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

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What is this study about?

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.

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

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

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

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

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 Study?

  • 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 Study?

  • 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

Where you can join this trial?

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Other Sites

Site Name City Country Status
Philipps-Universitaet Marburg Marburg Germany

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Germany Germany
Recruiting
01.09.2025

Trial locations

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.

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.

Trial ID:
2024-513155-32-00
Protocol code:
KKS-317
Trial Phase:
Therapeutic exploratory (Phase II)

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