Recruiting

Study of tildrakizumab to treat patients with chronic spontaneous urticaria who did not respond to previous treatments

Verified siteRegistered drugNo placebo

Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

What is this trial about?

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

This clinical trial focuses on evaluating tildrakizumab, a medication given as an injection under the skin, for treating chronic spontaneous urticaria - a condition that causes persistent hives and itching that occur without any obvious trigger. The study will test how well this medication works in patients whose symptoms have not improved with standard antihistamine treatment.

The study will examine if tildrakizumab, which is an anti-IL-23 antibody (a type of protein that affects the immune system), can reduce the severity of hives and itching in people with this condition. During the study, participants will receive injections of the medication over a period of 16 weeks, with each dose containing up to 200 mg of the medicine.

The main goal is to measure how the severity of urticaria symptoms changes after treatment with the medication. Participants will be monitored for improvements in their symptoms, including the frequency and intensity of hives and itching, as well as their overall quality of life. The study will also track how long any improvements in symptoms last after the treatment period ends.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Initial assessment
Your urticaria activity will be measured using a special score called UAS7
Blood tests will be performed to check your immune system profile
A pregnancy test will be conducted if applicable
Step 2
Treatment initiation
Ilumetri (tildrakizumab) 200 mg will be administered through an injection under the skin
You will continue taking your regular antihistamine medications
Your symptoms and any side effects will be monitored
Step 3
Follow-up visits
You will need to attend check-ups at weeks 4, 8, 12, 16, and 20
During these visits, your hives and itching symptoms will be assessed
Blood samples will be taken at weeks 4, 8, 16, and 20
Skin tissue samples will be collected at week 20
Step 4
Final evaluation period
Additional follow-up visits will occur at weeks 24 and 28
Your symptoms will continue to be monitored
Final blood tests will be performed at week 28
Your overall response to the treatment will be evaluated
Step 5
Safety measures
You must use appropriate birth control methods during the study and for 17 weeks after the last injection (for women who can become pregnant)
Male participants must use appropriate birth control methods during the study and for 90 days after the last injection
Any side effects will be recorded throughout the study period

Who can join the trial?

11 criteria

You must be at least 18 years old
You must have had chronic spontaneous urticaria (recurring hives and itching) for at least 6 weeks, even while taking antihistamine medications
You must be currently taking H1 antihistamine medications (medicines that help reduce allergy symptoms) regularly
You must have a specific immune system profile that shows increased IL-17 activity (determined by a special blood test)
Your urticaria symptoms must be moderate to severe, with a score of at least 16 on a special scale that measures hives and itching severity
You must be willing to sign an informed consent form
If you are a woman who can become pregnant, you must:
- Have a negative pregnancy test before starting the study
- Use reliable birth control during the study and for 17 weeks after the last study treatment
- If you are a man with female partners who can become pregnant, you must:
  - Use condoms during the study and for 90 days after the last treatment
  - Inform your partner(s) about the study requirements
  - Not donate sperm during this period

Who cannot join the trial?

15 criteria

Presence of other types of urticaria besides chronic spontaneous urticaria (a skin condition with recurring hives and itching)
Pregnancy or breastfeeding
History of severe allergic reactions to similar medications
Active or chronic infections
Significant liver or kidney problems
Uncontrolled high blood pressure
Major surgery within the last 3 months
Current participation in other clinical trials
Use of prohibited medications that may interfere with the study drug
Any condition that, in the opinion of the study doctor, would make participation unsafe
Inability to comply with study procedures and visits
History of cancer within the past 5 years (except treated non-melanoma skin cancer)
Severe mental health conditions that could affect participation
Substance abuse within the past 6 months
Blood disorders that could affect study results

Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.

We usually reply within a few days

Verified sites

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

Philipps-Universitaet Marburg
Verified
Marburg, Germany

Trial locations

Where you can join this trial

Countries are shaded by recruitment status. Click a recruiting country to ask about joining there.

Recruiting

Not finding your country?

Not sure what to do next?

Joining a clinical trial can seem overwhelming. We guide you step by step, so you know exactly what to expect and how we support you through the process.

See the full process and FAQ

Investigated drugs

Tildrakizumab is a medication that works by targeting a protein in the body called interleukin-23 (IL-23). It is a type of antibody therapy that helps reduce inflammation in the body. In this trial, it is being studied as a potential treatment for chronic spontaneous urticaria, a condition that causes recurring hives and itchy skin. The medication is administered through injections and works by modifying the immune system's response to help control the symptoms of urticaria.

Tildrakizumab

What is already known about the treatment

Tildrakizumab - A monoclonal antibody medication administered through subcutaneous injection that specifically targets interleukin-23 (IL-23), a protein involved in inflammatory responses. This biological drug is being investigated in clinical trials for the treatment of chronic spontaneous urticaria, a condition characterized by recurring hives and itching without an identifiable trigger. Tildrakizumab belongs to the class of immunosuppressive agents and works by blocking IL-23, thereby reducing inflammation and allergic responses in the body, with current studies focusing on its potential effectiveness in patients who haven't responded well to conventional treatments.

Investigated diseases

Chronic Spontaneous Urticaria - A skin condition characterized by the recurring appearance of itchy hives (wheals) and/or swelling (angioedema) that occur without any specific external trigger. The hives are temporary and typically last for less than 24 hours in one spot, but new ones may continuously appear. This condition is considered chronic when it persists for six weeks or longer. The wheals can appear anywhere on the body, varying in size and number throughout the day. The condition can cause significant discomfort due to intense itching and can affect daily activities.