermatitis, bullous pemphigoid, senile pruritus, or psoriasis. * Use of immunosuppressive drugs, such as prednisolone, azathioprine, methotrexate, or cyclosporine. * Predominantly experience symptoms from chronic inducible urticaria (CIndU). * Inability to complete study or comply with study procedures. Patients with a positive basophil histamine release assay (BHRA) are not eligible for the study. Patients may therefore be withdrawn from the trial after enrolment, if they are found to have a positive BHRA test in the initial blood work.

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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 Chronic urticaria, idiopathic

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Department of Dermatology, Bispebjerg Hospital

    RECRUITING

    Copenhagen, Copenhagen N, 2100, Denmark

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