Trial Outcomes & Findings for Safety and Efficacy Study of EVO101 Topical Cream in Atopic Dermatitis (NCT NCT05579899)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

119 participants

Primary outcome timeframe

8 weeks

Results posted on

2025-03-05

Participant Flow

Participant milestones

Participant milestones
Measure	EVO101 Cream Active Treatment, BID, 8 weeks EVO101: Topical Cream	Vehicle Cream Vehicle Treatment, BID, 8 weeks EVO101: Topical Cream
Overall Study STARTED	60	59
Overall Study COMPLETED	57	51
Overall Study NOT COMPLETED	3	8

Reasons for withdrawal

Reasons for withdrawal
Measure	EVO101 Cream Active Treatment, BID, 8 weeks EVO101: Topical Cream	Vehicle Cream Vehicle Treatment, BID, 8 weeks EVO101: Topical Cream
Overall Study Lost to Follow-up	3	1
Overall Study Adverse Event	0	3
Overall Study Pregnancy	0	1
Overall Study Withdrawal by Subject	0	3

Baseline Characteristics

Safety and Efficacy Study of EVO101 Topical Cream in Atopic Dermatitis

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	EVO101 Cream n=60 Participants Active Treatment, BID, 8 weeks EVO101: Topical Cream	Vehicle Cream n=59 Participants Vehicle Treatment, BID, 8 weeks EVO101: Topical Cream	Total n=119 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	51 Participants n=5 Participants	55 Participants n=7 Participants	106 Participants n=5 Participants
Age, Categorical >=65 years	9 Participants n=5 Participants	4 Participants n=7 Participants	13 Participants n=5 Participants
Sex: Female, Male Female	37 Participants n=5 Participants	37 Participants n=7 Participants	74 Participants n=5 Participants
Sex: Female, Male Male	23 Participants n=5 Participants	22 Participants n=7 Participants	45 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	20 Participants n=5 Participants	24 Participants n=7 Participants	44 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	39 Participants n=5 Participants	32 Participants n=7 Participants	71 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants	3 Participants n=7 Participants	4 Participants n=5 Participants

PRIMARY outcome

Timeframe: 8 weeks

Population: All participants assigned to EVO101 or Vehicle treatment.

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.

Outcome measures

Outcome measures
Measure	EVO101 Cream n=60 Participants Active Treatment, BID, 8 weeks EVO101: Topical Cream	Vehicle Cream n=59 Participants Vehicle Treatment, BID, 8 weeks EVO101: Topical 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	-62.0 Percent change from baseline Standard Deviation 38.78

SECONDARY outcome

Timeframe: 8 weeks

Population: Participants assigned to EVO101 or Vehicle with available data at 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.

Outcome measures

Outcome measures
Measure	EVO101 Cream n=57 Participants Active Treatment, BID, 8 weeks EVO101: Topical Cream	Vehicle Cream n=51 Participants Vehicle Treatment, BID, 8 weeks EVO101: Topical Cream
Investigator Global Assessment (IGA) Response (Number of Participants With >= 2 Points Change From Baseline to Week 8) Yes	20 Participants	23 Participants
Investigator Global Assessment (IGA) Response (Number of Participants With >= 2 Points Change From Baseline to Week 8) No	37 Participants	28 Participants

SECONDARY outcome

Timeframe: 8 weeks

Population: Participants assigned to EVO101 or Vehicle with available data at 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.

Outcome measures

Outcome measures
Measure	EVO101 Cream n=57 Participants Active Treatment, BID, 8 weeks EVO101: Topical Cream	Vehicle Cream n=51 Participants Vehicle Treatment, BID, 8 weeks EVO101: Topical 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	-3.5 percentage of total body surface area Standard Deviation 2.99

SECONDARY outcome

Timeframe: 8 weeks

Population: Participants assigned to EVO101 or Vehicle with available data at 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".

Outcome measures

Outcome measures
Measure	EVO101 Cream n=47 Participants Active Treatment, BID, 8 weeks EVO101: Topical Cream	Vehicle Cream n=42 Participants Vehicle Treatment, BID, 8 weeks EVO101: Topical Cream
Pruritus-NRS, Change From Baseline to Week 8	-2.5 Change in units on a scale Standard Deviation 2.16	-3.5 Change in units on a scale Standard Deviation 2.55

Adverse Events

EVO101 Cream

Serious events: 0 serious events

Other events: 19 other events

Deaths: 0 deaths

Vehicle Cream

Serious events: 0 serious events

Other events: 30 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	EVO101 Cream n=60 participants at risk Active Treatment, BID, 8 weeks EVO101: Topical Cream	Vehicle Cream n=58 participants at risk Vehicle Treatment, BID, 8 weeks EVO101: Topical Cream
Skin and subcutaneous tissue disorders Application site pruritus	13.3% 8/60 • Number of events 8 • 12 Weeks	20.7% 12/58 • Number of events 14 • 12 Weeks
Skin and subcutaneous tissue disorders Application site erythema	6.7% 4/60 • Number of events 5 • 12 Weeks	17.2% 10/58 • Number of events 11 • 12 Weeks
Skin and subcutaneous tissue disorders Application site oedema	5.0% 3/60 • Number of events 3 • 12 Weeks	19.0% 11/58 • Number of events 12 • 12 Weeks
Skin and subcutaneous tissue disorders Application site pain	10.0% 6/60 • Number of events 6 • 12 Weeks	12.1% 7/58 • Number of events 8 • 12 Weeks
Surgical and medical procedures Application site dryness	3.3% 2/60 • Number of events 2 • 12 Weeks	13.8% 8/58 • Number of events 8 • 12 Weeks
Skin and subcutaneous tissue disorders Application site exfoliation	5.0% 3/60 • Number of events 4 • 12 Weeks	12.1% 7/58 • Number of events 7 • 12 Weeks

Additional Information

Eugene Bauer, M.D., Chief Medical Officer

Evommune

Phone: 310-721-3364

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Upon written approval by Evommune, the PI may publicly disclose site results for only (1) non-commercial and (2) internal scientific research and educational purposes
Publication restrictions are in place

Restriction type: OTHER