EVO756 for Chronic Urticaria

Recruiting at 17 trial locations

Overseen By Polina Bukshpun

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Evommune, Inc.

Must not be taking: Antihistamines

Disqualifiers: Urticarial vasculitis, Erythema multiforme, others

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

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 6 weeks

30 Participants Needed

Trial Summary

What is the purpose of this trial?

This phase 2a trial will evaluate the safety and efficacy of EVO756 in subjects with chronic inducible urticaria, including symptomatic dermographism and cold urticaria.

Will I have to stop taking my current medications?

You may need to stop taking certain medications, like antihistamines, to participate in this trial.

What makes the drug EVO756 unique for treating chronic urticaria?

EVO756 is unique for chronic urticaria as it may offer a novel approach compared to traditional treatments like antihistamines and corticosteroids, which are often used but may not be effective for all patients. While the specific details of EVO756's mechanism are not provided, it could potentially target the underlying autoimmune aspects of chronic urticaria, similar to newer immunomodulatory drugs that have been explored for this condition. ^{1 2 3 4 5}

Eligibility Criteria

Adults with chronic inducible urticaria, which includes conditions like symptomatic dermographism and cold urticaria, can participate in this trial. Specific eligibility criteria are not provided.

Inclusion Criteria

Positive response following provocation using the TempTest or FricTest at Screening and Day 1.

I have been diagnosed with chronic inducible urticaria for over 3 months.

Exclusion Criteria

I am currently taking antihistamines or similar medications.

I have a history of skin conditions other than chronic hives.

I do not have skin conditions or markings that could affect study results.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive EVO756 to evaluate safety and efficacy in chronic inducible urticaria

6 weeks

Weekly visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• EVO756

Trial Overview The study is testing the safety and effectiveness of a medication called EVO756 taken orally by adults who suffer from chronic inducible urticaria to see if it helps reduce their symptoms.

Participant Groups

Group I: EVO756 Experimental Treatment 1 Intervention

Who Is Running the Clinical Trial?

Evommune, Inc.

Lead Sponsor

Trials

5

Recruited

380+

Findings from Research

Chronic urticaria is often an autoimmune disorder, with autoantibodies found in about half of patients, leading to a more aggressive treatment approach that includes immunomodulatory drugs.

First-line treatment involves non-sedating antihistamines, with corticosteroids used for severe cases; remission can be achieved in 20-50% of patients unresponsive to antihistamines, but long-term corticosteroid use should be minimized to reduce side effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Chronic urticaria: a role for newer immunomodulatory drugs? Tedeschi, A., Airaghi, L., Lorini, M., et al.[2018]

The updated WAO position paper provides new insights into the pathogenesis of chronic urticaria and highlights the effective use of biologics, particularly omalizumab, for patients with severe refractory cases.

This document aims to simplify and update guidance for general practitioners worldwide on diagnosing and managing chronic urticaria and angioedema, incorporating recent findings on epidemiology, comorbidities, and special considerations in treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The challenges of chronic urticaria part 2: Pharmacological treatment, chronic inducible urticaria, urticaria in special situations. Sánchez-Borges, M., Ansotegui, IJ., Baiardini, I., et al.[2023]

The updated WAO position paper highlights significant advancements in understanding chronic urticaria's causes and the effective use of biologics like omalizumab for patients with severe cases.

This review aims to provide simplified guidance for general practitioners worldwide, incorporating the latest information on the diagnosis and management of urticaria and angioedema, while not replacing existing national and international guidelines.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The challenges of chronic urticaria part 1: Epidemiology, immunopathogenesis, comorbidities, quality of life, and management. Sánchez-Borges, M., Ansotegui, IJ., Baiardini, I., et al.[2023]

Urticaria, a common mast cell-driven condition affecting about 20% of people at some point in their lives, can significantly reduce quality of life and impact work and school performance.

The guideline provides a comprehensive overview of urticaria, including its definition, classification, causes, and evidence-based diagnostic and treatment strategies, reflecting the latest research and expert consensus.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The EAACI/GA(2) LEN/EDF/WAO Guideline for the definition, classification, diagnosis, and management of urticaria: the 2013 revision and update. Zuberbier, T., Aberer, W., Asero, R., et al.[2022]

The updated international guideline for urticaria, developed by a collaboration of 64 delegates from 50 societies across 31 countries, emphasizes evidence-based diagnostic and therapeutic approaches for this common mast cell-driven condition affecting about 20% of the population.

Chronic urticaria can significantly impair quality of life and daily functioning, highlighting the importance of effective management strategies outlined in the new guidelines.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The international EAACI/GA²LEN/EuroGuiDerm/APAAACI guideline for the definition, classification, diagnosis, and management of urticaria. Zuberbier, T., Abdul Latiff, AH., Abuzakouk, M., et al.[2022]

References

1. New Zealand pubmed.ncbi.nlm.nih.gov

Chronic urticaria: a role for newer immunomodulatory drugs? [2018]

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

The challenges of chronic urticaria part 2: Pharmacological treatment, chronic inducible urticaria, urticaria in special situations. [2023]

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

The challenges of chronic urticaria part 1: Epidemiology, immunopathogenesis, comorbidities, quality of life, and management. [2023]

4. Denmark pubmed.ncbi.nlm.nih.gov

The EAACI/GA(2) LEN/EDF/WAO Guideline for the definition, classification, diagnosis, and management of urticaria: the 2013 revision and update. [2022]

5. Denmark pubmed.ncbi.nlm.nih.gov

The international EAACI/GA²LEN/EuroGuiDerm/APAAACI guideline for the definition, classification, diagnosis, and management of urticaria. [2022]