EP262 for Chronic Urticaria

(CALM-CIndU Trial)

Recruiting at 14 trial locations

Overseen By Escient Clinical Trials

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Escient Pharmaceuticals, Inc

Must not be taking: Antihistamines

Disqualifiers: Atopic dermatitis, Bullous pemphigoid, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 12 weeks

33 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

You will need to stop taking chronic antihistamines during the study.

How is the drug EP262 different from other treatments for chronic urticaria?

The research does not provide specific information about EP262, so it's unclear how it differs from existing treatments for chronic urticaria. ^{1 2 3 4 5}

Eligibility Criteria

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.

Inclusion Criteria

I have been diagnosed with chronic inducible urticaria for over 3 months and responded positively to skin tests.

I am willing to stop taking antihistamines for the study.

Exclusion Criteria

You have hives, but they are not caused by rubbing your skin or exposure to cold.

I do not have other skin conditions that could affect the study's results.

You often get large rashes in the area where the skin test will be done.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive EP262 150 mg once daily

12 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• EP262

Trial Overview 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.

Participant Groups

Group I: EP262 150 mg Experimental Treatment 1 Intervention

Once daily

EP262 is already approved in United States for the following indications:

Approved in United States as EP262 for:

• None approved yet; under investigation for chronic spontaneous urticaria, chronic inducible urticaria, and atopic dermatitis

Who Is Running the Clinical Trial?

Escient Pharmaceuticals, Inc

Lead Sponsor

Trials

6

Recruited

340+

Findings from Research

The updated international guidelines for treating chronic urticaria recommend a three-step approach starting with a standard dose of non-sedating H1 antihistamines, which can be increased if necessary.

For patients who do not respond to initial treatments, the guidelines suggest using omalizumab, cyclosporine A, or montelukast, while short-term corticosteroids may be considered for up to 10 days, reflecting a shift in treatment strategies based on the latest evidence.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Revisions to the international guidelines on the diagnosis and therapy of chronic urticaria. Maurer, M., Magerl, M., Metz, M., et al.[2022]

References

1. United States pubmed.ncbi.nlm.nih.gov

Chronic Spontaneous Urticaria: The Devil's Itch. [2023]

2. England pubmed.ncbi.nlm.nih.gov

Psychometric properties of the portuguese version of the chronic urticaria quality of life questionnaire (CU-Q2oL). [2020]

3. United States pubmed.ncbi.nlm.nih.gov

Bloodletting therapy for treating patients with chronic urticaria: A systematic review and meta-analysis protocol. [2022]

4. Korea (South) pubmed.ncbi.nlm.nih.gov

A case series study of eighty-five chronic spontaneous urticaria patients referred to a tertiary care center. [2021]

5. Germany pubmed.ncbi.nlm.nih.gov

Revisions to the international guidelines on the diagnosis and therapy of chronic urticaria. [2022]