Atopic DermatitisPhase 2NCT05121480
A Study Investigating the Effect of EDP1815 in the Treatment of Mild, Moderate and Severe Atopic Dermatitis
A Phase 2 study testing EDP1815 in people with Atopic Dermatitis, run by Evelo Biosciences, Inc. at 59 sites in 6 countries.
Trial summary
The purpose of this research study is to determine whether the study drug, EDP1815, is safe and effective in the treatment of atopic dermatitis compared with placebo. The study will look at different doses of the study drug, and whether there are differences when the drug is given once daily or twice daily. Read more about this study
- Who is it for?
- Ages 18 to 75 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?
- Yes, some participants may receive a placebo
- How many people
- 421 participants
- Where
- 59 sitesin 6 countries
- Study dates
- 31 Jan 2022to 28 Mar 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Provide written informed consent.
- Must meet age criteria.
- Must have a diagnosis of atopic dermatitis (AD)for at least 6 months.
- Must have severity of atopic dermatitis meeting the below criteria at both Screening and Day 1:
- An IGA of 2, 3 or 4 on the vIGA scale, and;
- A BSA of ≥5%, and;
Show all 9Show fewer
- An EASI score of ≥6.
- Must agree to use emollients.
- Must meet contraception requirements.
Who cannot join
- Have been in a clinical trial for EDP1815 prior to signing of ICF.
- Use of phototherapy or tanning beds; systemic medications/treatments that could affect AD or its symptoms including immunosuppressive therapy (e.g., oral or injectable corticosteroids, methotrexate, azathioprine, cyclosporine, mycophenolate mofetil, JAK inhibitors, tacrolimus, and/or leukotriene inhibitor) within 4 weeks of randomization.
- Treatment with topical agents that could affect atopic dermatitis, including topical corticosteroids, topical calcineurin inhibitors (e.g., tacrolimus or pimecrolimus), or topical PDE-4 inhibitor (e.g., crisaborole) within 14 days prior to randomization.
- Clinically significant abnormalities in screening laboratory values that in the opinion of the Investigator would make a participant unsuitable for inclusion in the study. One retest is permitted within the 28-day screening window.
- 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.
- Have any other conditions, which, in the opinion of the Investigator or Sponsor, would make the participant unsuitable for inclusion or could interfere with the participant participating in or completing the study.
Trial locations and contacts
59 sites in 6 countries.
59 sites in 6 countries
United States27 sites
USA-130
Ann Arbor, Michigan, 48103
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-114
Newport Beach, California, 92660
USA-102
Orlando, Florida, 32801
USA-110
Pflugerville, Texas, 78660
USA-104
Portland, Oregon, 97239
USA-118
Sandy Springs, Georgia, 30328
USA-125
Silver Spring, Maryland, 20902
USA-115
Sweetwater, Florida, 33172
USA-126
Tampa, Florida, 33613
USA-106
Tampa, Florida, 33624
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
Germany7 sites
DEU-105
Berlin
DEU-107
Bochum
DEU-106
Erlangen
DEU-102
Frankfurt am Main
DEU-104
Gera
DEU-101
Hamburg
DEU-103
Heidelberg
Poland7 sites
POL-104
Gdansk
POL-106
Gdynia
POL-107
Katowice
POL-105
Lodz
POL-101
Lublin
POL-102
Warsaw
POL-103
Wroclaw
Bulgaria5 sites
BGR-105
Pleven
BGR-104
Sevlievo
BGR-101
Sofia
BGR-102
Sofia
BGR-103
Sofia
Australia4 sites
AUS-102
Carlton
AUS-104
Kogarah
AUS-101
Melbourne
AUS-106
Woolloongabba
About this study
Official title: 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
The purpose of this research study is to determine whether the study drug, EDP1815, is safe and effective in the treatment of atopic dermatitis compared with placebo. The study will look at different doses of the study drug, and whether there are differences when the drug is given once daily or twice daily.
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 is a randomized, double blind, placebo controlled, parallel group, Phase 2 study to evaluate the efficacy and safety of EDP1815 in adult participants 18 to ≤75 years of age with mild, moderate, and severe atopic dermatitis (AD).
Participants will be screened within 28 days prior to the first dose of study intervention to confirm study eligibility. Subjects must have mild, moderate, or severe AD involving at least 5% Body Surface Area (BSA); an Investigator Global Assessment (IGA) score of 2, 3, or 4; and an Eczema Area Severity Index (EASI) of at least 6 at screening and Day 1.
All participants must agree to use a background therapy (per protocol) twice daily for at least 14 days prior to Day 1 in order to be considered eligible for the study.
Approximately 405 participants will be randomized to receive either EDP1815 or placebo (295 to EDP1815: 110 to placebo) and treated for 16 weeks. Participants in Cohorts 1, 2, \& 3 will be randomized in a 3:1 ratio (225 to EDP1815: 75 to placebo). Participants in Cohort 4 will be randomized in a 2:1 ratio (70 to EDP1815: 35 to placebo). Cohorts 1, 2 \& 3 will be run concurrently, and Cohort 4 recruitment will commence after enrollment for Cohorts 1, 2, \& 3 are completed.
Randomization will be stratified by baseline disease severity (mild [IGA = 2], moderate [IGA = 3] or severe [IGA = 4] AD). The investigational product will be administered either once or twice daily for 16 weeks. Background emollient (moisturizer) therapy must continue at least twice daily for the duration of the treatment and follow-up periods. Topical rescue therapy is allowed during the treatment period per protocol.
The primary efficacy endpoint is achievement of an EASI-50 response at Week 16. Secondary efficacy endpoints will look at EASI, IGA, BSA, SCORAD, DLQI, Pruritus-NRS, Sleep Disturbance-NRS, POEM, and the need for rescue therapy at Weeks 4, 8, 12 and 16 (unless otherwise specified in the protocol). Safety and efficacy assessments will be conducted at the investigator site by a clinical assessor blinded to treatment assignment. Scheduled clinic study visits for all subjects will occur at Screening, Day 1, Week 2, Week 4, Week 8, Week 12, Week 16 (end of treatment) and Week 20 (post-treatment follow-up). Participants discontinuing early from the study will undergo a 28-day follow-up period, where possible.
At the end of the 16-week study treatment, qualified participants completing the study will have the option to enter an open label study.
- Conditions
- Atopic Dermatitis
- Being tested
- EDP1815, Placebo
- 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
PlaceboDrug
Placebo oral capsule
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 | Experimental | 100 participants with mild, moderate or severe Atopic Dermatitis 75 participants on EDP1815 and 25 participants on matching placebo administered as 2 capsules (1.6 x 10^11 total cells) once daily for 16 weeks Receives: Drug: EDP1815; Drug: Placebo |
| Cohort 2 | Experimental | 100 participants with mild, moderate or severe Atopic Dermatitis 75 participants on EDP1815 and 25 participants on matching placebo administered as 2 capsules (6.4 x 10^11 total cells) once daily for 16 weeks Receives: Drug: EDP1815; Drug: Placebo |
| Cohort 3 | Experimental | 100 participants with mild, moderate or severe Atopic Dermatitis 75 participants on EDP1815 and 25 participants on matching placebo administered as 1 capsule (3.2 x 10^11 cells) twice daily (6.4 x 10^11 total cells) for 16 weeks Receives: Drug: EDP1815; Drug: Placebo |
| Cohort 4 | Experimental | 105 participants with mild, moderate or severe Atopic Dermatitis 70 participants on EDP1815 and 35 participants on matching placebo administered at 1 capsule (8.0x10^10 total cells) once daily for 16 weeks Receives: Drug: EDP1815; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Achievement of EASI-50
The efficacy of EDP1815 will be measured by achieving a decrease of at least 50% from baseline in Eczema Area Severity Index (EASI) score of 50 (EASI-50) at Week 16. The EASI is a validated measure of eczema severity, which considers a combination of the disease severity and body surface area affected across 4 body regions. The EASI score ranges from 0 - 72. A lower score indicates a better outcome.
Measured: 16 weeks
Secondary outcomes (33)
Percentage of Participants Achieving EASI-50
The efficacy of EDP1815 will be measured by the number of participants achieving an EASI-50 at Weeks 4, 8 and 12. The Eczema Area Severity Index (EASI) is a validated measure of eczema severity, which considers a combination of the disease severity and body surface area affected across 4 body regions (arms, legs, trunk, and head/neck). The EASI score ranges from 0 - 72, with a lower score indicating a better outcome.
Measured: 4, 8 and 12 weeks
Percentage of Participants Achieving EASI-75
The efficacy of EDP1815 will be measured by the number of participants achieving an EASI-75 at Weeks 4, 8, 12 and 16. The Eczema Area Severity Index (EASI) is a validated measure of eczema severity, which considers a combination of the disease severity and body surface area affected across 4 body regions (arms, legs, trunk, and head/neck). The EASI score ranges from 0 - 72, with a lower score indicating a better outcome.
Measured: 4, 8, 12, and 16 weeks
Percentage of Participants Achieving EASI-90
The efficacy of EDP1815 will be measured by the number of participants achieving an EASI-90 at Weeks 4, 8, 12 and 16. The Eczema Area Severity Index (EASI) is a validated measure of eczema severity, which considers a combination of the disease severity and body surface area affected across 4 body regions (arms, legs, trunk, and head/neck). The EASI score ranges from 0 - 72, with a lower score indicating a better outcome.
Measured: 4, 8, 12, and 16 weeks
Mean Absolute Change in EASI
The efficacy of EDP1815 will be measured using the mean absolute change from baseline in EASI at weeks 4, 8, 12 and 16. The Eczema Area Severity Index (EASI) is a validated measure of eczema severity, which considers a combination of the disease severity and body surface area affected across 4 body regions (arms, legs, trunk, and head/neck). The EASI score ranges from 0 - 72, with a lower score indicating a better outcome.
Measured: 4, 8, 12, and 16 weeks
Mean Percentage Change in EASI
The efficacy of EDP1815 will be measured using the mean percentage change from baseline in EASI from baseline at weeks 4, 8, 12 and 16. The Eczema Area Severity Index (EASI) is a validated measure of eczema severity, which considers a combination of the disease severity and body surface area affected across 4 body regions (arms, legs, trunk, and head/neck). The EASI score ranges from 0 - 72, with a lower score indicating a better outcome.
Measured: 4, 8, 12, and 16 weeks
Percentage of Participants Achieving Investigator's Global Assessment (vIGA) of 0 or 1 With a ≥2 Point Improvement
The efficacy of EDP1815 will be measured by the number of participants achieving a vIGA of 0 or 1 with a ≥2 Point Improvement from baseline at Weeks 4, 8, 12 and 16
Measured: 4, 8, 12, and 16 weeks
Percentage of Participants Achieving vIGA of 0 or 1
The efficacy of EDP1815 will be measured by the number of participants achieving a vIGA of 0 or 1 at Weeks 4, 8, 12 and 16
Measured: 4, 8, 12, and 16 weeks
Percentage of Participants Achieving vIGA of 0
The efficacy of EDP1815 will be measured by the number of participants achieving a vIGA of 0 at Week16
Measured: 16 weeks
Mean Absolute Change in vIGA*BSA
The efficacy of EDP1815 will be measured using the mean absolute change from baseline in vIGA (Validated Investigator Global Assessment) multiplied by the BSA (body surface area) at weeks 4, 8, 12 and 16.
Measured: 4, 8, 12, and 16 weeks
Mean Percentage Change in vIGA*BSA
The efficacy of EDP1815 will be measured using the mean percentage change from baseline in vIGA (Validated Investigator Global Assessment) multiplied by the BSA (body surface area) at weeks 4, 8, 12 and 16.
Measured: 4, 8, 12, and 16 weeks
Mean Absolute Change From Baseline in BSA
The efficacy of EDP1815 will be measured using the mean absolute change from baseline in BSA (body surface area) at weeks 4, 8, 12 and 16. The Body Surface Area (BSA) is a measure of the extent of atopic dermatitis at a given time. It is calculated by estimating the number of participant's handprints of active atopic dermatitis are present where one handprint represents 1% body surface area. This higher the BSA %, the more active atopic dermatitis is present.
Measured: 4, 8, 12, and 16 weeks
Mean Percentage Change From Baseline in BSA
The efficacy of EDP1815 will be measured using the mean percentage change from baseline in BSA (body surface area) at weeks 4, 8, 12 and 16. The Body Surface Area (BSA) is a measure of the extent of atopic dermatitis at a given time. It is calculated by estimating the number of participant's handprints of active atopic dermatitis are present where one handprint represents 1% body surface area. This higher the BSA %, the more active atopic dermatitis is present.
Measured: 4, 8, 12, and 16 weeks
Percentage of Participants Achieving BSA-50
The efficacy of EDP1815 will be measured by the number of participants achieving a BSA-50 at Weeks 4, 8, 12 and 16
Measured: 4, 8, 12, and 16 weeks
Percentage of Participants Achieving BSA-75
The efficacy of EDP1815 will be measured by the number of participants achieving a BSA-75 at Weeks 4, 8, 12 and 16
Measured: 4, 8, 12, and 16 weeks
Percentage of Participants Achieving BSA Reduction to 3% BSA or Less
The efficacy of EDP1815 will be measured by the number of participants achieving a BSA reduction to 3% BSA or less at Weeks 4, 8, 12 and 16
Measured: 4, 8, 12, and 16 weeks
Mean Absolute Change From Baseline in SCORing Atopic Dermatitis (SCORAD)
The efficacy of EDP1815 will be measured using the mean absolute change from baseline in SCORing Atopic Dermatitis (SCORAD) at weeks 4, 8, 12 and 16. The SCORAD is a clinical tool to assess the extent and severity of eczema, to assess treatment effects. There is both an investigator-rated area score using rule of nines to assess disease extent and a disease intensity score comprising erythema, swelling, oozing/crusting, exoriation, lichenification and dryness and a subjective symptoms component which considers itch and sleeplessness scored using a visual analog scale. These scores combine to give a SCORAD score between 0 - 103, with a higher score indicating worse atopic dermatitis.
Measured: 4, 8, 12, and 16 weeks
Mean Percentage Change From Baseline in SCORAD
The efficacy of EDP1815 will be measured using the mean percentage change from baseline in SCORAD at weeks 4, 8, 12 and 16. The SCORAD is a clinical tool to assess the extent and severity of eczema, to assess treatment effects. There is both an investigator-rated area score using rule of nines to assess disease extent and a disease intensity score comprising erythema, swelling, oozing/crusting, exoriation, lichenification and dryness and a subjective symptoms component which considers itch and sleeplessness scored using a visual analog scale. These scores combine to give a SCORAD score between 0 - 103, with a higher score indicating worse atopic dermatitis.
Measured: 4, 8, 12, and 16 weeks
Percentage of Participants Achieving SCORAD-50
The efficacy of EDP1815 will be measured by the number of participants achieving a SCORAD-50 at Weeks 4, 8, 12 and 16
Measured: 4, 8, 12, and 16 weeks
Percentage of Participants Achieving SCORAD-75
The efficacy of EDP1815 will be measured by the number of participants achieving a SCORAD-75 at Weeks 4, 8, 12 and 16
Measured: 4, 8, 12, and 16 weeks
Mean Absolute Change From Baseline in the Dermatology Quality of Life Index (DLQI)
The efficacy of EDP1815 will be measured using the mean absolute change from baseline in the Dermatology Quality of Life Index (DLQI) at weeks 4, 8, 12 and 16. The DLQI is a validated patient reported outcomes instrument comprised of 10 questions to assess how a participant's skin disease has affected their quality of life over the past week. The score ranges from 0 - 30, with a higher score indicating greater impairment of quality of life. A 4-point change from baseline is considered the minimal clinically important difference threshold.
Measured: 4, 8, 12, and 16 weeks
Mean Percentage Change From Baseline in DLQI
The efficacy of EDP1815 will be measured using the mean percentage change from baseline in the DLQI at weeks 4, 8, 12 and 16. The DLQI is a validated patient reported outcomes instrument comprised of 10 questions to assess how a participant's skin disease has affected their quality of life over the past week. The score ranges from 0 - 30, with a higher score indicating greater impairment of quality of life.
Measured: 4, 8, 12, and 16 weeks
Percentage of Participants Achieving a Reduction of ≥4 in the DLQI, of Those With a Score of ≥4 at Baseline
The efficacy of EDP1815 will be measured by the number of participants achieving a reduction of ≥4 in the DLQI, of those with a score of ≥4 at baseline at Week 16. The DLQI score ranges from 0 to 30, with higher scores indicating greater impairment of quality of life.
Measured: 16 weeks
Mean Absolute Change From Baseline in Worst Pruritus Numerical Rating Scale (PR-NRS)
The efficacy of EDP1815 will be measured using the mean absolute change from baseline in the worst Pruritus Numerical Rating Scale (PR-NRS) at weeks 4, 8, 12 and 16. The PP-NRS is a scale from 0 ("no itch") to 10 ("worse imaginable itch") for participants to rate their worst itch that they have experienced over the previous 24 hours. The value calculated for each visit is the mean of the daily values for the 7 days on and before the visit date as long as at least 4 non-missing scores are available.
Measured: 4, 8, 12, and 16 weeks
Percentage of Participants Achieving a Reduction of ≥2 in the Worst Pruritus-NRS, of Those With a Score of ≥2 at Baseline
The efficacy of EDP1815 will be measured by the number of participants achieving a reduction of ≥2 in the worst PR-NRS score, of those with a score of ≥2 at baseline at Weeks 4, 8, 12 and 16. The PP-NRS is a scale from 0 ("no itch") to 10 ("worse imaginable itch") for participants to rate their worst itch that they have experienced over the previous 24 hours.
Measured: 4, 8, 12, and 16 weeks
Percentage of Participants Achieving a Reduction of ≥4 in the Worst PR-NRS, of Those With a Score of ≥4 at Baseline
The efficacy of EDP1815 will be measured by the number of participants achieving a reduction of ≥4 in the worst PR-NRS score, of those with a score of ≥4 at baseline at Week 16. The PP-NRS is a scale from 0 ("no itch") to 10 ("worse imaginable itch") for participants to rate their worst itch that they have experienced over the previous 24 hours.
Measured: 16 weeks
Mean Absolute Change From Baseline in the Sleep Disturbance Numerical Rating Scale (SD-NRS) Score
The efficacy of EDP1815 will be measured using the mean absolute change from baseline in Sleep Disturbance Numerical Rating Scale (SD-NRS) score at weeks 4, 8, 12 and 16. The SD-NRS is a scale from 0 ("best possible sleep") to 10 ("worse possible sleep") for participants to rate their worst sleep that they have experienced over the previous 24 hours. The value calculated for each visit is the mean of the daily values for the 7 days on and before the visit date as long as at least 4 non-missing scores are available.
Measured: 4, 8, 12, and 16 weeks
Percentage of Participants Achieving a Reduction of ≥2 in SD-NRS Score, of Those With a Score of ≥2 at Baseline
The efficacy of EDP1815 will be measured by the number of participants achieving a reduction of ≥2 in the SD-NRS score, of those with a score of ≥2 at baseline at Week 16. The SD-NRS is a scale from 0 ("best possible sleep") to 10 ("worse possible sleep") for participants to rate their worst sleep that they have experienced over the previous 24 hours.
Measured: 16 weeks
Mean Absolute Change From Baseline in Patient Oriented Eczema Measure (POEM)
The efficacy of EDP1815 will be measured using the mean absolute change from baseline in the Patient Oriented Eczema Measure (POEM) at weeks 4, 8, 12 and 16. There are 7 questions scored from 0 (no days) to 4 (every day), giving a POEM score range from 0 to 28, with higher scores representing higher disease severity.
Measured: 4, 8, 12, and 16 weeks
Mean Percentage Change From Baseline in Patient Oriented Eczema Measure (POEM)
The efficacy of EDP1815 will be measured using the percentage change from baseline in the Patient Oriented Eczema Measure (POEM) at weeks 4, 8, 12 and 16. There are 7 questions scored from 0 (no days) to 4 (every day), giving a POEM score range from 0 to 28, with higher scores representing higher disease severity.
Measured: 4, 8, 12, and 16 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 EDP1815 will be measured by the number of participants achieving a reduction of ≥4 in the POEM score, of those with a score of ≥4 at baseline at Week 16. There are 7 questions scored from 0 (no days) to 4 (every day), giving a POEM score range from 0 to 28, with higher scores representing higher disease severity.
Measured: 16 weeks
Number of Courses of Rescue Therapy Per Participant
The efficacy of EDP1815 will be measured by the number of rescue therapy courses per participant at Weeks 4, 8, 12 and 16
Measured: 4, 8, 12, and 16 weeks
Number of Days of Treatment With Rescue Therapy Per Participant
The efficacy of EDP1815 will be measured by the number of rescue therapy treatment days per participant at Weeks 1-8 and 9-16
Measured: 16 weeks
Proportion of Participants Not Requiring Rescue Therapy
The efficacy of EDP1815 will be measured by the proportion of participants not requiring rescue therapy at Weeks 4, 8, 12 and 16
Measured: 4, 8, 12, and 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Nov 2021
- Study start31 Jan 2022
- Primary completion9 Mar 2023
- Study completion28 Mar 2023
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
- Cohorts 1, 2 \& 3 will be run concurrently, and Cohort 4 recruitment will commence after enrollment for Cohorts 1, 2, \& 3 are completed. Randomization to Cohort 4 will not start before randomization to Cohorts 1, 2 \& 3 have completed.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 421 participants (actual)
Sponsor and investigators
- Lead sponsor
- Evelo Biosciences, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Benjamin Ehst, MD, PhD, Principal investigator, Oregon Medical Research CenterYanislav Mihaylov, MD, Study director, Evelo Biosciences, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05121480
- Sponsor's protocol ID
- EDP1815-207
- Other IDs
- 2021-001805-63
- Status last verified
- Aug 2023
- First submitted
- 4 Nov 2021
- Last updated
- 16 Aug 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 16 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT05121480
- Acronym / sponsor ID
- EDP1815-207
- 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
- Completed
- Enrolment
- 421 participants (actual)
- Lead sponsor
- Evelo Biosciences, Inc.Industry (pharma, biotech, devices)
- Study start
- 31 Jan 2022 (actual)
- Primary completion
- 9 Mar 2023 (actual)
- Study completion
- 28 Mar 2023 (actual)
- First posted
- 16 Nov 2021 (actual)
- Results
- Posted 16 Aug 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this research study is to determine whether the study drug, EDP1815, is safe and effective in the treatment of atopic dermatitis compared with placebo. The study will look at different doses of the study drug, and whether there are differences when the drug is given once daily or twice daily.
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 is a randomized, double blind, placebo controlled, parallel group, Phase 2 study to evaluate the efficacy and safety of EDP1815 in adult participants 18 to ≤75 years of age with mild, moderate, and severe atopic dermatitis (AD).
Participants will be screened within 28 days prior to the first dose of study intervention to confirm study eligibility. Subjects must have mild, moderate, or severe AD involving at least 5% Body Surface Area (BSA); an Investigator Global Assessment (IGA) score of 2, 3, or 4; and an Eczema Area Severity Index (EASI) of at least 6 at screening and Day 1.
All participants must agree to use a background therapy (per protocol) twice daily for at least 14 days prior to Day 1 in order to be considered eligible for the study.
Approximately 405 participants will be randomized to receive either EDP1815 or placebo (295 to EDP1815: 110 to placebo) and treated for 16 weeks. Participants in Cohorts 1, 2, \& 3 will be randomized in a 3:1 ratio (225 to EDP1815: 75 to placebo). Participants in Cohort 4 will be randomized in a 2:1 ratio (70 to EDP1815: 35 to placebo). Cohorts 1, 2 \& 3 will be run concurrently, and Cohort 4 recruitment will commence after enrollment for Cohorts 1, 2, \& 3 are completed.
Randomization will be stratified by baseline disease severity (mild [IGA = 2], moderate [IGA = 3] or severe [IGA = 4] AD). The investigational product will be administered either once or twice daily for 16 weeks. Background emollient (moisturizer) therapy must continue at least twice daily for the duration of the treatment and follow-up periods. Topical rescue therapy is allowed during the treatment period per protocol.
The primary efficacy endpoint is achievement of an EASI-50 response at Week 16. Secondary efficacy endpoints will look at EASI, IGA, BSA, SCORAD, DLQI, Pruritus-NRS, Sleep Disturbance-NRS, POEM, and the need for rescue therapy at Weeks 4, 8, 12 and 16 (unless otherwise specified in the protocol). Safety and efficacy assessments will be conducted at the investigator site by a clinical assessor blinded to treatment assignment. Scheduled clinic study visits for all subjects will occur at Screening, Day 1, Week 2, Week 4, Week 8, Week 12, Week 16 (end of treatment) and Week 20 (post-treatment follow-up). Participants discontinuing early from the study will undergo a 28-day follow-up period, where possible.
At the end of the 16-week study treatment, qualified participants completing the study will have the option to enter an open label study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
- Model description
- Cohorts 1, 2 \& 3 will be run concurrently, and Cohort 4 recruitment will commence after enrollment for Cohorts 1, 2, \& 3 are completed. Randomization to Cohort 4 will not start before randomization to Cohorts 1, 2 \& 3 have completed.
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | Experimental | Drug: EDP1815, Drug: Placebo100 participants with mild, moderate or severe Atopic Dermatitis 75 participants on EDP1815 and 25 participants on matching placebo administered as 2 capsules (1.6 x 10^11 total cells) once daily for 16 weeks |
| Cohort 2 | Experimental | Drug: EDP1815, Drug: Placebo100 participants with mild, moderate or severe Atopic Dermatitis 75 participants on EDP1815 and 25 participants on matching placebo administered as 2 capsules (6.4 x 10^11 total cells) once daily for 16 weeks |
| Cohort 3 | Experimental | Drug: EDP1815, Drug: Placebo100 participants with mild, moderate or severe Atopic Dermatitis 75 participants on EDP1815 and 25 participants on matching placebo administered as 1 capsule (3.2 x 10^11 cells) twice daily (6.4 x 10^11 total cells) for 16 weeks |
| Cohort 4 | Experimental | Drug: EDP1815, Drug: Placebo105 participants with mild, moderate or severe Atopic Dermatitis 70 participants on EDP1815 and 35 participants on matching placebo administered at 1 capsule (8.0x10^10 total cells) once daily for 16 weeks |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Provide written informed consent.
- Must meet age criteria.
- Must have a diagnosis of atopic dermatitis (AD)for at least 6 months.
- Must have severity of atopic dermatitis meeting the below criteria at both Screening and Day 1:
- Must agree to use emollients.
Key exclusion criteria (7 listed)
- Have been in a clinical trial for EDP1815 prior to signing of ICF.
- Use of phototherapy or tanning beds; systemic medications/treatments that could affect AD or its symptoms including immunosuppressive therapy (e.g., oral or injectable corticosteroids, methotrexate, azathioprine, cyclosporine, mycophenolate mofetil, JAK inhibitors, tacrolimus, and/or leukotriene inhibitor) within 4 weeks of randomization.
- Treatment with topical agents that could affect atopic dermatitis, including topical corticosteroids, topical calcineurin inhibitors (e.g., tacrolimus or pimecrolimus), or topical PDE-4 inhibitor (e.g., crisaborole) within 14 days prior to randomization.
- Clinically significant abnormalities in screening laboratory values that in the opinion of the Investigator would make a participant unsuitable for inclusion in the study. One retest is permitted within the 28-day screening window.
- Hypersensitivity to P histicola or to any of the excipients.
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 | Cohort 1, Cohort 2, Cohort 3, Cohort 4 |
| PlaceboPlacebo oral capsule | Drug | Cohort 1, Cohort 2, Cohort 3, Cohort 4 |
Primary outcome
Achievement of EASI-50
Time frame: 16 weeks
The efficacy of EDP1815 will be measured by achieving a decrease of at least 50% from baseline in Eczema Area Severity Index (EASI) score of 50 (EASI-50) at Week 16. The EASI is a validated measure of eczema severity, which considers a combination of the disease severity and body surface area affected across 4 body regions. The EASI score ranges from 0 - 72. A lower score indicates a better outcome.
33 secondary outcomes
Percentage of Participants Achieving EASI-50
Time frame: 4, 8 and 12 weeks
Percentage of Participants Achieving EASI-75
Time frame: 4, 8, 12, and 16 weeks
Percentage of Participants Achieving EASI-90
Time frame: 4, 8, 12, and 16 weeks
Mean Absolute Change in EASI
Time frame: 4, 8, 12, and 16 weeks
Mean Percentage Change in EASI
Time frame: 4, 8, 12, and 16 weeks
Percentage of Participants Achieving Investigator's Global Assessment (vIGA) of 0 or 1 With a ≥2 Point Improvement
Time frame: 4, 8, 12, and 16 weeks
Percentage of Participants Achieving vIGA of 0 or 1
Time frame: 4, 8, 12, and 16 weeks
Percentage of Participants Achieving vIGA of 0
Time frame: 16 weeks
Mean Absolute Change in vIGA*BSA
Time frame: 4, 8, 12, and 16 weeks
Mean Percentage Change in vIGA*BSA
Time frame: 4, 8, 12, and 16 weeks
Mean Absolute Change From Baseline in BSA
Time frame: 4, 8, 12, and 16 weeks
Mean Percentage Change From Baseline in BSA
Time frame: 4, 8, 12, and 16 weeks
Percentage of Participants Achieving BSA-50
Time frame: 4, 8, 12, and 16 weeks
Percentage of Participants Achieving BSA-75
Time frame: 4, 8, 12, and 16 weeks
Percentage of Participants Achieving BSA Reduction to 3% BSA or Less
Time frame: 4, 8, 12, and 16 weeks
Mean Absolute Change From Baseline in SCORing Atopic Dermatitis (SCORAD)
Time frame: 4, 8, 12, and 16 weeks
Mean Percentage Change From Baseline in SCORAD
Time frame: 4, 8, 12, and 16 weeks
Percentage of Participants Achieving SCORAD-50
Time frame: 4, 8, 12, and 16 weeks
Percentage of Participants Achieving SCORAD-75
Time frame: 4, 8, 12, and 16 weeks
Mean Absolute Change From Baseline in the Dermatology Quality of Life Index (DLQI)
Time frame: 4, 8, 12, and 16 weeks
Mean Percentage Change From Baseline in DLQI
Time frame: 4, 8, 12, and 16 weeks
Percentage of Participants Achieving a Reduction of ≥4 in the DLQI, of Those With a Score of ≥4 at Baseline
Time frame: 16 weeks
Mean Absolute Change From Baseline in Worst Pruritus Numerical Rating Scale (PR-NRS)
Time frame: 4, 8, 12, and 16 weeks
Percentage of Participants Achieving a Reduction of ≥2 in the Worst Pruritus-NRS, of Those With a Score of ≥2 at Baseline
Time frame: 4, 8, 12, and 16 weeks
Percentage of Participants Achieving a Reduction of ≥4 in the Worst PR-NRS, of Those With a Score of ≥4 at Baseline
Time frame: 16 weeks
Mean Absolute Change From Baseline in the Sleep Disturbance Numerical Rating Scale (SD-NRS) Score
Time frame: 4, 8, 12, and 16 weeks
Percentage of Participants Achieving a Reduction of ≥2 in SD-NRS Score, of Those With a Score of ≥2 at Baseline
Time frame: 16 weeks
Mean Absolute Change From Baseline in Patient Oriented Eczema Measure (POEM)
Time frame: 4, 8, 12, and 16 weeks
Mean Percentage Change From Baseline in Patient Oriented Eczema Measure (POEM)
Time frame: 4, 8, 12, and 16 weeks
Percentage of Participants Achieving a Reduction of ≥4 in the POEM Score, of Those With a Score of ≥4 at Baseline
Time frame: 16 weeks
Number of Courses of Rescue Therapy Per Participant
Time frame: 4, 8, 12, and 16 weeks
Number of Days of Treatment With Rescue Therapy Per Participant
Time frame: 16 weeks
Proportion of Participants Not Requiring Rescue Therapy
Time frame: 4, 8, 12, and 16 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Aug 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.
Benjamin Ehst, MD, PhD principal investigator
Oregon Medical Research Center
Yanislav Mihaylov, MD study director
Evelo Biosciences, Inc.
59 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 59 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 9 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: finished, as of the sponsor's last update on 16 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 59 sites in United States, Canada, Germany, Poland, Bulgaria 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 16 Aug 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?
Achievement of EASI-50 (time frame: 16 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 16 Aug 2023.