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EVO101

Phase 2

Atopic Dermatitis Eczema | Small molecule | Dermatology |Evommune, Inc.|Last Updated: Mar 5, 2025

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment119

FDA Designations

No designations recorded

Clinical trial landscape

EVO101 · 2 trials · 2 indications

Phase 2 1Early Phase 1 1
NCT05579899Safety and Efficacy Study of EVO101 Topical Cream in Atopic DermatitisAtopic Dermatitis Eczema
COMPLETED119 Analytics
PHASE2COMPLETED
Safety and Efficacy Study of EVO101 Topical Cream in Atopic Dermatitis
Atopic Dermatitis EczemaUnlock trial analytics

Study Endpoints

Primary Endpoints

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.

The efficacy of EVO101 on hidradenitis suppurativa will be evaluated using two parameters: decrease in lesion count and change in patient reported outcomes (PRO)
12 Weeks

The change in the total HS lesion count will be assessed at Week 4, Week 8, and Week 12. The percent change from Baseline will be calculated.

Secondary Endpoints

Investigator Global Assessment (IGA) Response (Number of Participants With >= 2 Points Change From Baseline to Week 8)
8 weeks
Percent Body Surface Area (BSA) Affected by Atopic Dermatitis Over Time, Change From Baseline to Week 8
8 weeks
Pruritus-NRS, Change From Baseline to Week 8
8 weeks
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Study Design & Arms

AllocationRANDOMIZED
MaskingTRIPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
EVO101 CreamEXPERIMENTALActive Treatment, BID, 8 weeks
Vehicle CreamPLACEBO_COMPARATORVehicle Treatment, BID, 8 weeks
Open label EVO101 topical cream 0.1%EXPERIMENTALAll eligible subjects will receive open label EVO101 topical cream 0.1%

Interventions

NameTypeDescription
EVO101DRUGTopical Cream
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites21

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 ...

Countries:United States
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Frequently asked questions about EVO101

What is EVO101 used for?

EVO101 is an investigational topical cream being studied for atopic dermatitis (eczema) and hidradenitis suppurativa (HS). It is a small molecule developed by Evommune, Inc. for dermatological conditions. EVO101 is not FDA approved and remains in clinical development.

Who makes EVO101?

EVO101 is developed by Evommune, Inc., a biopharmaceutical company. The company is advancing EVO101 as a topical cream for atopic dermatitis and hidradenitis suppurativa. Evommune, Inc. is the sponsor of clinical trials evaluating EVO101.

What phase is EVO101 in?

EVO101 is in Phase 2 clinical development for atopic dermatitis, with a completed Phase 2 trial. It is also being studied in an early Phase 1 trial for hidradenitis suppurativa. EVO101 is investigational and not yet approved by regulatory authorities.

What clinical trials is EVO101 in?

EVO101 has two clinical trials. NCT05579899 is a completed Phase 2 study of EVO101 topical cream in atopic dermatitis with 119 participants. NCT06645821 is a recruiting early Phase 1 trial of EVO101 0.1% topical cream in mild to moderate hidradenitis suppurativa with 15 participants.

Is EVO101 FDA approved?

EVO101 is not FDA approved. It is an investigational drug currently in clinical trials for atopic dermatitis and hidradenitis suppurativa. The Phase 2 trial for atopic dermatitis has been completed, and an early Phase 1 trial for hidradenitis suppurativa is recruiting participants.