Atopic DermatitisPhase 2NCT05439941
A Long-Term Extension Trial in Participants With Atopic Dermatitis Who Participated in Previous EDP1815 Trials
A Phase 2 study testing EDP1815 in people with Atopic Dermatitis, run by Evelo Biosciences, Inc. at 54 sites in 6 countries.
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. Read more about this study
- Who is it for?
- Ages 18 to 76 years
- Conditions the study is for
- Atopic Dermatitis
- What is being tested?
- EDP1815
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 287 participants
- Where
- 54 sitesin 6 countries
- Study dates
- 6 Jun 2022to 7 Jun 2023
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 76 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Participants who are currently enrolled in another investigational drug study or plans to receive another investigational drug during this study.
- Have any other conditions, which would make the participant unsuitable for inclusion or could interfere with the participant participating in or completing the 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.
Trial locations and contacts
54 sites in 6 countries.
54 sites in 6 countries
United States24 sites
USA-119
Baton Rouge, Louisiana, 70806
USA-113
Bellevue, Washington, 98004
USA-131
Birmingham, Alabama, 35244
USA-111
Clarksville, Indiana, 47129
USA-121
Columbus, Ohio, 43221
USA-128
Concord, Ohio, 44077
USA -101
Fort Lauderdale, Florida, 33308
USA 112
Fountain Valley, California, 92708
USA 123
Fremont, California, 94538
USA-117
Frisco, Texas, 75034
USA-124
Jacksonville, Florida, 32216
USA-116
Louisville, Kentucky, 40241
USA-127
Memphis, Tennessee, 38119
USA-109
Metairie, Louisiana, 70006
USA-108
Miami, Florida, 33165
USA-120
Miami, Florida, 33175
USA-105
Miramar, Florida, 33027
USA-102
Orlando, Florida, 32801
USA-110
Pflugerville, Texas, 78660
USA-104
Portland, Oregon, 97239
USA-125
Silver Spring, Maryland, 20902
USA-115
Sweetwater, Florida, 33172
USA-106
Tampa, Florida, 33613
USA-126
Tampa, Florida, 33613
Canada9 sites
CAN-109
Barrie
CAN-108
Edmonton
CAN-105
Markham
CAN-104
Mississauga
CAN-101
Ottawa
CAN-107
Richmond Hill
CAN-103
Surrey
CAN-106
Waterloo
CAN-111
Winnipeg
Poland7 sites
POL-104
Gdansk
POL-106
Gdynia
POL-107
Katowice
POL-105
Lodz
POL-101
Lublin
POL-102
Warsaw
POL-103
Wroclaw
Germany6 sites
DEU-105
Berlin
DEU-106
Erlangen
DEU-102
Frankfurt am Main
DEU-104
Gera
DEU-101
Hamburg
DEU-103
Heidelberg
Australia4 sites
AUS-102
Carlton
AUS-104
Kogarah
AUS-101
Melbourne
AUS-106
Woolloongabba
About this study
Official title: A Long-Term Extension Trial in Participants With Atopic Dermatitis Who Participated in Previous Phase 2 And 3 EDP1815 Trials
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.
Read the 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
- Being tested
- EDP1815
- Keywords
- Mild Atopic Dermatitis, Moderate Atopic Dermatitis, Severe Atopic Dermatitis, Mild Eczema, Moderate Eczema, Severe Eczema
- Medical subject headings
- Dermatitis, Atopic, Eczema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EDP1815Drug
Also called Prevotella histicola
EDP1815 is an orally administered, pharmaceutical preparation of a single strain of bacteria
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: 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) Receives: 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) Receives: Drug: EDP1815 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 40 weeks
Secondary outcomes (34)
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
Measured: 40 weeks
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
Measured: 40 weeks
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
Measured: 40 weeks
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
Measured: 40 weeks
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
Measured: 40 weeks
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
Measured: 40 weeks
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
Measured: 40 weeks
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
Measured: 40 weeks
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
Measured: 40 weeks
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
Measured: 40 weeks
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
Measured: 40 weeks
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
Measured: 40 weeks
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
Measured: 40 weeks
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
Measured: 40 weeks
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
Measured: 40 weeks
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
Measured: 40 weeks
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
Measured: 40 weeks
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
Measured: 40 weeks
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
Measured: 40 weeks
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
Measured: 40 weeks
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
Measured: 40 weeks
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
Measured: 40 weeks
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
Measured: 40 weeks
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
Measured: 40 weeks
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
Measured: 40 weeks
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
Measured: 40 weeks
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
Measured: 40 weeks
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)
Measured: 40 weeks
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)
Measured: 40 weeks
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
Measured: 40 weeks
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)
Measured: 40 weeks
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
Measured: 40 weeks
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
Measured: 40 weeks
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
Measured: 40 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jun 2022
- Study start6 Jun 2022
- Primary completion25 May 2023
- Study completion7 Jun 2023
Why it stopped: Parent Study (NCT05121480) did not meet the primary endpoint.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Atopic DermatitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Open Label Extension Study.
- Masking
- None (open label)
- Enrolment
- 287 participants (actual)
Sponsor and investigators
- Lead sponsor
- Evelo Biosciences, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Douglas Maslin, MD, Study director, Evelo BiosciencesBen Ehst, PhD, Principal investigator, Oregon Medical Research Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05439941
- Sponsor's protocol ID
- EDP1815-208
- Other IDs
- 2022-000284-48
- Status last verified
- Aug 2023
- First submitted
- 27 Jun 2022
- Last updated
- 7 Sep 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Long-Term Extension Trial in Participants With Atopic Dermatitis Who Participated in Previous Phase 2 And 3 EDP1815 Trials
- ClinicalTrials.gov ID
- NCT05439941
- Acronym / sponsor ID
- EDP1815-208
- Conditions
- Atopic Dermatitis
- Keywords
- Mild Atopic Dermatitis, Moderate Atopic Dermatitis, Severe Atopic Dermatitis, Mild Eczema, Moderate Eczema, Severe Eczema
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Parent Study (NCT05121480) did not meet the primary endpoint.
- Enrolment
- 287 participants (actual)
- Lead sponsor
- Evelo Biosciences, Inc.Industry (pharma, biotech, devices)
- Study start
- 6 Jun 2022 (actual)
- Primary completion
- 25 May 2023 (actual)
- Study completion
- 7 Jun 2023 (actual)
- First posted
- 30 Jun 2022 (actual)
- Results
- Posted 7 Sep 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Open Label Extension Study.
| Arm | Type | Receives |
|---|---|---|
| Group 1 (1.6x10^11 total cells of EDP1815, 2 capsules once daily) | Experimental | Drug: EDP1815EDP1815-207 Cohort 1 participants will receive 1.6x10^11 total cells of EDP1815 in EDP1815-208 administered as 2 capsules once daily. (Group 1) |
| Group 2 (6.4x10^11 total cells of EDP1815, 2 capsules once daily) | Experimental | Drug: EDP1815EDP1815-207 Cohort 2 participants will receive 6.4x10^11 total cells of EDP1815 in EDP1815-208 administered as 2 capsules once daily. (Group 2) |
| Group 3 (8.0x10^10 total cells of EDP1815, 1 capsule once daily) | Experimental | Drug: EDP1815EDP1815-207 Cohort 4 participants will receive 8.0x10^10 total cells of EDP1815 in EDP1815-208 administered as 1 capsule once daily. (Group 3) |
Who may qualify
- Ages
- 18 to 76 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (7 listed)
- Participants who are currently enrolled in another investigational drug study or plans to receive another investigational drug during this study.
- Have any other conditions, which would make the participant unsuitable for inclusion or could interfere with the participant participating in or completing the 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EDP1815Also: Prevotella histicolaEDP1815 is an orally administered, pharmaceutical preparation of a single strain of bacteria | Drug | 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) |
Primary outcome
Incidence and Rate Per 100 Patient-years of Treatment-emergent Adverse Events
Time frame: 40 weeks
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.
34 secondary outcomes
Percentage of Participants Achieving EASI-50
Time frame: 40 weeks
Percentage of Participants Achieving EASI-75
Time frame: 40 weeks
Percentage of Participants Achieving EASI-90
Time frame: 40 weeks
Mean Absolute Change From Baseline in EASI Score
Time frame: 40 weeks
Mean Percentage Change From Baseline in EASI Score
Time frame: 40 weeks
Percentage of Participants Achieving IGA of 0 or 1 With a ≥2 Point Improvement From Baseline
Time frame: 40 weeks
Percentage of Participants Achieving IGA of 0 or 1
Time frame: 40 weeks
Percentage of Participants Achieving IGA of 0
Time frame: 40 weeks
Mean Absolute Change From Baseline in IGA*BSA
Time frame: 40 weeks
Mean Percentage Change From Baseline in IGA*BSA
Time frame: 40 weeks
Mean Absolute Change From Baseline in BSA
Time frame: 40 weeks
Mean Percentage Change From Baseline in BSA
Time frame: 40 weeks
Percentage of Participants Achieving BSA-50
Time frame: 40 weeks
Percentage of Participants Achieving BSA-75
Time frame: 40 weeks
Percentage of Participants Achieving BSA Reduction to 3% or Less
Time frame: 40 weeks
Mean Absolute Change From Baseline in SCORAD
Time frame: 40 weeks
Mean Percentage Change From Baseline in SCORAD
Time frame: 40 weeks
Percentage of Participants Achieving SCORAD-50
Time frame: 40 weeks
Percentage of Participants Achieving SCORAD-75
Time frame: 40 weeks
Mean Absolute Change From Baseline in DLQI
Time frame: 40 weeks
Mean Percentage Change From Baseline in DLQI
Time frame: 40 weeks
Percentage of Participants Achieving a Reduction of ≥4 in the DLQI, of Those With a Score of ≥4 at Baseline
Time frame: 40 weeks
Mean Absolute Change From Baseline in PP-NRS
Time frame: 40 weeks
Percentage of Participants Achieving a Reduction of ≥2 in the PP-NRS, of Those With a Score of ≥2 at Baseline
Time frame: 40 weeks
Percentage of Participants Achieving a Reduction of ≥4 in the PP-NRS, of Those With a Score of ≥4 at Baseline
Time frame: 40 weeks
Mean Absolute Change From Baseline in SD-NRS
Time frame: 40 weeks
Percentage of Participants Achieving a Reduction of ≥2 in the SD NRS, of Those With a Score of ≥2 at Baseline
Time frame: 40 weeks
Mean Absolute Change From Baseline in Patient Oriented Eczema Measure (POEM)
Time frame: 40 weeks
Mean Percentage Change From Baseline in Patient Oriented Eczema Measure (POEM)
Time frame: 40 weeks
Percentage of Participants Achieving a Reduction of ≥4 in the POEM Score, of Those With a Score of ≥4 at Baseline
Time frame: 40 weeks
Number of Courses Per Patient-year of Any Rescue Medication (Not Including Antibacterial Therapy)
Time frame: 40 weeks
Number of Courses Per Patient-year of Topical Corticosteroids of Any Potency
Time frame: 40 weeks
Number of Courses Per Patient-year of Topical Tacrolimus (0.1%), Topical Pimecrolimus (1%) or Grade VII Topical Corticosteroid
Time frame: 40 weeks
Number of Courses Per Patient Year of Moderate Potency (Grade IV and V) Topical Steroids
Time frame: 40 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Sep 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Douglas Maslin, MD study director
Evelo Biosciences
Ben Ehst, PhD principal investigator
Oregon Medical Research Center
54 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing EDP1815 in people with Atopic Dermatitis, run by Evelo Biosciences, Inc. at 54 sites in 6 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 7 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 54 sites in United States, Canada, Poland, Germany, Australia and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 7 Sep 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence and Rate Per 100 Patient-years of Treatment-emergent Adverse Events (time frame: 40 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Sep 2023; AzTrials last refreshed its copy on 6 Nov 2026.