Clinical trial NCT05439941: A Long-Term Extension Trial in Participants With Atopic Dermatitis Who Participated in Previous EDP1815 Trials
Official title: A Long-Term Extension Trial in Participants With Atopic Dermatitis Who Participated in Previous Phase 2 And 3 EDP1815 Trials
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Atopic Dermatitis
Keywords: Mild Atopic Dermatitis
Moderate Atopic Dermatitis
Severe Atopic Dermatitis
Mild Eczema
Moderate Eczema
Severe Eczema
Lead sponsor: Evelo Biosciences, Inc.
Sponsor class: INDUSTRY
First posted: 2022-06-30
Enrollment: 287
Sex: ALL
Minimum age (years): 18
Maximum age (years): 76
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Open Label Extension Study.
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Incidence and Rate Per 100 Patient-years of Treatment-emergent Adverse Events
timeFrame: 40 weeks
Secondary outcomes:
measure: Percentage of Participants Achieving EASI-50
timeFrame: 40 weeks
measure: Percentage of Participants Achieving EASI-75
timeFrame: 40 weeks
measure: Percentage of Participants Achieving EASI-90
timeFrame: 40 weeks
measure: Mean Absolute Change From Baseline in EASI Score
timeFrame: 40 weeks
measure: Mean Percentage Change From Baseline in EASI Score
timeFrame: 40 weeks
measure: Percentage of Participants Achieving IGA of 0 or 1 With a ≥2 Point Improvement From Baseline
timeFrame: 40 weeks
measure: Percentage of Participants Achieving IGA of 0 or 1
timeFrame: 40 weeks
measure: Percentage of Participants Achieving IGA of 0
timeFrame: 40 weeks
measure: Mean Absolute Change From Baseline in IGA*BSA
timeFrame: 40 weeks
measure: Mean Percentage Change From Baseline in IGA*BSA
timeFrame: 40 weeks
measure: Mean Absolute Change From Baseline in BSA
timeFrame: 40 weeks
measure: Mean Percentage Change From Baseline in BSA
timeFrame: 40 weeks
measure: Percentage of Participants Achieving BSA-50
timeFrame: 40 weeks
measure: Percentage of Participants Achieving BSA-75
timeFrame: 40 weeks
measure: Percentage of Participants Achieving BSA Reduction to 3% or Less
timeFrame: 40 weeks
measure: Mean Absolute Change From Baseline in SCORAD
timeFrame: 40 weeks
measure: Mean Percentage Change From Baseline in SCORAD
timeFrame: 40 weeks
measure: Percentage of Participants Achieving SCORAD-50
timeFrame: 40 weeks
measure: Percentage of Participants Achieving SCORAD-75
timeFrame: 40 weeks
measure: Mean Absolute Change From Baseline in DLQI
timeFrame: 40 weeks
measure: Mean Percentage Change From Baseline in DLQI
timeFrame: 40 weeks
measure: Percentage of Participants Achieving a Reduction of ≥4 in the DLQI, of Those With a Score of ≥4 at Baseline
timeFrame: 40 weeks
measure: Mean Absolute Change From Baseline in PP-NRS
timeFrame: 40 weeks
measure: Percentage of Participants Achieving a Reduction of ≥2 in the PP-NRS, of Those With a Score of ≥2 at Baseline
timeFrame: 40 weeks
measure: Percentage of Participants Achieving a Reduction of ≥4 in the PP-NRS, of Those With a Score of ≥4 at Baseline
timeFrame: 40 weeks
measure: Mean Absolute Change From Baseline in SD-NRS
timeFrame: 40 weeks
measure: Percentage of Participants Achieving a Reduction of ≥2 in the SD NRS, of Those With a Score of ≥2 at Baseline
timeFrame: 40 weeks
measure: Mean Absolute Change From Baseline in Patient Oriented Eczema Measure (POEM)
timeFrame: 40 weeks
measure: Mean Percentage Change From Baseline in Patient Oriented Eczema Measure (POEM)
timeFrame: 40 weeks
measure: Percentage of Participants Achieving a Reduction of ≥4 in the POEM Score, of Those With a Score of ≥4 at Baseline
timeFrame: 40 weeks
measure: Number of Courses Per Patient-year of Any Rescue Medication (Not Including Antibacterial Therapy)
timeFrame: 40 weeks
measure: Number of Courses Per Patient-year of Topical Corticosteroids of Any Potency
timeFrame: 40 weeks
measure: Number of Courses Per Patient-year of Topical Tacrolimus (0.1%), Topical Pimecrolimus (1%) or Grade VII Topical Corticosteroid
timeFrame: 40 weeks
measure: Number of Courses Per Patient Year of Moderate Potency (Grade IV and V) Topical Steroids
timeFrame: 40 weeks
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: USA-131
state: Alabama
city: Fountain Valley
country: United States
facility: USA 112
state: California
city: Fremont
country: United States
facility: USA 123
state: California
city: Fort Lauderdale
country: United States
facility: USA -101
state: Florida
city: Jacksonville
country: United States
facility: USA-124
state: Florida
city: Miami
country: United States
facility: USA-108
state: Florida
city: Miami
country: United States
facility: USA-120
state: Florida
city: Miramar
country: United States
facility: USA-105
state: Florida
city: Orlando
country: United States
facility: USA-102
state: Florida
city: Sweetwater
country: United States
facility: USA-115
state: Florida
city: Tampa
country: United States
facility: USA-106
state: Florida
city: Tampa
country: United States
facility: USA-126
state: Florida
city: Clarksville
country: United States
facility: USA-111
state: Indiana
city: Louisville
country: United States
facility: USA-116
state: Kentucky
city: Baton Rouge
country: United States
facility: USA-119
state: Louisiana
city: Metairie
country: United States
facility: USA-109
state: Louisiana
city: Silver Spring
country: United States
facility: USA-125
state: Maryland
city: Columbus
country: United States
facility: USA-121
state: Ohio
city: Concord
country: United States
facility: USA-128
state: Ohio
city: Portland
country: United States
facility: USA-104
state: Oregon
city: Memphis
country: United States
facility: USA-127
state: Tennessee
city: Frisco
country: United States
facility: USA-117
state: Texas
city: Pflugerville
country: United States
facility: USA-110
state: Texas
city: Bellevue
country: United States
facility: USA-113
state: Washington
city: Carlton
country: Australia
facility: AUS-102
city: Kogarah
country: Australia
facility: AUS-104
city: Melbourne
country: Australia
facility: AUS-101
city: Woolloongabba
country: Australia
facility: AUS-106
city: Pleven
country: Bulgaria
facility: BGR-105
city: Sevlievo
country: Bulgaria
facility: BGR-104
city: Sofia
country: Bulgaria
facility: BGR-101
city: Sofia
country: Bulgaria
facility: BGR-103
city: Barrie
country: Canada
facility: CAN-109
city: Edmonton
country: Canada
facility: CAN-108
city: Markham
country: Canada
facility: CAN-105
city: Mississauga
country: Canada
facility: CAN-104
city: Ottawa
country: Canada
facility: CAN-101
city: Richmond Hill
country: Canada
facility: CAN-107
city: Surrey
country: Canada
facility: CAN-103
city: Waterloo
country: Canada
facility: CAN-106
city: Winnipeg
country: Canada
facility: CAN-111
city: Berlin
country: Germany
facility: DEU-105
city: Erlangen
country: Germany
facility: DEU-106
city: Frankfurt am Main
country: Germany
facility: DEU-102
city: Gera
country: Germany
facility: DEU-104
city: Hamburg
country: Germany
facility: DEU-101
city: Heidelberg
country: Germany
facility: DEU-103
city: Gdańsk
country: Poland
facility: POL-104
city: Gdynia
country: Poland
facility: POL-106
city: Katowice
country: Poland
facility: POL-107
city: Lublin
country: Poland
facility: POL-101
city: Warszawa
country: Poland
facility: POL-102
city: Wrocław
country: Poland
facility: POL-103
city: Łódź
country: Poland
facility: POL-105
Study officials:
affiliation: Evelo Biosciences
name: Douglas Maslin, MD
role: STUDY_DIRECTOR
affiliation: Oregon Medical Research Center
name: Ben Ehst, PhD
role: PRINCIPAL_INVESTIGATOR
References: