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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT05439941
Other study ID # EDP1815-208
Secondary ID 2022-000284-48
Status Terminated
Phase Phase 2
First received
Last updated
Start date June 6, 2022
Est. completion date June 7, 2023

Study information

Verified date August 2023
Source Evelo Biosciences, Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Terminated
Enrollment 287
Est. completion date June 7, 2023
Est. primary completion date May 25, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years to 76 Years
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
Australia AUS-102 Carlton
Australia AUS-104 Kogarah
Australia AUS-101 Melbourne
Australia AUS-106 Woolloongabba
Bulgaria BGR-105 Pleven
Bulgaria BGR-104 Sevlievo
Bulgaria BGR-101 Sofia
Bulgaria BGR-103 Sofia
Canada 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
Germany 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
Poland POL-104 Gdansk
Poland POL-106 Gdynia
Poland POL-107 Katowice
Poland POL-105 Lódz
Poland POL-101 Lublin
Poland POL-102 Warszawa
Poland POL-103 Wroclaw
United States USA-119 Baton Rouge Louisiana
United States USA-113 Bellevue Washington
United States USA-131 Birmingham Alabama
United States USA-111 Clarksville Indiana
United States USA-121 Columbus Ohio
United States USA-128 Concord Ohio
United States USA -101 Fort Lauderdale Florida
United States USA 112 Fountain Valley California
United States USA 123 Fremont California
United States USA-117 Frisco Texas
United States USA-124 Jacksonville Florida
United States USA-116 Louisville Kentucky
United States USA-127 Memphis Tennessee
United States USA-109 Metairie Louisiana
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-110 Pflugerville Texas
United States USA-104 Portland Oregon
United States USA-125 Silver Spring Maryland
United States USA-115 Sweetwater Florida
United States USA-106 Tampa Florida
United States USA-126 Tampa Florida

Sponsors (1)

Lead Sponsor Collaborator
Evelo Biosciences, Inc.

Countries where clinical trial is conducted

United States,  Australia,  Bulgaria,  Canada,  Germany,  Poland, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Percentage of Participants Achieving EASI-50 The efficacy of long-term treatment with EDP1815 in the treatment of Atopic Dermatitis will be measured using the following EASI endpoints:
• Percentage of participants achieving EASI-50
40 weeks
Secondary Percentage of Participants Achieving EASI-75 The efficacy of long-term treatment with EDP1815 in the treatment of Atopic Dermatitis will be measured using the following EASI endpoints:
• Percentage of participants achieving EASI-75
40 weeks
Secondary Percentage of Participants Achieving EASI-90 The efficacy of long-term treatment with EDP1815 in the treatment of Atopic Dermatitis will be measured using the following EASI endpoints:
• Percentage of participants achieving EASI-90
40 weeks
Secondary Mean Absolute Change From Baseline in EASI Score The efficacy of long-term treatment with EDP1815 in the treatment of Atopic Dermatitis will be measured using the following EASI endpoints:
• Mean absolute change from baseline in EASI Score
40 weeks
Secondary Mean Percentage Change From Baseline in EASI Score The efficacy of long-term treatment with EDP1815 in the treatment of Atopic Dermatitis will be measured using the following EASI endpoints:
• Mean percentage change from baseline in EASI Score
40 weeks
Secondary Percentage of Participants Achieving IGA of 0 or 1 With a =2 Point Improvement From Baseline The efficacy of long-term treatment with EDP1815 in the treatment of Atopic Dermatitis will be measured using the following IGA endpoints:
• Percentage of participants achieving IGA of 0 or 1 with a =2 point improvement from baseline
40 weeks
Secondary Percentage of Participants Achieving IGA of 0 or 1 The efficacy of long-term treatment with EDP1815 in the treatment of Atopic Dermatitis will be measured using the following IGA endpoints:
• Percentage of participants achieving IGA of 0 or 1
40 weeks
Secondary Percentage of Participants Achieving IGA of 0 The efficacy of long-term treatment with EDP1815 in the treatment of Atopic Dermatitis will be measured using the following IGA endpoints:
• Percentage of participants achieving IGA of 0
40 weeks
Secondary Mean Absolute Change From Baseline in IGA*BSA The efficacy of long-term treatment with EDP1815 in the treatment of Atopic Dermatitis will be measured using the following IGA *BSA endpoints:
• Mean absolute change from baseline in IGA*BSA
40 weeks
Secondary Mean Percentage Change From Baseline in IGA*BSA The efficacy of long-term treatment with EDP1815 in the treatment of Atopic Dermatitis will be measured using the following IGA *BSA endpoints:
• Mean percentage change from baseline in IGA*BSA
40 weeks
Secondary Mean Absolute Change From Baseline in BSA The efficacy of long-term treatment with EDP1815 in the treatment of Atopic Dermatitis will be measured using the following IGA *BSA endpoints:
• Mean absolute change from baseline in BSA
40 weeks
Secondary Mean Percentage Change From Baseline in BSA The efficacy of long-term treatment with EDP1815 in the treatment of Atopic Dermatitis will be measured using the following IGA *BSA endpoints:
• Mean percentage change from baseline in BSA
40 weeks
Secondary Percentage of Participants Achieving BSA-50 The efficacy of long-term treatment with EDP1815 in the treatment of Atopic Dermatitis will be measured using the following IGA *BSA endpoints:
• Percentage of participants achieving BSA-50
40 weeks
Secondary Percentage of Participants Achieving BSA-75 The efficacy of long-term treatment with EDP1815 in the treatment of Atopic Dermatitis will be measured using the following BSA endpoints:
• Percentage of participants achieving BSA-75
40 weeks
Secondary Percentage of Participants Achieving BSA Reduction to 3% or Less The efficacy of long-term treatment with EDP1815 in the treatment of Atopic Dermatitis will be measured using the following IGA *BSA endpoints:
• Percentage of participants achieving BSA reduction to 3% or less
40 weeks
Secondary Mean Absolute Change From Baseline in SCORAD The efficacy of long-term treatment with EDP1815 in the treatment of Atopic Dermatitis will be measured using the following SCORAD endpoints:
• Mean absolute change from baseline in SCORAD
40 weeks
Secondary Mean Percentage Change From Baseline in SCORAD The efficacy of long-term treatment with EDP1815 in the treatment of Atopic Dermatitis will be measured using the following SCORAD endpoints:
• Mean percentage change from baseline in SCORAD
40 weeks
Secondary Percentage of Participants Achieving SCORAD-50 The efficacy of long-term treatment with EDP1815 in the treatment of Atopic Dermatitis will be measured using the following SCORAD endpoints:
• Percentage of participants achieving SCORAD-50
40 weeks
Secondary Percentage of Participants Achieving SCORAD-75 The efficacy of long-term treatment with EDP1815 in the treatment of Atopic Dermatitis will be measured using the following SCORAD endpoints:
• Percentage of participants achieving SCORAD-75
40 weeks
Secondary Mean Absolute Change From Baseline in DLQI The efficacy of long-term treatment with EDP1815 in the treatment of Atopic Dermatitis will be measured using the following DLQI endpoints:
• Mean absolute change from baseline in DLQI
40 weeks
Secondary Mean Percentage Change From Baseline in DLQI The efficacy of long-term treatment with EDP1815 in the treatment of Atopic Dermatitis will be measured using the following DLQI endpoints:
• Mean percentage change from baseline in DLQI
40 weeks
Secondary Percentage of Participants Achieving a Reduction of =4 in the DLQI, of Those With a Score of =4 at Baseline The efficacy of long-term treatment with EDP1815 in the treatment of Atopic Dermatitis will be measured using the following DLQI endpoints:
• Percentage of participants achieving a reduction of =4 in the DLQI, of those with a score of =4 at baseline
40 weeks
Secondary Mean Absolute Change From Baseline in PP-NRS The efficacy of long-term treatment with EDP1815 in the treatment of Atopic Dermatitis will be measured using the following PP-NRS endpoints:
• Mean absolute change from baseline in PP-NRS
40 weeks
Secondary Percentage of Participants Achieving a Reduction of =2 in the PP-NRS, of Those With a Score of =2 at Baseline The efficacy of long-term treatment with EDP1815 in the treatment of Atopic Dermatitis will be measured using the following PP-NRS endpoints:
• Percentage of participants achieving a reduction of =2 in the PP-NRS, of those with a score of =2 at baseline
40 weeks
Secondary Percentage of Participants Achieving a Reduction of =4 in the PP-NRS, of Those With a Score of =4 at Baseline The efficacy of long-term treatment with EDP1815 in the treatment of Atopic Dermatitis will be measured using the following PP-NRS endpoints:
• Percentage of participants achieving a reduction of =4 in the PP-NRS, of those with a score of =4 at baseline
40 weeks
Secondary Mean Absolute Change From Baseline in SD-NRS The efficacy of long-term treatment with EDP1815 in the treatment of Atopic Dermatitis will be measured using the following SD-NRS endpoints:
• Mean absolute change from baseline in SD-NRS
40 weeks
Secondary Percentage of Participants Achieving a Reduction of =2 in the SD NRS, of Those With a Score of =2 at Baseline The efficacy of long-term treatment with EDP1815 in the treatment of Atopic Dermatitis will be measured using the following SD-NRS endpoints:
• Percentage of participants achieving a reduction of =2 in the SD NRS, of those with a score of =2 at baseline
40 weeks
Secondary Mean Absolute Change From Baseline in Patient Oriented Eczema Measure (POEM) The efficacy of long-term treatment with EDP1815 in the treatment of Atopic Dermatitis will be measured using the following POEM endpoints:
• Mean absolute change from baseline in Patient Oriented Eczema Measure (POEM)
40 weeks
Secondary Mean Percentage Change From Baseline in Patient Oriented Eczema Measure (POEM) The efficacy of long-term treatment with EDP1815 in the treatment of Atopic Dermatitis will be measured using the following POEM endpoints:
• Mean percentage change from baseline in Patient Oriented Eczema Measure (POEM)
40 weeks
Secondary Percentage of Participants Achieving a Reduction of =4 in the POEM Score, of Those With a Score of =4 at Baseline The efficacy of long-term treatment with EDP1815 in the treatment of Atopic Dermatitis will be measured using the following POEM endpoints:
• Percentage of participants achieving a reduction of =4 in the POEM score, of those with a score of =4 at baseline
40 weeks
Secondary Number of Courses Per Patient-year of Any Rescue Medication (Not Including Antibacterial Therapy) The efficacy of long-term treatment with EDP1815 in the treatment of Atopic Dermatitis will be measured using the following Rescue therapy use endpoints:
• Number of courses per patient-year of any rescue medication (not including antibacterial therapy)
40 weeks
Secondary Number of Courses Per Patient-year of Topical Corticosteroids of Any Potency The efficacy of long-term treatment with EDP1815 in the treatment of Atopic Dermatitis will be measured using the following Rescue therapy use endpoints:
• Number of courses per patient-year of topical corticosteroids of any potency
40 weeks
Secondary Number of Courses Per Patient-year of Topical Tacrolimus (0.1%), Topical Pimecrolimus (1%) or Grade VII Topical Corticosteroid The efficacy of long-term treatment with EDP1815 in the treatment of Atopic Dermatitis will be measured using the following Rescue therapy use endpoints:
• Number of courses per patient-year of topical tacrolimus (0.1%), topical pimecrolimus
(1%) or grade VII topical corticosteroid
40 weeks
Secondary Number of Courses Per Patient Year of Moderate Potency (Grade IV and V) Topical Steroids The efficacy of long-term treatment with EDP1815 in the treatment of Atopic Dermatitis will be measured using the following Rescue therapy use endpoints:
• Number of courses per patient year of moderate potency (grade IV and V) topical steroids
40 weeks
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