Atopic Dermatitis Eczema
Conditions
Brief summary
This is a Phase 2a safety and efficacy study of EVO101 for the treatment of adults with atopic dermatitis
Detailed description
This is a Phase 2a safety and efficacy study of EVO101 Topical Cream, 0.1%, applied twice daily for 8 weeks in adults with mild-to moderate atopic dermatitis.
Interventions
DRUGEVO101
Topical Cream
Sponsors
Evommune, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Masking description
Matching vehicle
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Males or non-pregnant, non-lactating females, age 18 years or older 2. Chronic atopic dermatitis for at least 1 year 3. IGA score of 2 or 3 4. BSA of AD involvement of 4-12% 5. EASI of 5-20
Exclusion criteria
1. Significant AD flare with 4 weeks 2. Use of biologic therapy within 12 weeks 3. Regular use of tanning booth within 4 weeks 4. Skin condition that could interfere with study assessments
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percent Change in Eczema Area and Severity Index (EASI) From Baseline to Week 8 | 8 weeks | EASI assesses the extent and severity of atopic dermatitis. EASI is a composite index with scores ranging from 0 to 72. Higher values indicate more severe or extensive disease. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Investigator Global Assessment (IGA) Response (Number of Participants With >= 2 Points Change From Baseline to Week 8) | 8 weeks | The IGA assesses the overall appearance and severity of atopic dermatitis using a 5-point scale \[0 (clear) to 4 (severe)\]. The outcome measures is reported as the number of participants achieving a reduction of 2 or greater on the IGA from baseline to Week 8. |
| Percent Body Surface Area (BSA) Affected by Atopic Dermatitis Over Time, Change From Baseline to Week 8 | 8 weeks | BSA estimates the extent of atopic dermatitis involvement and is expressed as a percentage of total body surface area. The outcome measure describes the mean change from baseline in percent of the body surface area affected by AD. |
| Pruritus-NRS, Change From Baseline to Week 8 | 8 weeks | The pruritus-NRS is an 11-point scale used by subjects to rate their worst itch severity over the past 24 hours with 0 indicating no itch and 10 indicating worst itch imaginable. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| EVO101 Cream Active Treatment, BID, 8 weeks
EVO101: Topical Cream | 60 |
| Vehicle Cream Vehicle Treatment, BID, 8 weeks
EVO101: Topical Cream | 59 |
| Total | 119 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 0 | 3 |
| Overall Study | Lost to Follow-up | 3 | 1 |
| Overall Study | Pregnancy | 0 | 1 |
| Overall Study | Withdrawal by Subject | 0 | 3 |
Baseline characteristics
| Characteristic | Vehicle Cream | Total | EVO101 Cream |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 4 Participants | 13 Participants | 9 Participants |
| Age, Categorical Between 18 and 65 years | 55 Participants | 106 Participants | 51 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 24 Participants | 44 Participants | 20 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 32 Participants | 71 Participants | 39 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 3 Participants | 4 Participants | 1 Participants |
| Sex: Female, Male Female | 37 Participants | 74 Participants | 37 Participants |
| Sex: Female, Male Male | 22 Participants | 45 Participants | 23 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 60 | 0 / 58 |
| other Total, other adverse events | 19 / 60 | 30 / 58 |
| serious Total, serious adverse events | 0 / 60 | 0 / 58 |
Outcome results
Primary
Percent Change in Eczema Area and Severity Index (EASI) From Baseline to Week 8
EASI assesses the extent and severity of atopic dermatitis. EASI is a composite index with scores ranging from 0 to 72. Higher values indicate more severe or extensive disease.
Time frame: 8 weeks
Population: All participants assigned to EVO101 or Vehicle treatment.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| EVO101 Cream | Percent Change in Eczema Area and Severity Index (EASI) From Baseline to Week 8 | -43.5 Percent change from baseline | Standard Deviation 60.85 |
| Vehicle Cream | Percent Change in Eczema Area and Severity Index (EASI) From Baseline to Week 8 | -62.0 Percent change from baseline | Standard Deviation 38.78 |
Secondary
Investigator Global Assessment (IGA) Response (Number of Participants With >= 2 Points Change From Baseline to Week 8)
The IGA assesses the overall appearance and severity of atopic dermatitis using a 5-point scale \[0 (clear) to 4 (severe)\]. The outcome measures is reported as the number of participants achieving a reduction of 2 or greater on the IGA from baseline to Week 8.
Time frame: 8 weeks
Population: Participants assigned to EVO101 or Vehicle with available data at Week 8
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| EVO101 Cream | Investigator Global Assessment (IGA) Response (Number of Participants With >= 2 Points Change From Baseline to Week 8) | Yes | 20 Participants |
| EVO101 Cream | Investigator Global Assessment (IGA) Response (Number of Participants With >= 2 Points Change From Baseline to Week 8) | No | 37 Participants |
| Vehicle Cream | Investigator Global Assessment (IGA) Response (Number of Participants With >= 2 Points Change From Baseline to Week 8) | Yes | 23 Participants |
| Vehicle Cream | Investigator Global Assessment (IGA) Response (Number of Participants With >= 2 Points Change From Baseline to Week 8) | No | 28 Participants |
Secondary
Percent Body Surface Area (BSA) Affected by Atopic Dermatitis Over Time, Change From Baseline to Week 8
BSA estimates the extent of atopic dermatitis involvement and is expressed as a percentage of total body surface area. The outcome measure describes the mean change from baseline in percent of the body surface area affected by AD.
Time frame: 8 weeks
Population: Participants assigned to EVO101 or Vehicle with available data at Week 8
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| EVO101 Cream | Percent Body Surface Area (BSA) Affected by Atopic Dermatitis Over Time, Change From Baseline to Week 8 | -2.1 percentage of total body surface area | Standard Deviation 6.45 |
| Vehicle Cream | Percent Body Surface Area (BSA) Affected by Atopic Dermatitis Over Time, Change From Baseline to Week 8 | -3.5 percentage of total body surface area | Standard Deviation 2.99 |
Secondary
Pruritus-NRS, Change From Baseline to Week 8
The pruritus-NRS is an 11-point scale used by subjects to rate their worst itch severity over the past 24 hours with 0 indicating no itch and 10 indicating worst itch imaginable.
Time frame: 8 weeks
Population: Participants assigned to EVO101 or Vehicle with available data at Week 8
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| EVO101 Cream | Pruritus-NRS, Change From Baseline to Week 8 | -2.5 Change in units on a scale | Standard Deviation 2.16 |
| Vehicle Cream | Pruritus-NRS, Change From Baseline to Week 8 | -3.5 Change in units on a scale | Standard Deviation 2.55 |