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This phase 2a trial will evaluate the safety and efficacy of EVO756 in subjects with chronic inducible urticaria, including symptomatic dermographism and cold urticaria.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| EVO756 300 mg QD | Experimental | Oral EVO756 300 mg QD |
|
| EVO756 50 mg BID | Experimental | Oral EVO756 50 mg BID |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Oral EVO756 300 mg QD | Drug | Oral EVO756, 300 mg once daily |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Safety and Tolerability | Safety will be assessed by the total number of subjects with at least one TEAE | Day 1 to Week 6 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Total Fric Score (TFS) | The Total Fric Score represents the total number of linear wheals with a width of ≥3 mm induced following the Fric Test, from 0 to 4; 0 representing the minimum score (better outcome), and 4 representing the maximum score (worse outcome). A complete response is equal to a response of 0, where a subject began with at least a score of 1. A partial response is equal to a decrease of at least 2 points in the score (wheals), where a subject began with at least a score of 2. Partial responders may also be considered complete responders if their final score is equal to 0. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cahaba Dermatology & Skin Health Center, LLC | Birmingham | Alabama | 35244 | United States | ||
| California Allergy and Asthma Medical Group |
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| ID | Title | Description |
|---|---|---|
| FG000 | EVO756 300 mg QD | Active Treatment |
| FG001 | EVO756 50 mg BID | Active Treatment |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jan 10, 2025 | Mar 30, 2026 |
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| Oral EVO756 50 mg BID |
| Drug |
Oral EVO756 50 mg twice daily |
|
| Day 1 to Week 4 |
| Change in Pruritus Severity at the Provocation Test Site | The Pruritus Severity is determined based on the Pruritus Numeric Rating Scale, or P-NRS. This is an 11-point scale completed by the subject prior to and approximately 10 minutes after completion of the provocation test, where 10 represents the worst itch (maximum), and 0 represents no itch (minimum) at the site of the urticaria provocation test. | Day 1 to Week 4 |
| Los Angeles |
| California |
| 90025 |
| United States |
| Integrative Skin Science and Research | Sacramento | California | 95815 | United States |
| West Dermatology Research Center | San Diego | California | 92121 | United States |
| Advanced Clinical Research Institute | Tampa | Florida | 33607 | United States |
| Aeroallergy Research Laboratories of Savannah, Inc. | Savannah | Georgia | 31406 | United States |
| Treasure Valley Medical Research | Boise | Idaho | 83706 | United States |
| Dawes Fretzin Clinical Research Group, LLC | Indianapolis | Indiana | 46250 | United States |
| Southern Indiana Clinical Trials | New Albany | Indiana | 47150 | United States |
| Indiana Clinical Trials Center, P.C. | Plainfield | Indiana | 46168 | United States |
| DelRicht Research | Baton Rouge | Louisiana | 70809 | United States |
| Chesapeake Clinical Research, Inc | White Marsh | Maryland | 21162 | United States |
| OptiSkin Medical | New York | New York | 10128 | United States |
| Red River Research Partners | Fargo | North Dakota | 58013 | United States |
| Bexley Dermatology Research | Bexley | Ohio | 43209 | United States |
| Allergy, Asthma, and Clinical Research Center | Oklahoma City | Oklahoma | 73120 | United States |
| Allergy and Clinical Immunology Associates | Pittsburgh | Pennsylvania | 15241 | United States |
| Austin Institute for Clinical Research | Pflugerville | Texas | 78660 | United States |
| COMPLETED |
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| NOT COMPLETED |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | EVO756 300 mg QD | Active Treatment |
| BG001 | EVO756 50 mg BID | Active Treatment |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Safety and Tolerability | Safety will be assessed by the total number of subjects with at least one TEAE | Posted | Number | Participants with a TEAE | Day 1 to Week 6 |
|
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| ||||||||||||||||||||||||||||||
| Secondary | Change in Total Fric Score (TFS) | The Total Fric Score represents the total number of linear wheals with a width of ≥3 mm induced following the Fric Test, from 0 to 4; 0 representing the minimum score (better outcome), and 4 representing the maximum score (worse outcome). A complete response is equal to a response of 0, where a subject began with at least a score of 1. A partial response is equal to a decrease of at least 2 points in the score (wheals), where a subject began with at least a score of 2. Partial responders may also be considered complete responders if their final score is equal to 0. | Total number of participants assessed is equal to 27, the count of subjects that completed Week 4 visits. | Posted | Mean | Standard Deviation | Total Fric Score | Day 1 to Week 4 |
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| Secondary | Change in Pruritus Severity at the Provocation Test Site | The Pruritus Severity is determined based on the Pruritus Numeric Rating Scale, or P-NRS. This is an 11-point scale completed by the subject prior to and approximately 10 minutes after completion of the provocation test, where 10 represents the worst itch (maximum), and 0 represents no itch (minimum) at the site of the urticaria provocation test. | Total number of participants assessed is equal to 27, the count of subjects that completed Week 4 visits. | Posted | Mean | Standard Deviation | scores on a scale | Day 1 to Week 4 |
|
|
6 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | EVO756 300 mg QD | Active Treatment | 0 | 11 | 0 | 11 | 3 | 11 |
| EG001 | EVO756 50 mg BID | Active Treatment | 0 | 19 | 0 | 19 | 7 | 19 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Fatigue | General disorders | Non-systematic Assessment |
| ||
| Hepatic Cyst | Hepatobiliary disorders | Non-systematic Assessment |
| ||
| Gastroenteritis | Infections and infestations | Non-systematic Assessment |
| ||
| Viral Upper Respiratory Tract Infection | Infections and infestations | Non-systematic Assessment |
| ||
| Vulvovaginal Mycotic Infection | Infections and infestations | Non-systematic Assessment |
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| Procedural Pain | Injury, poisoning and procedural complications | Non-systematic Assessment |
| ||
| Alanine Aminotransferase Increased | Investigations | Non-systematic Assessment |
| ||
| Aspartate Aminotransferase Increased | Investigations | Non-systematic Assessment |
| ||
| Vitamin D Deficiency | Metabolism and nutrition disorders | Non-systematic Assessment |
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| Back Pain | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
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| Dizziness | Nervous system disorders | Non-systematic Assessment |
| ||
| Headache | Nervous system disorders | Non-systematic Assessment |
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| Sciatica | Nervous system disorders | Non-systematic Assessment |
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| Somnolence | Nervous system disorders | Non-systematic Assessment |
| ||
| Agitation | Psychiatric disorders | Non-systematic Assessment |
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| Insomnia | Psychiatric disorders | Non-systematic Assessment |
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| Renal Cyst | Renal and urinary disorders | Non-systematic Assessment |
| ||
| Pruritus | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
| ||
| Acne | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Eugene Bauer, MD | Evommune, Inc. | 650-223-7745 | Eugene.Bauer@Evommune.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Apr 14, 2025 | Mar 30, 2026 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D000094482 | Chronic Inducible Urticaria |
| ID | Term |
|---|---|
| D000080223 | Chronic Urticaria |
| D014581 | Urticaria |
| D017445 | Skin Diseases, Vascular |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| C494814 | BID protein, human |
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| >=65 years |
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| Male |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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