We’re now enrolling individuals in a chronic spontaneous urticaria (CSU) clinical trial. Fill out our survey to see if you qualify.

Chronic Hives Can Make Life Harder. There is Hope For New Potential Care Options.

The disruption to one’s daily life and physical discomfort suffered by those living with chronic hives can’t be overstated. Chronic spontaneous urticaria, or CSU as the condition is known, is an inflammation-based disease that is made more complicated since the potential cause has yet to be identified. For many, “treating” the telltale signs of CSU — like itchy, raised, swollen red bumps or welts that can occur anywhere on the body, and for prolonged periods of time — can primarily involve symptom management. However, promising strides are being made in the study of chronic hives, offering new hope to CSU patients for the possibility of new treatment options. By participating in a clinical trial, participants help shed valuable insight for researchers to better understand the landscape of this condition, and positively affect its trajectory.
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How It Works

Starting the process only takes a few minutes

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Complete The Survey

Answer some brief, easy questions and we’ll let you know whether you may be eligible to participate in the study.

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Schedule An Appointment

If you qualify, the next step is speaking with a team member. Just find 10 – 15 free minutes in your day and we’ll get you connected.

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Speak To A Team Member

Our dedicated specialists understand your situation and will listen, answer any questions, and address your concerns. We’re here to help.

See If You Qualify

Who Can Participate?

Here are the qualifications participants need to meet in order to join the chronic spontaneous urticaria (CSU) study.

  • Are at least 18 years old
  • Have had a confirmed diagnosis of CSU for three months or more
  • Do not have a history of diseases with hives or swelling symptoms, such as urticarial vasculitis, erythema multiforme, cutaneous mastocytosis (urticaria pigmentosa), hereditary or acquired angioedema, or any other skin disease that may impede the study team’s ability to assess
  • If taking antihistamines, participant must be on a stable regimen for at least four weeks prior to screening commencing, and throughout the study

Learn more about our participation criteria to see if you may be a good fit for this trial.

See If You Qualify

Understanding urticaria

What exactly is chronic spontaneous urticaria (CSU)?

There are multiple forms of urticaria, but chronic spontaneous urticaria (CSU) is defined as hives that come and go unexpectedly, with their root cause unknown. These hives—or raised, red, itchy bumps or welts on the skin—cause discomfort in sufferers, and occur frequently (almost daily) for a duration of six weeks or more. They typically last between 30 minutes and 24 hours. Additionally, with CSU, hives may be big or small, occur anywhere on your body, the affected area may be warm to the touch, and in more severe cases, may cause swelling, headache, fatigue, joint pain, wheezing, diarrhea and/or rapid heartbeat.

Skin-condition

How is it treated?

Because CSU is considered an “idiopathic” condition, in other words there’s no clear cause, often treatment involves managing patient symptoms and discomfort.1. This is accomplished through the use of antihistamines, taken topically or by mouth. Available medicines have made progress treating inflammation, but we know there’s a need for more effective therapy options, which is where we hope to make a difference.

What We Hope To Do

We’re committed to advancing the study of immunology, and are focused on better understanding the progression of debilitating chronic inflammatory diseases. That’s why the purpose of the investigational drug being studied, EVO756, is to target receptors on the mast (immune) cells in an attempt to prevent them from undergoing a process called degranulation, that causes the release of histamine and other inflammatory mediators. It is our hope that this approach, if successful, may potentially help not just patients with CSU, but also other mast cell-based inflammatory diseases as well.

More than 500,000 Americans are estimated to suffer from chronic urticaria. The spontaneous form is particularly frustrating, as what causes patients’ to break out in hives is unknown.2

1. Source: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5235931/

2. Source: https://pubmed.ncbi.nlm.nih.gov/30872154/

Frequently Asked Questions

What are the symptoms of chronic spontaneous urticaria?

Signs may include:3

  • Raised, red bumps or welts on the skin
  • Hives that last between 30 minutes and 24 hours, but occur most days of the week and persist for a period of 6 weeks or more
  • Itchiness (pruritus) that can be intense
  • Swelling of the affected skin area
  • Welts that vary in size, change shape, and appear and fade repeatedly
  • Headache
  • Joint Pain
  • Wheezing
  • Rapid Heartbeat

3. Source: https://www.mayoclinic.org/diseases-conditions/chronic-hives/symptoms-causes/syc-20352719

Who may be a good candidate to apply for this study?

You should consider applying for the CSU study if you:

  • Are at least 18 years old
  • Have had a confirmed diagnosis of CSU for at least three months
  • Do not have a history of diseases with hives or swelling symptoms, such as urticarial vasculitis, erythema multiforme, cutaneous mastocytosis (urticaria pigmentosa), hereditary or acquired angioedema, or any other skin disease that may impede the study team’s ability to assess
  • If taking antihistamines, participant must be on a stable regimen for at least four weeks prior to screening commencing (and throughout the study)

What will happen during the study?

This study is randomized and double-blind, which means neither participants nor study staff will know whether participants receive the investigational treatment, EVO756, in varying dose levels, or a placebo, which contains no active medication. Participants will receive either the study drug or placebo in tablet form to take for 12 weeks and be evaluated on an out-patient basis. Total duration of participation for each subject is expected to be approximately 18 weeks, including up to 30 days for screening, the 12-week treatment window, and two subsequent weeks of follow-up.

Are there any costs to participate in this study?

No, there is no cost to participate. In addition to receiving the investigational treatment (EVO756) at no cost, patients will be offered reimbursement for their time and travel, and certain travel accommodations may be arranged upon approval by the study team.
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Still have questions?

Contact us anytime at help@clinicalenrollment.com.

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