160 Participants Needed

EVO756 for Chronic Urticaria

Recruiting at 40 trial locations
PB
Overseen ByPolina Bukshpun
Age: 18+
Sex: Any
Trial Phase: Phase 2
Sponsor: Evommune, Inc.
Must be taking: H1-antihistamines
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

This study will evaluate the efficacy and safety of different doses of EVO756 in adults with moderate to severe chronic spontaneous urticaria (CSU).

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 EVO756 safe for humans?

The research on omalizumab, which may be related to EVO756, shows it generally has a good safety profile in treating chronic urticaria, with fewer safety concerns compared to other treatments like cyclosporine.12345

How does the drug EVO756 differ from other treatments for chronic urticaria?

EVO756 is unique because it may offer a novel approach to treating chronic urticaria, potentially targeting the autoimmune aspect of the condition, unlike traditional antihistamines or corticosteroids that primarily address symptoms. This could make it particularly beneficial for patients who do not respond well to existing therapies.36789

What evidence supports the effectiveness of the drug EVO756 for chronic urticaria?

The research highlights the effectiveness of omalizumab, a biologic drug, in improving disease control and quality of life for patients with chronic urticaria. While EVO756 is not directly mentioned, the success of similar biologic treatments like omalizumab suggests potential effectiveness for EVO756 in treating chronic urticaria.136710

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.
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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?
4Treatment groups
Experimental Treatment
Placebo Group
Group I: Dose 3Experimental Treatment1 Intervention
Orally administered EVO756, dose 3
Group II: Dose 2Experimental Treatment1 Intervention
Orally administered EVO756, dose 2
Group III: Dose 1Experimental Treatment1 Intervention
Orally administered EVO756, dose 1
Group IV: Placebo controlPlacebo Group1 Intervention
Orally administered placebo control

Find a Clinic Near You

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

Citations

The challenges of chronic urticaria part 2: Pharmacological treatment, chronic inducible urticaria, urticaria in special situations. [2023]
The challenges of chronic urticaria part 1: Epidemiology, immunopathogenesis, comorbidities, quality of life, and management. [2023]
Revisions to the international guidelines on the diagnosis and therapy of chronic urticaria. [2022]
The EAACI/GA²LEN/EDF/WAO guideline for the definition, classification, diagnosis and management of urticaria. [2022]
Omalizumab Drug Survival in Chronic Urticaria: A Retrospective Multicentric French Study. [2023]
[Omalizumab for the treatment of chronic urticaria: Real-life findings]. [2019]
Chronic Urticaria: Following Practice Guidelines. [2018]
Effectiveness and Safety of Immunosuppressants and Biological Therapy for Chronic Spontaneous Urticaria: A Network Meta-Analysis. [2022]
Chronic Spontaneous Urticaria: The Devil's Itch. [2023]
Chronic urticaria: a role for newer immunomodulatory drugs? [2018]
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