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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

Timeline

Screening 3 weeks

Treatment Varies

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

Awards & highlights

CALM-CSU Trial 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.Check my eligibility

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.See study design

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.

CALM-CSU Trial 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.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change in Urticaria Activity Score (UAS) over a 7-day period (UAS7)

Secondary outcome measures

Change in Hive Severity Score (HSS) over a 7-day period (HSS7)

Change in Itch Severity Score (ISS) over a 7-day period (ISS7)

Safety and tolerability of EP262

CALM-CSU Trial Design

3Treatment groups

Experimental Treatment

Placebo Group

Group I: EP262 50 mgExperimental Treatment1 Intervention

Group II: EP262 150 mgExperimental Treatment1 Intervention

Group III: PlaceboPlacebo Group1 Intervention

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Escient Pharmaceuticals, IncLead Sponsor

4 Previous Clinical Trials

207 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are participants aged 35 or over accepted into this research study?

"According to the eligibility guidelines, those aged 18 or over and 80 or under are allowed to participate in this trial."

Answered by AI

Are there specific inclusion criteria for participants in this research endeavor?

"Inclusion criteria for this medical trial specify that participants must suffer from chronic urticaria, be between 18 and 80 years of age. A total of 90 individuals may participate in the study."

Answered by AI

Is there still a call for volunteers to participate in this clinical experiment?

"According to clinicaltrials.gov, this experiment is accepting participants at the moment and was initially advertised on October 1st 2023 with its most recent update occurring on October 5th of the same year."

Answered by AI

Are there many Canadian medical sites administering this experiment?

"Eight medical centres across the United States are taking part in this trial, including Antelope Valley Clinical Trials located in Los Angeles, Advanced Clinical Research Institute based out of Tampa and Treasure Valley Medical Research situated in Boise."

Answered by AI

How might EP262 50 mg pose a risk to patients?

"The safety of EP262 50 mg has been evaluated and given a rating of 2, as there are some data points that support the safety but none to suggest efficacy."

Answered by AI

How many participants are currently taking part in the clinical trial?

"Affirmative. Evidence from clinicaltrials.gov reveals that this research project, originally made available on October 1st 2023, is actively seeking participants. Approximately 90 subjects must be sourced from 8 distinct locations."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Effects of EP262 in Subjects With Chronic Spontaneous Urticaria

2023. "Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Effects of EP262 in Subjects With Chronic Spontaneous Urticaria". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06077773.

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