Clinical trial NCT05579899: Safety and Efficacy Study of EVO101 Topical Cream in Atopic Dermatitis
Official title: A Randomized, Vehicle-controlled, Safety and Efficacy Study of EVO101 in Adult Subjects With Atopic Dermatitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Atopic Dermatitis Eczema
Lead sponsor: Evommune, Inc.
Sponsor class: INDUSTRY
First posted: 2022-10-14
Enrollment: 119
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Percent Change in Eczema Area and Severity Index (EASI) From Baseline to Week 8
timeFrame: 8 weeks
Secondary outcomes:
measure: Investigator Global Assessment (IGA) Response (Number of Participants With >= 2 Points Change From Baseline to Week 8)
timeFrame: 8 weeks
measure: Percent Body Surface Area (BSA) Affected by Atopic Dermatitis Over Time, Change From Baseline to Week 8
timeFrame: 8 weeks
measure: Pruritus-NRS, Change From Baseline to Week 8
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Saguaro Dermatology
state: Arizona
city: Fayetteville
country: United States
facility: Clinical Trials Institute of Northwest Arkansas
state: Arkansas
city: Rogers
country: United States
facility: Northwest AR Clinical Trials Center, PLLC
state: Arkansas
city: Encinitas
country: United States
facility: California Dermatology & Clinical Research Institute
state: California
city: Los Angeles
country: United States
facility: Metropolis Dermatology
state: California
city: Los Angeles
country: United States
facility: Dermatology Research Associate
state: California
city: Santa Monica
country: United States
facility: Clinical Science Institute
state: California
city: Coral Gables
country: United States
facility: Driven Research, LLC
state: Florida
city: Miami
country: United States
facility: Lenus Research and Medical Group
state: Florida
city: Indianapolis
country: United States
facility: Dawes Fretzin Clinical Research Group
state: Indiana
city: Plainfield
country: United States
facility: The Indiana Clinical Trials Center
state: Indiana
city: New Brighton
country: United States
facility: Minnesota Clinical Study Center
state: Minnesota
city: Omaha
country: United States
facility: SkinSpecialists, LLC
state: Nebraska
city: Las Vegas
country: United States
facility: JDR Dermatology Research, LLC
state: Nevada
city: High Point
country: United States
facility: Dermatology Consulting Services, PLLC
state: North Carolina
city: Mason
country: United States
facility: Dermatologists of Southwest Ohio
state: Ohio
city: Portland
country: United States
facility: Oregon Medical Research Center
state: Oregon
city: Austin
country: United States
facility: DermResearch
state: Texas
city: College Station
country: United States
facility: J&S Studies, Inc
state: Texas
city: Houston
country: United States
facility: Center for Clinical Studies, Ltd LLC
state: Texas
city: Norfolk
country: United States
facility: Pariser Dermatology Specialists
state: Virginia
Study officials:
affiliation: Evommune, Inc.
name: Eugene Bauer, MD
role: STUDY_DIRECTOR
References: