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14 Chronic Spontaneous Urticaria Trials

Power is an online platform that helps thousands of Chronic Spontaneous Urticaria patients discover FDA-reviewed trials every day. Every trial we feature meets safety and ethical standards, giving patients an easy way to discover promising new treatments in the research stage.

The purpose of this study is to establish the efficacy, safety and tolerability of barzolvolimab in adult participants with Chronic Spontaneous Urticaria (CSU) inadequately controlled by non-sedating second generation H1-antihistamines in comparison to placebo.
Pivotal Trial
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 3
Age:18+
Sex:All
915 Participants Needed
The purpose of this study is to establish the efficacy, safety and tolerability of barzolvolimab in adult participants with Chronic Spontaneous Urticaria (CSU) inadequately controlled by non-sedating second generation H1-antihistamines in comparison to placebo.
Pivotal Trial
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 3
Age:18+
Sex:All
915 Participants Needed
This trial tests remibrutinib, a medication for adults with chronic hives not helped by standard treatments. It aims to see if remibrutinib can reduce symptoms by blocking signals that cause hives. Remibrutinib is a highly selective, oral medication that has shown promising efficacy and safety in treating chronic spontaneous urticaria.
Prior Safety Data
Pivotal Trial
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 3
Age:18 - 100
Sex:All
694 Participants Needed
This trial is testing a new medication called povorcitinib for adults with a chronic skin condition called CSU. These patients haven't found relief with standard treatments. The medication works by reducing the body's overactive immune response.
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 2
Age:18 - 65
Sex:All
136 Participants Needed
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EP262 for Chronic Hives

Cincinnati, Ohio
Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Effects of EP262 in Subjects with Chronic Spontaneous Urticaria
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 2
Age:18 - 80
Sex:All
154 Participants Needed
This trial will be performed as a three-part dose escalating clinical trial where Parts 1 is open label and Parts 2 and 3 are randomized, double-blinded, and placebo-controlled. The trial is intended to determine the safety and tolerability and assess the preliminary efficacy of briquilimab in adult participants with chronic spontaneous urticaria (CSU), who remain symptomatic despite treatment with H1 antihistamines and omalizumab. Additionally, pharmacokinetic (PK) properties of briquilimab, and other pharmacodynamic (PD) parameters (such as effects on mast cells (MC), serum tryptase levels, and on allergic skin reactivity) will be investigated.
Prior Safety Data
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 1, 2
Age:18+
Sex:All
80 Participants Needed
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AK006 IV for Hives

Cincinnati, Ohio
An open label extension (OLE) study offered to subjects with Chronic Spontaneous Urticaria that have completed the AK006-001 (NCT06072157) Part C referred to as the Main study portion of the study. Qualified subjects will receive up to four doses of the study drug (AK006) through an intravenous infusion every 4 weeks. There is a 16-week follow up period once all the scheduled infusions have been completed. Subjects will be follow for evaluation of safety, tolerability, PK, immunogenicity, and clinical response.
No Placebo Group
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 1
Age:18 - 65
Sex:All
29 Participants Needed
This trial is testing a medication called dupilumab in children with chronic spontaneous urticaria (CSU) who do not improve with regular allergy medicines. The study aims to see if dupilumab is safe and how it behaves in the body over several months. Dupilumab helps by blocking proteins that cause inflammation, reducing symptoms. Dupilumab is approved in the United States for the treatment of moderate-to-severe atopic dermatitis in adults and children aged 6 and up, demonstrating rapid and sustained efficacy.
No Placebo Group
Prior Safety Data
Pivotal Trial
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 3
Age:2 - 11
Sex:All
15 Participants Needed
This trial tests remibrutinib in teenagers with chronic hives not helped by standard treatments. The medication aims to reduce hives and itching by blocking signals that cause these symptoms.
Prior Safety Data
Pivotal Trial
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 3
Age:12 - 17
Sex:All
100 Participants Needed
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EVO756 for Chronic Urticaria

Lexington, Kentucky
This study will evaluate the efficacy and safety of different doses of EVO756 in adults with moderate to severe chronic spontaneous urticaria (CSU).
Trial Details
Trial Status:Not Yet Recruiting
Trial Phase:Phase 2
Age:18+
Sex:All
160 Participants Needed
This trial is testing a new medication called barzolvolimab to help people with Chronic Spontaneous Urticaria, a condition that causes persistent hives and itching. The medication works by calming the immune system to reduce these symptoms.
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 2
Age:18+
Sex:All
208 Participants Needed
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Remibrutinib for Hives

London, Ontario
The purpose of the core phase of the trial is to assess the efficacy, safety and tolerability of remibrutinib (LOU064) 25 milligrams (mg) twice a day (b.i.d.) over placebo for 24 weeks and in comparison to omalizumab 300 mg every 4 weeks (q4w) for 52 weeks in participants with chronic spontaneous urticaria (CSU) inadequately controlled by H1-antihistamines (H1-AH). The purpose of the open-label extension phase is to assess efficacy, safety and tolerability up to two years for patients treated with remibrutinib and patients transitioned from omalizumab to remibrutinib at Week 52. In the extension phase, treatment will be with remibrutinib only (i.e., no background therapy). The extension phase will also fulfill the Novartis commitment to provide post-trial access to participants of the previous core phase.
Prior Safety Data
Pivotal Trial
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 3
Age:18 - 100
Sex:All
468 Participants Needed
The purpose of this research study is to see if a drug called ritlecitinib is safe and effective for treating chronic spontaneous urticaria (CSU). CSU is hives and itching lasting over six weeks. Ritlecitinib is approved by the Food and Drug Administration (FDA) to treat another condition, but it is not approved for treating CSU. Participation is expected to last 20 weeks and include 7 clinic visits. This study will involve physical examinations, blood tests, looking at and taking pictures of participant's skin and hives, optional skin biopsies, and hearing tests. Eligible participants for this study will take ritlecitinib for 12 weeks and complete a daily diary about their skin and hives. The main risks of being in this study are side effects from ritlecitinib. Less than 1 in 10 people taking ritlecitinib experience diarrhea, acne, hives, rash, inflammation of hair follicles, dizziness, and increased blood levels of creatine phosphokinase (a muscle protein). Participants could also experience a rare but serious side effect, such as shingles, unusual infection, cancer, or blood clot. Benefits of participating in this study include a potential improvement in participant's condition and quality of life. Participating in this study may also help researchers develop new ways of helping future patients.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 2
Age:18 - 65
Sex:All
20 Participants Needed
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Mepolizumab for Hives

Jacksonville, Florida
This trial is testing Mepolizumab, a medication that reduces inflammation, in patients with chronic spontaneous urticaria who do not respond well to typical treatments. The drug works by decreasing the number of certain immune cells that cause hives and itching.
No Placebo Group
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Early Phase 1
Age:18+
Sex:All
24 Participants Needed
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Frequently Asked Questions

How much do Chronic Spontaneous Urticaria clinical trials pay?

Each trial will compensate patients a different amount, but $50-100 for each visit is a fairly common range for Phase 2–4 trials (Phase 1 trials often pay substantially more). Further, most trials will cover the costs of a travel to-and-from the clinic.

How do Chronic Spontaneous Urticaria clinical trials work?

After a researcher reviews your profile, they may choose to invite you in to a screening appointment, where they'll determine if you meet 100% of the eligibility requirements. If you do, you'll be sorted into one of the treatment groups, and receive your study drug. For some trials, there is a chance you'll receive a placebo. Across Chronic Spontaneous Urticaria trials 30% of clinical trials have a placebo. Typically, you'll be required to check-in with the clinic every month or so. The average trial length for Chronic Spontaneous Urticaria is 12 months.

How do I participate in a study as a "healthy volunteer"?

Not all studies recruit healthy volunteers: usually, Phase 1 studies do. Participating as a healthy volunteer means you will go to a research facility several times over a few days or weeks to receive a dose of either the test treatment or a "placebo," which is a harmless substance that helps researchers compare results. You will have routine tests during these visits, and you'll be compensated for your time and travel, with the number of appointments and details varying by study.

What does the "phase" of a clinical trial mean?

The phase of a trial reveals what stage the drug is in to get approval for a specific condition. Phase 1 trials are the trials to collect safety data in humans. Phase 2 trials are those where the drug has some data showing safety in humans, but where further human data is needed on drug effectiveness. Phase 3 trials are in the final step before approval. The drug already has data showing both safety and effectiveness. As a general rule, Phase 3 trials are more promising than Phase 2, and Phase 2 trials are more promising than phase 1.

Do I need to be insured to participate in a Chronic Spontaneous Urticaria medical study ?

Clinical trials are almost always free to participants, and so do not require insurance. The only exception here are trials focused on cancer, because only a small part of the typical treatment plan is actually experimental. For these cancer trials, participants typically need insurance to cover all the non-experimental components.

What are the newest Chronic Spontaneous Urticaria clinical trials ?

Most recently, we added EVO756 for Chronic Urticaria, Ritlecitinib for Chronic Urticaria and AK006 IV for Hives to the Power online platform.