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

Atopic Dermatitis Clinical Trial

Official title:

A Long-Term Extension Trial in Participants With Atopic Dermatitis Who Participated in Previous Phase 2 And 3 EDP1815 Trials

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
• 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
• 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.

Related Conditions & MeSH terms

• Atopic Dermatitis
• Dermatitis
• Dermatitis, Atopic
• Eczema

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