#1 Clinical Trials Search in Europe

Urticaria – Trials in Disease

Go back

Ongoing Clinical Trials for Chronic Spontaneous Urticaria

Currently, 13 clinical trials are investigating new treatments for chronic spontaneous urticaria, a condition causing persistent hives and itching without a known cause. These trials are testing various medications across multiple European countries, offering hope for patients who have not responded well to standard antihistamine treatments.

Clinical trial locations

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

This trial is testing a new treatment called BP11 and comparing it with an established medication known as omalizumab. Both treatments are given as injections under the skin every four weeks for up to 24 weeks.

Who can join: Adults aged 18 to 75 years who have had chronic spontaneous urticaria for at least six months and whose symptoms have not improved with H1 antihistamine treatment. Participants must be able to complete an electronic diary twice daily and have completed entries for at least seven consecutive days before starting the trial. Women who can become pregnant and men with partners who can become pregnant must use reliable birth control throughout the study and for six months after the last treatment dose.

Who cannot join: The trial information does not specify exclusion criteria.

Main goal: The primary aim is to determine if BP11 works as well as omalizumab in treating hives that do not respond to standard antihistamines. The study will measure changes in itch severity and urticaria activity scores at weeks 4, 8, and 12, with a comprehensive evaluation at week 12. Secondary goals include assessing quality of life improvements and safety of the treatment.

Medications being tested: BP11 is a new medication targeting the same protein as omalizumab. Omalizumab works by blocking immunoglobulin E, a molecule involved in allergic reactions, helping to reduce symptoms like itching and hives.

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

This study evaluates barzolvolimab, a medication given by injection under the skin, for treating hives that persist despite antihistamine treatment.

Who can join: 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 H1 antihistamines for at least four weeks. Participants must have a urticaria activity score of 16 or higher and an itch severity score of 8 or higher. They must be willing to complete a daily symptom diary throughout the study.

Who cannot join: People with severe allergic reactions to study medications, those currently in another clinical trial, individuals with significant medical conditions like uncontrolled diabetes or heart disease, pregnant or breastfeeding women, those who have used certain medications within a specific timeframe, people with a history of drug or alcohol abuse, mental health conditions affecting study participation, recent or planned surgery, active infections requiring treatment, or cancer diagnosis within the past five years (except certain skin cancers).

Main goal: The trial aims to assess how effectively barzolvolimab reduces urticaria symptoms over 12 weeks, measuring changes in the urticaria activity score. Secondary assessments include evaluating symptom reduction percentages and changes in other symptom scores.

Medications being tested: Barzolvolimab targets specific molecules in the immune system to reduce inflammation and alleviate symptoms. It is designed as a monoclonal antibody to interact with specific targets in the body.

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

This trial investigates barzolvolimab for adults whose urticaria symptoms continue despite H1 antihistamine treatment.

Who can join: Adults aged 18 or older with a diagnosis of chronic spontaneous urticaria for at least six months. Participants must have experienced itchy hives for at least six weeks before screening while taking H1 antihistamines, with a urticaria activity score of 16 or higher and an itch severity score of 8 or higher. They must maintain a stable antihistamine dose and be willing to keep a daily symptom diary.

Main goal: To evaluate the change in the urticaria activity score from baseline to week 12. The study also examines changes in itch and hive severity scores and the percentage of participants achieving complete symptom control.

Medications being tested: Barzolvolimab is administered via injection and works by targeting specific pathways involved in the inflammatory response, helping to alleviate symptoms in patients who do not respond to standard antihistamine treatments.

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

This trial investigates whether patients with well-controlled symptoms can extend the time between their omalizumab injections while maintaining symptom control.

Who can join: Adults aged 18 or older with a diagnosis of chronic spontaneous urticaria according to medical guidelines. Participants must have a urticaria control test score of 12 or higher at week 12 after starting 300 mg omalizumab every four weeks. They should not have used omalizumab before the current treatment, must be taking four antihistamines daily, have Type 1 CSU (negative BHRA test), and be suitable candidates for omalizumab according to Danish medical practice.

Who cannot join: People without chronic spontaneous urticaria, non-adults, those not currently treated with omalizumab, patients unable to maintain condition control with current treatment, and individuals from vulnerable populations.

Main goal: To determine if extending the intervals between omalizumab injections maintains symptom control. The study monitors the absolute difference in average urticaria control test scores between different treatment schedules at week 36.

Medications being tested: Omalizumab targets and blocks immunoglobulin E, a molecule involved in allergic reactions, thereby reducing symptoms like itching and hives.

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

This trial evaluates INF904, an oral medication taken as a soft capsule, for people with moderate to severe chronic spontaneous urticaria or hidradenitis suppurativa.

Who can join: Adults aged 18 or older who can provide signed informed consent. For urticaria participants: diagnosis present for at least six months with symptoms inadequately controlled by H1-antihistamines, urticaria activity score of 16 or more, itch severity score of 8 or more, and previous non-response to anti-IgE therapy. For hidradenitis suppurativa participants: diagnosis for at least six months with inadequate response to oral antibiotics, moderate or severe condition (Hurley Stage II or III) with at least five active nodules affecting at least two body areas. All participants must be capable of completing a daily symptom diary and attending scheduled visits.

Who cannot join: People without moderate to severe chronic spontaneous urticaria or hidradenitis suppurativa, those outside the specified age range, individuals not meeting gender requirements, and members of vulnerable populations.

Main goal: To determine the safety of INF904 when taken in multiple doses, tracking how the medication is absorbed and processed in the body and monitoring any side effects or adverse events.

Medications being tested: INF904 is a C5aR1 inhibitor designed to manage these conditions by targeting specific pathways in the body that contribute to inflammation and symptoms.

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

This trial tests tildrakizumab, an injection given under the skin, for treating persistent hives and itching in patients whose symptoms have not improved with standard antihistamine treatment.

Who can join: Adults aged 18 or older who have had chronic spontaneous urticaria for at least six weeks despite antihistamine treatment, are currently taking H1 antihistamines regularly, have a specific immune system profile showing increased IL-17 activity, and have moderate to severe symptoms with a urticaria activity score of at least 16. Female participants who can become pregnant must have a negative pregnancy test and use reliable birth control during the study and for 17 weeks after. Male participants with female partners who can become pregnant must use condoms during the study and for 90 days after, inform partners about study requirements, and not donate sperm during this period.

Who cannot join: People with other types of urticaria besides chronic spontaneous urticaria, pregnant or breastfeeding individuals, those with severe allergic reactions to similar medications, active or chronic infections, significant liver or kidney problems, uncontrolled high blood pressure, major surgery within three months, current participation in other trials, use of prohibited medications, conditions making participation unsafe, inability to comply with procedures, cancer within the past five years (except treated non-melanoma skin cancer), severe mental health conditions, substance abuse within six months, or blood disorders.

Main goal: To measure how the severity of urticaria symptoms changes after treatment with tildrakizumab over 16 weeks. The study monitors improvements in symptom frequency and intensity, as well as overall quality of life.

Medications being tested: Tildrakizumab is a monoclonal antibody that specifically targets interleukin-23, a protein involved in inflammatory responses, helping to reduce inflammation and allergic responses in the body.

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

This trial evaluates EVO756 Potassium in tablet form for adults with moderate to severe chronic spontaneous urticaria.

Who can join: Adults aged 18 or older who can provide written informed consent, have a confirmed diagnosis of chronic spontaneous urticaria for at least three months with inadequate response to H1 antihistamines, and have a urticaria activity score of 16 or higher with at least four completed daily entries in the week before starting. Participants taking H1 antihistamines must maintain a stable regimen for four weeks before and during the study.

Who cannot join: People with serious health conditions interfering with the study, severe allergic reactions to medications, current participation in another trial, use of investigational drugs within 30 days, pregnancy or breastfeeding, drug or alcohol abuse within the past year, compromised immune systems, major surgery within three months, uncontrolled high blood pressure or significant heart problems, or cancer history within five years (except certain skin cancers).

Main goal: To assess how effective and safe EVO756 Potassium is at different dose levels over 12 weeks. The study measures the mean change in urticaria activity score and evaluates symptom reduction percentages.

Medications being tested: EVO756 is being tested to determine if it can reduce hive severity and improve quality of life for those affected by this condition.

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

This study evaluates remibrutinib, taken as a film-coated tablet by mouth, for long-term treatment in patients who have already participated in previous remibrutinib studies.

Who can join: Adults aged 18 or older who have provided written consent before participating, successfully completed one of the specified previous studies (CLOU064A2301, CLOU064A2302, CLOU064A1301, or CLOU064A2305), and are willing and able to follow all study procedures and attend all scheduled visits.

Who cannot join: People below 18 or above 75 years, pregnant or breastfeeding women, those with severe allergic reactions to similar medications, current participation in other trials, other skin conditions interfering with assessment, uncontrolled or severe medical conditions, use of prohibited medications within specified timeframes, urticaria activity score of 16 or higher at week 52 of previous study, previous discontinuation due to lack of efficacy, hypersensitivity to remibrutinib, significant liver or kidney dysfunction, active or chronic infections, malignancy within five years, mental conditions affecting compliance, or substance abuse or dependence.

Main goal: To monitor how long symptom control lasts in patients who showed improvement. Participants maintaining good control are randomly assigned to continue either remibrutinib or switch to placebo for up to 24 weeks. The study tracks symptom return and safety throughout, with treatment potentially lasting up to 160 weeks depending on participant response.

Medications being tested: Remibrutinib blocks specific proteins in the body involved in allergic reactions and inflammation. A placebo is also used as a control substance with no active ingredients.

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

This trial tests Danicopan, a factor D inhibitor, in adults with chronic spontaneous urticaria who have not responded well to H1-antihistamines.

Who can join: Adults aged 18 or older with a diagnosis of chronic spontaneous urticaria for more than six months, moderate to severe condition resistant to standard treatments, urticaria activity score of 16 or higher in the week before starting, and complete vaccination against Neisseria meningitidis within the last three years or willingness to receive necessary vaccinations or boosters.

Who cannot join: Those with severe allergic reactions to study medication, current participation in another trial, other significant health conditions, pregnancy or breastfeeding, use of certain interfering medications, drug or alcohol abuse history, recent major surgery, unstable mental health, inability to comply with procedures, or known infection affecting the study.

Main goal: To assess if Danicopan can help reduce symptoms in patients who have not found relief with other treatments. The study measures changes in urticaria activity score from baseline to week 17, quality of life effects, and medication use for relief.

Medications being tested: Danicopan is provided as a film-coated tablet taken orally and works by blocking a part of the immune system that might be involved in causing the hives.

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

This trial evaluates Povorcitinib, taken in tablet form, for adults with chronic spontaneous urticaria that does not respond well to H1 antihistamines.

Who can join: Adults aged 18 to 65 who can understand and sign a written consent form, have been diagnosed with chronic spontaneous urticaria for at least three months before screening, have symptoms not improving with H1 antihistamines, are willing to follow study rules and procedures, can fill out a daily electronic diary for the entire study period, and agree to use birth control methods as described in study guidelines.

Who cannot join: Those with severe allergic reactions to study medication ingredients, currently taking interfering medications, other skin conditions affecting results, significant health issues like heart, liver, or kidney problems, pregnant or breastfeeding women, recent participation in another trial, drug or alcohol abuse history, inability to follow procedures or attend visits.

Main goal: To assess how well Povorcitinib works in reducing symptoms and ensuring its safety. The primary outcome is the change from baseline in the urticaria activity score over seven days at week 12, with secondary outcomes including the proportion achieving controlled disease and complete symptom control.

Medications being tested: Povorcitinib is administered orally in tablet form and works by inhibiting certain enzymes involved in the inflammatory process, classified as a Janus kinase inhibitor targeting pathways contributing to inflammation and immune response.

Study on the Effects of Briquilimab in Adults with Chronic Spontaneous Urticaria Unresponsive to Antihistamines

This trial tests briquilimab, given as a subcutaneous injection, for adults whose urticaria symptoms continue despite antihistamine or omalizumab treatment.

Who can join: Adults aged 18 or older who provide written informed consent, have had chronic spontaneous urticaria for at least six months with symptoms for at least eight consecutive weeks despite H1-antihistamine use or after omalizumab treatment or intolerance, urticaria activity score of 16 or more and itch severity score of 8 or more, stable H1-antihistamine dose up to four times the approved dose not changing during the first 12 weeks, adequate blood test results (hemoglobin 11 g/dl or more, platelets 100,000/mm3 or more, leucocytes 3,000/mm3 or more, neutrophils 2,000/mm3 or more), and willingness to complete a daily diary and attend all scheduled visits.

Who cannot join: Those with serious health conditions interfering with the study, pregnant or breastfeeding women, severe allergic reactions to similar medications, current participation in another trial, use of certain interfering medications, substance abuse or alcohol dependency history, uncontrolled high blood pressure or heart problems, active infections requiring treatment, unstable autoimmune diseases, or recent major surgery.

Main goal: To evaluate the safety and tolerability of briquilimab and determine if it can reduce symptoms and improve quality of life for patients. Participants will be monitored for side effects and symptom changes throughout the study.

Medications being tested: Briquilimab is administered as an injection and targets specific molecules in the immune system to reduce inflammation and allergic reactions. Epinephrine may be used as a safety measure via intramuscular injection in case of allergic reactions.

Summary

These 13 clinical trials represent a significant effort to find better treatment options for people with chronic spontaneous urticaria who have not found relief with standard antihistamine medications. The trials are spread across multiple European countries, with Germany, Poland, and Spain hosting the most studies. Most trials focus on adults, though one specifically targets adolescents aged 12 to 17 years.

Several investigational drugs appear multiple times across different trials. Barzolvolimab is being tested in three separate studies across numerous countries, while remibrutinib appears in two trials, including one for long-term treatment in patients who previously participated in earlier studies. Most of these medications are monoclonal antibodies or small molecule inhibitors that work by targeting specific parts of the immune system involved in causing hives and itching.

The trials vary in duration from 12 weeks to several years, with some offering optional extension phases for long-term safety monitoring. Most studies require participants to have moderate to severe symptoms with specific urticaria activity scores, typically 16 or higher on the UAS7 scale. All trials emphasize the importance of daily symptom tracking through electronic diaries and regular follow-up visits to monitor both effectiveness and safety.

These studies offer hope for patients struggling with this challenging condition, potentially providing new treatment options beyond the currently available therapies.

Ongoing Clinical Trials on Urticaria

More information about
Urticaria:

Connected medications: