A Study Investigating the Effect of EDP1815 in the Treatment of Mild, Moderate and Severe Atopic Dermatitis

NCT ID: NCT05121480

Last Updated: 2023-08-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 421 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-01-31
• Study Completion Date: 2023-03-28

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.

Detailed Description

Atopic dermatitis (atopic eczema) is a very common type of skin disease. It typically causes red, dry, and itchy skin and may have a significant impact on quality of life. Rashes may appear on the arms and behind the knees, or anywhere else on the body. While there are existing therapies, there is currently no cure for atopic dermatitis.

This is a randomized, double blind, placebo controlled, parallel group, Phase 2 study to evaluate the efficacy and safety of EDP1815 in adult participants 18 to ≤75 years of age with mild, moderate, and severe atopic dermatitis (AD).

Participants will be screened within 28 days prior to the first dose of study intervention to confirm study eligibility. Subjects must have mild, moderate, or severe AD involving at least 5% Body Surface Area (BSA); an Investigator Global Assessment (IGA) score of 2, 3, or 4; and an Eczema Area Severity Index (EASI) of at least 6 at screening and Day 1.

All participants must agree to use a background therapy (per protocol) twice daily for at least 14 days prior to Day 1 in order to be considered eligible for the study.

Approximately 405 participants will be randomized to receive either EDP1815 or placebo (295 to EDP1815: 110 to placebo) and treated for 16 weeks. Participants in Cohorts 1, 2, & 3 will be randomized in a 3:1 ratio (225 to EDP1815: 75 to placebo). Participants in Cohort 4 will be randomized in a 2:1 ratio (70 to EDP1815: 35 to placebo). Cohorts 1, 2 & 3 will be run concurrently, and Cohort 4 recruitment will commence after enrollment for Cohorts 1, 2, & 3 are completed.

Randomization will be stratified by baseline disease severity (mild [IGA = 2], moderate [IGA = 3] or severe [IGA = 4] AD). The investigational product will be administered either once or twice daily for 16 weeks. Background emollient (moisturizer) therapy must continue at least twice daily for the duration of the treatment and follow-up periods. Topical rescue therapy is allowed during the treatment period per protocol.

The primary efficacy endpoint is achievement of an EASI-50 response at Week 16. Secondary efficacy endpoints will look at EASI, IGA, BSA, SCORAD, DLQI, Pruritus-NRS, Sleep Disturbance-NRS, POEM, and the need for rescue therapy at Weeks 4, 8, 12 and 16 (unless otherwise specified in the protocol). Safety and efficacy assessments will be conducted at the investigator site by a clinical assessor blinded to treatment assignment. Scheduled clinic study visits for all subjects will occur at Screening, Day 1, Week 2, Week 4, Week 8, Week 12, Week 16 (end of treatment) and Week 20 (post-treatment follow-up). Participants discontinuing early from the study will undergo a 28-day follow-up period, where possible.

At the end of the 16-week study treatment, qualified participants completing the study will have the option to enter an open label study.

Conditions

Atopic Dermatitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Cohort 1

100 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

Group Type: EXPERIMENTAL

EDP1815

Intervention Type: DRUG

EDP1815 is an orally administered, pharmaceutical preparation of a single strain of bacteria

Placebo

Intervention Type: DRUG

Placebo oral capsule

Cohort 2

100 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

Group Type: EXPERIMENTAL

EDP1815

Intervention Type: DRUG

EDP1815 is an orally administered, pharmaceutical preparation of a single strain of bacteria

Placebo

Intervention Type: DRUG

Placebo oral capsule

Cohort 3

100 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

Group Type: EXPERIMENTAL

EDP1815

Intervention Type: DRUG

EDP1815 is an orally administered, pharmaceutical preparation of a single strain of bacteria

Placebo

Intervention Type: DRUG

Placebo oral capsule

Cohort 4

105 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

Group Type: EXPERIMENTAL

EDP1815

Intervention Type: DRUG

EDP1815 is an orally administered, pharmaceutical preparation of a single strain of bacteria

Placebo

Intervention Type: DRUG

Placebo oral capsule

Interventions

EDP1815

EDP1815 is an orally administered, pharmaceutical preparation of a single strain of bacteria

Intervention Type: DRUG

Placebo

Placebo oral capsule

Intervention Type: DRUG

Other Intervention Names

Prevotella histicola

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.
• Clinically significant abnormalities in screening laboratory values that in the opinion of the Investigator would make a participant unsuitable for inclusion in the study. One retest is permitted within the 28-day screening window.
• 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.
• Have any other conditions, which, in the opinion of the Investigator or Sponsor, would make the participant unsuitable for inclusion or could interfere with the participant participating in or completing the study.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Evelo Biosciences, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Benjamin Ehst, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Oregon Medical Research Center

Yanislav Mihaylov, MD

Role: STUDY_DIRECTOR

Evelo Biosciences, Inc.

Locations

USA-131

Birmingham, Alabama, United States

USA-112

Fountain Valley, California, United States

USA-123

Fremont, California, United States

USA-114

Newport Beach, California, United States

USA-101

Fort Lauderdale, Florida, United States

USA-124

Jacksonville, Florida, United States

USA-108

Miami, Florida, United States

USA-120

Miami, Florida, United States

USA-105

Miramar, Florida, United States

USA-102

Orlando, Florida, United States

USA-115

Sweetwater, Florida, United States

USA-126

Tampa, Florida, United States

USA-106

Tampa, Florida, United States

USA-118

Sandy Springs, Georgia, United States

USA-111

Clarksville, Indiana, United States

USA-116

Louisville, Kentucky, United States

USA-119

Baton Rouge, Louisiana, United States

USA-109

Metairie, Louisiana, United States

USA-125

Silver Spring, Maryland, United States

USA-130

Ann Arbor, Michigan, United States

USA-121

Columbus, Ohio, United States

USA-128

Concord, Ohio, United States

USA-104

Portland, Oregon, United States

USA-127

Memphis, Tennessee, United States

USA-117

Frisco, Texas, United States

USA-110

Pflugerville, Texas, United States

USA-113

Bellevue, Washington, 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

Countries

United States; Australia; Bulgaria; Canada; Germany; Poland

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

2021-001805-63

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

EDP1815-207

Identifier Type: -

Identifier Source: org_study_id