EVO756 for Chronic Urticaria

Recruiting at 50 trial locations

Overseen By Polina Bukshpun

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Evommune, Inc.

Must be taking: H1-antihistamines

Disqualifiers: Abnormal labs, Urticaria history, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 8-12 weeks

160 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 to determine its effectiveness for adults with chronic spontaneous urticaria (CSU), a condition causing persistent hives and itching. Researchers aim to assess the effectiveness and safety of different EVO756 doses compared to a placebo (a harmless pill with no active drug). Suitable participants have had CSU for at least three months and have not found relief from H1-antihistamines (common allergy medications). Participants will receive one of three doses of EVO756 or a placebo to observe changes in their symptoms. As a Phase 2 trial, this research focuses on measuring the treatment's effectiveness in an initial, smaller group of people.

Will I have to stop taking my current medications?

If you are taking H1-antihistamines, you must continue on a stable regimen for at least 4 weeks before starting the trial and throughout the study. The protocol does not specify about other medications, so it's best to discuss with the trial team.

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

Research has shown that EVO756 was safe in earlier studies. In tests involving individuals with chronic inducible urticaria, EVO756 was generally well-tolerated. Approximately 30% of participants experienced complete relief after four weeks of treatment. Importantly, these studies found no major safety issues. This suggests that EVO756 might be safe for humans, but individual experiences can vary. Discussing potential risks with a healthcare provider is always advisable. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for chronic urticaria?

Most treatments for chronic urticaria, like antihistamines and corticosteroids, aim to manage symptoms by reducing inflammation and allergic response. But EVO756 works differently, targeting specific pathways involved in the immune response to potentially offer more precise relief. What makes EVO756 particularly exciting is its oral administration, which could offer a more convenient and potentially faster-acting option for patients compared to current treatments. Researchers are hopeful that EVO756's unique mechanism will lead to improved outcomes for those struggling with chronic urticaria.

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

Research has shown that EVO756 may help treat chronic urticaria, a condition that causes itchy hives. One study found that 30% of patients with a type of chronic urticaria experienced significant symptom improvement or resolution after just four weeks of treatment. EVO756 works by affecting mast cells, which play a role in allergic reactions. Early results suggest that some people may start to feel better as soon as one week after starting treatment. Overall, these studies suggest that EVO756 could effectively reduce symptoms for people with chronic urticaria. ^{2 3 4 6 7}

Are You a Good Fit for This Trial?

Adults with moderate to severe chronic spontaneous urticaria (CSU) who haven't responded well to antihistamines can join. They must have a Urticaria Activity Score of 16 or more and been diagnosed for at least 3 months. Participants should not have other diseases causing similar symptoms, significant health issues unrelated to CSU, or be on certain medications.

Inclusion Criteria

Urticaria Activity Score (UAS7) equal to or greater than 16 at Day 1. UAS entries must be completed for a minimum of 4 out of the 7 days prior to Day 1

I have had chronic hives for 3+ months and antihistamines don't work well.

I have been on a stable dose of antihistamines for at least 4 weeks.

Exclusion Criteria

History of diseases with urticaria or angioedema symptoms, other than CSU and symptomatic dermographism

Any clinically significant abnormality in laboratory evaluations, physical examinations, vital signs, or ECG at Screening, according to the Investigator's discretion

I am taking specific medications.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive different doses of EVO756 or placebo to evaluate efficacy and safety

8-12 weeks

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 trial is testing how effective and safe different doses of EVO756 are compared to a placebo in adults with CSU. It's randomized, meaning people will be put into the EVO756 or placebo group by chance.

How Is the Trial Designed?

Group I: Dose 3 Experimental Treatment 1 Intervention

Orally administered EVO756, dose 3

Group II: Dose 2 Experimental Treatment 1 Intervention

Orally administered EVO756, dose 2

Group III: Dose 1 Experimental Treatment 1 Intervention

Orally administered EVO756, dose 1

Group IV: Placebo control Placebo Group 1 Intervention

Orally administered placebo control

Who Is Running the Clinical Trial?

Evommune, Inc.

Lead Sponsor

Trials

5

Recruited

380+

Published Research Related to This Trial

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 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]

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]

In a study of 23 patients with chronic urticaria who were unresponsive to standard treatments, omalizumab resulted in complete or significant remission in 83% of cases, with nearly half experiencing remission within 72 hours of the first injection.

While 52% of patients reported non-serious side effects, only one patient had to stop treatment due to adverse events, indicating that omalizumab is generally safe and effective for managing chronic urticaria in real-life settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Omalizumab for the treatment of chronic urticaria: Real-life findings]. Hamelin, A., Amsler, E., Mathelier-Fusade, P., et al.[2019]

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]

In a study of 878 French patients with chronic urticaria, omalizumab (OMA) showed a longer drug survival rate compared to previous studies, with 50% of patients still on treatment 2.4 years after starting.

The main reason for discontinuing OMA was achieving well-controlled disease in 50% of patients, but many were able to restart treatment, indicating its effectiveness in managing chronic urticaria.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Omalizumab Drug Survival in Chronic Urticaria: A Retrospective Multicentric French Study. Litovsky, J., Hacard, F., Tétart, F., et al.[2023]

Omalizumab was found to be more effective than placebo and cyclosporine in improving quality of life and urticaria activity scores in patients with chronic spontaneous urticaria, based on a review of 14 randomized control trials.

Omalizumab also had a better safety profile, showing lower incidences of adverse events compared to other immunosuppressants like cyclosporine, making it a preferable treatment option for CSU.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness and Safety of Immunosuppressants and Biological Therapy for Chronic Spontaneous Urticaria: A Network Meta-Analysis. Lin, WK., Lin, SJ., Lee, WR., 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. 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 ...

7. 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 ...