Trial Outcomes & Findings for A Study Evaluating the Safety, Tolerability, and Efficacy of EVO756 in Adults With Chronic Inducible Urticaria (NCT NCT06603220)
NCT ID: NCT06603220
Last Updated: 2026-05-19
Results Overview
Safety will be assessed by the total number of subjects with at least one TEAE
COMPLETED
PHASE2
30 participants
Day 1 to Week 6
2026-05-19
Participant Flow
Participant milestones
| Measure |
EVO756 300 mg QD
Active Treatment
|
EVO756 50 mg BID
Active Treatment
|
|---|---|---|
|
Overall Study
STARTED
|
11
|
19
|
|
Overall Study
COMPLETED
|
10
|
18
|
|
Overall Study
NOT COMPLETED
|
1
|
1
|
Reasons for withdrawal
| Measure |
EVO756 300 mg QD
Active Treatment
|
EVO756 50 mg BID
Active Treatment
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
|
Overall Study
Lost to Follow-up
|
0
|
1
|
Baseline Characteristics
A Study Evaluating the Safety, Tolerability, and Efficacy of EVO756 in Adults With Chronic Inducible Urticaria
Baseline characteristics by cohort
| Measure |
EVO756 300 mg QD
n=11 Participants
Active Treatment
|
EVO756 50 mg BID
n=19 Participants
Active Treatment
|
Total
n=30 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=30 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=60 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
11 Participants
n=30 Participants
|
19 Participants
n=30 Participants
|
30 Participants
n=60 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=30 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=60 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=30 Participants
|
17 Participants
n=30 Participants
|
24 Participants
n=60 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=30 Participants
|
2 Participants
n=30 Participants
|
6 Participants
n=60 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=30 Participants
|
5 Participants
n=30 Participants
|
6 Participants
n=60 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
10 Participants
n=30 Participants
|
14 Participants
n=30 Participants
|
24 Participants
n=60 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=30 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=60 Participants
|
PRIMARY outcome
Timeframe: Day 1 to Week 6Safety will be assessed by the total number of subjects with at least one TEAE
Outcome measures
| Measure |
EVO756 300 mg QD
n=11 Participants
Active Treatment
|
EVO756 50 mg BID
n=19 Participants
Active Treatment
|
|---|---|---|
|
Safety and Tolerability
|
3 Participants with a TEAE
|
7 Participants with a TEAE
|
SECONDARY outcome
Timeframe: Day 1 to Week 4Population: Total number of participants assessed is equal to 27, the count of subjects that completed Week 4 visits.
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.
Outcome measures
| Measure |
EVO756 300 mg QD
n=10 Participants
Active Treatment
|
EVO756 50 mg BID
n=17 Participants
Active Treatment
|
|---|---|---|
|
Change in Total Fric Score (TFS)
|
-1.4 Total Fric Score
Standard Deviation 1.58
|
-1.5 Total Fric Score
Standard Deviation 1.33
|
SECONDARY outcome
Timeframe: Day 1 to Week 4Population: Total number of participants assessed is equal to 27, the count of subjects that completed Week 4 visits.
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.
Outcome measures
| Measure |
EVO756 300 mg QD
n=10 Participants
Active Treatment
|
EVO756 50 mg BID
n=17 Participants
Active Treatment
|
|---|---|---|
|
Change in Pruritus Severity at the Provocation Test Site
|
-2.4 scores on a scale
Standard Deviation 2.17 • Interval -3.95 to -0.85
|
-2.1 scores on a scale
Standard Deviation 2.77 • Interval -3.48 to -0.63
|
Adverse Events
EVO756 300 mg QD
EVO756 50 mg BID
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
EVO756 300 mg QD
n=11 participants at risk
Active Treatment
|
EVO756 50 mg BID
n=19 participants at risk
Active Treatment
|
|---|---|---|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/11 • 6 weeks
|
5.3%
1/19 • 6 weeks
|
|
General disorders
Fatigue
|
9.1%
1/11 • 6 weeks
|
0.00%
0/19 • 6 weeks
|
|
Hepatobiliary disorders
Hepatic Cyst
|
9.1%
1/11 • 6 weeks
|
0.00%
0/19 • 6 weeks
|
|
Infections and infestations
Gastroenteritis
|
9.1%
1/11 • 6 weeks
|
5.3%
1/19 • 6 weeks
|
|
Infections and infestations
Viral Upper Respiratory Tract Infection
|
9.1%
1/11 • 6 weeks
|
0.00%
0/19 • 6 weeks
|
|
Infections and infestations
Vulvovaginal Mycotic Infection
|
9.1%
1/11 • 6 weeks
|
0.00%
0/19 • 6 weeks
|
|
Injury, poisoning and procedural complications
Procedural Pain
|
0.00%
0/11 • 6 weeks
|
5.3%
1/19 • 6 weeks
|
|
Investigations
Alanine Aminotransferase Increased
|
18.2%
2/11 • 6 weeks
|
0.00%
0/19 • 6 weeks
|
|
Investigations
Aspartate Aminotransferase Increased
|
18.2%
2/11 • 6 weeks
|
0.00%
0/19 • 6 weeks
|
|
Metabolism and nutrition disorders
Vitamin D Deficiency
|
0.00%
0/11 • 6 weeks
|
5.3%
1/19 • 6 weeks
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
9.1%
1/11 • 6 weeks
|
0.00%
0/19 • 6 weeks
|
|
Nervous system disorders
Dizziness
|
0.00%
0/11 • 6 weeks
|
5.3%
1/19 • 6 weeks
|
|
Nervous system disorders
Headache
|
0.00%
0/11 • 6 weeks
|
5.3%
1/19 • 6 weeks
|
|
Nervous system disorders
Sciatica
|
9.1%
1/11 • 6 weeks
|
0.00%
0/19 • 6 weeks
|
|
Nervous system disorders
Somnolence
|
0.00%
0/11 • 6 weeks
|
5.3%
1/19 • 6 weeks
|
|
Psychiatric disorders
Agitation
|
0.00%
0/11 • 6 weeks
|
5.3%
1/19 • 6 weeks
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/11 • 6 weeks
|
5.3%
1/19 • 6 weeks
|
|
Renal and urinary disorders
Renal Cyst
|
9.1%
1/11 • 6 weeks
|
0.00%
0/19 • 6 weeks
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
9.1%
1/11 • 6 weeks
|
5.3%
1/19 • 6 weeks
|
|
Skin and subcutaneous tissue disorders
Acne
|
0.00%
0/11 • 6 weeks
|
5.3%
1/19 • 6 weeks
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place