What side effects are associated with this type of intervention?

Common treatments for Chronic Urticaria include antihistamines, corticosteroids, and immunomodulatory therapies. Antihistamines are generally well-tolerated but can cause drowsiness, dry mouth, and dizziness. Corticosteroids, particularly when used long-term, can lead to side effects such as weight gain, hypertension, diabetes, osteoporosis, and increased risk of infections. Immunomodulatory therapies, such as omalizumab, can cause injection site reactions, headaches, and, rarely, anaphylaxis. It is important to discuss potential side effects with a healthcare provider to tailor the treatment plan to individual needs.

What prior FDA approvals exist?

Chronic Urticaria has been treated with several FDA-approved medications. Antihistamines, such as cetirizine and loratadine, are commonly used as first-line treatments. For patients who do not respond to antihistamines, omalizumab, an anti-IgE monoclonal antibody, has been approved and shown efficacy in reducing symptoms. Additionally, cyclosporine, an immunosuppressant, is sometimes used off-label for severe cases. These treatments aim to reduce the immune response and alleviate symptoms of Chronic Urticaria.

What other types of research exist?

Promising novel alternatives for Chronic Urticaria patients in 2024 include anti-nerve growth factor monoclonal antibodies, which are being developed for pain management and may have applications in chronic urticaria. Additionally, targeting MRGPRX2 with synthetic small-molecule inhibitors, as suggested by recent research, could provide effective treatment options. These alternatives focus on novel mechanisms that could offer new therapeutic benefits.

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EP262 for Chronic Urticaria (CALM-CIndU Trial)

Phase 1

Waitlist Available

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

No Placebo-Only Group

Summary

This trial is testing a new treatment called EP262 to help people who have chronic hives triggered by specific conditions like skin scratching or cold temperatures.

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.

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.

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.

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.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ measured from day 1 to end of study or early termination (up to 12 weeks)

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Safety and tolerability of EP262

Secondary study objectives

Change in Critical Friction Threshold (CFT)

Change in Critical Temperature Threshold (CTT)

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: EP262 150 mgExperimental Treatment1 Intervention

Once daily

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Oral EP262

2023

Completed Phase 2

~40

0 / 2Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for Chronic Urticaria are H1-antihistamines, which work by blocking the H1 histamine receptors on cells, thereby preventing the action of histamine—a key mediator in allergic reactions that causes symptoms like itching and swelling. This is crucial for Chronic Urticaria patients as it helps to alleviate persistent symptoms and improve quality of life. Other treatments under investigation, such as EP262, may target different pathways involved in the immune response, offering potential new options for patients who do not respond to antihistamines.

H1-antihistamines for chronic spontaneous urticaria: an abridged Cochrane Systematic Review.