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EP262 for Chronic Urticaria (CALM-CIndU Trial)

Phase 1
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
Diagnosis of CIndU (symptomatic dermographism or cold urticaria) for greater than 3 months and positive response to applicable skin provocation testing
Willing to discontinue chronic treatment with antihistamines during the study
Timeline
Screening 3 weeks
Treatment Varies
Follow Up measured from day 1 to end of study or early termination (up to 12 weeks)
Awards & highlights

CALM-CIndU Trial Summary

This trial will test a new medicine to see if it can help people with skin allergies like hives, itching & cold reactions.

Who is the study for?
This trial is for individuals with Chronic Inducible Urticaria (CIndU), specifically those who have had symptomatic dermographism or cold urticaria for more than three months. Participants must respond positively to skin tests and are willing to stop taking antihistamines during the study. People with other underlying causes of hives or active skin diseases that could affect results, or those who regularly have extensive wheals where testing occurs, cannot join.Check my eligibility
What is being tested?
The trial is testing an oral medication called EP262 on people with CIndU to see how safe it is and how it affects their condition. It's in Phase 1b, which means they're still early in studying this drug's effects on humans after initial safety has been assessed.See study design
What are the potential side effects?
Since this is a Phase 1b study primarily focused on safety and tolerability, specific side effects of EP262 are not yet fully known but may include typical drug-related reactions such as gastrointestinal discomfort, headaches, or allergic responses.

CALM-CIndU Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have been diagnosed with chronic inducible urticaria for over 3 months and responded positively to skin tests.
Select...
I am willing to stop taking antihistamines for the study.

CALM-CIndU Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~measured from day 1 to end of study or early termination (up to 12 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 12 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
Safety and tolerability of EP262
Secondary outcome measures
Change in Critical Friction Threshold (CFT)
Change in Critical Temperature Threshold (CTT)

CALM-CIndU Trial Design

1Treatment groups
Experimental Treatment
Group I: EP262 150 mgExperimental Treatment1 Intervention
Once daily

Find a Location

Who is running the clinical trial?

Escient Pharmaceuticals, IncLead Sponsor
4 Previous Clinical Trials
267 Total Patients Enrolled
1 Trials studying Chronic Urticaria
90 Patients Enrolled for Chronic Urticaria

Frequently Asked Questions

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

What kind of individuals would be considered qualified to join this research project?

"Those wishing to enter this clinical study must suffer from chronic urticaria and be between 18-80 years of age. The trial is currently registering a maximum capacity of 30 individuals."

Answered by AI

Has the federal agency sanctioned EP262 150 mg for public use?

"EP262 150 mg has not been widely tested in clinical trials, thus it was assigned a safety rating of 1. This indicates that there is limited data available to assess its efficacy and potential side effects."

Answered by AI

Could individuals aged less than fifty-five years old become part of this medical experiment?

"The requirements for this clinical trial state that patients must be between 18 and 80 years of age. For those below the legal threshold or above 65, there are 6 trials and 31 trials respectively available to them."

Answered by AI

Are researchers still taking on new participants for this trial?

"That is correct. The data available on clinicaltrials.gov indicates that the trial, which was initially published on September 1st 2023, is currently recruiting patients. 30 individuals need to be enrolled from 6 different medical centres."

Answered by AI

How many medical institutions have implemented this experiment?

"Treasure Valley Medical Research in Boise, Idaho, Allergy and Clinical Immunology Associates in Pittsburgh, Pennsylvania, and National Allergy and Asthma Research LLC. in North Charleston South carolina are some of the 8 medical centres participating in this investigation."

Answered by AI

What is the upper limit of patients who can participate in this medical research?

"Affirmative. Clinicaltrials.gov lists this trial as actively seeking participants with its original posting on September 1st 2023 and most recent update being 18th of the same month. The study needs to recruit 30 individuals from 6 medical centres."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Phase 1b, Open-Label Study to Evaluate the Safety, Tolerability, and Pharmacodynamics of EP262 in Subjects With Chronic Inducible Urticaria
2023. "Phase 1b, Open-Label Study to Evaluate the Safety, Tolerability, and Pharmacodynamics of EP262 in Subjects With Chronic Inducible Urticaria". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06050928.
All > Meridian
~10 spots leftby Sep 2024
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