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Study on Extending Omalizumab Treatment Intervals for Adults with Well-Controlled Chronic Spontaneous Urticaria

Verified siteRegistered drugNo placebo

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying a condition known as chronic spontaneous urticaria, which is a type of hives that occurs without a known cause and can be persistent. The treatment being investigated in this study is a medication called omalizumab, also known by its brand name Xolair. Omalizumab is administered as a solution for injection using a pre-filled syringe. The purpose of the study is to determine if patients with well-controlled chronic spontaneous urticaria can extend the time between their omalizumab treatments while still keeping their symptoms under control.

Participants in the study will receive omalizumab injections, and the intervals between these injections will be adjusted to see if longer periods between doses are effective. The study will monitor the control of urticaria symptoms over a period of time to ensure that extending the treatment intervals does not lead to a loss of symptom control. The trial aims to provide insights into whether patients can maintain their quality of life with fewer injections.

The study is designed to be open-label, meaning that both the participants and the researchers will know which treatment is being administered. This approach helps in closely monitoring the effects of extending the treatment intervals. The trial will last for a total of 36 weeks, during which the participants' symptoms and overall health will be regularly assessed to ensure their well-being and the effectiveness of the treatment strategy.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Initial treatment phase
The trial begins with the administration of omalizumab, a medication used to treat chronic spontaneous urticaria. This medication is provided as a solution for injection in a pre-filled syringe.
The initial dosage is 300 mg of omalizumab, administered subcutaneously (under the skin) every four weeks. This phase ensures that the condition is well controlled before considering any changes to the treatment schedule.
Step 2
Evaluation of treatment control
After 12 weeks of treatment, the effectiveness of the medication is evaluated using the urticaria control test (UCT). A score of 12 or higher indicates well-controlled symptoms.
This evaluation determines eligibility for extending the intervals between treatments.
Step 3
Extended treatment intervals
If the condition is well controlled, the intervals between omalizumab injections may be extended. The goal is to maintain symptom control while reducing the frequency of injections.
The trial will monitor the absolute difference in average UCT scores between different treatment schedules at week 36 to assess the effectiveness of extended intervals.
Step 4
Ongoing monitoring and assessment
Throughout the trial, regular assessments are conducted to monitor the condition and adjust treatment as necessary.
The trial is expected to continue until April 2025, with ongoing evaluations to ensure the safety and effectiveness of the treatment.

Who can join the trial?

7 criteria

You must have a diagnosis of chronic spontaneous urticaria (CSU), which is a condition that causes hives or itchy welts on the skin without a known cause, according to specific medical guidelines.
You need to be 18 years or older.
You should have a UCT score of 12 or higher at week 12 after starting treatment with 300 mg of omalizumab every four weeks. The UCT score is a way to measure how well your urticaria is controlled.
You must not have used omalizumab before starting the current treatment. Omalizumab is a medication used to treat CSU.
You should be taking 4 antihistamines daily. Antihistamines are medicines that help reduce allergy symptoms like itching and swelling.
You need to have Type 1 CSU, which means you have a negative BHRA test. BHRA is a test to check for certain reactions in your blood.
You must be a suitable candidate for omalizumab treatment according to Danish medical practice.

Who cannot join the trial?

5 criteria

Patients who do not have chronic spontaneous urticaria. This is a condition where hives or itchy welts appear on the skin without a known cause.
Patients who are not adults. The study is only for adult participants.
Patients who are not currently being treated with omalizumab. This is a medication used to help control symptoms of chronic spontaneous urticaria.
Patients who cannot maintain control of their condition with their current treatment.
Patients who belong to a vulnerable population. This means groups of people who might need special protection or care.

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Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

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Aarhus University Hospital
Aarhus, Denmark
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Bispebjerg Hospital
Copenhagen, Denmark

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Investigated drugs

Omalizumab is a medication used in this trial to treat patients with chronic spontaneous urticaria, a condition characterized by hives and itching without a known cause. The trial aims to determine if patients who have their symptoms well controlled with omalizumab can extend the time between treatments while still keeping their condition under control. Omalizumab works by targeting and blocking a specific protein in the immune system that can contribute to allergic reactions, helping to reduce symptoms like itching and hives.

Omalizumab

What is already known about the treatment

Omalizumab – Omalizumab is administered as an injection under the skin, typically in a healthcare setting. It is currently well-established in medical literature and is used for treating chronic spontaneous urticaria, especially in patients who do not respond well to antihistamines. The medication works by targeting and blocking immunoglobulin E (IgE), a molecule involved in allergic reactions, thereby reducing symptoms like itching and hives. Omalizumab is classified as a monoclonal antibody, which is a type of biologic drug designed to interfere with specific molecules in the immune system.

Investigated diseases

Chronic Spontaneous Urticaria – This is a skin condition characterized by the sudden appearance of itchy hives or welts on the skin, which can occur without an obvious trigger. The hives can vary in size and may appear anywhere on the body, often changing shape and location. The condition is considered chronic when the hives persist for six weeks or longer. It is not caused by an allergic reaction, and the exact cause is often unknown. The symptoms can be uncomfortable and may interfere with daily activities. The condition can fluctuate, with periods of worsening and improvement.