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

NCT05439941 | Terminated Phase 2 Results FDA Drug

• 2 other identifiers: EDP1815-2082022-000284-48
• Study Type: interventional
• Target: 287
• Locations: 6 countries
• Sites: 54

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.

Conditions

Atopic Dermatitis

Keywords

Mild Atopic Dermatitis; Moderate Atopic Dermatitis; Severe Atopic Dermatitis; Mild Eczema; Moderate Eczema; Severe Eczema

Outcome Measures

Primary Outcomes (1)

• Incidence and Rate Per 100 Patient-years of Treatment-emergent Adverse Events

  The long-term safety and tolerability of EDP1815 in the treatment of atopic dermatitis will be measured by evaluating 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 relevant parent study.

  40 weeks

Secondary Outcomes (34)

• Percentage of Participants Achieving EASI-50

  40 weeks

• Percentage of Participants Achieving EASI-75

  40 weeks

• Percentage of Participants Achieving EASI-90

  40 weeks

• Mean Absolute Change From Baseline in EASI Score

  40 weeks

• Mean Percentage Change From Baseline in EASI Score

  40 weeks

Study Arms (3)

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

EXPERIMENTAL

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)

Drug: EDP1815

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

EXPERIMENTAL

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)

Drug: EDP1815

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

EXPERIMENTAL

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)

Drug: EDP1815

Interventions

EDP1815 DRUG

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

Also known as: Prevotella histicola

Group 1 (1.6x10^11 total cells of EDP1815, 2 capsules once daily); Group 2 (6.4x10^11 total cells of EDP1815, 2 capsules once daily); Group 3 (8.0x10^10 total cells of EDP1815, 1 capsule once daily)

Eligibility Criteria

• Age: 18 Years - 76 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Must have provided informed consent.
• Must have completed the treatment period in a parent study of EDP1815 in atopic dermatitis and complied with the parent protocol.
• Must agree to use emollients.
• Must continue to follow contraception criteria.

You may not qualify if:

• Participants who are currently enrolled in another investigational drug study or plans to receive another investigational drug during this study.
• 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.
• 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.
• Has received live or live-attenuated vaccination prior to enrollment or intends to have such a vaccination during the study.
• 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.

Sponsors & Collaborators

• Evelo Biosciences, Inc.: lead

Study Sites (54)

USA-131

Birmingham, Alabama, 35244, United States

Location

USA 112

Fountain Valley, California, 92708, United States

Location

USA 123

Fremont, California, 94538, United States

Location

USA -101

Fort Lauderdale, Florida, 33308, United States

Location

USA-124

Jacksonville, Florida, 32216, United States

Location

USA-108

Miami, Florida, 33165, United States

Location

USA-120

Miami, Florida, 33175, United States

Location

USA-105

Miramar, Florida, 33027, United States

Location

USA-102

Orlando, Florida, 32801, United States

Location

USA-115

Sweetwater, Florida, 33172, United States

Location

USA-106

Tampa, Florida, 33613, United States

Location

USA-126

Tampa, Florida, 33613, United States

Location

USA-111

Clarksville, Indiana, 47129, United States

Location

USA-116

Louisville, Kentucky, 40241, United States

Location

USA-119

Baton Rouge, Louisiana, 70806, United States

Location

USA-109

Metairie, Louisiana, 70006, United States

Location

USA-125

Silver Spring, Maryland, 20902, United States

Location

USA-121

Columbus, Ohio, 43221, United States

Location

USA-128

Concord, Ohio, 44077, United States

Location

USA-104

Portland, Oregon, 97239, United States

Location

USA-127

Memphis, Tennessee, 38119, United States

Location

USA-117

Frisco, Texas, 75034, United States

Location

USA-110

Pflugerville, Texas, 78660, United States

Location

USA-113

Bellevue, Washington, 98004, United States

Location

AUS-102

Carlton, Australia

Location

AUS-104

Kogarah, Australia

Location

AUS-101

Melbourne, Australia

Location

AUS-106

Woolloongabba, Australia

Location

BGR-105

Pleven, Bulgaria

Location

BGR-104

Sevlievo, Bulgaria

Location

BGR-101

Sofia, Bulgaria

Location

BGR-103

Sofia, Bulgaria

Location

CAN-109

Barrie, Canada

Location

CAN-108

Edmonton, Canada

Location

CAN-105

Markham, Canada

Location

CAN-104

Mississauga, Canada

Location

CAN-101

Ottawa, Canada

Location

CAN-107

Richmond Hill, Canada

Location

CAN-103

Surrey, Canada

Location

CAN-106

Waterloo, Canada

Location

CAN-111

Winnipeg, Canada

Location

DEU-105

Berlin, Germany

Location

DEU-106

Erlangen, Germany

Location

DEU-102

Frankfurt am Main, Germany

Location

DEU-104

Gera, Germany

Location

DEU-101

Hamburg, Germany

Location

DEU-103

Heidelberg, Germany

Location

POL-104

Gdansk, Poland

Location

POL-106

Gdynia, Poland

Location

POL-107

Katowice, Poland

Location

POL-105

Lodz, Poland

Location

POL-101

Lublin, Poland

Location

POL-102

Warsaw, Poland

Location

POL-103

Wroclaw, Poland

Location

MeSH Terms

Conditions

Dermatitis, Atopic; Eczema

Condition Hierarchy (Ancestors)

Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Results Point of Contact

• Title: Duncan McHale, MBBS, MRCP, PhD
• Organization: Evelo Biosciences, Inc

duncan@evelobio.com

+447500128938

Study Officials

• Douglas Maslin, MD

  Evelo Biosciences

  STUDY DIRECTOR

• Ben Ehst, PhD

  Oregon Medical Research Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Open Label Extension Study.

Study Record Dates

• First Submitted: June 27, 2022
• First Posted: June 30, 2022
• Study Start: June 6, 2022
• Primary Completion: May 25, 2023
• Study Completion: June 7, 2023
• Last Updated: September 7, 2023
• Results First Posted: September 7, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

BU (4); AU (4); DE (6); US (24); PL (7); CA (9)