Chronic Inducible UrticariaPhase 2NCT06603220
A Study Evaluating the Safety, Tolerability, and Efficacy of EVO756 in Adults With Chronic Inducible Urticaria
A Phase 2 study testing Oral EVO756 300 mg QD and Oral EVO756 50 mg BID in people with Chronic Inducible Urticaria, run by Evommune, Inc. at 18 sites in United States.
Trial summary
This phase 2a trial will evaluate the safety and efficacy of EVO756 in subjects with chronic inducible urticaria, including symptomatic dermographism and cold urticaria. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Chronic Inducible Urticaria
- What is being tested?
- Oral EVO756 300 mg QD and Oral EVO756 50 mg BID
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 18 sitesUnited States
- Study dates
- 14 Aug 2024to 8 May 2025
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Confirmed diagnosis of chronic inducible urticaria for at least 3 months.
- Positive response following provocation using the TempTest or FricTest at Screening and Day 1.
Who cannot join
- History of diseases other than chronic inducible urticaria or chronic spontaneous urticaria with urticaria or angioedema symptoms, such as urticarial vasculitis, erythema multiforme, cutaneous mastocytosis (urticaria pigmentosa), and hereditary or acquired angioedema.
- Concurrent use of certain medications, including antihistamines.
- Any clinically significant disease, or other skin disease or skin markings (e.g., extensive scarring, tattoos), that might confound the evaluation of safety or efficacy.
Trial locations and contacts
18 sites in 1 country.
18 sites in 1 country
United States18 sites
DelRicht Research
Baton Rouge, Louisiana, 70809
Bexley Dermatology Research
Bexley, Ohio, 43209
Cahaba Dermatology & Skin Health Center, LLC
Birmingham, Alabama, 35244
Treasure Valley Medical Research
Boise, Idaho, 83706
Red River Research Partners
Fargo, North Dakota, 58013
Dawes Fretzin Clinical Research Group, LLC
Indianapolis, Indiana, 46250
California Allergy and Asthma Medical Group
Los Angeles, California, 90025
Southern Indiana Clinical Trials
New Albany, Indiana, 47150
OptiSkin Medical
New York, New York, 10128
Allergy, Asthma, and Clinical Research Center
Oklahoma City, Oklahoma, 73120
Austin Institute for Clinical Research
Pflugerville, Texas, 78660
Allergy and Clinical Immunology Associates
Pittsburgh, Pennsylvania, 15241
Indiana Clinical Trials Center, P.C.
Plainfield, Indiana, 46168
Integrative Skin Science and Research
Sacramento, California, 95815
West Dermatology Research Center
San Diego, California, 92121
Aeroallergy Research Laboratories of Savannah, Inc.
Savannah, Georgia, 31406
Advanced Clinical Research Institute
Tampa, Florida, 33607
Chesapeake Clinical Research, Inc
White Marsh, Maryland, 21162
About this study
Official title: An Open Label Study Evaluating the Safety, Tolerability, and Efficacy of EVO756 in Adults With Chronic Inducible Urticaria
This phase 2a trial will evaluate the safety and efficacy of EVO756 in subjects with chronic inducible urticaria, including symptomatic dermographism and cold urticaria.
- Conditions
- Chronic Inducible Urticaria
- Being tested
- Oral EVO756 300 mg QD, Oral EVO756 50 mg BID
- Keywords
- chronic inducible urticaria, inducible urticaria
- Medical subject headings
- Chronic Inducible Urticaria
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oral EVO756 300 mg QDDrug
Oral EVO756, 300 mg once daily
Oral EVO756 50 mg BIDDrug
Oral EVO756 50 mg twice daily
| Study group | Role | What they receive |
|---|---|---|
| EVO756 300 mg QD | Experimental | Oral EVO756 300 mg QD Receives: Drug: Oral EVO756 300 mg QD |
| EVO756 50 mg BID | Experimental | Oral EVO756 50 mg BID Receives: Drug: Oral EVO756 50 mg BID |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and Tolerability
Safety will be assessed by the total number of subjects with at least one TEAE
Measured: Day 1 to Week 6
Secondary outcomes (2)
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.
Measured: 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.
Measured: Day 1 to Week 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start14 Aug 2024
- Primary completion8 May 2025
- Study completion8 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Chronic Inducible UrticariaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Evommune, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06603220
- Sponsor's protocol ID
- EVO756-CIU001
- Status last verified
- Apr 2026
- First submitted
- 17 Sep 2024
- Last updated
- 19 May 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open Label Study Evaluating the Safety, Tolerability, and Efficacy of EVO756 in Adults With Chronic Inducible Urticaria
- ClinicalTrials.gov ID
- NCT06603220
- Acronym / sponsor ID
- EVO756-CIU001
- Conditions
- Chronic Inducible Urticaria
- Keywords
- chronic inducible urticaria, inducible urticaria
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Evommune, Inc.Industry (pharma, biotech, devices)
- Study start
- 14 Aug 2024 (actual)
- Primary completion
- 8 May 2025 (actual)
- Study completion
- 8 May 2025 (actual)
- First posted
- 19 Sep 2024 (actual)
- Results
- Posted 19 May 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This phase 2a trial will evaluate the safety and efficacy of EVO756 in subjects with chronic inducible urticaria, including symptomatic dermographism and cold urticaria.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| EVO756 300 mg QD | Experimental | Drug: Oral EVO756 300 mg QDOral EVO756 300 mg QD |
| EVO756 50 mg BID | Experimental | Drug: Oral EVO756 50 mg BIDOral EVO756 50 mg BID |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Confirmed diagnosis of chronic inducible urticaria for at least 3 months.
- Positive response following provocation using the TempTest or FricTest at Screening and Day 1.
Key exclusion criteria (3 listed)
- History of diseases other than chronic inducible urticaria or chronic spontaneous urticaria with urticaria or angioedema symptoms, such as urticarial vasculitis, erythema multiforme, cutaneous mastocytosis (urticaria pigmentosa), and hereditary or acquired angioedema.
- Concurrent use of certain medications, including antihistamines.
- Any clinically significant disease, or other skin disease or skin markings (e.g., extensive scarring, tattoos), that might confound the evaluation of safety or efficacy.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Oral EVO756 300 mg QDOral EVO756, 300 mg once daily | Drug | EVO756 300 mg QD |
| Oral EVO756 50 mg BIDOral EVO756 50 mg twice daily | Drug | EVO756 50 mg BID |
Primary outcome
Safety and Tolerability
Time frame: Day 1 to Week 6
Safety will be assessed by the total number of subjects with at least one TEAE
2 secondary outcomes
Change in Total Fric Score (TFS)
Time frame: Day 1 to Week 4
Change in Pruritus Severity at the Provocation Test Site
Time frame: Day 1 to Week 4
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 May 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Chronic Inducible Urticaria
RecruitingPhase 3
A Study to Investigate Efficacy, Safety and Tolerability of Barzolvolimab Versus Placebo in Adults With Cold Induced Urticaria and Symptomatic Dermographism Inadequately Controlled by H1-antihistamines (EMBARQ - ColdU and SD)
Chronic Inducible Urticaria, Cold Urticaria
RecruitingPhase 1
A Phase 1 Study of GTX-B001 in Healthy Subjects and Patients With Chronic Inducible Urticaria
Healthy Subjects, Cold Urticaria
Active, not recruitingPhase 3
A Study to Investigate Efficacy, Safety, and Tolerability of Remibrutinib Compared With Placebo in Adults With CINDU Inadequately Controlled by H1-antihistamines
Chronic Inducible Urticaria
Enrolling by invitationPhase 2
Apremilast Added to Antihistamines in Chronic Urticaria
Chronic Urticaria, Chronic Spontaneous Urticaria
RecruitingPhase 2
Study of Remibrutinib (LOU064) Efficacy and Safety and Exploration of Its Mechanism of Action in Participants With Chronic Urticaria
Chronic Urticaria (CU): Chronic Inducible Urticaria (CINDU) and Chronic Spontaneous Urticaria (CSU)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
18 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Oral EVO756 300 mg QD and Oral EVO756 50 mg BID in people with Chronic Inducible Urticaria, run by Evommune, Inc. at 18 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 18 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 19 May 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety and Tolerability (time frame: Day 1 to Week 6). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 May 2026.