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EVO101

Phase 2

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

EVO101 development status

Highest phase Phase 2
Registered trials 2 across 2 sponsors since Oct 2022

EVO101 target and mechanism

Molecular targetIRAK4
ModalitySmall molecule

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials2
Total Enrollment134

FDA Designations

No designations recorded

EVO101 clinical trials

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 small molecule being developed for dermatology conditions, specifically atopic dermatitis (eczema) and hidradenitis suppurativa (HS). It is being studied as a topical cream formulation. EVO101 is not FDA approved and remains in clinical development.

What does EVO101 target?

EVO101 targets IRAK4, an enzyme involved in inflammatory signaling pathways. By inhibiting IRAK4, EVO101 is designed to modulate inflammation relevant to skin conditions like atopic dermatitis and hidradenitis suppurativa. The drug is administered as a topical cream.

Who is developing EVO101?

EVO101 is being developed by Evommune, Inc., a biopharmaceutical company. Evommune is publicly traded under the ticker symbol EVMN. The company is conducting clinical trials to evaluate EVO101 for dermatological indications.

What phase is EVO101 in?

EVO101 is in Phase 2 clinical development for atopic dermatitis, based on a completed Phase 2 trial. An additional early Phase 1 trial for hidradenitis suppurativa is currently recruiting participants. EVO101 is investigational and has not received FDA approval.

What clinical trials is EVO101 in?

EVO101 has been studied in two clinical trials. NCT05579899 was a completed Phase 2 trial evaluating EVO101 topical cream in 119 participants with atopic dermatitis. NCT06645821 is an early Phase 1 trial currently recruiting 15 participants with hidradenitis suppurativa in the United States.

Is EVO101 the same as a topical cream for hidradenitis suppurativa?

EVO101 is being studied as a topical cream 0.1% for hidradenitis suppurativa in an early Phase 1 trial (NCT06645821). This trial is recruiting 15 adult participants in the United States. The same drug is also being evaluated for atopic dermatitis in a separate Phase 2 study.