A Study Investigating the Effect of EDP1815 in the Treatment of Mild, Moderate and Severe Atopic Dermatitis
A Phase 2, Multicenter, Double-Blind, Placebo-Controlled, Multiple-Cohort Study Investigating the Effect of EDP1815 in Participants for the Treatment of Mild, Moderate and Severe Atopic Dermatitis
2 other identifiers
interventional
421
6 countries
59
Brief Summary
The purpose of this research study is to determine whether the study drug, EDP1815, is safe and effective in the treatment of atopic dermatitis compared with placebo. The study will look at different doses of the study drug, and whether there are differences when the drug is given once daily or twice daily.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Jan 2022
Shorter than P25 for phase_2
59 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 4, 2021
CompletedFirst Posted
Study publicly available on registry
November 16, 2021
CompletedStudy Start
First participant enrolled
January 31, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 9, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
March 28, 2023
CompletedResults Posted
Study results publicly available
August 16, 2023
CompletedAugust 16, 2023
August 1, 2023
1.1 years
November 4, 2021
June 12, 2023
August 13, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Achievement of EASI-50
The efficacy of EDP1815 will be measured by achieving a decrease of at least 50% from baseline in Eczema Area Severity Index (EASI) score of 50 (EASI-50) at Week 16. The EASI is a validated measure of eczema severity, which considers a combination of the disease severity and body surface area affected across 4 body regions. The EASI score ranges from 0 - 72. A lower score indicates a better outcome.
16 weeks
Secondary Outcomes (33)
Percentage of Participants Achieving EASI-50
4, 8 and 12 weeks
Percentage of Participants Achieving EASI-75
4, 8, 12, and 16 weeks
Percentage of Participants Achieving EASI-90
4, 8, 12, and 16 weeks
Mean Absolute Change in EASI
4, 8, 12, and 16 weeks
Mean Percentage Change in EASI
4, 8, 12, and 16 weeks
- +28 more secondary outcomes
Study Arms (4)
Cohort 1
EXPERIMENTAL100 participants with mild, moderate or severe Atopic Dermatitis 75 participants on EDP1815 and 25 participants on matching placebo administered as 2 capsules (1.6 x 10\^11 total cells) once daily for 16 weeks
Cohort 2
EXPERIMENTAL100 participants with mild, moderate or severe Atopic Dermatitis 75 participants on EDP1815 and 25 participants on matching placebo administered as 2 capsules (6.4 x 10\^11 total cells) once daily for 16 weeks
Cohort 3
EXPERIMENTAL100 participants with mild, moderate or severe Atopic Dermatitis 75 participants on EDP1815 and 25 participants on matching placebo administered as 1 capsule (3.2 x 10\^11 cells) twice daily (6.4 x 10\^11 total cells) for 16 weeks
Cohort 4
EXPERIMENTAL105 participants with mild, moderate or severe Atopic Dermatitis 70 participants on EDP1815 and 35 participants on matching placebo administered at 1 capsule (8.0x10\^10 total cells) once daily for 16 weeks
Interventions
Eligibility Criteria
You may qualify if:
- Provide written informed consent.
- Must meet age criteria.
- Must have a diagnosis of atopic dermatitis (AD)for at least 6 months.
- Must have severity of atopic dermatitis meeting the below criteria at both Screening and Day 1:
- An IGA of 2, 3 or 4 on the vIGA scale, and;
- A BSA of ≥5%, and;
- An EASI score of ≥6.
- Must agree to use emollients.
- Must meet contraception requirements.
You may not qualify if:
- Have been in a clinical trial for EDP1815 prior to signing of ICF.
- Use of phototherapy or tanning beds; systemic medications/treatments that could affect AD or its symptoms including immunosuppressive therapy (e.g., oral or injectable corticosteroids, methotrexate, azathioprine, cyclosporine, mycophenolate mofetil, JAK inhibitors, tacrolimus, and/or leukotriene inhibitor) within 4 weeks of randomization.
- Treatment with topical agents that could affect atopic dermatitis, including topical corticosteroids, topical calcineurin inhibitors (e.g., tacrolimus or pimecrolimus), or topical PDE-4 inhibitor (e.g., crisaborole) within 14 days prior to randomization.
- Hypersensitivity to P histicola or to any of the excipients.
- Unwillingness to comply with study procedures, including follow-up, as specified by this protocol, or unwillingness to cooperate fully with the Investigator.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (59)
USA-131
Birmingham, Alabama, 35244, United States
USA-112
Fountain Valley, California, 92708, United States
USA-123
Fremont, California, 94538, United States
USA-114
Newport Beach, California, 92660, United States
USA-101
Fort Lauderdale, Florida, 33308, United States
USA-124
Jacksonville, Florida, 32216, United States
USA-108
Miami, Florida, 33165, United States
USA-120
Miami, Florida, 33175, United States
USA-105
Miramar, Florida, 33027, United States
USA-102
Orlando, Florida, 32801, United States
USA-115
Sweetwater, Florida, 33172, United States
USA-126
Tampa, Florida, 33613, United States
USA-106
Tampa, Florida, 33624, United States
USA-118
Sandy Springs, Georgia, 30328, United States
USA-111
Clarksville, Indiana, 47129, United States
USA-116
Louisville, Kentucky, 40241, United States
USA-119
Baton Rouge, Louisiana, 70806, United States
USA-109
Metairie, Louisiana, 70006, United States
USA-125
Silver Spring, Maryland, 20902, United States
USA-130
Ann Arbor, Michigan, 48103, United States
USA-121
Columbus, Ohio, 43221, United States
USA-128
Concord, Ohio, 44077, United States
USA-104
Portland, Oregon, 97239, United States
USA-127
Memphis, Tennessee, 38119, United States
USA-117
Frisco, Texas, 75034, United States
USA-110
Pflugerville, Texas, 78660, United States
USA-113
Bellevue, Washington, 98004, United States
AUS-102
Carlton, Australia
AUS-104
Kogarah, Australia
AUS-101
Melbourne, Australia
AUS-106
Woolloongabba, Australia
BGR-105
Pleven, Bulgaria
BGR-104
Sevlievo, Bulgaria
BGR-101
Sofia, Bulgaria
BGR-102
Sofia, Bulgaria
BGR-103
Sofia, Bulgaria
CAN-109
Barrie, Canada
CAN-108
Edmonton, Canada
CAN-105
Markham, Canada
CAN-104
Mississauga, Canada
CAN-101
Ottawa, Canada
CAN-107
Richmond Hill, Canada
CAN-103
Surrey, Canada
CAN-106
Waterloo, Canada
CAN-111
Winnipeg, Canada
DEU-105
Berlin, Germany
DEU-107
Bochum, Germany
DEU-106
Erlangen, Germany
DEU-102
Frankfurt am Main, Germany
DEU-104
Gera, Germany
DEU-101
Hamburg, Germany
DEU-103
Heidelberg, Germany
POL-104
Gdansk, Poland
POL-106
Gdynia, Poland
POL-107
Katowice, Poland
POL-105
Lodz, Poland
POL-101
Lublin, Poland
POL-102
Warsaw, Poland
POL-103
Wroclaw, Poland
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Duncan McHale, MBBS, MRCP, PhD
- Organization
- Evelo Biosciences, Inc
Study Officials
- PRINCIPAL INVESTIGATOR
Benjamin Ehst, MD, PhD
Oregon Medical Research Center
- STUDY DIRECTOR
Yanislav Mihaylov, MD
Evelo Biosciences, Inc.
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 4, 2021
First Posted
November 16, 2021
Study Start
January 31, 2022
Primary Completion
March 9, 2023
Study Completion
March 28, 2023
Last Updated
August 16, 2023
Results First Posted
August 16, 2023
Record last verified: 2023-08
Data Sharing
- IPD Sharing
- Will not share