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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called EVO756 for individuals with chronic urticaria, a condition that causes itchy and swollen skin. The trial aims to assess the safety and effectiveness of EVO756 for those with skin reactions triggered by physical factors like scratching (symptomatic dermographism) or cold temperatures (cold urticaria). Individuals who have experienced these symptoms for at least three months and react to certain tests may be suitable candidates for this trial. As a Phase 2 trial, it focuses on measuring the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to important research.

Will I have to stop taking my current medications?

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

Is there any evidence suggesting that EVO756 is likely to be safe for humans?

Research has shown that EVO756 was well-tolerated in earlier studies. In one study, 30% of patients with chronic inducible urticaria, a type of skin condition, experienced complete relief after four weeks of treatment with EVO756. This suggests that the treatment is effective and generally safe.

Moreover, these studies have reported no major side effects, indicating that EVO756 could be a safe option for people with this condition. It is important to understand that these results come from an ongoing phase 2 study. This means the treatment has shown enough promise in earlier tests to continue being studied, but it is still being evaluated for safety and effectiveness. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Most treatments for chronic urticaria, like antihistamines or corticosteroids, focus on calming the immune response. But EVO756 works differently, targeting the underlying pathways that cause inflammation. This new mechanism of action might offer relief for those who don't respond well to standard therapies. Researchers are excited about EVO756 because it has the potential to reduce symptoms more effectively and potentially with fewer side effects.

What evidence suggests that EVO756 might be an effective treatment for chronic urticaria?

In this trial, participants will receive EVO756, which previous studies have shown to be promising for treating chronic inducible urticaria, a type of hives. Research indicates that 30% of patients experienced a complete response after just four weeks of treatment, with symptoms significantly improving or disappearing. The treatment targets mast cells, which are part of the immune system and involved in allergic reactions. Improvements with EVO756 appeared as early as one week, highlighting its potential for quick relief. Overall, clinical studies have demonstrated both the effectiveness and good safety profile of EVO756. ^{1 2 3 4 6}

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

Group I: EVO756 Experimental Treatment 1 Intervention

Who Is Running the Clinical Trial?

Evommune, Inc.

Lead Sponsor

Trials

5

Recruited

380+

Published Research Related to This Trial

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 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 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 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]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06603220

NCT06603220 | A Study Evaluating the Safety, Tolerability ... This phase 2a trial will evaluate the safety and efficacy of EVO756 in subjects with chronic inducible urticaria, including symptomatic dermographism and cold ...

2. evommune.com evommune.com/wp-content/uploads/2025/09/29b_Evommune_EADV_CIndU_091925.pdf

Evommune Presents Full Phase 2 Data for Oral MRGPRX2 ... “The full Phase 2 data presented today highlight EVO756's differentiated mast cell dual mechanism, with responses observed as early as one week ...

3. prnewswire.com prnewswire.com/news-releases/evommune-announces-top-line-data-from-phase-2-trial-of-evo756-in-chronic-inducible-urticaria-demonstrating-robust-activity-and-favorable-safety-profile-302466088.html

Evommune Announces Top Line Data from Phase 2 Trial ... "We are very pleased to report data that demonstrate excellent responses after only four weeks of treatment, supporting EVO756's potential to ...

4. thedermdigest.com thedermdigest.com/evommunes-evo756-performs-well-in-phase-2-study-of-adults-with-cindu/

Evommune's EVO756 Performs Well in Phase 2 Study of ... Fully 30% of adult chronic inducible urticaria (CIndU) patients achieved a complete response after four weeks of dosing with EVO756.

5. evommune.com evommune.com/wp-content/uploads/2024/12/23_Evommune_EVO756_Trial_Results_Preso.pdf

Evommune Presents Positive Clinical Results of its ... Proof-of-concept trial of EVO756 in 132 subjects, demonstrated an excellent safety profile, robust efficacy, and a pharmacokinetic profile ...

6. evommune.com evommune.com/mrgprx2-antagonist/

Chronic Inflammation | MRGPRX2 Antagonist EVO756 Blocking MRGPRX2 has the potential to be the first oral treatment for a variety of mast cell-mediated diseases, including chronic spontaneous urticaria. In ...