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Urticaria is a condition characterized by hives, rash, and itchy skin. Doctors participating in the CALM clinical studies are testing an investigational drug (EP262) to see if it may decrease hives in patients with either Chronic Inducible Urticaria (CIndU) or Chronic Spontaneous Urticaria (CSU).

Hives can develop when mast cells (a type of immune cell present in the skin) get activated. MRGPRX2 is one of the receptors on the mast cell and EP262 is a potent, highly selective small molecule drug designed to block activators of this receptor, which may lead to fewer hives.

EP262 represents a new, targeted approach to the treatment of urticaria with the potential for once-daily oral administration without the serious side effects observed with other treatments.

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

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CALM-CIndU Study for
Chronic Inducible Urticaria

Chronic Inducible Urticaria (CIndU) has specific known causes. Hives are induced by triggers including physical pressure or force on the skin such as scratching or rubbing (called symptomatic dermographism) or exposure to cold temperatures (cold urticaria).
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CALM-CSU Study for Chronic
Spontaneous Urticaria

In Chronic Spontaneous Urticaria (CSU), hives appear without a known cause and remain for at least six weeks. The majority of all chronic urticaria cases are spontaneous.
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CALM-CIndU Study only
CALM-CSU Study only
Participating in CALM-CIndU and CALM-CSU Studies
Chronic Inducible Urticaria

Who can participate?

  • Age 18 to 80 years old
  • Have a clinical diagnosis of Chronic Inducible Urticaria (CIndU) for at least 3 months with either:
    • Hives triggered by physical pressure or force on the skin such as scratching or rubbing (symptomatic dermographism)
    • Hives due to exposure to cold temperatures (cold urticaria)
CIndU

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.
Open-Label Dosing (4 weeks) : All participants will receive active study drug, EP262, as oral capsules to be taken once daily. They will have 5 study visits during this time for tests and health checks.
Follow-Up (8 weeks): There will be 2 visits during this period for the study doctor to check on their health and to have tests.
Total participation time is approximately 16 weeks with 8 study site visits.
Am I Qualified?
Learn more on ClinicalTrials.gov
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.

These studies cannot promise any direct benefit. However, the information collected in these studies 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 these studies, 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 studies, is always voluntary. It is your choice. If you meet the eligibility criteria, you can choose to join one of these studies. 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 these studies.

Am I Qualified?

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