EP262 for Chronic Hives (CALM-CSU Trial)

Phase 2

Recruiting

Research Sponsored by Escient Pharmaceuticals, Inc

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Must not have

Other active skin diseases associated with chronic pruritus (eg, atopic dermatitis, bullous pemphigoid, prurigo nodularis, dermatitis herpetiformis)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up measured from day 1 to end of study or early termination (up to 10 weeks)

Summary

This trial tests a drug to see if it helps people with long-term hives from unknown causes.

Who is the study for?

This trial is for people with chronic spontaneous urticaria (CSU), also known as hives, who still have symptoms despite taking up to four times the normal dose of H1 antihistamines. Participants must have a documented history of CSU and a UAS7 score of 16 or higher.

What is being tested?

The study is testing EP262, an oral medication, against a placebo to see if it can help with CSU. It's conducted across multiple centers where participants are randomly assigned to receive either EP262 or a placebo without knowing which one they're getting.

What are the potential side effects?

While specific side effects for EP262 aren't provided here, common side effects from treatments in trials like this may include digestive issues, headaches, dizziness, and possible allergic reactions.

Eligibility Criteria

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I have a skin condition that causes long-term itching.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ measured from day 1 to end of study or early termination (up to 10 weeks)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~measured from day 1 to end of study or early termination (up to 10 weeks)

This trial's timeline: 3 weeks for screening, Varies for treatment, and measured from day 1 to end of study or early termination (up to 10 weeks) for reporting.