A Long-Term Extension Trial in Participants With Atopic Dermatitis Who Participated in Previous EDP1815 Trials

NCT ID: NCT05439941

Last Updated: 2023-09-07

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 287 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-06-06
• Study Completion Date: 2023-06-07

Brief Summary

This is an Open-Label Extension (OLE) study to evaluate the long-term safety, tolerability, and efficacy of EDP1815 in participants with mild, moderate, and severe atopic dermatitis who have completed the treatment period of a prior clinical study ("parent study") with EDP1815.

The current parent study of this protocol is the EDP1815-207 study; 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.

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 study is an Open Label Extension (OLE) study to the first parent study; i.e., the EDP1815-207 study (NCT05121480). The total number of participants will be dependent on the number of participants who elect and are eligible to participate in the Open Label Extension study following participation in EDP1815-207.

All participants in this study will be treated with EDP1815, regardless of the treatment assignment in the EDP1815-207 study. There will be no placebo drug administered in this study. To minimize bias, during dosing in EDP1815-208, investigators and participants will continue to be blinded to participants' treatment allocation in the parent study whilst it is ongoing. Participants in this study will be treated with EDP1815 for up to 36 weeks, followed by a follow-up visit at approximately 4 weeks after the end of treatment.

The maximum study duration is up to 40 weeks for all participants. The participants may move directly from the parent study into the open label treatment phase without a break in study treatment, or within 7 days of completing the treatment period of the parent study. If the participants move directly into this study without a break in treatment from the parent study, the Day -1 visit should be performed at the same time as the end of treatment visit of the parent study.

The primary endpoint of safety and tolerability will be measured using the incidence and rate per 100 patient-years of treatment-emergent adverse events during the 36-week treatment period and the 4-week follow-up period of this study; and during the treatment period of this study and the parent study. TEAEs will be defined as all events starting after first dose of study drug, and on or before 28 days after last dose for each participant. All TEAEs will be included in the assessments of incidences and rates, regardless of compliance with study medication, use of other medications or deviations from the study protocol.

The secondary endpoint of efficacy will be measured using the Eczema Area and Severity Index (EASI) Score. Additionally, the Investigator's Global Assessment (IGA), percentage of Body Surface Area (BSA), Product of the IGA and BSA (IGA*BSA), the SCORing Atopic Dermatitis (SCORAD), the Dermatology Life Quality Index (DLQI), the Peak Pruritus Numerical Rating Scale (PP-NRS), the Sleep Disturbance Numerical Rating Scale (SD-NRS), the Patient Oriented Eczema Measure (POEM) and the Atopic Dermatitis Control Tool (ADCT) will also be measured throughout the study. The number of courses of treatment with rescue therapies; and with antibiotic treatment due to skin infection, per participant, will also be measured.

Conditions

Atopic Dermatitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Group 1 (1.6x10^11 total cells of EDP1815, 2 capsules once daily)

EDP1815-207 Cohort 1 participants will receive 1.6x10\^11 total cells of EDP1815 in EDP1815-208 administered as 2 capsules once daily. (Group 1)

Group Type: EXPERIMENTAL

EDP1815

Intervention Type: DRUG

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

Group 2 (6.4x10^11 total cells of EDP1815, 2 capsules once daily)

EDP1815-207 Cohort 2 participants will receive 6.4x10\^11 total cells of EDP1815 in EDP1815-208 administered as 2 capsules once daily. (Group 2)

Group Type: EXPERIMENTAL

EDP1815

Intervention Type: DRUG

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

Group 3 (8.0x10^10 total cells of EDP1815, 1 capsule once daily)

EDP1815-207 Cohort 4 participants will receive 8.0x10\^10 total cells of EDP1815 in EDP1815-208 administered as 1 capsule once daily. (Group 3)

Group Type: EXPERIMENTAL

EDP1815

Intervention Type: DRUG

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

Interventions

EDP1815

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

Intervention Type: DRUG

Other Intervention Names

Prevotella histicola

Eligibility Criteria

Inclusion Criteria

1. Must have provided informed consent.

2. Must have completed the treatment period in a parent study of EDP1815 in atopic dermatitis and complied with the parent protocol.

3. Must agree to use emollients.

4. Must continue to follow contraception criteria.

Exclusion Criteria

1. Participants who are currently enrolled in another investigational drug study or plans to receive another investigational drug during this study.

2. Have any other conditions, which would make the participant unsuitable for inclusion or could interfere with the participant participating in or completing the study.

3. Use of phototherapy, a biologic agent, or a systemic immunosuppressive agent that could affect AD, including systemic corticosteroids, within 7 days prior to Day -1, unless used as a rescue treatment as part of the parent study protocol.

4. Use of topical atopic dermatitis therapies, including topical corticosteroids, topical calcineurin inhibitors, topical PDE-4 inhibitors, and topical JAK inhibitors, within 7 days prior to enrolling in the study, unless used as a rescue treatment as part of the EDP1815-207 protocol.

5. Has received live or live-attenuated vaccination prior to enrollment or intends to have such a vaccination during the study.

6. Hypersensitivity to P histicola or to any of the excipients.

7. Unwillingness to comply with study procedures, including follow-up, as specified by this protocol, or unwillingness to cooperate fully with the Investigator.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 76 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Evelo Biosciences, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Douglas Maslin, MD

Role: STUDY_DIRECTOR

Evelo Biosciences

Ben Ehst, PhD

Role: PRINCIPAL_INVESTIGATOR

Oregon Medical Research Center

Locations

USA-131

Birmingham, Alabama, United States

USA 112

Fountain Valley, California, United States

USA 123

Fremont, 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-106

Tampa, Florida, United States

USA-126

Tampa, Florida, 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-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-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-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

2022-000284-48

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

EDP1815-208

Identifier Type: -

Identifier Source: org_study_id