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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06723405




Registration number
NCT06723405
Ethics application status
Date submitted
4/12/2024
Date registered
9/12/2024
Date last updated
9/12/2024

Titles & IDs
Public title
Efficacy Study of EVO301 in Moderate to Severe Atopic Dermatitis
Scientific title
A Randomized, Double-blind, Placebo-controlled, Proof-of-concept Study of EVO301 in Adults with Atopic Dermatitis
Secondary ID [1] 0 0
EVO301-AD001
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Atopic Dermatitis (AD) 0 0
Eczema 0 0
Eczema Atopic Dermatitis 0 0
Condition category
Condition code
Skin 0 0 0 0
Dermatological conditions
Skin 0 0 0 0
Other skin conditions
Inflammatory and Immune System 0 0 0 0
Other inflammatory or immune system disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Other - EVO301
Treatment: Other - Placebo

Experimental: Intravenous EVO301 -

Placebo comparator: Placebo -


Treatment: Other: EVO301
Intravenous EVO301

Treatment: Other: Placebo
Placebo
Intervention code [1] 0 0
Treatment: Other
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Eczema Area and Severity Index (EASI)
Timepoint [1] 0 0
12 weeks
Secondary outcome [1] 0 0
Investigator Global Assessment (IGA)
Timepoint [1] 0 0
12 weeks
Secondary outcome [2] 0 0
Body Surface Area (BSA)
Timepoint [2] 0 0
12 weeks
Secondary outcome [3] 0 0
Pruritus-NRS
Timepoint [3] 0 0
12 weeks

Eligibility
Key inclusion criteria
1. Males or non-pregnant, non-lactating females, age 18 years or older
2. Chronic atopic dermatitis for at least 6 months
3. BSA of AD involvement of at least 10%
4. EASI score of at least 16.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
1/02/2025
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/01/2026
Actual
Sample size
Target
60
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Cornerstone Dermatology - Coorparoo
Recruitment hospital [2] 0 0
Momentum Clinical Research Darlinghurst - Darlinghurst
Recruitment postcode(s) [1] 0 0
QLD 4151 - Coorparoo
Recruitment postcode(s) [2] 0 0
NSW 2010 - Darlinghurst
Recruitment outside Australia
Country [1] 0 0
New Zealand
State/province [1] 0 0
Auckland
Country [2] 0 0
New Zealand
State/province [2] 0 0
Christchurch
Country [3] 0 0
New Zealand
State/province [3] 0 0
Hamilton
Country [4] 0 0
New Zealand
State/province [4] 0 0
Hutt Central
Country [5] 0 0
New Zealand
State/province [5] 0 0
Nelson
Country [6] 0 0
New Zealand
State/province [6] 0 0
Paraparaumu

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Evommune, Inc.
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Polina Bukshpun
Address 0 0
Country 0 0
Phone 0 0
+1-818-536-2358
Fax 0 0
Email 0 0
polina.bukshpun@evommune.com
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT06723405