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Chronic spontaneous urticaria – Trials in Disease

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Ongoing Clinical Trials for Chronic Spontaneous Urticaria

There are currently 13 clinical trials underway exploring new treatment options for chronic spontaneous urticaria, a condition characterized by recurring hives and itching without an identifiable cause. These trials are testing various medications including antibody therapies, oral medications, and alternative dosing strategies across multiple countries in Europe.

Clinical trial locations

Study Comparing BP11 and Omalizumab for Patients with Chronic Spontaneous Urticaria Resistant to H1 Antihistamines

This trial is designed for adults aged 18 to 75 years who have experienced chronic spontaneous urticaria for at least six months and have not responded adequately to H1 antihistamine medications. Participants must be able to maintain an electronic symptom diary throughout the study and must have completed entries for at least seven consecutive days before joining.

The study focuses on comparing two treatments given as injections under the skin: BP11, an investigational medication, and Xolair (omalizumab), an established treatment. Both medications target proteins involved in allergic reactions to reduce symptoms like itching and hives. The trial aims to determine whether BP11 works as well as Xolair in controlling urticaria symptoms.

Throughout the study, participants will receive regular injections every four weeks and attend scheduled assessments at weeks 4, 8, 12, 16, 20, and 24. Researchers will monitor changes in itch severity and urticaria activity scores, along with quality of life measures and any adverse reactions. The study will help establish whether BP11 represents a viable alternative to current treatment options for patients who struggle to manage their symptoms with antihistamines alone.

Study on Barzolvolimab for Patients with Chronic Spontaneous Urticaria Unresponsive to H1 Antihistamines

This trial welcomes adults aged 18 or older who have had chronic spontaneous urticaria for at least six months and continue to experience symptoms despite taking a stable dose of second-generation H1 antihistamines for at least four weeks. To qualify, participants must have a weekly urticaria activity score of 16 or higher and an itch severity score of 8 or higher.

The study excludes individuals with severe allergic reactions to study medications, those participating in other clinical trials, people with significant medical conditions like uncontrolled diabetes or heart disease, pregnant or breastfeeding women, and those with recent drug or alcohol abuse history.

Barzolvolimab, administered through subcutaneous injections, is a monoclonal antibody being tested for its ability to reduce urticaria symptoms. The trial is double-blind, meaning neither participants nor researchers know who receives the actual medication versus placebo. The primary goal is to evaluate changes in the urticaria activity score at week 12, with ongoing monitoring for up to 24 weeks. Participants will keep daily symptom diaries and attend regular assessments throughout the study period.

Study on Barzolvolimab for Patients with Chronic Spontaneous Urticaria Unresponsive to H1 Antihistamines

This study has similar inclusion criteria to the previous barzolvolimab trial, requiring adults 18 or older with chronic spontaneous urticaria lasting at least six months, experiencing symptoms despite H1 antihistamine treatment. Participants must maintain a weekly urticaria activity score of 16 or higher and an itch severity score of 8 or higher during the week before randomization.

Barzolvolimab is being investigated as a factor D inhibitor, targeting specific pathways involved in the inflammatory response to alleviate symptoms in patients who don’t respond to standard H1 antihistamine treatments. The medication is in phase 3 clinical trials, indicating testing in a larger patient group for safety and efficacy.

The study follows a similar design to the previous barzolvolimab trial, with participants randomly assigned to receive either the medication or placebo via injection. Researchers will monitor changes in urticaria activity scores at multiple time points, including weeks 4, 12, and 24. Participants must keep daily symptom diaries and attend regular follow-up visits to track their progress and any potential side effects.

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

This Danish trial takes a different approach, focusing on adults who are already successfully managing their chronic spontaneous urticaria with omalizumab (Xolair). Participants must be 18 or older with a confirmed diagnosis, currently receiving 300 mg of omalizumab every four weeks, and achieving an urticaria control test score of 12 or higher at week 12 of treatment. They must also be taking four antihistamines daily and have Type 1 chronic spontaneous urticaria.

The trial excludes patients not currently being treated with omalizumab, those unable to maintain symptom control, non-adults, and members of vulnerable populations.

The study’s innovative goal is to determine whether patients with well-controlled symptoms can extend the intervals between their omalizumab injections while maintaining symptom control. This could reduce treatment frequency and potentially improve quality of life. The trial is open-label, meaning both participants and researchers know which treatment schedule is being followed. The study will last 36 weeks, with regular monitoring using urticaria control test scores to ensure safety and effectiveness of extended treatment intervals.

Study on the Safety of INF904 for Patients with Moderate to Severe Chronic Spontaneous Urticaria or Hidradenitis Suppurativa

This trial is unique in studying INF904 for two different conditions: chronic spontaneous urticaria and hidradenitis suppurativa. For urticaria patients, participants must be 18 or older with moderate to severe symptoms lasting at least six months that are inadequately controlled by second-generation H1-antihistamines. They must have a urticaria activity score of 16 or more and be non-responders to anti-IgE therapy, having received at least four injections of 300 mg without adequate response.

The study excludes pregnant or breastfeeding women, those in other clinical trials, patients with severe allergic reactions to study medications, and those with significant medical conditions, substance abuse history, or recent major surgery.

INF904 is an oral C5aR1 inhibitor taken as a soft capsule, designed to manage inflammation by targeting specific immune system pathways. The trial will evaluate the safety and pharmacokinetics of multiple doses over the study period. Participants will maintain daily symptom diaries and attend regular follow-up visits including physical examinations and blood tests to monitor their response and any side effects.

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

This German trial focuses on patients aged 18 or older with chronic spontaneous urticaria lasting at least six weeks who continue to experience symptoms despite taking H1 antihistamine medications regularly. A unique requirement is that participants must have a specific immune system profile showing increased IL-17 activity, determined through a special blood test. They must also have moderate to severe symptoms with a urticaria activity score of at least 16.

Exclusions include other types of urticaria, pregnancy or breastfeeding, severe allergic reactions to similar medications, active infections, significant liver or kidney problems, uncontrolled high blood pressure, recent major surgery, cancer within the past five years, and substance abuse within the past six months.

Tildrakizumab is a monoclonal antibody that specifically targets interleukin-23 (IL-23), a protein involved in inflammatory responses. Administered through subcutaneous injections of up to 200 mg over 16 weeks, it works by blocking IL-23 to reduce inflammation and allergic responses. The study will monitor changes in urticaria activity scores at weeks 4, 8, 12, 16, and 20, with additional follow-up at weeks 24 and 28. Participants must use appropriate birth control methods during the study and for specified periods afterward.

Study on the Effects of EVO756 in Adults with Moderate to Severe Chronic Spontaneous Urticaria

This trial is recruiting male and female adults aged 18 or older with confirmed chronic spontaneous urticaria lasting at least three months that has not responded well to H1 antihistamines. Participants must have a urticaria activity score of 16 or higher on day one, with completed score entries for at least four out of seven days before starting. Those taking H1 antihistamines must maintain a stable regimen for four weeks before and during the study.

Excluded are patients with serious health conditions that could interfere with the study, those with severe allergic reactions to medications, current participants in other trials, pregnant or breastfeeding women, those with drug or alcohol abuse history within the past year, individuals with compromised immune systems, and those who had major surgery within the last three months.

EVO756 Potassium is an investigational drug being tested in tablet form at different dose levels for up to 12 weeks. The study is designed as a double-blind trial comparing EVO756 with placebo. Researchers will assess changes in symptoms at weeks 1, 2, 4, 8, and 12, measuring improvements in urticaria activity scores and quality of life. The trial aims to identify the most effective dose while ensuring safety through regular monitoring.

Study of remibrutinib for long-term treatment of adult patients with chronic spontaneous urticaria who completed previous remibrutinib studies

This unique trial is exclusively for adults who have already completed one of four previous remibrutinib studies. Participants must be 18 or older and willing to follow all study procedures and attend scheduled visits. The study excludes those below 18 or above 75 years, pregnant or breastfeeding women, patients with severe allergic reactions to similar medications, those with other interfering skin conditions, significant liver or kidney dysfunction, and individuals with mental conditions that could interfere with study compliance.

Remibrutinib is an oral BTK (Bruton’s tyrosine kinase) inhibitor that works by blocking an enzyme crucial to the immune system’s response that leads to allergic reactions and inflammation. The trial evaluates long-term efficacy and safety in patients who showed positive initial responses. Participants with well-controlled urticaria (urticaria activity score below 16) will be randomly assigned to continue remibrutinib or receive placebo for up to 24 weeks, with monitoring for symptom relapse.

The study includes an optional open-label extension lasting up to three additional years, followed by a long-term follow-up period for safety monitoring. Throughout the study, participants will complete daily symptom diaries and attend regular health assessments. The trial continues until April 2027, providing valuable long-term data on remibrutinib’s sustained effectiveness.

Study on the Effectiveness and Safety of Danicopan for Adults with Chronic Spontaneous Urticaria Resistant to H1-Antihistamines

This German trial recruits adults aged 18 or older with moderate to severe chronic spontaneous urticaria lasting more than six months that has not responded to standard H1-antihistamine treatments. Participants must have a urticaria activity score of 16 or higher during the week before joining. An important safety requirement is complete vaccination against Neisseria meningitidis within the last three years, or willingness to receive necessary vaccinations or boosters.

Danicopan is a factor D inhibitor administered as a film-coated tablet taken orally, working by blocking a specific protein involved in the immune system’s complement pathway to potentially reduce inflammation and urticaria symptoms. It is classified as an immunomodulatory agent, with ongoing research to determine its safety and efficacy.

The 17-week study will monitor changes in urticaria activity scores from baseline, along with secondary assessments including the urticaria control test, angioedema activity score, and quality of life measures. Participants will undergo regular evaluations throughout the treatment phase to track effectiveness and safety. Because the treatment affects the immune system, vaccination against meningococcal bacteria is required as a precautionary measure.

Study on the Effects and Safety of Povorcitinib for Adults with Chronic Spontaneous Urticaria

This trial, conducted in Poland and Germany, enrolls adults aged 18 to 65 years with chronic spontaneous urticaria diagnosed for at least three months before screening. Participants must have symptoms that don’t improve with second-generation H1 antihistamines and be willing to complete a daily electronic diary throughout the entire study period. They must also agree to use birth control methods as described in the study guidelines.

Povorcitinib is administered orally in tablet form as a Janus kinase (JAK) inhibitor, targeting pathways that contribute to inflammation and immune response. The Phase 2 study is designed to assess effectiveness in reducing symptoms and ensuring safety for adult use. The trial is double-blind, with participants randomly assigned to receive either povorcitinib or placebo.

The primary outcome measures changes from baseline in the urticaria activity score over seven days at week 12. Secondary outcomes include the proportion of participants achieving controlled disease (score of 6 or lower) and those with zero urticaria activity at week 12. Participants must maintain their electronic diaries recording symptoms and side effects throughout the study, which is estimated to conclude in July 2025.

Summary

The 13 ongoing clinical trials for chronic spontaneous urticaria represent a diverse approach to finding effective treatments for patients who don’t respond adequately to standard antihistamine therapy. The trials are spread across multiple European countries, with Germany hosting the largest number of studies (10 trials), followed by Poland (9 trials), Bulgaria (7 trials), Spain (6 trials), and Italy (5 trials).

Several medications are being tested multiple times in different trial designs. Barzolvolimab appears in two separate trials testing similar approaches across multiple countries. Remibrutinib is featured in two distinct studies: one evaluating long-term treatment effects in adults who completed previous trials, and another testing effectiveness and safety specifically in adolescents aged 12 to less than 18 years.

The trials employ various therapeutic approaches. Most investigate injectable monoclonal antibodies like BP11, barzolvolimab, omalizumab, and briquilimab, which target specific proteins involved in allergic reactions. Others test oral medications including INF904, tildrakizumab, EVO756, danicopan, povorcitinib, and EP262, which work through different mechanisms such as enzyme inhibition or immune system modulation.

One trial stands out for its innovative approach: instead of testing a new medication, it examines whether patients already successfully controlled on omalizumab can extend intervals between treatments while maintaining symptom control. This could significantly improve quality of life by reducing treatment frequency.

All trials share common inclusion criteria requiring confirmed chronic spontaneous urticaria diagnosis lasting at least three to six months with inadequate response to H1 antihistamines. Most require specific urticaria activity scores demonstrating moderate to severe symptoms. Common exclusions include pregnancy, breastfeeding, severe medical conditions, recent participation in other trials, and substance abuse history.

These trials collectively offer hope for patients struggling with chronic spontaneous urticaria, exploring multiple therapeutic pathways and treatment strategies to address this challenging condition.

Ongoing Clinical Trials on Chronic spontaneous urticaria

  • A study to evaluate the efficacy and safety of lesigercept in adults with chronic spontaneous urticaria who do not have enough relief from antihistamines

    Recruiting

    2 1
    Investigated diseases:
    Bulgaria Poland

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

    Recruiting

    2 1 1 1
    Investigated diseases:
    Investigated drugs:
    Germany

  • Study of epinephrine nasal spray (ARS-2) for treating chronic spontaneous urticaria symptoms in adult patients

    Not yet recruiting

    2 1
    Investigated diseases:
    Investigated drugs:
    Germany

  • Study on Barzolvolimab for Patients with Chronic Spontaneous Urticaria Unresponsive to H1 Antihistamines

    Not recruiting

    3 1 1
    Investigated diseases:
    Investigated drugs:
    Belgium Bulgaria Czechia Denmark France Germany +5

  • Study on the Safety of INF904 for Patients with Moderate to Severe Chronic Spontaneous Urticaria or Hidradenitis Suppurativa

    Not recruiting

    2 1 1
    Investigated diseases:
    Investigated drugs:
    Bulgaria Germany Greece Poland

  • Study of remibrutinib for long-term treatment of adult patients with chronic spontaneous urticaria who completed previous remibrutinib studies

    Not recruiting

    3 1 1
    Investigated diseases:
    Investigated drugs:
    Bulgaria Czechia Denmark France Germany Hungary +4

  • Study Comparing BP11 and Omalizumab for Patients with Chronic Spontaneous Urticaria Resistant to H1 Antihistamines

    Not recruiting

    3 1 1
    Investigated diseases:
    Investigated drugs:
    Bulgaria Hungary Latvia Lithuania Poland Slovakia

  • Study on the Effectiveness and Safety of Danicopan for Adults with Chronic Spontaneous Urticaria Resistant to H1-Antihistamines

    Not recruiting

    2 1 1 1
    Investigated diseases:
    Investigated drugs:
    Germany

  • Study on the Effects and Safety of Povorcitinib for Adults with Chronic Spontaneous Urticaria

    Not recruiting

    2 1
    Investigated diseases:
    Investigated drugs:
    Germany Poland

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

    Not recruiting

    3 1 1 1
    Investigated diseases:
    Investigated drugs:
    Denmark

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