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

FAQ

What are the symptoms of chronic spontaneous urticaria (CSU)?

Signs may include:1

  • 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

1. 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 this 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 has been on a stable regimen for at least four weeks prior to screening, and will remain so throughout the study

What are the benefits of participating?

The information gathered in this study may help identify new treatment options in the future for patients living with chronic hives. Study participants will be connected to a team of physicians and research scientists who understand their situation and can help answer questions and address concerns. Participants will enjoy a professional clinical environment and be treated with respect throughout the trial.

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 a stipend for their time and travel, and certain travel accommodations may be arranged upon approval by the study team.

Are there any risks to participating?

As all drugs and medical procedures carry a risk of side effects, the possibility that participants may experience some side effects, discomfort, or alternate reaction. The study staff will explain these potential risks before participants decide whether to participate, and address any concerns.

What is being researched in the trial?

The study will be evaluating how well EVO756 blocks a novel receptor (called MRGPRX2) on immune cells (specifically mast cells), as well as its safety in patients with chronic hives.

What will happen during the trial?

This is a Phase 2b, randomized, double-blind study, in which neither participants nor study staff will know whether patients receive the investigational treatment, EVO756, in varying dose levels, or a placebo, which contains no active medication. Participants will receive the study drug or placebo to take in tablet form for 12 weeks, and will be evaluated on an out-patient basis. The duration of participation for each subject is expected to be approximately 18 weeks total, including up to 30 days for screening, 12 weeks of treatment, and two subsequent weeks of follow-up. During the study, participants will enjoy a professional clinical environment and be treated with respect.

Does qualifying ensure my participation in the study?

Before a potential participant decides whether to take part in the study, the study staff will review the informed consent form with them and answer any questions. Once the consent form has been signed by the participant, the screening period of the study begins. During this period, the staff will review medical history and conduct any relevant assessments. All participants who meet all of the study criteria will be invited to participate.

What is the likelihood that I receive the placebo?

The probability that a participant will receive the placebo is 25%, or 1 in 4.

Can I change my mind about participating in the study?

Participation is entirely voluntary. Even if you are already involved in the study, you can change your mind at any time for any reason.

What if I have more questions?

If you are interested in learning more, please contact us at any time. You may email us at help@clinicalenrollment.com.