study

Hives, also known as urticaria, is a skin condition characterized by itchy bumps or welts on the skin. Chronic hives are welts that last for more than 6 weeks and often come back over months or years. The CALM clinical study is testing an investigational drug (EP262) to see if it will decrease hives in patients with Chronic Spontaneous Urticaria (CSU).

EP262 represents a new, targeted approach for the treatment of hives taken by mouth once a day.

If you experience chronic hives you may be interested in learning more about the CALM study.

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CALM-CSU Study for Chronic
Spontaneous Urticaria

In Chronic Spontaneous Urticaria (CSU), hives appear without a known cause and are present on most days of the week for at least 6 weeks. Two-thirds of all chronic urticaria cases are spontaneous, meaning we do not know why the hives appear.
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Chronic Spontaneous Urticaria

Who can participate?

  • Age 18 to 80 years old
  • Have a clinical diagnosis of Chronic Spontaneous Urticaria (CSU) for at least 6 months
  • Experience itch and hives most days of the week
CSU

What to Expect

Screening (2-4 weeks): Participants will have 1 study visit where their medical history will be reviewed and tests will be done to see if they qualify for this study.
Double-Blind Treatment (6 weeks): Participants will receive either active study drug, EP262, or placebo as oral capsules to be taken once daily. They will have 3 study visits during this time for tests and health checks.
Follow-Up (4 weeks): There will be 1 visit 4 weeks after the last dose of study drug for a final health check.
Total participation time is approximately 14 weeks with 5 study site visits.
Am I Qualified?
Learn more on ClinicalTrials.gov
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Frequently asked questions about clinical trials

A clinical study, also known as a clinical trial, is designed to learn more about an investigational drug’s ability to treat a specific disease or condition, and what side effects the drug may have. Clinical studies are conducted by experienced and trained medical professionals who monitor the health of participants throughout the study. In addition, an external review board helps to ensure that the study is conducted safely and that the rights and welfare of study participants are protected.

This study cannot promise any direct benefit. However, the information collected in this study will help researchers learn more about the study drug (EP262). What researchers learn may help others with this condition in the future. By participating in this study, you may be helping to advance understanding of this condition and development of a potential new treatment.

All research studies include potential risks. If you are interested in joining this study, you will be given a Patient Information Sheet to read. This document describes what the study involves, including the known potential risks in more detail. You should review these carefully and discuss them with your study doctor before you decide if you want to take part in this study. There may also be some risks that are not currently known.

Taking part in any study, including the CALM study, is always voluntary. It is your choice. If you meet the eligibility criteria, you can choose to join this study. If you join, you can change your mind and leave the study at any time.

The study drug, assessments and procedures will be provided at no cost to you.

In addition, you may be eligible for travel support and reimbursement of costs related to your study visits. You may also be eligible to receive compensation for completing study visits. Your study doctor and the study staff will explain what support may be available at your study site and how it works.

You can visit any doctor to meet your health needs during enrollment. You should tell other health professionals you see that you are participating in a study. You should also let your study doctor know about any care you receive outside of this study.

Am I Qualified?

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