Atopic Dermatitis
Conditions
Keywords
Mild Atopic Dermatitis, Moderate Atopic Dermatitis, Severe Atopic Dermatitis, Mild Eczema, Moderate Eczema, Severe Eczema
Brief 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.
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.
Interventions
DRUGEDP1815
EDP1815 is an orally administered, pharmaceutical preparation of a single strain of bacteria
DRUGPlacebo
Placebo oral capsule
Sponsors
Evelo Biosciences, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Intervention 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.
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* 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; * An EASI score of ≥6. * Must agree to use emollients. * Must meet contraception requirements.
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Achievement of EASI-50 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Achieving EASI-75 | 4, 8, 12, and 16 weeks | 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. |
| Percentage of Participants Achieving EASI-90 | 4, 8, 12, and 16 weeks | 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. |
| Mean Absolute Change in EASI | 4, 8, 12, and 16 weeks | 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. |
| Mean Percentage Change in EASI | 4, 8, 12, and 16 weeks | 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. |
| Percentage of Participants Achieving Investigator's Global Assessment (vIGA) of 0 or 1 With a ≥2 Point Improvement | 4, 8, 12, and 16 weeks | 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 |
| Percentage of Participants Achieving vIGA of 0 or 1 | 4, 8, 12, and 16 weeks | 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 |
| Percentage of Participants Achieving vIGA of 0 | 16 weeks | The efficacy of EDP1815 will be measured by the number of participants achieving a vIGA of 0 at Week16 |
| Mean Absolute Change in vIGA*BSA | 4, 8, 12, and 16 weeks | 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. |
| Mean Percentage Change in vIGA*BSA | 4, 8, 12, and 16 weeks | 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. |
| Mean Absolute Change From Baseline in BSA | 4, 8, 12, and 16 weeks | 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. |
| Mean Percentage Change From Baseline in BSA | 4, 8, 12, and 16 weeks | 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. |
| Percentage of Participants Achieving BSA-50 | 4, 8, 12, and 16 weeks | The efficacy of EDP1815 will be measured by the number of participants achieving a BSA-50 at Weeks 4, 8, 12 and 16 |
| Percentage of Participants Achieving BSA-75 | 4, 8, 12, and 16 weeks | The efficacy of EDP1815 will be measured by the number of participants achieving a BSA-75 at Weeks 4, 8, 12 and 16 |
| Percentage of Participants Achieving BSA Reduction to 3% BSA or Less | 4, 8, 12, and 16 weeks | 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 |
| Mean Absolute Change From Baseline in SCORing Atopic Dermatitis (SCORAD) | 4, 8, 12, and 16 weeks | 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. |
| Mean Percentage Change From Baseline in SCORAD | 4, 8, 12, and 16 weeks | 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. |
| Percentage of Participants Achieving EASI-50 | 4, 8 and 12 weeks | 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. |
| Percentage of Participants Achieving SCORAD-75 | 4, 8, 12, and 16 weeks | The efficacy of EDP1815 will be measured by the number of participants achieving a SCORAD-75 at Weeks 4, 8, 12 and 16 |
| Mean Absolute Change From Baseline in the Dermatology Quality of Life Index (DLQI) | 4, 8, 12, and 16 weeks | 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. |
| Mean Percentage Change From Baseline in DLQI | 4, 8, 12, and 16 weeks | 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. |
| Percentage of Participants Achieving a Reduction of ≥4 in the DLQI, of Those With a Score of ≥4 at Baseline | 16 weeks | 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. |
| Mean Absolute Change From Baseline in Worst Pruritus Numerical Rating Scale (PR-NRS) | 4, 8, 12, and 16 weeks | 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. |
| Percentage of Participants Achieving a Reduction of ≥2 in the Worst Pruritus-NRS, of Those With a Score of ≥2 at Baseline | 4, 8, 12, and 16 weeks | 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. |
| Percentage of Participants Achieving a Reduction of ≥4 in the Worst PR-NRS, of Those With a Score of ≥4 at Baseline | 16 weeks | 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. |
| Mean Absolute Change From Baseline in the Sleep Disturbance Numerical Rating Scale (SD-NRS) Score | 4, 8, 12, and 16 weeks | 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. |
| Percentage of Participants Achieving a Reduction of ≥2 in SD-NRS Score, of Those With a Score of ≥2 at Baseline | 16 weeks | 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. |
| Mean Absolute Change From Baseline in Patient Oriented Eczema Measure (POEM) | 4, 8, 12, and 16 weeks | 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. |
| Mean Percentage Change From Baseline in Patient Oriented Eczema Measure (POEM) | 4, 8, 12, and 16 weeks | 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. |
| Percentage of Participants Achieving a Reduction of ≥4 in the POEM Score, of Those With a Score of ≥4 at Baseline | 16 weeks | 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. |
| Number of Courses of Rescue Therapy Per Participant | 4, 8, 12, and 16 weeks | The efficacy of EDP1815 will be measured by the number of rescue therapy courses per participant at Weeks 4, 8, 12 and 16 |
| Number of Days of Treatment With Rescue Therapy Per Participant | 16 weeks | The efficacy of EDP1815 will be measured by the number of rescue therapy treatment days per participant at Weeks 1-8 and 9-16 |
| Proportion of Participants Not Requiring Rescue Therapy | 4, 8, 12, and 16 weeks | The efficacy of EDP1815 will be measured by the proportion of participants not requiring rescue therapy at Weeks 4, 8, 12 and 16 |
| Percentage of Participants Achieving SCORAD-50 | 4, 8, 12, and 16 weeks | The efficacy of EDP1815 will be measured by the number of participants achieving a SCORAD-50 at Weeks 4, 8, 12 and 16 |
Countries
Australia, Bulgaria, Canada, Germany, Poland, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Cohort 1 - Placebo Participants with mild, moderate or severe Atopic Dermatitis who received placebo oral capsules. | 25 |
| Cohort 1 - Active Participants with mild, moderate or severe Atopic Dermatitis who received 2 capsules (1.6 x 10\^11 total cells) of EDP1815 (an orally administered, pharmaceutical preparation of a single strain of bacteria) once daily for 16 weeks. | 74 |
| Cohort 2 - Placebo Participants with mild, moderate or severe Atopic Dermatitis who received placebo oral capsules | 25 |
| Cohort 2 - Active Participants with mild, moderate or severe Atopic Dermatitis who received 2 capsules (6.4 x 10\^11 total cells) of EDP1815 (an orally administered, pharmaceutical preparation of a single strain of bacteria) once daily for 16 weeks. | 74 |
| Cohort 3 - Placebo Participants with mild, moderate or severe Atopic Dermatitis who received placebo oral capsules. | 25 |
| Cohort 3 - Active Participants with mild, moderate or severe Atopic Dermatitis who received 1 capsule (3.2 x 10\^11 cells) twice daily (6.4 x 10\^11 total cells) of EDP1815 (an orally administered, pharmaceutical preparation of a single strain of bacteria) once daily for 16 weeks. | 86 |
| Cohort 4 - Placebo Participants with mild, moderate or severe Atopic Dermatitis who received placebo oral capsules. | 38 |
| Cohort 4 - Active Participants with mild, moderate or severe Atopic Dermatitis who received 1 capsule (8.0x10\^10 total cells) of EDP1815 (an orally administered, pharmaceutical preparation of a single strain of bacteria) once daily for 16 weeks. | 74 |
| Total | 421 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 | FG006 | FG007 |
|---|---|---|---|---|---|---|---|---|---|
| Overall Study | Adverse Event | 0 | 1 | 0 | 5 | 3 | 2 | 0 | 4 |
| Overall Study | Lack of Efficacy | 2 | 2 | 1 | 4 | 0 | 1 | 0 | 2 |
| Overall Study | Lost to Follow-up | 0 | 4 | 1 | 3 | 1 | 1 | 1 | 4 |
| Overall Study | Non-compliance with the protocol | 0 | 0 | 0 | 0 | 1 | 6 | 0 | 1 |
| Overall Study | Other Reason | 0 | 0 | 0 | 0 | 0 | 1 | 1 | 1 |
| Overall Study | Physician Decision | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 1 |
| Overall Study | Treatment Failure | 0 | 2 | 0 | 1 | 0 | 0 | 0 | 0 |
| Overall Study | Withdrawal by Subject | 4 | 9 | 1 | 8 | 0 | 9 | 0 | 4 |
Baseline characteristics
| Characteristic | Cohort 2 - Active | Total | Cohort 4 - Active | Cohort 4 - Placebo | Cohort 1 - Active | Cohort 1 - Placebo | Cohort 2 - Placebo | Cohort 3 - Active | Cohort 3 - Placebo |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | 37.6 years STANDARD_DEVIATION 14.38 | 39.3 years STANDARD_DEVIATION 15.15 | 42.7 years STANDARD_DEVIATION 14.97 | 38.6 years STANDARD_DEVIATION 14.78 | 36.1 years STANDARD_DEVIATION 16.08 | 39.3 years STANDARD_DEVIATION 14.79 | 42.9 years STANDARD_DEVIATION 14.27 | 39.6 years STANDARD_DEVIATION 14.72 | 40.2 years STANDARD_DEVIATION 17.35 |
| Baseline BSA | 22.76 percentage of BSA STANDARD_DEVIATION 15.069 | 22.03 percentage of BSA STANDARD_DEVIATION 15.78 | 19.11 percentage of BSA STANDARD_DEVIATION 14.651 | 21.86 percentage of BSA STANDARD_DEVIATION 18.053 | 23.16 percentage of BSA STANDARD_DEVIATION 15.036 | 19.78 percentage of BSA STANDARD_DEVIATION 12.304 | 17.92 percentage of BSA STANDARD_DEVIATION 9.939 | 24.96 percentage of BSA STANDARD_DEVIATION 18.291 | 21.08 percentage of BSA STANDARD_DEVIATION 17.518 |
| Baseline EASI Score | 16.25 EASI Score STANDARD_DEVIATION 8.535 | 15.81 EASI Score STANDARD_DEVIATION 9.11 | 13.30 EASI Score STANDARD_DEVIATION 8.049 | 15.40 EASI Score STANDARD_DEVIATION 9.142 | 16.57 EASI Score STANDARD_DEVIATION 9.42 | 15.08 EASI Score STANDARD_DEVIATION 5.851 | 13.74 EASI Score STANDARD_DEVIATION 5.66 | 18.07 EASI Score STANDARD_DEVIATION 10.905 | 15.39 EASI Score STANDARD_DEVIATION 10.175 |
| Baseline IGA Score IGA 2 | 12 Participants | 67 Participants | 13 Participants | 7 Participants | 13 Participants | 4 Participants | 4 Participants | 10 Participants | 4 Participants |
| Baseline IGA Score IGA 3 | 51 Participants | 296 Participants | 54 Participants | 26 Participants | 50 Participants | 17 Participants | 17 Participants | 64 Participants | 17 Participants |
| Baseline IGA Score IGA 4 | 11 Participants | 57 Participants | 7 Participants | 5 Participants | 11 Participants | 4 Participants | 4 Participants | 11 Participants | 4 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 6 Participants | 22 Participants | 4 Participants | 3 Participants | 2 Participants | 3 Participants | 2 Participants | 2 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 68 Participants | 396 Participants | 69 Participants | 35 Participants | 72 Participants | 22 Participants | 23 Participants | 84 Participants | 23 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 3 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 2 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 9 Participants | 48 Participants | 11 Participants | 4 Participants | 9 Participants | 3 Participants | 3 Participants | 8 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 8 Participants | 51 Participants | 14 Participants | 5 Participants | 9 Participants | 3 Participants | 4 Participants | 7 Participants | 1 Participants |
| Race (NIH/OMB) More than one race | 1 Participants | 11 Participants | 0 Participants | 3 Participants | 1 Participants | 0 Participants | 2 Participants | 4 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants | 4 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 2 Participants | 1 Participants |
| Race (NIH/OMB) White | 55 Participants | 307 Participants | 49 Participants | 26 Participants | 55 Participants | 19 Participants | 16 Participants | 65 Participants | 22 Participants |
| Region of Enrollment Australia | 1 Participants | 14 Participants | 2 Participants | 0 Participants | 2 Participants | 0 Participants | 0 Participants | 8 Participants | 1 Participants |
| Region of Enrollment Bulgaria | 12 Participants | 55 Participants | 6 Participants | 3 Participants | 11 Participants | 3 Participants | 4 Participants | 11 Participants | 5 Participants |
| Region of Enrollment Canada | 16 Participants | 84 Participants | 15 Participants | 12 Participants | 11 Participants | 5 Participants | 5 Participants | 13 Participants | 7 Participants |
| Region of Enrollment Germany | 9 Participants | 34 Participants | 2 Participants | 3 Participants | 9 Participants | 1 Participants | 1 Participants | 7 Participants | 2 Participants |
| Region of Enrollment Poland | 16 Participants | 113 Participants | 22 Participants | 10 Participants | 22 Participants | 8 Participants | 6 Participants | 23 Participants | 6 Participants |
| Region of Enrollment United States | 20 Participants | 121 Participants | 27 Participants | 10 Participants | 19 Participants | 8 Participants | 9 Participants | 24 Participants | 4 Participants |
| Sex: Female, Male Female | 37 Participants | 213 Participants | 43 Participants | 19 Participants | 36 Participants | 15 Participants | 16 Participants | 37 Participants | 10 Participants |
| Sex: Female, Male Male | 37 Participants | 208 Participants | 31 Participants | 19 Participants | 38 Participants | 10 Participants | 9 Participants | 49 Participants | 15 Participants |
| Time Since Diagnosis | 18.91 years STANDARD_DEVIATION 14.111 | 21.34 years STANDARD_DEVIATION 16.057 | 23.95 years STANDARD_DEVIATION 17.248 | 24.93 years STANDARD_DEVIATION 16.592 | 19.59 years STANDARD_DEVIATION 15.221 | 20.30 years STANDARD_DEVIATION 13.308 | 21.82 years STANDARD_DEVIATION 18.216 | 21.44 years STANDARD_DEVIATION 16.96 | 20.79 years STANDARD_DEVIATION 16.586 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk |
|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 113 | 0 / 74 | 0 / 74 | 0 / 85 | 0 / 74 |
| other Total, other adverse events | 36 / 113 | 21 / 74 | 25 / 74 | 31 / 85 | 18 / 74 |
| serious Total, serious adverse events | 1 / 113 | 2 / 74 | 2 / 74 | 1 / 85 | 0 / 74 |
Outcome results
Primary
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.
Time frame: 16 weeks
Population: Randomized participants who completed the EASI at Week 16 or dropped out before Week 16 for treatment-related reasons.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Cohorts 1-3 - Placebo | Achievement of EASI-50 | 38 Participants |
| Cohort 1 - Active | Achievement of EASI-50 | 27 Participants |
| Cohort 2 - Active | Achievement of EASI-50 | 25 Participants |
| Cohort 3 - Active | Achievement of EASI-50 | 23 Participants |
| Cohort 4 - Placebo | Achievement of EASI-50 | 17 Participants |
| Cohort 4 - Active | Achievement of EASI-50 | 25 Participants |
Secondary
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.
Time frame: 4, 8, 12, and 16 weeks
Population: Randomized participants who completed the BSA at the relevant visit or dropped out before the relevant visit for treatment-related reasons.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cohorts 1-3 - Placebo | Mean Absolute Change From Baseline in BSA | Week 4 | -2.06 percentage of BSA | Standard Deviation 7.127 |
| Cohorts 1-3 - Placebo | Mean Absolute Change From Baseline in BSA | Week 8 | -3.96 percentage of BSA | Standard Deviation 8.354 |
| Cohorts 1-3 - Placebo | Mean Absolute Change From Baseline in BSA | Week 12 | -5.61 percentage of BSA | Standard Deviation 9.432 |
| Cohorts 1-3 - Placebo | Mean Absolute Change From Baseline in BSA | Week 16 | -7.18 percentage of BSA | Standard Deviation 9.772 |
| Cohort 1 - Active | Mean Absolute Change From Baseline in BSA | Week 12 | -6.79 percentage of BSA | Standard Deviation 14.42 |
| Cohort 1 - Active | Mean Absolute Change From Baseline in BSA | Week 8 | -5.58 percentage of BSA | Standard Deviation 10.766 |
| Cohort 1 - Active | Mean Absolute Change From Baseline in BSA | Week 4 | -3.87 percentage of BSA | Standard Deviation 8.429 |
| Cohort 1 - Active | Mean Absolute Change From Baseline in BSA | Week 16 | -5.65 percentage of BSA | Standard Deviation 14.554 |
| Cohort 2 - Active | Mean Absolute Change From Baseline in BSA | Week 16 | -4.30 percentage of BSA | Standard Deviation 12.902 |
| Cohort 2 - Active | Mean Absolute Change From Baseline in BSA | Week 12 | -3.21 percentage of BSA | Standard Deviation 12.99 |
| Cohort 2 - Active | Mean Absolute Change From Baseline in BSA | Week 8 | -4.10 percentage of BSA | Standard Deviation 12.211 |
| Cohort 2 - Active | Mean Absolute Change From Baseline in BSA | Week 4 | -1.81 percentage of BSA | Standard Deviation 10.573 |
| Cohort 3 - Active | Mean Absolute Change From Baseline in BSA | Week 4 | -3.09 percentage of BSA | Standard Deviation 13.025 |
| Cohort 3 - Active | Mean Absolute Change From Baseline in BSA | Week 16 | -4.96 percentage of BSA | Standard Deviation 15.289 |
| Cohort 3 - Active | Mean Absolute Change From Baseline in BSA | Week 8 | -4.09 percentage of BSA | Standard Deviation 14.854 |
| Cohort 3 - Active | Mean Absolute Change From Baseline in BSA | Week 12 | -5.13 percentage of BSA | Standard Deviation 15.342 |
| Cohort 4 - Placebo | Mean Absolute Change From Baseline in BSA | Week 12 | -7.96 percentage of BSA | Standard Deviation 11.601 |
| Cohort 4 - Placebo | Mean Absolute Change From Baseline in BSA | Week 16 | -8.87 percentage of BSA | Standard Deviation 11.221 |
| Cohort 4 - Placebo | Mean Absolute Change From Baseline in BSA | Week 8 | -5.42 percentage of BSA | Standard Deviation 8.712 |
| Cohort 4 - Placebo | Mean Absolute Change From Baseline in BSA | Week 4 | -2.50 percentage of BSA | Standard Deviation 7.886 |
| Cohort 4 - Active | Mean Absolute Change From Baseline in BSA | Week 8 | -4.50 percentage of BSA | Standard Deviation 8.021 |
| Cohort 4 - Active | Mean Absolute Change From Baseline in BSA | Week 12 | -5.36 percentage of BSA | Standard Deviation 8.55 |
| Cohort 4 - Active | Mean Absolute Change From Baseline in BSA | Week 16 | -6.28 percentage of BSA | Standard Deviation 9.078 |
| Cohort 4 - Active | Mean Absolute Change From Baseline in BSA | Week 4 | -3.43 percentage of BSA | Standard Deviation 7.503 |
Secondary
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.
Time frame: 4, 8, 12, and 16 weeks
Population: Randomized participants who completed the POEM at the relevant visit or dropped out before the relevant visit for treatment-related reasons.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cohorts 1-3 - Placebo | Mean Absolute Change From Baseline in Patient Oriented Eczema Measure (POEM) | Week 4 | -2.1 score on a scale | Standard Deviation 5.48 |
| Cohorts 1-3 - Placebo | Mean Absolute Change From Baseline in Patient Oriented Eczema Measure (POEM) | Week 8 | -3.7 score on a scale | Standard Deviation 6.31 |
| Cohorts 1-3 - Placebo | Mean Absolute Change From Baseline in Patient Oriented Eczema Measure (POEM) | Week 12 | -5.1 score on a scale | Standard Deviation 7.3 |
| Cohorts 1-3 - Placebo | Mean Absolute Change From Baseline in Patient Oriented Eczema Measure (POEM) | Week 16 | -6.3 score on a scale | Standard Deviation 7.2 |
| Cohort 1 - Active | Mean Absolute Change From Baseline in Patient Oriented Eczema Measure (POEM) | Week 12 | -4.1 score on a scale | Standard Deviation 7.58 |
| Cohort 1 - Active | Mean Absolute Change From Baseline in Patient Oriented Eczema Measure (POEM) | Week 8 | -3.8 score on a scale | Standard Deviation 6.99 |
| Cohort 1 - Active | Mean Absolute Change From Baseline in Patient Oriented Eczema Measure (POEM) | Week 4 | -2.4 score on a scale | Standard Deviation 5.75 |
| Cohort 1 - Active | Mean Absolute Change From Baseline in Patient Oriented Eczema Measure (POEM) | Week 16 | -3.7 score on a scale | Standard Deviation 7.93 |
| Cohort 2 - Active | Mean Absolute Change From Baseline in Patient Oriented Eczema Measure (POEM) | Week 16 | -3.8 score on a scale | Standard Deviation 6.41 |
| Cohort 2 - Active | Mean Absolute Change From Baseline in Patient Oriented Eczema Measure (POEM) | Week 12 | -2.0 score on a scale | Standard Deviation 5.44 |
| Cohort 2 - Active | Mean Absolute Change From Baseline in Patient Oriented Eczema Measure (POEM) | Week 8 | -2.9 score on a scale | Standard Deviation 5.8 |
| Cohort 2 - Active | Mean Absolute Change From Baseline in Patient Oriented Eczema Measure (POEM) | Week 4 | -1.6 score on a scale | Standard Deviation 5.24 |
| Cohort 3 - Active | Mean Absolute Change From Baseline in Patient Oriented Eczema Measure (POEM) | Week 4 | -3.0 score on a scale | Standard Deviation 5.57 |
| Cohort 3 - Active | Mean Absolute Change From Baseline in Patient Oriented Eczema Measure (POEM) | Week 16 | -3.8 score on a scale | Standard Deviation 7.32 |
| Cohort 3 - Active | Mean Absolute Change From Baseline in Patient Oriented Eczema Measure (POEM) | Week 8 | -3.3 score on a scale | Standard Deviation 5.88 |
| Cohort 3 - Active | Mean Absolute Change From Baseline in Patient Oriented Eczema Measure (POEM) | Week 12 | -3.9 score on a scale | Standard Deviation 6.24 |
| Cohort 4 - Placebo | Mean Absolute Change From Baseline in Patient Oriented Eczema Measure (POEM) | Week 12 | -4.9 score on a scale | Standard Deviation 8.38 |
| Cohort 4 - Placebo | Mean Absolute Change From Baseline in Patient Oriented Eczema Measure (POEM) | Week 16 | -5.5 score on a scale | Standard Deviation 7.53 |
| Cohort 4 - Placebo | Mean Absolute Change From Baseline in Patient Oriented Eczema Measure (POEM) | Week 8 | -5.4 score on a scale | Standard Deviation 6.94 |
| Cohort 4 - Placebo | Mean Absolute Change From Baseline in Patient Oriented Eczema Measure (POEM) | Week 4 | -3.1 score on a scale | Standard Deviation 5.66 |
| Cohort 4 - Active | Mean Absolute Change From Baseline in Patient Oriented Eczema Measure (POEM) | Week 8 | -3.2 score on a scale | Standard Deviation 6.8 |
| Cohort 4 - Active | Mean Absolute Change From Baseline in Patient Oriented Eczema Measure (POEM) | Week 12 | -3.5 score on a scale | Standard Deviation 7.17 |
| Cohort 4 - Active | Mean Absolute Change From Baseline in Patient Oriented Eczema Measure (POEM) | Week 16 | -4.3 score on a scale | Standard Deviation 7.58 |
| Cohort 4 - Active | Mean Absolute Change From Baseline in Patient Oriented Eczema Measure (POEM) | Week 4 | -2.7 score on a scale | Standard Deviation 6.37 |
Secondary
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.
Time frame: 4, 8, 12, and 16 weeks
Population: Randomized participants who completed the SCORAD at the relevant visit or dropped out before the relevant visit for treatment-related reasons.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cohorts 1-3 - Placebo | Mean Absolute Change From Baseline in SCORing Atopic Dermatitis (SCORAD) | Week 4 | -7.53 score on a scale | Standard Deviation 10.655 |
| Cohorts 1-3 - Placebo | Mean Absolute Change From Baseline in SCORing Atopic Dermatitis (SCORAD) | Week 8 | -10.92 score on a scale | Standard Deviation 13.228 |
| Cohorts 1-3 - Placebo | Mean Absolute Change From Baseline in SCORing Atopic Dermatitis (SCORAD) | Week 12 | -15.74 score on a scale | Standard Deviation 15.335 |
| Cohorts 1-3 - Placebo | Mean Absolute Change From Baseline in SCORing Atopic Dermatitis (SCORAD) | Week 16 | -18.47 score on a scale | Standard Deviation 15.92 |
| Cohort 1 - Active | Mean Absolute Change From Baseline in SCORing Atopic Dermatitis (SCORAD) | Week 12 | -12.43 score on a scale | Standard Deviation 16.2 |
| Cohort 1 - Active | Mean Absolute Change From Baseline in SCORing Atopic Dermatitis (SCORAD) | Week 8 | -11.82 score on a scale | Standard Deviation 14.587 |
| Cohort 1 - Active | Mean Absolute Change From Baseline in SCORing Atopic Dermatitis (SCORAD) | Week 4 | -9.79 score on a scale | Standard Deviation 14.561 |
| Cohort 1 - Active | Mean Absolute Change From Baseline in SCORing Atopic Dermatitis (SCORAD) | Week 16 | -12.05 score on a scale | Standard Deviation 16.072 |
| Cohort 2 - Active | Mean Absolute Change From Baseline in SCORing Atopic Dermatitis (SCORAD) | Week 16 | -11.80 score on a scale | Standard Deviation 16.573 |
| Cohort 2 - Active | Mean Absolute Change From Baseline in SCORing Atopic Dermatitis (SCORAD) | Week 12 | -9.19 score on a scale | Standard Deviation 15.339 |
| Cohort 2 - Active | Mean Absolute Change From Baseline in SCORing Atopic Dermatitis (SCORAD) | Week 8 | -9.22 score on a scale | Standard Deviation 15.082 |
| Cohort 2 - Active | Mean Absolute Change From Baseline in SCORing Atopic Dermatitis (SCORAD) | Week 4 | -5.03 score on a scale | Standard Deviation 12.977 |
| Cohort 3 - Active | Mean Absolute Change From Baseline in SCORing Atopic Dermatitis (SCORAD) | Week 4 | -5.61 score on a scale | Standard Deviation 12.761 |
| Cohort 3 - Active | Mean Absolute Change From Baseline in SCORing Atopic Dermatitis (SCORAD) | Week 16 | -11.04 score on a scale | Standard Deviation 18.009 |
| Cohort 3 - Active | Mean Absolute Change From Baseline in SCORing Atopic Dermatitis (SCORAD) | Week 8 | -7.45 score on a scale | Standard Deviation 16.543 |
| Cohort 3 - Active | Mean Absolute Change From Baseline in SCORing Atopic Dermatitis (SCORAD) | Week 12 | -9.81 score on a scale | Standard Deviation 15.782 |
| Cohort 4 - Placebo | Mean Absolute Change From Baseline in SCORing Atopic Dermatitis (SCORAD) | Week 12 | -13.61 score on a scale | Standard Deviation 15.179 |
| Cohort 4 - Placebo | Mean Absolute Change From Baseline in SCORing Atopic Dermatitis (SCORAD) | Week 16 | -14.58 score on a scale | Standard Deviation 16.659 |
| Cohort 4 - Placebo | Mean Absolute Change From Baseline in SCORing Atopic Dermatitis (SCORAD) | Week 8 | -14.95 score on a scale | Standard Deviation 15.082 |
| Cohort 4 - Placebo | Mean Absolute Change From Baseline in SCORing Atopic Dermatitis (SCORAD) | Week 4 | -9.57 score on a scale | Standard Deviation 13.608 |
| Cohort 4 - Active | Mean Absolute Change From Baseline in SCORing Atopic Dermatitis (SCORAD) | Week 8 | -9.22 score on a scale | Standard Deviation 13.271 |
| Cohort 4 - Active | Mean Absolute Change From Baseline in SCORing Atopic Dermatitis (SCORAD) | Week 12 | -11.16 score on a scale | Standard Deviation 14.688 |
| Cohort 4 - Active | Mean Absolute Change From Baseline in SCORing Atopic Dermatitis (SCORAD) | Week 16 | -11.60 score on a scale | Standard Deviation 15.521 |
| Cohort 4 - Active | Mean Absolute Change From Baseline in SCORing Atopic Dermatitis (SCORAD) | Week 4 | -8.08 score on a scale | Standard Deviation 13.525 |
Secondary
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.
Time frame: 4, 8, 12, and 16 weeks
Population: Randomized participants who completed the DLQI at the relevant visit or dropped out before the relevant visit for treatment-related reasons.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cohorts 1-3 - Placebo | Mean Absolute Change From Baseline in the Dermatology Quality of Life Index (DLQI) | Week 16 | -5.4 score on a scale | Standard Deviation 5.49 |
| Cohorts 1-3 - Placebo | Mean Absolute Change From Baseline in the Dermatology Quality of Life Index (DLQI) | Week 12 | -4.2 score on a scale | Standard Deviation 5.15 |
| Cohorts 1-3 - Placebo | Mean Absolute Change From Baseline in the Dermatology Quality of Life Index (DLQI) | Week 4 | -2.6 score on a scale | Standard Deviation 4.34 |
| Cohorts 1-3 - Placebo | Mean Absolute Change From Baseline in the Dermatology Quality of Life Index (DLQI) | Week 8 | -3.6 score on a scale | Standard Deviation 5.27 |
| Cohort 1 - Active | Mean Absolute Change From Baseline in the Dermatology Quality of Life Index (DLQI) | Week 12 | -3.5 score on a scale | Standard Deviation 5.75 |
| Cohort 1 - Active | Mean Absolute Change From Baseline in the Dermatology Quality of Life Index (DLQI) | Week 4 | -2.7 score on a scale | Standard Deviation 4.93 |
| Cohort 1 - Active | Mean Absolute Change From Baseline in the Dermatology Quality of Life Index (DLQI) | Week 16 | -3.6 score on a scale | Standard Deviation 6.47 |
| Cohort 1 - Active | Mean Absolute Change From Baseline in the Dermatology Quality of Life Index (DLQI) | Week 8 | -3.4 score on a scale | Standard Deviation 6.4 |
| Cohort 2 - Active | Mean Absolute Change From Baseline in the Dermatology Quality of Life Index (DLQI) | Week 16 | -3.5 score on a scale | Standard Deviation 5.12 |
| Cohort 2 - Active | Mean Absolute Change From Baseline in the Dermatology Quality of Life Index (DLQI) | Week 4 | -2.4 score on a scale | Standard Deviation 4.2 |
| Cohort 2 - Active | Mean Absolute Change From Baseline in the Dermatology Quality of Life Index (DLQI) | Week 8 | -3.1 score on a scale | Standard Deviation 5.09 |
| Cohort 2 - Active | Mean Absolute Change From Baseline in the Dermatology Quality of Life Index (DLQI) | Week 12 | -2.1 score on a scale | Standard Deviation 4.78 |
| Cohort 3 - Active | Mean Absolute Change From Baseline in the Dermatology Quality of Life Index (DLQI) | Week 8 | -3.0 score on a scale | Standard Deviation 6.39 |
| Cohort 3 - Active | Mean Absolute Change From Baseline in the Dermatology Quality of Life Index (DLQI) | Week 4 | -2.4 score on a scale | Standard Deviation 5.61 |
| Cohort 3 - Active | Mean Absolute Change From Baseline in the Dermatology Quality of Life Index (DLQI) | Week 16 | -3.7 score on a scale | Standard Deviation 6.49 |
| Cohort 3 - Active | Mean Absolute Change From Baseline in the Dermatology Quality of Life Index (DLQI) | Week 12 | -3.7 score on a scale | Standard Deviation 5.74 |
| Cohort 4 - Placebo | Mean Absolute Change From Baseline in the Dermatology Quality of Life Index (DLQI) | Week 8 | -5.1 score on a scale | Standard Deviation 6.76 |
| Cohort 4 - Placebo | Mean Absolute Change From Baseline in the Dermatology Quality of Life Index (DLQI) | Week 4 | -3.0 score on a scale | Standard Deviation 5.77 |
| Cohort 4 - Placebo | Mean Absolute Change From Baseline in the Dermatology Quality of Life Index (DLQI) | Week 12 | -4.2 score on a scale | Standard Deviation 6.81 |
| Cohort 4 - Placebo | Mean Absolute Change From Baseline in the Dermatology Quality of Life Index (DLQI) | Week 16 | -4.3 score on a scale | Standard Deviation 5.78 |
| Cohort 4 - Active | Mean Absolute Change From Baseline in the Dermatology Quality of Life Index (DLQI) | Week 16 | -4.5 score on a scale | Standard Deviation 6.76 |
| Cohort 4 - Active | Mean Absolute Change From Baseline in the Dermatology Quality of Life Index (DLQI) | Week 4 | -3.1 score on a scale | Standard Deviation 6.03 |
| Cohort 4 - Active | Mean Absolute Change From Baseline in the Dermatology Quality of Life Index (DLQI) | Week 8 | -3.3 score on a scale | Standard Deviation 6.55 |
| Cohort 4 - Active | Mean Absolute Change From Baseline in the Dermatology Quality of Life Index (DLQI) | Week 12 | -3.5 score on a scale | Standard Deviation 6.95 |
Secondary
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.
Time frame: 4, 8, 12, and 16 weeks
Population: Randomized participants who completed the SD-NRS at the relevant visit or dropped out before the relevant visit for treatment-related reasons.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cohorts 1-3 - Placebo | Mean Absolute Change From Baseline in the Sleep Disturbance Numerical Rating Scale (SD-NRS) Score | Week 4 | -0.36 score on a scale | Standard Deviation 1.834 |
| Cohorts 1-3 - Placebo | Mean Absolute Change From Baseline in the Sleep Disturbance Numerical Rating Scale (SD-NRS) Score | Week 8 | -1.09 score on a scale | Standard Deviation 2.342 |
| Cohorts 1-3 - Placebo | Mean Absolute Change From Baseline in the Sleep Disturbance Numerical Rating Scale (SD-NRS) Score | Week 12 | -1.24 score on a scale | Standard Deviation 2.568 |
| Cohorts 1-3 - Placebo | Mean Absolute Change From Baseline in the Sleep Disturbance Numerical Rating Scale (SD-NRS) Score | Week 16 | 01.48 score on a scale | Standard Deviation 2.457 |
| Cohort 1 - Active | Mean Absolute Change From Baseline in the Sleep Disturbance Numerical Rating Scale (SD-NRS) Score | Week 12 | -1.06 score on a scale | Standard Deviation 2.315 |
| Cohort 1 - Active | Mean Absolute Change From Baseline in the Sleep Disturbance Numerical Rating Scale (SD-NRS) Score | Week 8 | -0.97 score on a scale | Standard Deviation 2.128 |
| Cohort 1 - Active | Mean Absolute Change From Baseline in the Sleep Disturbance Numerical Rating Scale (SD-NRS) Score | Week 4 | -0.52 score on a scale | Standard Deviation 1.872 |
| Cohort 1 - Active | Mean Absolute Change From Baseline in the Sleep Disturbance Numerical Rating Scale (SD-NRS) Score | Week 16 | -1.23 score on a scale | Standard Deviation 2.336 |
| Cohort 2 - Active | Mean Absolute Change From Baseline in the Sleep Disturbance Numerical Rating Scale (SD-NRS) Score | Week 16 | -0.77 score on a scale | Standard Deviation 1.936 |
| Cohort 2 - Active | Mean Absolute Change From Baseline in the Sleep Disturbance Numerical Rating Scale (SD-NRS) Score | Week 12 | -0.62 score on a scale | Standard Deviation 2.003 |
| Cohort 2 - Active | Mean Absolute Change From Baseline in the Sleep Disturbance Numerical Rating Scale (SD-NRS) Score | Week 8 | -0.56 score on a scale | Standard Deviation 1.985 |
| Cohort 2 - Active | Mean Absolute Change From Baseline in the Sleep Disturbance Numerical Rating Scale (SD-NRS) Score | Week 4 | -0.27 score on a scale | Standard Deviation 1.985 |
| Cohort 3 - Active | Mean Absolute Change From Baseline in the Sleep Disturbance Numerical Rating Scale (SD-NRS) Score | Week 4 | -0.16 score on a scale | Standard Deviation 1.457 |
| Cohort 3 - Active | Mean Absolute Change From Baseline in the Sleep Disturbance Numerical Rating Scale (SD-NRS) Score | Week 16 | -0.63 score on a scale | Standard Deviation 1.988 |
| Cohort 3 - Active | Mean Absolute Change From Baseline in the Sleep Disturbance Numerical Rating Scale (SD-NRS) Score | Week 8 | -0.49 score on a scale | Standard Deviation 1.84 |
| Cohort 3 - Active | Mean Absolute Change From Baseline in the Sleep Disturbance Numerical Rating Scale (SD-NRS) Score | Week 12 | -0.58 score on a scale | Standard Deviation 1.916 |
| Cohort 4 - Placebo | Mean Absolute Change From Baseline in the Sleep Disturbance Numerical Rating Scale (SD-NRS) Score | Week 12 | -1.22 score on a scale | Standard Deviation 2.06 |
| Cohort 4 - Placebo | Mean Absolute Change From Baseline in the Sleep Disturbance Numerical Rating Scale (SD-NRS) Score | Week 16 | -1.36 score on a scale | Standard Deviation 2.102 |
| Cohort 4 - Placebo | Mean Absolute Change From Baseline in the Sleep Disturbance Numerical Rating Scale (SD-NRS) Score | Week 8 | -1.28 score on a scale | Standard Deviation 1.956 |
| Cohort 4 - Placebo | Mean Absolute Change From Baseline in the Sleep Disturbance Numerical Rating Scale (SD-NRS) Score | Week 4 | -0.93 score on a scale | Standard Deviation 2.226 |
| Cohort 4 - Active | Mean Absolute Change From Baseline in the Sleep Disturbance Numerical Rating Scale (SD-NRS) Score | Week 8 | -0.35 score on a scale | Standard Deviation 2.145 |
| Cohort 4 - Active | Mean Absolute Change From Baseline in the Sleep Disturbance Numerical Rating Scale (SD-NRS) Score | Week 12 | -0.42 score on a scale | Standard Deviation 2.369 |
| Cohort 4 - Active | Mean Absolute Change From Baseline in the Sleep Disturbance Numerical Rating Scale (SD-NRS) Score | Week 16 | -0.51 score on a scale | Standard Deviation 2.374 |
| Cohort 4 - Active | Mean Absolute Change From Baseline in the Sleep Disturbance Numerical Rating Scale (SD-NRS) Score | Week 4 | -0.11 score on a scale | Standard Deviation 2.126 |
Secondary
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.
Time frame: 4, 8, 12, and 16 weeks
Population: Randomized participants who completed the PP-NRS at the relevant visit or dropped out before the relevant visit for treatment-related reasons.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cohorts 1-3 - Placebo | Mean Absolute Change From Baseline in Worst Pruritus Numerical Rating Scale (PR-NRS) | Week 4 | -0.53 score on a scale | Standard Deviation 1.933 |
| Cohorts 1-3 - Placebo | Mean Absolute Change From Baseline in Worst Pruritus Numerical Rating Scale (PR-NRS) | Week 8 | -1.18 score on a scale | Standard Deviation 2.452 |
| Cohorts 1-3 - Placebo | Mean Absolute Change From Baseline in Worst Pruritus Numerical Rating Scale (PR-NRS) | Week 12 | -1.54 score on a scale | Standard Deviation 2.581 |
| Cohorts 1-3 - Placebo | Mean Absolute Change From Baseline in Worst Pruritus Numerical Rating Scale (PR-NRS) | Week 16 | -1.84 score on a scale | Standard Deviation 2.454 |
| Cohort 1 - Active | Mean Absolute Change From Baseline in Worst Pruritus Numerical Rating Scale (PR-NRS) | Week 12 | -1.24 score on a scale | Standard Deviation 2.613 |
| Cohort 1 - Active | Mean Absolute Change From Baseline in Worst Pruritus Numerical Rating Scale (PR-NRS) | Week 8 | -1.04 score on a scale | Standard Deviation 2.483 |
| Cohort 1 - Active | Mean Absolute Change From Baseline in Worst Pruritus Numerical Rating Scale (PR-NRS) | Week 4 | -0.45 score on a scale | Standard Deviation 1.962 |
| Cohort 1 - Active | Mean Absolute Change From Baseline in Worst Pruritus Numerical Rating Scale (PR-NRS) | Week 16 | -1.35 score on a scale | Standard Deviation 2.674 |
| Cohort 2 - Active | Mean Absolute Change From Baseline in Worst Pruritus Numerical Rating Scale (PR-NRS) | Week 16 | -1.00 score on a scale | Standard Deviation 2.167 |
| Cohort 2 - Active | Mean Absolute Change From Baseline in Worst Pruritus Numerical Rating Scale (PR-NRS) | Week 12 | -0.99 score on a scale | Standard Deviation 2.171 |
| Cohort 2 - Active | Mean Absolute Change From Baseline in Worst Pruritus Numerical Rating Scale (PR-NRS) | Week 8 | -0.83 score on a scale | Standard Deviation 2.103 |
| Cohort 2 - Active | Mean Absolute Change From Baseline in Worst Pruritus Numerical Rating Scale (PR-NRS) | Week 4 | -0.65 score on a scale | Standard Deviation 2.052 |
| Cohort 3 - Active | Mean Absolute Change From Baseline in Worst Pruritus Numerical Rating Scale (PR-NRS) | Week 4 | -0.57 score on a scale | Standard Deviation 1.692 |
| Cohort 3 - Active | Mean Absolute Change From Baseline in Worst Pruritus Numerical Rating Scale (PR-NRS) | Week 16 | -1.37 score on a scale | Standard Deviation 2.218 |
| Cohort 3 - Active | Mean Absolute Change From Baseline in Worst Pruritus Numerical Rating Scale (PR-NRS) | Week 8 | -1.17 score on a scale | Standard Deviation 1.986 |
| Cohort 3 - Active | Mean Absolute Change From Baseline in Worst Pruritus Numerical Rating Scale (PR-NRS) | Week 12 | -1.34 score on a scale | Standard Deviation 1.921 |
| Cohort 4 - Placebo | Mean Absolute Change From Baseline in Worst Pruritus Numerical Rating Scale (PR-NRS) | Week 12 | -1.73 score on a scale | Standard Deviation 1.955 |
| Cohort 4 - Placebo | Mean Absolute Change From Baseline in Worst Pruritus Numerical Rating Scale (PR-NRS) | Week 16 | -1.91 score on a scale | Standard Deviation 2.007 |
| Cohort 4 - Placebo | Mean Absolute Change From Baseline in Worst Pruritus Numerical Rating Scale (PR-NRS) | Week 8 | -1.97 score on a scale | Standard Deviation 1.978 |
| Cohort 4 - Placebo | Mean Absolute Change From Baseline in Worst Pruritus Numerical Rating Scale (PR-NRS) | Week 4 | -1.52 score on a scale | Standard Deviation 1.845 |
| Cohort 4 - Active | Mean Absolute Change From Baseline in Worst Pruritus Numerical Rating Scale (PR-NRS) | Week 8 | -0.84 score on a scale | Standard Deviation 1.856 |
| Cohort 4 - Active | Mean Absolute Change From Baseline in Worst Pruritus Numerical Rating Scale (PR-NRS) | Week 12 | -0.95 score on a scale | Standard Deviation 2.095 |
| Cohort 4 - Active | Mean Absolute Change From Baseline in Worst Pruritus Numerical Rating Scale (PR-NRS) | Week 16 | -1.08 score on a scale | Standard Deviation 2.305 |
| Cohort 4 - Active | Mean Absolute Change From Baseline in Worst Pruritus Numerical Rating Scale (PR-NRS) | Week 4 | -0.72 score on a scale | Standard Deviation 1.828 |
Secondary
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.
Time frame: 4, 8, 12, and 16 weeks
Population: Randomized participants who completed the EASI at the relevant visit or dropped out before the relevant visit for treatment-related reasons.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cohorts 1-3 - Placebo | Mean Absolute Change in EASI | Week 4 | -2.88 score on a scale | Standard Deviation 5.229 |
| Cohorts 1-3 - Placebo | Mean Absolute Change in EASI | Week 8 | -4.30 score on a scale | Standard Deviation 5.642 |
| Cohorts 1-3 - Placebo | Mean Absolute Change in EASI | Week 12 | -5.42 score on a scale | Standard Deviation 5.59 |
| Cohorts 1-3 - Placebo | Mean Absolute Change in EASI | Week 16 | -6.48 score on a scale | Standard Deviation 6.36 |
| Cohort 1 - Active | Mean Absolute Change in EASI | Week 12 | -6.38 score on a scale | Standard Deviation 7.924 |
| Cohort 1 - Active | Mean Absolute Change in EASI | Week 8 | -5.68 score on a scale | Standard Deviation 6.823 |
| Cohort 1 - Active | Mean Absolute Change in EASI | Week 4 | -4.57 score on a scale | Standard Deviation 6.248 |
| Cohort 1 - Active | Mean Absolute Change in EASI | Week 16 | -5.83 score on a scale | Standard Deviation 7.915 |
| Cohort 2 - Active | Mean Absolute Change in EASI | Week 16 | -4.55 score on a scale | Standard Deviation 7.897 |
| Cohort 2 - Active | Mean Absolute Change in EASI | Week 12 | -3.56 score on a scale | Standard Deviation 8.049 |
| Cohort 2 - Active | Mean Absolute Change in EASI | Week 8 | -3.05 score on a scale | Standard Deviation 8.001 |
| Cohort 2 - Active | Mean Absolute Change in EASI | Week 4 | -1.87 score on a scale | Standard Deviation 7.02 |
| Cohort 3 - Active | Mean Absolute Change in EASI | Week 4 | -3.72 score on a scale | Standard Deviation 7.947 |
| Cohort 3 - Active | Mean Absolute Change in EASI | Week 16 | -5.11 score on a scale | Standard Deviation 9.116 |
| Cohort 3 - Active | Mean Absolute Change in EASI | Week 8 | -4.54 score on a scale | Standard Deviation 8.93 |
| Cohort 3 - Active | Mean Absolute Change in EASI | Week 12 | -5.12 score on a scale | Standard Deviation 8.982 |
| Cohort 4 - Placebo | Mean Absolute Change in EASI | Week 12 | -6.58 score on a scale | Standard Deviation 6.758 |
| Cohort 4 - Placebo | Mean Absolute Change in EASI | Week 16 | -6.99 score on a scale | Standard Deviation 6.806 |
| Cohort 4 - Placebo | Mean Absolute Change in EASI | Week 8 | -5.57 score on a scale | Standard Deviation 6.665 |
| Cohort 4 - Placebo | Mean Absolute Change in EASI | Week 4 | -3.09 score on a scale | Standard Deviation 5.834 |
| Cohort 4 - Active | Mean Absolute Change in EASI | Week 8 | -4.22 score on a scale | Standard Deviation 5.056 |
| Cohort 4 - Active | Mean Absolute Change in EASI | Week 12 | -4.82 score on a scale | Standard Deviation 5.063 |
| Cohort 4 - Active | Mean Absolute Change in EASI | Week 16 | -4.82 score on a scale | Standard Deviation 5.48 |
| Cohort 4 - Active | Mean Absolute Change in EASI | Week 4 | -3.36 score on a scale | Standard Deviation 5.293 |
Secondary
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.
Time frame: 4, 8, 12, and 16 weeks
Population: Randomized participants who completed the vIGA and BSA at the relevant visit or dropped out before the relevant visit for treatment-related reasons.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cohorts 1-3 - Placebo | Mean Absolute Change in vIGA*BSA | Week 8 | -14.49 score on a scale | Standard Deviation 36.336 |
| Cohorts 1-3 - Placebo | Mean Absolute Change in vIGA*BSA | Week 16 | -25.70 score on a scale | Standard Deviation 36.633 |
| Cohorts 1-3 - Placebo | Mean Absolute Change in vIGA*BSA | Week 12 | -20.83 score on a scale | Standard Deviation 36.619 |
| Cohorts 1-3 - Placebo | Mean Absolute Change in vIGA*BSA | Week 4 | -6.47 score on a scale | Standard Deviation 27.832 |
| Cohort 1 - Active | Mean Absolute Change in vIGA*BSA | Week 16 | -18.90 score on a scale | Standard Deviation 58.271 |
| Cohort 1 - Active | Mean Absolute Change in vIGA*BSA | Week 8 | -21.31 score on a scale | Standard Deviation 41.564 |
| Cohort 1 - Active | Mean Absolute Change in vIGA*BSA | Week 12 | -24.85 score on a scale | Standard Deviation 58.901 |
| Cohort 1 - Active | Mean Absolute Change in vIGA*BSA | Week 4 | -15.84 score on a scale | Standard Deviation 33.96 |
| Cohort 2 - Active | Mean Absolute Change in vIGA*BSA | Week 8 | -12.46 score on a scale | Standard Deviation 45.651 |
| Cohort 2 - Active | Mean Absolute Change in vIGA*BSA | Week 4 | -5.96 score on a scale | Standard Deviation 40.678 |
| Cohort 2 - Active | Mean Absolute Change in vIGA*BSA | Week 16 | -14.52 score on a scale | Standard Deviation 46.948 |
| Cohort 2 - Active | Mean Absolute Change in vIGA*BSA | Week 12 | -10.48 score on a scale | Standard Deviation 45.919 |
| Cohort 3 - Active | Mean Absolute Change in vIGA*BSA | Week 8 | -14.53 score on a scale | Standard Deviation 59.754 |
| Cohort 3 - Active | Mean Absolute Change in vIGA*BSA | Week 4 | -10.92 score on a scale | Standard Deviation 52.802 |
| Cohort 3 - Active | Mean Absolute Change in vIGA*BSA | Week 16 | -18.10 score on a scale | Standard Deviation 59.953 |
| Cohort 3 - Active | Mean Absolute Change in vIGA*BSA | Week 12 | -17.26 score on a scale | Standard Deviation 60.858 |
| Cohort 4 - Placebo | Mean Absolute Change in vIGA*BSA | Week 12 | -28.91 score on a scale | Standard Deviation 40.904 |
| Cohort 4 - Placebo | Mean Absolute Change in vIGA*BSA | Week 4 | -11.04 score on a scale | Standard Deviation 29.77 |
| Cohort 4 - Placebo | Mean Absolute Change in vIGA*BSA | Week 8 | -21.63 score on a scale | Standard Deviation 32.517 |
| Cohort 4 - Placebo | Mean Absolute Change in vIGA*BSA | Week 16 | -31.00 score on a scale | Standard Deviation 42.25 |
| Cohort 4 - Active | Mean Absolute Change in vIGA*BSA | Week 16 | -24.23 score on a scale | Standard Deviation 35.523 |
| Cohort 4 - Active | Mean Absolute Change in vIGA*BSA | Week 4 | -14.07 score on a scale | Standard Deviation 30.797 |
| Cohort 4 - Active | Mean Absolute Change in vIGA*BSA | Week 8 | -17.88 score on a scale | Standard Deviation 29.523 |
| Cohort 4 - Active | Mean Absolute Change in vIGA*BSA | Week 12 | -19.56 score on a scale | Standard Deviation 30.25 |
Secondary
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.
Time frame: 4, 8, 12, and 16 weeks
Population: Randomized participants who completed the BSA at the relevant visit or dropped out before the relevant visit for treatment-related reasons.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cohorts 1-3 - Placebo | Mean Percentage Change From Baseline in BSA | Week 4 | -12.70 percentage change from baseline | Standard Deviation 38.657 |
| Cohorts 1-3 - Placebo | Mean Percentage Change From Baseline in BSA | Week 8 | -23.23 percentage change from baseline | Standard Deviation 37.106 |
| Cohorts 1-3 - Placebo | Mean Percentage Change From Baseline in BSA | Week 12 | -31.79 percentage change from baseline | Standard Deviation 45.657 |
| Cohorts 1-3 - Placebo | Mean Percentage Change From Baseline in BSA | Week 16 | -41.54 percentage change from baseline | Standard Deviation 48.345 |
| Cohort 1 - Active | Mean Percentage Change From Baseline in BSA | Week 12 | -30.78 percentage change from baseline | Standard Deviation 57.815 |
| Cohort 1 - Active | Mean Percentage Change From Baseline in BSA | Week 8 | -27.19 percentage change from baseline | Standard Deviation 44.087 |
| Cohort 1 - Active | Mean Percentage Change From Baseline in BSA | Week 4 | -18.45 percentage change from baseline | Standard Deviation 36.769 |
| Cohort 1 - Active | Mean Percentage Change From Baseline in BSA | Week 16 | -26.73 percentage change from baseline | Standard Deviation 60.521 |
| Cohort 2 - Active | Mean Percentage Change From Baseline in BSA | Week 16 | -21.74 percentage change from baseline | Standard Deviation 56.381 |
| Cohort 2 - Active | Mean Percentage Change From Baseline in BSA | Week 12 | -16.34 percentage change from baseline | Standard Deviation 59.085 |
| Cohort 2 - Active | Mean Percentage Change From Baseline in BSA | Week 8 | -20.92 percentage change from baseline | Standard Deviation 53.115 |
| Cohort 2 - Active | Mean Percentage Change From Baseline in BSA | Week 4 | -7.55 percentage change from baseline | Standard Deviation 48.616 |
| Cohort 3 - Active | Mean Percentage Change From Baseline in BSA | Week 4 | -12.51 percentage change from baseline | Standard Deviation 56.294 |
| Cohort 3 - Active | Mean Percentage Change From Baseline in BSA | Week 16 | -20.93 percentage change from baseline | Standard Deviation 63.59 |
| Cohort 3 - Active | Mean Percentage Change From Baseline in BSA | Week 8 | -14.54 percentage change from baseline | Standard Deviation 61.187 |
| Cohort 3 - Active | Mean Percentage Change From Baseline in BSA | Week 12 | -22.17 percentage change from baseline | Standard Deviation 61.255 |
| Cohort 4 - Placebo | Mean Percentage Change From Baseline in BSA | Week 12 | -39.35 percentage change from baseline | Standard Deviation 46.518 |
| Cohort 4 - Placebo | Mean Percentage Change From Baseline in BSA | Week 16 | -40.61 percentage change from baseline | Standard Deviation 52.352 |
| Cohort 4 - Placebo | Mean Percentage Change From Baseline in BSA | Week 8 | -34.23 percentage change from baseline | Standard Deviation 41.835 |
| Cohort 4 - Placebo | Mean Percentage Change From Baseline in BSA | Week 4 | -15.29 percentage change from baseline | Standard Deviation 44.347 |
| Cohort 4 - Active | Mean Percentage Change From Baseline in BSA | Week 8 | -28.75 percentage change from baseline | Standard Deviation 40.087 |
| Cohort 4 - Active | Mean Percentage Change From Baseline in BSA | Week 12 | -31.91 percentage change from baseline | Standard Deviation 44.645 |
| Cohort 4 - Active | Mean Percentage Change From Baseline in BSA | Week 16 | -34.81 percentage change from baseline | Standard Deviation 37.995 |
| Cohort 4 - Active | Mean Percentage Change From Baseline in BSA | Week 4 | -20.56 percentage change from baseline | Standard Deviation 36.664 |
Secondary
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.
Time frame: 4, 8, 12, and 16 weeks
Population: Randomized participants who completed the DLQI at the relevant visit or dropped out before the relevant visit for treatment-related reasons.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cohorts 1-3 - Placebo | Mean Percentage Change From Baseline in DLQI | Week 4 | -20.56 percentage change from baseline | Standard Deviation 42.424 |
| Cohorts 1-3 - Placebo | Mean Percentage Change From Baseline in DLQI | Week 8 | -28.63 percentage change from baseline | Standard Deviation 57.232 |
| Cohorts 1-3 - Placebo | Mean Percentage Change From Baseline in DLQI | Week 12 | -31.11 percentage change from baseline | Standard Deviation 63.58 |
| Cohorts 1-3 - Placebo | Mean Percentage Change From Baseline in DLQI | Week 16 | -45.78 percentage change from baseline | Standard Deviation 52.438 |
| Cohort 1 - Active | Mean Percentage Change From Baseline in DLQI | Week 12 | -25.89 percentage change from baseline | Standard Deviation 47.527 |
| Cohort 1 - Active | Mean Percentage Change From Baseline in DLQI | Week 8 | -27.49 percentage change from baseline | Standard Deviation 46.333 |
| Cohort 1 - Active | Mean Percentage Change From Baseline in DLQI | Week 4 | -21.97 percentage change from baseline | Standard Deviation 43.095 |
| Cohort 1 - Active | Mean Percentage Change From Baseline in DLQI | Week 16 | -20.13 percentage change from baseline | Standard Deviation 67.256 |
| Cohort 2 - Active | Mean Percentage Change From Baseline in DLQI | Week 16 | -29.67 percentage change from baseline | Standard Deviation 46.996 |
| Cohort 2 - Active | Mean Percentage Change From Baseline in DLQI | Week 12 | -12.86 percentage change from baseline | Standard Deviation 65.083 |
| Cohort 2 - Active | Mean Percentage Change From Baseline in DLQI | Week 8 | -25.84 percentage change from baseline | Standard Deviation 46.946 |
| Cohort 2 - Active | Mean Percentage Change From Baseline in DLQI | Week 4 | -19.48 percentage change from baseline | Standard Deviation 47.134 |
| Cohort 3 - Active | Mean Percentage Change From Baseline in DLQI | Week 4 | -14.35 percentage change from baseline | Standard Deviation 76.35 |
| Cohort 3 - Active | Mean Percentage Change From Baseline in DLQI | Week 16 | -26.63 percentage change from baseline | Standard Deviation 79.367 |
| Cohort 3 - Active | Mean Percentage Change From Baseline in DLQI | Week 8 | -18.56 percentage change from baseline | Standard Deviation 84.619 |
| Cohort 3 - Active | Mean Percentage Change From Baseline in DLQI | Week 12 | -27.61 percentage change from baseline | Standard Deviation 76.072 |
| Cohort 4 - Placebo | Mean Percentage Change From Baseline in DLQI | Week 12 | -25.25 percentage change from baseline | Standard Deviation 76.866 |
| Cohort 4 - Placebo | Mean Percentage Change From Baseline in DLQI | Week 16 | -37.04 percentage change from baseline | Standard Deviation 49.074 |
| Cohort 4 - Placebo | Mean Percentage Change From Baseline in DLQI | Week 8 | -30.29 percentage change from baseline | Standard Deviation 61.213 |
| Cohort 4 - Placebo | Mean Percentage Change From Baseline in DLQI | Week 4 | -22.67 percentage change from baseline | Standard Deviation 52.475 |
| Cohort 4 - Active | Mean Percentage Change From Baseline in DLQI | Week 8 | -12.05 percentage change from baseline | Standard Deviation 79.431 |
| Cohort 4 - Active | Mean Percentage Change From Baseline in DLQI | Week 12 | -10.44 percentage change from baseline | Standard Deviation 84.857 |
| Cohort 4 - Active | Mean Percentage Change From Baseline in DLQI | Week 16 | -17.68 percentage change from baseline | Standard Deviation 82.217 |
| Cohort 4 - Active | Mean Percentage Change From Baseline in DLQI | Week 4 | -10.28 percentage change from baseline | Standard Deviation 73.896 |
Secondary
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.
Time frame: 4, 8, 12, and 16 weeks
Population: Randomized participants who completed the POEM at the relevant visit or dropped out before the relevant visit for treatment-related reasons.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cohorts 1-3 - Placebo | Mean Percentage Change From Baseline in Patient Oriented Eczema Measure (POEM) | Week 4 | -10.43 percentage change from baseline | Standard Deviation 35.777 |
| Cohorts 1-3 - Placebo | Mean Percentage Change From Baseline in Patient Oriented Eczema Measure (POEM) | Week 8 | -20.37 percentage change from baseline | Standard Deviation 38.202 |
| Cohorts 1-3 - Placebo | Mean Percentage Change From Baseline in Patient Oriented Eczema Measure (POEM) | Week 12 | -27.85 percentage change from baseline | Standard Deviation 44.63 |
| Cohorts 1-3 - Placebo | Mean Percentage Change From Baseline in Patient Oriented Eczema Measure (POEM) | Week 16 | -34.70 percentage change from baseline | Standard Deviation 41.593 |
| Cohort 1 - Active | Mean Percentage Change From Baseline in Patient Oriented Eczema Measure (POEM) | Week 12 | -19.14 percentage change from baseline | Standard Deviation 47.984 |
| Cohort 1 - Active | Mean Percentage Change From Baseline in Patient Oriented Eczema Measure (POEM) | Week 8 | -19.07 percentage change from baseline | Standard Deviation 39.531 |
| Cohort 1 - Active | Mean Percentage Change From Baseline in Patient Oriented Eczema Measure (POEM) | Week 4 | -12.19 percentage change from baseline | Standard Deviation 36.533 |
| Cohort 1 - Active | Mean Percentage Change From Baseline in Patient Oriented Eczema Measure (POEM) | Week 16 | -13.27 percentage change from baseline | Standard Deviation 54.785 |
| Cohort 2 - Active | Mean Percentage Change From Baseline in Patient Oriented Eczema Measure (POEM) | Week 16 | -19.75 percentage change from baseline | Standard Deviation 46.292 |
| Cohort 2 - Active | Mean Percentage Change From Baseline in Patient Oriented Eczema Measure (POEM) | Week 12 | -5.42 percentage change from baseline | Standard Deviation 61.699 |
| Cohort 2 - Active | Mean Percentage Change From Baseline in Patient Oriented Eczema Measure (POEM) | Week 8 | -12.99 percentage change from baseline | Standard Deviation 54.065 |
| Cohort 2 - Active | Mean Percentage Change From Baseline in Patient Oriented Eczema Measure (POEM) | Week 4 | -6.68 percentage change from baseline | Standard Deviation 36.687 |
| Cohort 3 - Active | Mean Percentage Change From Baseline in Patient Oriented Eczema Measure (POEM) | Week 4 | -17.24 percentage change from baseline | Standard Deviation 35.159 |
| Cohort 3 - Active | Mean Percentage Change From Baseline in Patient Oriented Eczema Measure (POEM) | Week 16 | -20.97 percentage change from baseline | Standard Deviation 42.685 |
| Cohort 3 - Active | Mean Percentage Change From Baseline in Patient Oriented Eczema Measure (POEM) | Week 8 | -20.40 percentage change from baseline | Standard Deviation 36.544 |
| Cohort 3 - Active | Mean Percentage Change From Baseline in Patient Oriented Eczema Measure (POEM) | Week 12 | -23.68 percentage change from baseline | Standard Deviation 37.052 |
| Cohort 4 - Placebo | Mean Percentage Change From Baseline in Patient Oriented Eczema Measure (POEM) | Week 12 | -18.28 percentage change from baseline | Standard Deviation 69.762 |
| Cohort 4 - Placebo | Mean Percentage Change From Baseline in Patient Oriented Eczema Measure (POEM) | Week 16 | -25.05 percentage change from baseline | Standard Deviation 64.982 |
| Cohort 4 - Placebo | Mean Percentage Change From Baseline in Patient Oriented Eczema Measure (POEM) | Week 8 | -25.58 percentage change from baseline | Standard Deviation 44.885 |
| Cohort 4 - Placebo | Mean Percentage Change From Baseline in Patient Oriented Eczema Measure (POEM) | Week 4 | -14.30 percentage change from baseline | Standard Deviation 42.346 |
| Cohort 4 - Active | Mean Percentage Change From Baseline in Patient Oriented Eczema Measure (POEM) | Week 8 | -17.22 percentage change from baseline | Standard Deviation 41.533 |
| Cohort 4 - Active | Mean Percentage Change From Baseline in Patient Oriented Eczema Measure (POEM) | Week 12 | -20.35 percentage change from baseline | Standard Deviation 46.029 |
| Cohort 4 - Active | Mean Percentage Change From Baseline in Patient Oriented Eczema Measure (POEM) | Week 16 | -21.56 percentage change from baseline | Standard Deviation 47.588 |
| Cohort 4 - Active | Mean Percentage Change From Baseline in Patient Oriented Eczema Measure (POEM) | Week 4 | -12.84 percentage change from baseline | Standard Deviation 44.818 |
Secondary
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.
Time frame: 4, 8, 12, and 16 weeks
Population: Randomized participants who completed the SCORAD at the relevant visit or dropped out before the relevant visit for treatment-related reasons.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cohorts 1-3 - Placebo | Mean Percentage Change From Baseline in SCORAD | Week 4 | -15.27 percentage change from baseline | Standard Deviation 20.788 |
| Cohorts 1-3 - Placebo | Mean Percentage Change From Baseline in SCORAD | Week 8 | -21.29 percentage change from baseline | Standard Deviation 24.598 |
| Cohorts 1-3 - Placebo | Mean Percentage Change From Baseline in SCORAD | Week 12 | -30.92 percentage change from baseline | Standard Deviation 28.283 |
| Cohorts 1-3 - Placebo | Mean Percentage Change From Baseline in SCORAD | Week 16 | -36.37 percentage change from baseline | Standard Deviation 29.64 |
| Cohort 1 - Active | Mean Percentage Change From Baseline in SCORAD | Week 12 | -22.70 percentage change from baseline | Standard Deviation 32.777 |
| Cohort 1 - Active | Mean Percentage Change From Baseline in SCORAD | Week 8 | -21.74 percentage change from baseline | Standard Deviation 29.649 |
| Cohort 1 - Active | Mean Percentage Change From Baseline in SCORAD | Week 4 | -17.42 percentage change from baseline | Standard Deviation 28.161 |
| Cohort 1 - Active | Mean Percentage Change From Baseline in SCORAD | Week 16 | -21.52 percentage change from baseline | Standard Deviation 33.038 |
| Cohort 2 - Active | Mean Percentage Change From Baseline in SCORAD | Week 16 | -20.96 percentage change from baseline | Standard Deviation 31.086 |
| Cohort 2 - Active | Mean Percentage Change From Baseline in SCORAD | Week 12 | -17.69 percentage change from baseline | Standard Deviation 30.135 |
| Cohort 2 - Active | Mean Percentage Change From Baseline in SCORAD | Week 8 | -17.75 percentage change from baseline | Standard Deviation 30.305 |
| Cohort 2 - Active | Mean Percentage Change From Baseline in SCORAD | Week 4 | -9.30 percentage change from baseline | Standard Deviation 27.186 |
| Cohort 3 - Active | Mean Percentage Change From Baseline in SCORAD | Week 4 | -11.94 percentage change from baseline | Standard Deviation 25.258 |
| Cohort 3 - Active | Mean Percentage Change From Baseline in SCORAD | Week 16 | -20.42 percentage change from baseline | Standard Deviation 33.785 |
| Cohort 3 - Active | Mean Percentage Change From Baseline in SCORAD | Week 8 | -14.62 percentage change from baseline | Standard Deviation 32.958 |
| Cohort 3 - Active | Mean Percentage Change From Baseline in SCORAD | Week 12 | -19.71 percentage change from baseline | Standard Deviation 31.608 |
| Cohort 4 - Placebo | Mean Percentage Change From Baseline in SCORAD | Week 12 | -27.25 percentage change from baseline | Standard Deviation 30.64 |
| Cohort 4 - Placebo | Mean Percentage Change From Baseline in SCORAD | Week 16 | -27.57 percentage change from baseline | Standard Deviation 32.326 |
| Cohort 4 - Placebo | Mean Percentage Change From Baseline in SCORAD | Week 8 | -30.08 percentage change from baseline | Standard Deviation 29.043 |
| Cohort 4 - Placebo | Mean Percentage Change From Baseline in SCORAD | Week 4 | -18.01 percentage change from baseline | Standard Deviation 25.219 |
| Cohort 4 - Active | Mean Percentage Change From Baseline in SCORAD | Week 8 | -20.06 percentage change from baseline | Standard Deviation 27.947 |
| Cohort 4 - Active | Mean Percentage Change From Baseline in SCORAD | Week 12 | -24.52 percentage change from baseline | Standard Deviation 32.251 |
| Cohort 4 - Active | Mean Percentage Change From Baseline in SCORAD | Week 16 | -24.10 percentage change from baseline | Standard Deviation 32.563 |
| Cohort 4 - Active | Mean Percentage Change From Baseline in SCORAD | Week 4 | -16.43 percentage change from baseline | Standard Deviation 26.07 |
Secondary
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.
Time frame: 4, 8, 12, and 16 weeks
Population: Randomized participants who completed the EASI at the relevant visit or dropped out before the relevant visit for treatment-related reasons.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cohorts 1-3 - Placebo | Mean Percentage Change in EASI | Week 4 | -20.13 percentage change from baseline | Standard Deviation 36.926 |
| Cohorts 1-3 - Placebo | Mean Percentage Change in EASI | Week 8 | -30.96 percentage change from baseline | Standard Deviation 36.521 |
| Cohorts 1-3 - Placebo | Mean Percentage Change in EASI | Week 12 | -40.05 percentage change from baseline | Standard Deviation 38.45 |
| Cohorts 1-3 - Placebo | Mean Percentage Change in EASI | Week 16 | -46.97 percentage change from baseline | Standard Deviation 44.193 |
| Cohort 1 - Active | Mean Percentage Change in EASI | Week 12 | -38.40 percentage change from baseline | Standard Deviation 48.605 |
| Cohort 1 - Active | Mean Percentage Change in EASI | Week 8 | -35.33 percentage change from baseline | Standard Deviation 42.92 |
| Cohort 1 - Active | Mean Percentage Change in EASI | Week 4 | -27.36 percentage change from baseline | Standard Deviation 38.993 |
| Cohort 1 - Active | Mean Percentage Change in EASI | Week 16 | -35.72 percentage change from baseline | Standard Deviation 49.737 |
| Cohort 2 - Active | Mean Percentage Change in EASI | Week 16 | -31.03 percentage change from baseline | Standard Deviation 46.957 |
| Cohort 2 - Active | Mean Percentage Change in EASI | Week 12 | -24.69 percentage change from baseline | Standard Deviation 49.969 |
| Cohort 2 - Active | Mean Percentage Change in EASI | Week 8 | -22.70 percentage change from baseline | Standard Deviation 50.991 |
| Cohort 2 - Active | Mean Percentage Change in EASI | Week 4 | -13.96 percentage change from baseline | Standard Deviation 48.008 |
| Cohort 3 - Active | Mean Percentage Change in EASI | Week 4 | -22.80 percentage change from baseline | Standard Deviation 40.131 |
| Cohort 3 - Active | Mean Percentage Change in EASI | Week 16 | -32.68 percentage change from baseline | Standard Deviation 45.752 |
| Cohort 3 - Active | Mean Percentage Change in EASI | Week 8 | -27.14 percentage change from baseline | Standard Deviation 43.544 |
| Cohort 3 - Active | Mean Percentage Change in EASI | Week 12 | -31.95 percentage change from baseline | Standard Deviation 44.916 |
| Cohort 4 - Placebo | Mean Percentage Change in EASI | Week 12 | -44.99 percentage change from baseline | Standard Deviation 34.922 |
| Cohort 4 - Placebo | Mean Percentage Change in EASI | Week 16 | -45.58 percentage change from baseline | Standard Deviation 35.526 |
| Cohort 4 - Placebo | Mean Percentage Change in EASI | Week 8 | -43.08 percentage change from baseline | Standard Deviation 36.432 |
| Cohort 4 - Placebo | Mean Percentage Change in EASI | Week 4 | -23.30 percentage change from baseline | Standard Deviation 35.369 |
| Cohort 4 - Active | Mean Percentage Change in EASI | Week 8 | -35.92 percentage change from baseline | Standard Deviation 40.244 |
| Cohort 4 - Active | Mean Percentage Change in EASI | Week 12 | -41.28 percentage change from baseline | Standard Deviation 40.377 |
| Cohort 4 - Active | Mean Percentage Change in EASI | Week 16 | -39.35 percentage change from baseline | Standard Deviation 39.316 |
| Cohort 4 - Active | Mean Percentage Change in EASI | Week 4 | -27.30 percentage change from baseline | Standard Deviation 41.493 |
Secondary
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.
Time frame: 4, 8, 12, and 16 weeks
Population: Randomized participants who completed the vIGA and BSA at the relevant visit or dropped out before the relevant visit for treatment-related reasons.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cohorts 1-3 - Placebo | Mean Percentage Change in vIGA*BSA | Week 4 | -14.82 percentage of change | Standard Deviation 47.171 |
| Cohorts 1-3 - Placebo | Mean Percentage Change in vIGA*BSA | Week 8 | -25.95 percentage of change | Standard Deviation 51.703 |
| Cohorts 1-3 - Placebo | Mean Percentage Change in vIGA*BSA | Week 12 | -39.10 percentage of change | Standard Deviation 50.435 |
| Cohorts 1-3 - Placebo | Mean Percentage Change in vIGA*BSA | Week 16 | -49.25 percentage of change | Standard Deviation 51.883 |
| Cohort 1 - Active | Mean Percentage Change in vIGA*BSA | Week 12 | -33.23 percentage of change | Standard Deviation 74.662 |
| Cohort 1 - Active | Mean Percentage Change in vIGA*BSA | Week 8 | -32.16 percentage of change | Standard Deviation 54.509 |
| Cohort 1 - Active | Mean Percentage Change in vIGA*BSA | Week 4 | -21.83 percentage of change | Standard Deviation 47.44 |
| Cohort 1 - Active | Mean Percentage Change in vIGA*BSA | Week 16 | -28.17 percentage of change | Standard Deviation 78.637 |
| Cohort 2 - Active | Mean Percentage Change in vIGA*BSA | Week 16 | -23.15 percentage of change | Standard Deviation 71.749 |
| Cohort 2 - Active | Mean Percentage Change in vIGA*BSA | Week 12 | -18.83 percentage of change | Standard Deviation 68.537 |
| Cohort 2 - Active | Mean Percentage Change in vIGA*BSA | Week 8 | -21.27 percentage of change | Standard Deviation 65.335 |
| Cohort 2 - Active | Mean Percentage Change in vIGA*BSA | Week 4 | -9.70 percentage of change | Standard Deviation 59.41 |
| Cohort 3 - Active | Mean Percentage Change in vIGA*BSA | Week 4 | -13.26 percentage of change | Standard Deviation 75.742 |
| Cohort 3 - Active | Mean Percentage Change in vIGA*BSA | Week 16 | -23.74 percentage of change | Standard Deviation 81.817 |
| Cohort 3 - Active | Mean Percentage Change in vIGA*BSA | Week 8 | -15.77 percentage of change | Standard Deviation 78.29 |
| Cohort 3 - Active | Mean Percentage Change in vIGA*BSA | Week 12 | -23.49 percentage of change | Standard Deviation 79.946 |
| Cohort 4 - Placebo | Mean Percentage Change in vIGA*BSA | Week 12 | -43.64 percentage of change | Standard Deviation 52.832 |
| Cohort 4 - Placebo | Mean Percentage Change in vIGA*BSA | Week 16 | -44.29 percentage of change | Standard Deviation 60.14 |
| Cohort 4 - Placebo | Mean Percentage Change in vIGA*BSA | Week 8 | -42.98 percentage of change | Standard Deviation 44.572 |
| Cohort 4 - Placebo | Mean Percentage Change in vIGA*BSA | Week 4 | -19.01 percentage of change | Standard Deviation 49.996 |
| Cohort 4 - Active | Mean Percentage Change in vIGA*BSA | Week 8 | -35.85 percentage of change | Standard Deviation 47.881 |
| Cohort 4 - Active | Mean Percentage Change in vIGA*BSA | Week 12 | -37.27 percentage of change | Standard Deviation 51.582 |
| Cohort 4 - Active | Mean Percentage Change in vIGA*BSA | Week 16 | -43.02 percentage of change | Standard Deviation 41.198 |
| Cohort 4 - Active | Mean Percentage Change in vIGA*BSA | Week 4 | -25.99 percentage of change | Standard Deviation 51.487 |
Secondary
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
Time frame: 4, 8, 12, and 16 weeks
Population: Participants who received rescue therapy at each study visit listed were included as part of the analysis.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Cohorts 1-3 - Placebo | Number of Courses of Rescue Therapy Per Participant | Week 8 | 0 | 55 Participants |
| Cohorts 1-3 - Placebo | Number of Courses of Rescue Therapy Per Participant | Week 4 | 1 | 5 Participants |
| Cohorts 1-3 - Placebo | Number of Courses of Rescue Therapy Per Participant | Week 4 | 2 | 6 Participants |
| Cohorts 1-3 - Placebo | Number of Courses of Rescue Therapy Per Participant | Week 4 | 3 or more | 3 Participants |
| Cohorts 1-3 - Placebo | Number of Courses of Rescue Therapy Per Participant | Week 4 | 0 | 61 Participants |
| Cohorts 1-3 - Placebo | Number of Courses of Rescue Therapy Per Participant | Week 8 | 1 | 6 Participants |
| Cohorts 1-3 - Placebo | Number of Courses of Rescue Therapy Per Participant | Week 8 | 2 | 6 Participants |
| Cohorts 1-3 - Placebo | Number of Courses of Rescue Therapy Per Participant | Week 8 | 3 or more | 1 Participants |
| Cohorts 1-3 - Placebo | Number of Courses of Rescue Therapy Per Participant | Week 12 | 0 | 59 Participants |
| Cohorts 1-3 - Placebo | Number of Courses of Rescue Therapy Per Participant | Week 12 | 1 | 3 Participants |
| Cohorts 1-3 - Placebo | Number of Courses of Rescue Therapy Per Participant | Week 12 | 2 | 2 Participants |
| Cohorts 1-3 - Placebo | Number of Courses of Rescue Therapy Per Participant | Week 12 | 3 or more | 0 Participants |
| Cohorts 1-3 - Placebo | Number of Courses of Rescue Therapy Per Participant | Week 16 | 0 | 62 Participants |
| Cohorts 1-3 - Placebo | Number of Courses of Rescue Therapy Per Participant | Week 16 | 1 | 1 Participants |
| Cohorts 1-3 - Placebo | Number of Courses of Rescue Therapy Per Participant | Week 16 | 2 | 0 Participants |
| Cohorts 1-3 - Placebo | Number of Courses of Rescue Therapy Per Participant | Week 16 | 3 or more | 0 Participants |
| Cohort 1 - Active | Number of Courses of Rescue Therapy Per Participant | Week 4 | 3 or more | 3 Participants |
| Cohort 1 - Active | Number of Courses of Rescue Therapy Per Participant | Week 12 | 0 | 55 Participants |
| Cohort 1 - Active | Number of Courses of Rescue Therapy Per Participant | Week 8 | 3 or more | 1 Participants |
| Cohort 1 - Active | Number of Courses of Rescue Therapy Per Participant | Week 8 | 2 | 2 Participants |
| Cohort 1 - Active | Number of Courses of Rescue Therapy Per Participant | Week 4 | 2 | 5 Participants |
| Cohort 1 - Active | Number of Courses of Rescue Therapy Per Participant | Week 4 | 0 | 58 Participants |
| Cohort 1 - Active | Number of Courses of Rescue Therapy Per Participant | Week 16 | 1 | 2 Participants |
| Cohort 1 - Active | Number of Courses of Rescue Therapy Per Participant | Week 16 | 0 | 53 Participants |
| Cohort 1 - Active | Number of Courses of Rescue Therapy Per Participant | Week 12 | 3 or more | 0 Participants |
| Cohort 1 - Active | Number of Courses of Rescue Therapy Per Participant | Week 8 | 0 | 59 Participants |
| Cohort 1 - Active | Number of Courses of Rescue Therapy Per Participant | Week 4 | 1 | 6 Participants |
| Cohort 1 - Active | Number of Courses of Rescue Therapy Per Participant | Week 16 | 3 or more | 0 Participants |
| Cohort 1 - Active | Number of Courses of Rescue Therapy Per Participant | Week 12 | 2 | 4 Participants |
| Cohort 1 - Active | Number of Courses of Rescue Therapy Per Participant | Week 12 | 1 | 3 Participants |
| Cohort 1 - Active | Number of Courses of Rescue Therapy Per Participant | Week 16 | 2 | 0 Participants |
| Cohort 1 - Active | Number of Courses of Rescue Therapy Per Participant | Week 8 | 1 | 4 Participants |
| Cohort 2 - Active | Number of Courses of Rescue Therapy Per Participant | Week 16 | 2 | 0 Participants |
| Cohort 2 - Active | Number of Courses of Rescue Therapy Per Participant | Week 4 | 3 or more | 4 Participants |
| Cohort 2 - Active | Number of Courses of Rescue Therapy Per Participant | Week 8 | 0 | 52 Participants |
| Cohort 2 - Active | Number of Courses of Rescue Therapy Per Participant | Week 8 | 1 | 8 Participants |
| Cohort 2 - Active | Number of Courses of Rescue Therapy Per Participant | Week 8 | 2 | 5 Participants |
| Cohort 2 - Active | Number of Courses of Rescue Therapy Per Participant | Week 8 | 3 or more | 1 Participants |
| Cohort 2 - Active | Number of Courses of Rescue Therapy Per Participant | Week 12 | 0 | 47 Participants |
| Cohort 2 - Active | Number of Courses of Rescue Therapy Per Participant | Week 12 | 1 | 6 Participants |
| Cohort 2 - Active | Number of Courses of Rescue Therapy Per Participant | Week 12 | 2 | 6 Participants |
| Cohort 2 - Active | Number of Courses of Rescue Therapy Per Participant | Week 12 | 3 or more | 0 Participants |
| Cohort 2 - Active | Number of Courses of Rescue Therapy Per Participant | Week 16 | 3 or more | 0 Participants |
| Cohort 2 - Active | Number of Courses of Rescue Therapy Per Participant | Week 16 | 0 | 51 Participants |
| Cohort 2 - Active | Number of Courses of Rescue Therapy Per Participant | Week 16 | 1 | 3 Participants |
| Cohort 2 - Active | Number of Courses of Rescue Therapy Per Participant | Week 4 | 0 | 59 Participants |
| Cohort 2 - Active | Number of Courses of Rescue Therapy Per Participant | Week 4 | 1 | 5 Participants |
| Cohort 2 - Active | Number of Courses of Rescue Therapy Per Participant | Week 4 | 2 | 6 Participants |
| Cohort 3 - Active | Number of Courses of Rescue Therapy Per Participant | Week 4 | 3 or more | 4 Participants |
| Cohort 3 - Active | Number of Courses of Rescue Therapy Per Participant | Week 12 | 0 | 54 Participants |
| Cohort 3 - Active | Number of Courses of Rescue Therapy Per Participant | Week 8 | 0 | 59 Participants |
| Cohort 3 - Active | Number of Courses of Rescue Therapy Per Participant | Week 4 | 2 | 7 Participants |
| Cohort 3 - Active | Number of Courses of Rescue Therapy Per Participant | Week 4 | 1 | 12 Participants |
| Cohort 3 - Active | Number of Courses of Rescue Therapy Per Participant | Week 12 | 3 or more | 4 Participants |
| Cohort 3 - Active | Number of Courses of Rescue Therapy Per Participant | Week 16 | 2 | 2 Participants |
| Cohort 3 - Active | Number of Courses of Rescue Therapy Per Participant | Week 16 | 1 | 3 Participants |
| Cohort 3 - Active | Number of Courses of Rescue Therapy Per Participant | Week 12 | 2 | 4 Participants |
| Cohort 3 - Active | Number of Courses of Rescue Therapy Per Participant | Week 12 | 1 | 6 Participants |
| Cohort 3 - Active | Number of Courses of Rescue Therapy Per Participant | Week 8 | 3 or more | 4 Participants |
| Cohort 3 - Active | Number of Courses of Rescue Therapy Per Participant | Week 16 | 0 | 58 Participants |
| Cohort 3 - Active | Number of Courses of Rescue Therapy Per Participant | Week 4 | 0 | 58 Participants |
| Cohort 3 - Active | Number of Courses of Rescue Therapy Per Participant | Week 8 | 1 | 5 Participants |
| Cohort 3 - Active | Number of Courses of Rescue Therapy Per Participant | Week 16 | 3 or more | 1 Participants |
| Cohort 3 - Active | Number of Courses of Rescue Therapy Per Participant | Week 8 | 2 | 4 Participants |
| Cohort 4 - Placebo | Number of Courses of Rescue Therapy Per Participant | Week 4 | 3 or more | 6 Participants |
| Cohort 4 - Placebo | Number of Courses of Rescue Therapy Per Participant | Week 4 | 2 | 1 Participants |
| Cohort 4 - Placebo | Number of Courses of Rescue Therapy Per Participant | Week 8 | 0 | 32 Participants |
| Cohort 4 - Placebo | Number of Courses of Rescue Therapy Per Participant | Week 4 | 0 | 25 Participants |
| Cohort 4 - Placebo | Number of Courses of Rescue Therapy Per Participant | Week 8 | 2 | 1 Participants |
| Cohort 4 - Placebo | Number of Courses of Rescue Therapy Per Participant | Week 8 | 1 | 2 Participants |
| Cohort 4 - Placebo | Number of Courses of Rescue Therapy Per Participant | Week 8 | 3 or more | 3 Participants |
| Cohort 4 - Placebo | Number of Courses of Rescue Therapy Per Participant | Week 16 | 2 | 0 Participants |
| Cohort 4 - Placebo | Number of Courses of Rescue Therapy Per Participant | Week 12 | 2 | 2 Participants |
| Cohort 4 - Placebo | Number of Courses of Rescue Therapy Per Participant | Week 16 | 3 or more | 1 Participants |
| Cohort 4 - Placebo | Number of Courses of Rescue Therapy Per Participant | Week 12 | 3 or more | 2 Participants |
| Cohort 4 - Placebo | Number of Courses of Rescue Therapy Per Participant | Week 12 | 0 | 29 Participants |
| Cohort 4 - Placebo | Number of Courses of Rescue Therapy Per Participant | Week 4 | 1 | 6 Participants |
| Cohort 4 - Placebo | Number of Courses of Rescue Therapy Per Participant | Week 12 | 1 | 4 Participants |
| Cohort 4 - Placebo | Number of Courses of Rescue Therapy Per Participant | Week 16 | 0 | 35 Participants |
| Cohort 4 - Placebo | Number of Courses of Rescue Therapy Per Participant | Week 16 | 1 | 0 Participants |
| Cohort 4 - Active | Number of Courses of Rescue Therapy Per Participant | Week 8 | 3 or more | 4 Participants |
| Cohort 4 - Active | Number of Courses of Rescue Therapy Per Participant | Week 12 | 0 | 55 Participants |
| Cohort 4 - Active | Number of Courses of Rescue Therapy Per Participant | Week 16 | 2 | 1 Participants |
| Cohort 4 - Active | Number of Courses of Rescue Therapy Per Participant | Week 8 | 0 | 50 Participants |
| Cohort 4 - Active | Number of Courses of Rescue Therapy Per Participant | Week 16 | 1 | 3 Participants |
| Cohort 4 - Active | Number of Courses of Rescue Therapy Per Participant | Week 12 | 1 | 4 Participants |
| Cohort 4 - Active | Number of Courses of Rescue Therapy Per Participant | Week 16 | 3 or more | 1 Participants |
| Cohort 4 - Active | Number of Courses of Rescue Therapy Per Participant | Week 12 | 2 | 1 Participants |
| Cohort 4 - Active | Number of Courses of Rescue Therapy Per Participant | Week 12 | 3 or more | 4 Participants |
| Cohort 4 - Active | Number of Courses of Rescue Therapy Per Participant | Week 4 | 3 or more | 6 Participants |
| Cohort 4 - Active | Number of Courses of Rescue Therapy Per Participant | Week 4 | 1 | 4 Participants |
| Cohort 4 - Active | Number of Courses of Rescue Therapy Per Participant | Week 16 | 0 | 53 Participants |
| Cohort 4 - Active | Number of Courses of Rescue Therapy Per Participant | Week 4 | 2 | 6 Participants |
| Cohort 4 - Active | Number of Courses of Rescue Therapy Per Participant | Week 8 | 1 | 3 Participants |
| Cohort 4 - Active | Number of Courses of Rescue Therapy Per Participant | Week 8 | 2 | 9 Participants |
| Cohort 4 - Active | Number of Courses of Rescue Therapy Per Participant | Week 4 | 0 | 58 Participants |
Secondary
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
Time frame: 16 weeks
Population: All participants who received rescue therapy during the study were included as part of the analysis.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Cohorts 1-3 - Placebo | Number of Days of Treatment With Rescue Therapy Per Participant | Weeks 1-8 | 15-21 | 2 Participants |
| Cohorts 1-3 - Placebo | Number of Days of Treatment With Rescue Therapy Per Participant | Weeks 1-8 | 8-14 | 9 Participants |
| Cohorts 1-3 - Placebo | Number of Days of Treatment With Rescue Therapy Per Participant | Week 9-16 | 22 or more | 0 Participants |
| Cohorts 1-3 - Placebo | Number of Days of Treatment With Rescue Therapy Per Participant | Week 9-16 | 15-21 | 1 Participants |
| Cohorts 1-3 - Placebo | Number of Days of Treatment With Rescue Therapy Per Participant | Week 9-16 | 8-14 | 2 Participants |
| Cohorts 1-3 - Placebo | Number of Days of Treatment With Rescue Therapy Per Participant | Week 9-16 | 1-7 | 8 Participants |
| Cohorts 1-3 - Placebo | Number of Days of Treatment With Rescue Therapy Per Participant | Weeks 1-8 | 1-7 | 10 Participants |
| Cohorts 1-3 - Placebo | Number of Days of Treatment With Rescue Therapy Per Participant | Weeks 1-8 | 0 | 54 Participants |
| Cohorts 1-3 - Placebo | Number of Days of Treatment With Rescue Therapy Per Participant | Week 9-16 | 0 | 53 Participants |
| Cohorts 1-3 - Placebo | Number of Days of Treatment With Rescue Therapy Per Participant | Weeks 1-8 | 22 or more | 0 Participants |
| Cohort 1 - Active | Number of Days of Treatment With Rescue Therapy Per Participant | Weeks 1-8 | 1-7 | 8 Participants |
| Cohort 1 - Active | Number of Days of Treatment With Rescue Therapy Per Participant | Weeks 1-8 | 0 | 55 Participants |
| Cohort 1 - Active | Number of Days of Treatment With Rescue Therapy Per Participant | Weeks 1-8 | 8-14 | 7 Participants |
| Cohort 1 - Active | Number of Days of Treatment With Rescue Therapy Per Participant | Weeks 1-8 | 15-21 | 2 Participants |
| Cohort 1 - Active | Number of Days of Treatment With Rescue Therapy Per Participant | Weeks 1-8 | 22 or more | 0 Participants |
| Cohort 1 - Active | Number of Days of Treatment With Rescue Therapy Per Participant | Week 9-16 | 0 | 51 Participants |
| Cohort 1 - Active | Number of Days of Treatment With Rescue Therapy Per Participant | Week 9-16 | 1-7 | 7 Participants |
| Cohort 1 - Active | Number of Days of Treatment With Rescue Therapy Per Participant | Week 9-16 | 8-14 | 4 Participants |
| Cohort 1 - Active | Number of Days of Treatment With Rescue Therapy Per Participant | Week 9-16 | 15-21 | 0 Participants |
| Cohort 1 - Active | Number of Days of Treatment With Rescue Therapy Per Participant | Week 9-16 | 22 or more | 0 Participants |
| Cohort 2 - Active | Number of Days of Treatment With Rescue Therapy Per Participant | Weeks 1-8 | 15-21 | 2 Participants |
| Cohort 2 - Active | Number of Days of Treatment With Rescue Therapy Per Participant | Week 9-16 | 8-14 | 9 Participants |
| Cohort 2 - Active | Number of Days of Treatment With Rescue Therapy Per Participant | Weeks 1-8 | 0 | 53 Participants |
| Cohort 2 - Active | Number of Days of Treatment With Rescue Therapy Per Participant | Weeks 1-8 | 22 or more | 3 Participants |
| Cohort 2 - Active | Number of Days of Treatment With Rescue Therapy Per Participant | Weeks 1-8 | 8-14 | 7 Participants |
| Cohort 2 - Active | Number of Days of Treatment With Rescue Therapy Per Participant | Weeks 1-8 | 1-7 | 9 Participants |
| Cohort 2 - Active | Number of Days of Treatment With Rescue Therapy Per Participant | Week 9-16 | 0 | 42 Participants |
| Cohort 2 - Active | Number of Days of Treatment With Rescue Therapy Per Participant | Week 9-16 | 15-21 | 0 Participants |
| Cohort 2 - Active | Number of Days of Treatment With Rescue Therapy Per Participant | Week 9-16 | 22 or more | 0 Participants |
| Cohort 2 - Active | Number of Days of Treatment With Rescue Therapy Per Participant | Week 9-16 | 1-7 | 8 Participants |
| Cohort 3 - Active | Number of Days of Treatment With Rescue Therapy Per Participant | Week 9-16 | 1-7 | 7 Participants |
| Cohort 3 - Active | Number of Days of Treatment With Rescue Therapy Per Participant | Week 9-16 | 8-14 | 8 Participants |
| Cohort 3 - Active | Number of Days of Treatment With Rescue Therapy Per Participant | Weeks 1-8 | 1-7 | 16 Participants |
| Cohort 3 - Active | Number of Days of Treatment With Rescue Therapy Per Participant | Week 9-16 | 22 or more | 1 Participants |
| Cohort 3 - Active | Number of Days of Treatment With Rescue Therapy Per Participant | Week 9-16 | 15-21 | 2 Participants |
| Cohort 3 - Active | Number of Days of Treatment With Rescue Therapy Per Participant | Weeks 1-8 | 0 | 55 Participants |
| Cohort 3 - Active | Number of Days of Treatment With Rescue Therapy Per Participant | Week 9-16 | 0 | 50 Participants |
| Cohort 3 - Active | Number of Days of Treatment With Rescue Therapy Per Participant | Weeks 1-8 | 22 or more | 2 Participants |
| Cohort 3 - Active | Number of Days of Treatment With Rescue Therapy Per Participant | Weeks 1-8 | 15-21 | 4 Participants |
| Cohort 3 - Active | Number of Days of Treatment With Rescue Therapy Per Participant | Weeks 1-8 | 8-14 | 4 Participants |
| Cohort 4 - Placebo | Number of Days of Treatment With Rescue Therapy Per Participant | Week 9-16 | 1-7 | 5 Participants |
| Cohort 4 - Placebo | Number of Days of Treatment With Rescue Therapy Per Participant | Weeks 1-8 | 15-21 | 1 Participants |
| Cohort 4 - Placebo | Number of Days of Treatment With Rescue Therapy Per Participant | Weeks 1-8 | 22 or more | 2 Participants |
| Cohort 4 - Placebo | Number of Days of Treatment With Rescue Therapy Per Participant | Week 9-16 | 0 | 27 Participants |
| Cohort 4 - Placebo | Number of Days of Treatment With Rescue Therapy Per Participant | Weeks 1-8 | 0 | 25 Participants |
| Cohort 4 - Placebo | Number of Days of Treatment With Rescue Therapy Per Participant | Week 9-16 | 8-14 | 4 Participants |
| Cohort 4 - Placebo | Number of Days of Treatment With Rescue Therapy Per Participant | Week 9-16 | 22 or more | 0 Participants |
| Cohort 4 - Placebo | Number of Days of Treatment With Rescue Therapy Per Participant | Week 9-16 | 15-21 | 1 Participants |
| Cohort 4 - Placebo | Number of Days of Treatment With Rescue Therapy Per Participant | Weeks 1-8 | 8-14 | 5 Participants |
| Cohort 4 - Placebo | Number of Days of Treatment With Rescue Therapy Per Participant | Weeks 1-8 | 1-7 | 5 Participants |
| Cohort 4 - Active | Number of Days of Treatment With Rescue Therapy Per Participant | Week 9-16 | 0 | 48 Participants |
| Cohort 4 - Active | Number of Days of Treatment With Rescue Therapy Per Participant | Week 9-16 | 22 or more | 2 Participants |
| Cohort 4 - Active | Number of Days of Treatment With Rescue Therapy Per Participant | Weeks 1-8 | 1-7 | 8 Participants |
| Cohort 4 - Active | Number of Days of Treatment With Rescue Therapy Per Participant | Weeks 1-8 | 8-14 | 8 Participants |
| Cohort 4 - Active | Number of Days of Treatment With Rescue Therapy Per Participant | Weeks 1-8 | 22 or more | 3 Participants |
| Cohort 4 - Active | Number of Days of Treatment With Rescue Therapy Per Participant | Week 9-16 | 1-7 | 6 Participants |
| Cohort 4 - Active | Number of Days of Treatment With Rescue Therapy Per Participant | Weeks 1-8 | 15-21 | 1 Participants |
| Cohort 4 - Active | Number of Days of Treatment With Rescue Therapy Per Participant | Week 9-16 | 8-14 | 7 Participants |
| Cohort 4 - Active | Number of Days of Treatment With Rescue Therapy Per Participant | Weeks 1-8 | 0 | 54 Participants |
| Cohort 4 - Active | Number of Days of Treatment With Rescue Therapy Per Participant | Week 9-16 | 15-21 | 1 Participants |
Secondary
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.
Time frame: 16 weeks
Population: Randomized participants who completed the SD-NRS at the relevant visit or dropped out before the relevant visit for treatment-related reasons.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Cohorts 1-3 - Placebo | Percentage of Participants Achieving a Reduction of ≥2 in SD-NRS Score, of Those With a Score of ≥2 at Baseline | 25 Participants |
| Cohort 1 - Active | Percentage of Participants Achieving a Reduction of ≥2 in SD-NRS Score, of Those With a Score of ≥2 at Baseline | 16 Participants |
| Cohort 2 - Active | Percentage of Participants Achieving a Reduction of ≥2 in SD-NRS Score, of Those With a Score of ≥2 at Baseline | 11 Participants |
| Cohort 3 - Active | Percentage of Participants Achieving a Reduction of ≥2 in SD-NRS Score, of Those With a Score of ≥2 at Baseline | 13 Participants |
| Cohort 4 - Placebo | Percentage of Participants Achieving a Reduction of ≥2 in SD-NRS Score, of Those With a Score of ≥2 at Baseline | 8 Participants |
| Cohort 4 - Active | Percentage of Participants Achieving a Reduction of ≥2 in SD-NRS Score, of Those With a Score of ≥2 at Baseline | 9 Participants |
Secondary
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.
Time frame: 4, 8, 12, and 16 weeks
Population: Randomized participants who completed the PP-NRS at the relevant visit or dropped out before the relevant visit for treatment-related reasons.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Cohorts 1-3 - Placebo | Percentage of Participants Achieving a Reduction of ≥2 in the Worst Pruritus-NRS, of Those With a Score of ≥2 at Baseline | Week 4 | 11 Participants |
| Cohorts 1-3 - Placebo | Percentage of Participants Achieving a Reduction of ≥2 in the Worst Pruritus-NRS, of Those With a Score of ≥2 at Baseline | Week 8 | 21 Participants |
| Cohorts 1-3 - Placebo | Percentage of Participants Achieving a Reduction of ≥2 in the Worst Pruritus-NRS, of Those With a Score of ≥2 at Baseline | Week 12 | 25 Participants |
| Cohorts 1-3 - Placebo | Percentage of Participants Achieving a Reduction of ≥2 in the Worst Pruritus-NRS, of Those With a Score of ≥2 at Baseline | Week 16 | 29 Participants |
| Cohort 1 - Active | Percentage of Participants Achieving a Reduction of ≥2 in the Worst Pruritus-NRS, of Those With a Score of ≥2 at Baseline | Week 12 | 20 Participants |
| Cohort 1 - Active | Percentage of Participants Achieving a Reduction of ≥2 in the Worst Pruritus-NRS, of Those With a Score of ≥2 at Baseline | Week 8 | 20 Participants |
| Cohort 1 - Active | Percentage of Participants Achieving a Reduction of ≥2 in the Worst Pruritus-NRS, of Those With a Score of ≥2 at Baseline | Week 4 | 14 Participants |
| Cohort 1 - Active | Percentage of Participants Achieving a Reduction of ≥2 in the Worst Pruritus-NRS, of Those With a Score of ≥2 at Baseline | Week 16 | 18 Participants |
| Cohort 2 - Active | Percentage of Participants Achieving a Reduction of ≥2 in the Worst Pruritus-NRS, of Those With a Score of ≥2 at Baseline | Week 16 | 14 Participants |
| Cohort 2 - Active | Percentage of Participants Achieving a Reduction of ≥2 in the Worst Pruritus-NRS, of Those With a Score of ≥2 at Baseline | Week 12 | 15 Participants |
| Cohort 2 - Active | Percentage of Participants Achieving a Reduction of ≥2 in the Worst Pruritus-NRS, of Those With a Score of ≥2 at Baseline | Week 8 | 14 Participants |
| Cohort 2 - Active | Percentage of Participants Achieving a Reduction of ≥2 in the Worst Pruritus-NRS, of Those With a Score of ≥2 at Baseline | Week 4 | 12 Participants |
| Cohort 3 - Active | Percentage of Participants Achieving a Reduction of ≥2 in the Worst Pruritus-NRS, of Those With a Score of ≥2 at Baseline | Week 4 | 11 Participants |
| Cohort 3 - Active | Percentage of Participants Achieving a Reduction of ≥2 in the Worst Pruritus-NRS, of Those With a Score of ≥2 at Baseline | Week 16 | 22 Participants |
| Cohort 3 - Active | Percentage of Participants Achieving a Reduction of ≥2 in the Worst Pruritus-NRS, of Those With a Score of ≥2 at Baseline | Week 8 | 20 Participants |
| Cohort 3 - Active | Percentage of Participants Achieving a Reduction of ≥2 in the Worst Pruritus-NRS, of Those With a Score of ≥2 at Baseline | Week 12 | 25 Participants |
| Cohort 4 - Placebo | Percentage of Participants Achieving a Reduction of ≥2 in the Worst Pruritus-NRS, of Those With a Score of ≥2 at Baseline | Week 12 | 10 Participants |
| Cohort 4 - Placebo | Percentage of Participants Achieving a Reduction of ≥2 in the Worst Pruritus-NRS, of Those With a Score of ≥2 at Baseline | Week 16 | 12 Participants |
| Cohort 4 - Placebo | Percentage of Participants Achieving a Reduction of ≥2 in the Worst Pruritus-NRS, of Those With a Score of ≥2 at Baseline | Week 8 | 11 Participants |
| Cohort 4 - Placebo | Percentage of Participants Achieving a Reduction of ≥2 in the Worst Pruritus-NRS, of Those With a Score of ≥2 at Baseline | Week 4 | 10 Participants |
| Cohort 4 - Active | Percentage of Participants Achieving a Reduction of ≥2 in the Worst Pruritus-NRS, of Those With a Score of ≥2 at Baseline | Week 8 | 13 Participants |
| Cohort 4 - Active | Percentage of Participants Achieving a Reduction of ≥2 in the Worst Pruritus-NRS, of Those With a Score of ≥2 at Baseline | Week 12 | 13 Participants |
| Cohort 4 - Active | Percentage of Participants Achieving a Reduction of ≥2 in the Worst Pruritus-NRS, of Those With a Score of ≥2 at Baseline | Week 16 | 13 Participants |
| Cohort 4 - Active | Percentage of Participants Achieving a Reduction of ≥2 in the Worst Pruritus-NRS, of Those With a Score of ≥2 at Baseline | Week 4 | 10 Participants |
Secondary
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.
Time frame: 16 weeks
Population: Randomized participants who completed the DLQI at the relevant visit or dropped out before the relevant visit for treatment-related reasons.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Cohorts 1-3 - Placebo | Percentage of Participants Achieving a Reduction of ≥4 in the DLQI, of Those With a Score of ≥4 at Baseline | 40 Participants |
| Cohort 1 - Active | Percentage of Participants Achieving a Reduction of ≥4 in the DLQI, of Those With a Score of ≥4 at Baseline | 24 Participants |
| Cohort 2 - Active | Percentage of Participants Achieving a Reduction of ≥4 in the DLQI, of Those With a Score of ≥4 at Baseline | 23 Participants |
| Cohort 3 - Active | Percentage of Participants Achieving a Reduction of ≥4 in the DLQI, of Those With a Score of ≥4 at Baseline | 30 Participants |
| Cohort 4 - Placebo | Percentage of Participants Achieving a Reduction of ≥4 in the DLQI, of Those With a Score of ≥4 at Baseline | 17 Participants |
| Cohort 4 - Active | Percentage of Participants Achieving a Reduction of ≥4 in the DLQI, of Those With a Score of ≥4 at Baseline | 24 Participants |
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 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.
Time frame: 16 weeks
Population: Randomized participants who completed the POEM at the relevant visit or dropped out before the relevant visit for treatment-related reasons.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Cohorts 1-3 - Placebo | Percentage of Participants Achieving a Reduction of ≥4 in the POEM Score, of Those With a Score of ≥4 at Baseline | 41 Participants |
| Cohort 1 - Active | Percentage of Participants Achieving a Reduction of ≥4 in the POEM Score, of Those With a Score of ≥4 at Baseline | 24 Participants |
| Cohort 2 - Active | Percentage of Participants Achieving a Reduction of ≥4 in the POEM Score, of Those With a Score of ≥4 at Baseline | 26 Participants |
| Cohort 3 - Active | Percentage of Participants Achieving a Reduction of ≥4 in the POEM Score, of Those With a Score of ≥4 at Baseline | 26 Participants |
| Cohort 4 - Placebo | Percentage of Participants Achieving a Reduction of ≥4 in the POEM Score, of Those With a Score of ≥4 at Baseline | 20 Participants |
| Cohort 4 - Active | Percentage of Participants Achieving a Reduction of ≥4 in the POEM Score, of Those With a Score of ≥4 at Baseline | 27 Participants |
Secondary
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.
Time frame: 16 weeks
Population: Randomized participants who completed the PP-NRS at the relevant visit or dropped out before the relevant visit for treatment-related reasons.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Cohorts 1-3 - Placebo | Percentage of Participants Achieving a Reduction of ≥4 in the Worst PR-NRS, of Those With a Score of ≥4 at Baseline | 13 Participants |
| Cohort 1 - Active | Percentage of Participants Achieving a Reduction of ≥4 in the Worst PR-NRS, of Those With a Score of ≥4 at Baseline | 9 Participants |
| Cohort 2 - Active | Percentage of Participants Achieving a Reduction of ≥4 in the Worst PR-NRS, of Those With a Score of ≥4 at Baseline | 5 Participants |
| Cohort 3 - Active | Percentage of Participants Achieving a Reduction of ≥4 in the Worst PR-NRS, of Those With a Score of ≥4 at Baseline | 7 Participants |
| Cohort 4 - Placebo | Percentage of Participants Achieving a Reduction of ≥4 in the Worst PR-NRS, of Those With a Score of ≥4 at Baseline | 5 Participants |
| Cohort 4 - Active | Percentage of Participants Achieving a Reduction of ≥4 in the Worst PR-NRS, of Those With a Score of ≥4 at Baseline | 3 Participants |
Secondary
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
Time frame: 4, 8, 12, and 16 weeks
Population: Randomized participants who completed the BSA at the relevant visit or dropped out before the relevant visit for treatment-related reasons.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Cohorts 1-3 - Placebo | Percentage of Participants Achieving BSA-50 | Week 4 | 12 Participants |
| Cohorts 1-3 - Placebo | Percentage of Participants Achieving BSA-50 | Week 8 | 19 Participants |
| Cohorts 1-3 - Placebo | Percentage of Participants Achieving BSA-50 | Week 12 | 23 Participants |
| Cohorts 1-3 - Placebo | Percentage of Participants Achieving BSA-50 | Week 16 | 32 Participants |
| Cohort 1 - Active | Percentage of Participants Achieving BSA-50 | Week 12 | 27 Participants |
| Cohort 1 - Active | Percentage of Participants Achieving BSA-50 | Week 8 | 21 Participants |
| Cohort 1 - Active | Percentage of Participants Achieving BSA-50 | Week 4 | 12 Participants |
| Cohort 1 - Active | Percentage of Participants Achieving BSA-50 | Week 16 | 23 Participants |
| Cohort 2 - Active | Percentage of Participants Achieving BSA-50 | Week 16 | 19 Participants |
| Cohort 2 - Active | Percentage of Participants Achieving BSA-50 | Week 12 | 18 Participants |
| Cohort 2 - Active | Percentage of Participants Achieving BSA-50 | Week 8 | 21 Participants |
| Cohort 2 - Active | Percentage of Participants Achieving BSA-50 | Week 4 | 12 Participants |
| Cohort 3 - Active | Percentage of Participants Achieving BSA-50 | Week 4 | 17 Participants |
| Cohort 3 - Active | Percentage of Participants Achieving BSA-50 | Week 16 | 18 Participants |
| Cohort 3 - Active | Percentage of Participants Achieving BSA-50 | Week 8 | 18 Participants |
| Cohort 3 - Active | Percentage of Participants Achieving BSA-50 | Week 12 | 20 Participants |
| Cohort 4 - Placebo | Percentage of Participants Achieving BSA-50 | Week 12 | 17 Participants |
| Cohort 4 - Placebo | Percentage of Participants Achieving BSA-50 | Week 16 | 16 Participants |
| Cohort 4 - Placebo | Percentage of Participants Achieving BSA-50 | Week 8 | 15 Participants |
| Cohort 4 - Placebo | Percentage of Participants Achieving BSA-50 | Week 4 | 6 Participants |
| Cohort 4 - Active | Percentage of Participants Achieving BSA-50 | Week 8 | 19 Participants |
| Cohort 4 - Active | Percentage of Participants Achieving BSA-50 | Week 12 | 24 Participants |
| Cohort 4 - Active | Percentage of Participants Achieving BSA-50 | Week 16 | 20 Participants |
| Cohort 4 - Active | Percentage of Participants Achieving BSA-50 | Week 4 | 16 Participants |
Secondary
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
Time frame: 4, 8, 12, and 16 weeks
Population: Randomized participants who completed the BSA at the relevant visit or dropped out before the relevant visit for treatment-related reasons.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Cohorts 1-3 - Placebo | Percentage of Participants Achieving BSA-75 | Week 4 | 4 Participants |
| Cohorts 1-3 - Placebo | Percentage of Participants Achieving BSA-75 | Week 8 | 3 Participants |
| Cohorts 1-3 - Placebo | Percentage of Participants Achieving BSA-75 | Week 12 | 11 Participants |
| Cohorts 1-3 - Placebo | Percentage of Participants Achieving BSA-75 | Week 16 | 21 Participants |
| Cohort 1 - Active | Percentage of Participants Achieving BSA-75 | Week 12 | 15 Participants |
| Cohort 1 - Active | Percentage of Participants Achieving BSA-75 | Week 8 | 11 Participants |
| Cohort 1 - Active | Percentage of Participants Achieving BSA-75 | Week 4 | 7 Participants |
| Cohort 1 - Active | Percentage of Participants Achieving BSA-75 | Week 16 | 12 Participants |
| Cohort 2 - Active | Percentage of Participants Achieving BSA-75 | Week 16 | 8 Participants |
| Cohort 2 - Active | Percentage of Participants Achieving BSA-75 | Week 12 | 6 Participants |
| Cohort 2 - Active | Percentage of Participants Achieving BSA-75 | Week 8 | 6 Participants |
| Cohort 2 - Active | Percentage of Participants Achieving BSA-75 | Week 4 | 2 Participants |
| Cohort 3 - Active | Percentage of Participants Achieving BSA-75 | Week 4 | 2 Participants |
| Cohort 3 - Active | Percentage of Participants Achieving BSA-75 | Week 16 | 13 Participants |
| Cohort 3 - Active | Percentage of Participants Achieving BSA-75 | Week 8 | 6 Participants |
| Cohort 3 - Active | Percentage of Participants Achieving BSA-75 | Week 12 | 10 Participants |
| Cohort 4 - Placebo | Percentage of Participants Achieving BSA-75 | Week 12 | 10 Participants |
| Cohort 4 - Placebo | Percentage of Participants Achieving BSA-75 | Week 16 | 7 Participants |
| Cohort 4 - Placebo | Percentage of Participants Achieving BSA-75 | Week 8 | 6 Participants |
| Cohort 4 - Placebo | Percentage of Participants Achieving BSA-75 | Week 4 | 2 Participants |
| Cohort 4 - Active | Percentage of Participants Achieving BSA-75 | Week 8 | 11 Participants |
| Cohort 4 - Active | Percentage of Participants Achieving BSA-75 | Week 12 | 13 Participants |
| Cohort 4 - Active | Percentage of Participants Achieving BSA-75 | Week 16 | 12 Participants |
| Cohort 4 - Active | Percentage of Participants Achieving BSA-75 | Week 4 | 4 Participants |
Secondary
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
Time frame: 4, 8, 12, and 16 weeks
Population: Randomized participants who completed the BSA at the relevant visit or dropped out before the relevant visit for treatment-related reasons.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Cohorts 1-3 - Placebo | Percentage of Participants Achieving BSA Reduction to 3% BSA or Less | Week 8 | 2 Participants |
| Cohorts 1-3 - Placebo | Percentage of Participants Achieving BSA Reduction to 3% BSA or Less | Week 4 | 3 Participants |
| Cohorts 1-3 - Placebo | Percentage of Participants Achieving BSA Reduction to 3% BSA or Less | Week 12 | 12 Participants |
| Cohorts 1-3 - Placebo | Percentage of Participants Achieving BSA Reduction to 3% BSA or Less | Week 16 | 20 Participants |
| Cohort 1 - Active | Percentage of Participants Achieving BSA Reduction to 3% BSA or Less | Week 12 | 11 Participants |
| Cohort 1 - Active | Percentage of Participants Achieving BSA Reduction to 3% BSA or Less | Week 4 | 5 Participants |
| Cohort 1 - Active | Percentage of Participants Achieving BSA Reduction to 3% BSA or Less | Week 8 | 8 Participants |
| Cohort 1 - Active | Percentage of Participants Achieving BSA Reduction to 3% BSA or Less | Week 16 | 12 Participants |
| Cohort 2 - Active | Percentage of Participants Achieving BSA Reduction to 3% BSA or Less | Week 4 | 3 Participants |
| Cohort 2 - Active | Percentage of Participants Achieving BSA Reduction to 3% BSA or Less | Week 8 | 7 Participants |
| Cohort 2 - Active | Percentage of Participants Achieving BSA Reduction to 3% BSA or Less | Week 12 | 5 Participants |
| Cohort 2 - Active | Percentage of Participants Achieving BSA Reduction to 3% BSA or Less | Week 16 | 7 Participants |
| Cohort 3 - Active | Percentage of Participants Achieving BSA Reduction to 3% BSA or Less | Week 16 | 10 Participants |
| Cohort 3 - Active | Percentage of Participants Achieving BSA Reduction to 3% BSA or Less | Week 12 | 8 Participants |
| Cohort 3 - Active | Percentage of Participants Achieving BSA Reduction to 3% BSA or Less | Week 4 | 4 Participants |
| Cohort 3 - Active | Percentage of Participants Achieving BSA Reduction to 3% BSA or Less | Week 8 | 6 Participants |
| Cohort 4 - Placebo | Percentage of Participants Achieving BSA Reduction to 3% BSA or Less | Week 8 | 10 Participants |
| Cohort 4 - Placebo | Percentage of Participants Achieving BSA Reduction to 3% BSA or Less | Week 16 | 8 Participants |
| Cohort 4 - Placebo | Percentage of Participants Achieving BSA Reduction to 3% BSA or Less | Week 4 | 3 Participants |
| Cohort 4 - Placebo | Percentage of Participants Achieving BSA Reduction to 3% BSA or Less | Week 12 | 8 Participants |
| Cohort 4 - Active | Percentage of Participants Achieving BSA Reduction to 3% BSA or Less | Week 12 | 14 Participants |
| Cohort 4 - Active | Percentage of Participants Achieving BSA Reduction to 3% BSA or Less | Week 8 | 12 Participants |
| Cohort 4 - Active | Percentage of Participants Achieving BSA Reduction to 3% BSA or Less | Week 4 | 8 Participants |
| Cohort 4 - Active | Percentage of Participants Achieving BSA Reduction to 3% BSA or Less | Week 16 | 10 Participants |
Secondary
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.
Time frame: 4, 8 and 12 weeks
Population: Randomized participants who completed the EASI at the relevant visit or dropped out before the relevant visit for treatment-related reasons.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Cohorts 1-3 - Placebo | Percentage of Participants Achieving EASI-50 | Week 8 | 23 Participants |
| Cohorts 1-3 - Placebo | Percentage of Participants Achieving EASI-50 | Week 4 | 20 Participants |
| Cohorts 1-3 - Placebo | Percentage of Participants Achieving EASI-50 | Week 12 | 26 Participants |
| Cohort 1 - Active | Percentage of Participants Achieving EASI-50 | Week 8 | 29 Participants |
| Cohort 1 - Active | Percentage of Participants Achieving EASI-50 | Week 4 | 18 Participants |
| Cohort 1 - Active | Percentage of Participants Achieving EASI-50 | Week 12 | 33 Participants |
| Cohort 2 - Active | Percentage of Participants Achieving EASI-50 | Week 8 | 21 Participants |
| Cohort 2 - Active | Percentage of Participants Achieving EASI-50 | Week 4 | 14 Participants |
| Cohort 2 - Active | Percentage of Participants Achieving EASI-50 | Week 12 | 21 Participants |
| Cohort 3 - Active | Percentage of Participants Achieving EASI-50 | Week 8 | 22 Participants |
| Cohort 3 - Active | Percentage of Participants Achieving EASI-50 | Week 4 | 18 Participants |
| Cohort 3 - Active | Percentage of Participants Achieving EASI-50 | Week 12 | 24 Participants |
| Cohort 4 - Placebo | Percentage of Participants Achieving EASI-50 | Week 8 | 16 Participants |
| Cohort 4 - Placebo | Percentage of Participants Achieving EASI-50 | Week 4 | 8 Participants |
| Cohort 4 - Placebo | Percentage of Participants Achieving EASI-50 | Week 12 | 17 Participants |
| Cohort 4 - Active | Percentage of Participants Achieving EASI-50 | Week 4 | 23 Participants |
| Cohort 4 - Active | Percentage of Participants Achieving EASI-50 | Week 12 | 24 Participants |
| Cohort 4 - Active | Percentage of Participants Achieving EASI-50 | Week 8 | 27 Participants |
Secondary
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.
Time frame: 4, 8, 12, and 16 weeks
Population: Randomized participants who completed the EASI at the relevant visit or dropped out before the relevant visit for treatment-related reasons.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Cohorts 1-3 - Placebo | Percentage of Participants Achieving EASI-75 | Week 12 | 11 Participants |
| Cohorts 1-3 - Placebo | Percentage of Participants Achieving EASI-75 | Week 8 | 5 Participants |
| Cohorts 1-3 - Placebo | Percentage of Participants Achieving EASI-75 | Week 16 | 22 Participants |
| Cohorts 1-3 - Placebo | Percentage of Participants Achieving EASI-75 | Week 4 | 1 Participants |
| Cohort 1 - Active | Percentage of Participants Achieving EASI-75 | Week 12 | 13 Participants |
| Cohort 1 - Active | Percentage of Participants Achieving EASI-75 | Week 4 | 9 Participants |
| Cohort 1 - Active | Percentage of Participants Achieving EASI-75 | Week 16 | 13 Participants |
| Cohort 1 - Active | Percentage of Participants Achieving EASI-75 | Week 8 | 11 Participants |
| Cohort 2 - Active | Percentage of Participants Achieving EASI-75 | Week 12 | 8 Participants |
| Cohort 2 - Active | Percentage of Participants Achieving EASI-75 | Week 16 | 9 Participants |
| Cohort 2 - Active | Percentage of Participants Achieving EASI-75 | Week 4 | 4 Participants |
| Cohort 2 - Active | Percentage of Participants Achieving EASI-75 | Week 8 | 11 Participants |
| Cohort 3 - Active | Percentage of Participants Achieving EASI-75 | Week 16 | 13 Participants |
| Cohort 3 - Active | Percentage of Participants Achieving EASI-75 | Week 12 | 13 Participants |
| Cohort 3 - Active | Percentage of Participants Achieving EASI-75 | Week 8 | 9 Participants |
| Cohort 3 - Active | Percentage of Participants Achieving EASI-75 | Week 4 | 6 Participants |
| Cohort 4 - Placebo | Percentage of Participants Achieving EASI-75 | Week 8 | 9 Participants |
| Cohort 4 - Placebo | Percentage of Participants Achieving EASI-75 | Week 4 | 2 Participants |
| Cohort 4 - Placebo | Percentage of Participants Achieving EASI-75 | Week 12 | 10 Participants |
| Cohort 4 - Placebo | Percentage of Participants Achieving EASI-75 | Week 16 | 9 Participants |
| Cohort 4 - Active | Percentage of Participants Achieving EASI-75 | Week 8 | 11 Participants |
| Cohort 4 - Active | Percentage of Participants Achieving EASI-75 | Week 4 | 7 Participants |
| Cohort 4 - Active | Percentage of Participants Achieving EASI-75 | Week 16 | 11 Participants |
| Cohort 4 - Active | Percentage of Participants Achieving EASI-75 | Week 12 | 15 Participants |
Secondary
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.
Time frame: 4, 8, 12, and 16 weeks
Population: Randomized participants who completed the EASI at the relevant visit or dropped out before the relevant visit for treatment-related reasons.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Cohorts 1-3 - Placebo | Percentage of Participants Achieving EASI-90 | Week 8 | 1 Participants |
| Cohorts 1-3 - Placebo | Percentage of Participants Achieving EASI-90 | Week 16 | 8 Participants |
| Cohorts 1-3 - Placebo | Percentage of Participants Achieving EASI-90 | Week 12 | 6 Participants |
| Cohorts 1-3 - Placebo | Percentage of Participants Achieving EASI-90 | Week 4 | 0 Participants |
| Cohort 1 - Active | Percentage of Participants Achieving EASI-90 | Week 8 | 3 Participants |
| Cohort 1 - Active | Percentage of Participants Achieving EASI-90 | Week 16 | 3 Participants |
| Cohort 1 - Active | Percentage of Participants Achieving EASI-90 | Week 4 | 3 Participants |
| Cohort 1 - Active | Percentage of Participants Achieving EASI-90 | Week 12 | 5 Participants |
| Cohort 2 - Active | Percentage of Participants Achieving EASI-90 | Week 16 | 5 Participants |
| Cohort 2 - Active | Percentage of Participants Achieving EASI-90 | Week 8 | 3 Participants |
| Cohort 2 - Active | Percentage of Participants Achieving EASI-90 | Week 12 | 5 Participants |
| Cohort 2 - Active | Percentage of Participants Achieving EASI-90 | Week 4 | 1 Participants |
| Cohort 3 - Active | Percentage of Participants Achieving EASI-90 | Week 12 | 3 Participants |
| Cohort 3 - Active | Percentage of Participants Achieving EASI-90 | Week 16 | 6 Participants |
| Cohort 3 - Active | Percentage of Participants Achieving EASI-90 | Week 8 | 4 Participants |
| Cohort 3 - Active | Percentage of Participants Achieving EASI-90 | Week 4 | 1 Participants |
| Cohort 4 - Placebo | Percentage of Participants Achieving EASI-90 | Week 8 | 2 Participants |
| Cohort 4 - Placebo | Percentage of Participants Achieving EASI-90 | Week 16 | 1 Participants |
| Cohort 4 - Placebo | Percentage of Participants Achieving EASI-90 | Week 12 | 4 Participants |
| Cohort 4 - Placebo | Percentage of Participants Achieving EASI-90 | Week 4 | 0 Participants |
| Cohort 4 - Active | Percentage of Participants Achieving EASI-90 | Week 16 | 4 Participants |
| Cohort 4 - Active | Percentage of Participants Achieving EASI-90 | Week 4 | 1 Participants |
| Cohort 4 - Active | Percentage of Participants Achieving EASI-90 | Week 8 | 4 Participants |
| Cohort 4 - Active | Percentage of Participants Achieving EASI-90 | Week 12 | 7 Participants |
Secondary
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
Time frame: 4, 8, 12, and 16 weeks
Population: Randomized participants who completed the vIGA at the relevant visit or dropped out before the relevant visit for treatment-related reasons.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Cohorts 1-3 - Placebo | Percentage of Participants Achieving Investigator's Global Assessment (vIGA) of 0 or 1 With a ≥2 Point Improvement | Week 4 | 1 Participants |
| Cohorts 1-3 - Placebo | Percentage of Participants Achieving Investigator's Global Assessment (vIGA) of 0 or 1 With a ≥2 Point Improvement | Week 8 | 3 Participants |
| Cohorts 1-3 - Placebo | Percentage of Participants Achieving Investigator's Global Assessment (vIGA) of 0 or 1 With a ≥2 Point Improvement | Week 12 | 6 Participants |
| Cohorts 1-3 - Placebo | Percentage of Participants Achieving Investigator's Global Assessment (vIGA) of 0 or 1 With a ≥2 Point Improvement | Week 16 | 12 Participants |
| Cohort 1 - Active | Percentage of Participants Achieving Investigator's Global Assessment (vIGA) of 0 or 1 With a ≥2 Point Improvement | Week 12 | 6 Participants |
| Cohort 1 - Active | Percentage of Participants Achieving Investigator's Global Assessment (vIGA) of 0 or 1 With a ≥2 Point Improvement | Week 8 | 5 Participants |
| Cohort 1 - Active | Percentage of Participants Achieving Investigator's Global Assessment (vIGA) of 0 or 1 With a ≥2 Point Improvement | Week 4 | 5 Participants |
| Cohort 1 - Active | Percentage of Participants Achieving Investigator's Global Assessment (vIGA) of 0 or 1 With a ≥2 Point Improvement | Week 16 | 5 Participants |
| Cohort 2 - Active | Percentage of Participants Achieving Investigator's Global Assessment (vIGA) of 0 or 1 With a ≥2 Point Improvement | Week 16 | 7 Participants |
| Cohort 2 - Active | Percentage of Participants Achieving Investigator's Global Assessment (vIGA) of 0 or 1 With a ≥2 Point Improvement | Week 12 | 5 Participants |
| Cohort 2 - Active | Percentage of Participants Achieving Investigator's Global Assessment (vIGA) of 0 or 1 With a ≥2 Point Improvement | Week 8 | 5 Participants |
| Cohort 2 - Active | Percentage of Participants Achieving Investigator's Global Assessment (vIGA) of 0 or 1 With a ≥2 Point Improvement | Week 4 | 3 Participants |
| Cohort 3 - Active | Percentage of Participants Achieving Investigator's Global Assessment (vIGA) of 0 or 1 With a ≥2 Point Improvement | Week 4 | 2 Participants |
| Cohort 3 - Active | Percentage of Participants Achieving Investigator's Global Assessment (vIGA) of 0 or 1 With a ≥2 Point Improvement | Week 16 | 10 Participants |
| Cohort 3 - Active | Percentage of Participants Achieving Investigator's Global Assessment (vIGA) of 0 or 1 With a ≥2 Point Improvement | Week 8 | 6 Participants |
| Cohort 3 - Active | Percentage of Participants Achieving Investigator's Global Assessment (vIGA) of 0 or 1 With a ≥2 Point Improvement | Week 12 | 6 Participants |
| Cohort 4 - Placebo | Percentage of Participants Achieving Investigator's Global Assessment (vIGA) of 0 or 1 With a ≥2 Point Improvement | Week 12 | 6 Participants |
| Cohort 4 - Placebo | Percentage of Participants Achieving Investigator's Global Assessment (vIGA) of 0 or 1 With a ≥2 Point Improvement | Week 16 | 2 Participants |
| Cohort 4 - Placebo | Percentage of Participants Achieving Investigator's Global Assessment (vIGA) of 0 or 1 With a ≥2 Point Improvement | Week 8 | 5 Participants |
| Cohort 4 - Placebo | Percentage of Participants Achieving Investigator's Global Assessment (vIGA) of 0 or 1 With a ≥2 Point Improvement | Week 4 | 2 Participants |
| Cohort 4 - Active | Percentage of Participants Achieving Investigator's Global Assessment (vIGA) of 0 or 1 With a ≥2 Point Improvement | Week 8 | 9 Participants |
| Cohort 4 - Active | Percentage of Participants Achieving Investigator's Global Assessment (vIGA) of 0 or 1 With a ≥2 Point Improvement | Week 12 | 9 Participants |
| Cohort 4 - Active | Percentage of Participants Achieving Investigator's Global Assessment (vIGA) of 0 or 1 With a ≥2 Point Improvement | Week 16 | 7 Participants |
| Cohort 4 - Active | Percentage of Participants Achieving Investigator's Global Assessment (vIGA) of 0 or 1 With a ≥2 Point Improvement | Week 4 | 4 Participants |
Secondary
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
Time frame: 4, 8, 12, and 16 weeks
Population: Randomized participants who completed the SCORAD at the relevant visit or dropped out before the relevant visit for treatment-related reasons.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Cohorts 1-3 - Placebo | Percentage of Participants Achieving SCORAD-50 | Week 4 | 2 Participants |
| Cohorts 1-3 - Placebo | Percentage of Participants Achieving SCORAD-50 | Week 8 | 6 Participants |
| Cohorts 1-3 - Placebo | Percentage of Participants Achieving SCORAD-50 | Week 12 | 15 Participants |
| Cohorts 1-3 - Placebo | Percentage of Participants Achieving SCORAD-50 | Week 16 | 21 Participants |
| Cohort 1 - Active | Percentage of Participants Achieving SCORAD-50 | Week 12 | 12 Participants |
| Cohort 1 - Active | Percentage of Participants Achieving SCORAD-50 | Week 8 | 12 Participants |
| Cohort 1 - Active | Percentage of Participants Achieving SCORAD-50 | Week 4 | 10 Participants |
| Cohort 1 - Active | Percentage of Participants Achieving SCORAD-50 | Week 16 | 8 Participants |
| Cohort 2 - Active | Percentage of Participants Achieving SCORAD-50 | Week 16 | 9 Participants |
| Cohort 2 - Active | Percentage of Participants Achieving SCORAD-50 | Week 12 | 7 Participants |
| Cohort 2 - Active | Percentage of Participants Achieving SCORAD-50 | Week 8 | 10 Participants |
| Cohort 2 - Active | Percentage of Participants Achieving SCORAD-50 | Week 4 | 4 Participants |
| Cohort 3 - Active | Percentage of Participants Achieving SCORAD-50 | Week 4 | 6 Participants |
| Cohort 3 - Active | Percentage of Participants Achieving SCORAD-50 | Week 16 | 16 Participants |
| Cohort 3 - Active | Percentage of Participants Achieving SCORAD-50 | Week 8 | 9 Participants |
| Cohort 3 - Active | Percentage of Participants Achieving SCORAD-50 | Week 12 | 12 Participants |
| Cohort 4 - Placebo | Percentage of Participants Achieving SCORAD-50 | Week 12 | 9 Participants |
| Cohort 4 - Placebo | Percentage of Participants Achieving SCORAD-50 | Week 16 | 10 Participants |
| Cohort 4 - Placebo | Percentage of Participants Achieving SCORAD-50 | Week 8 | 10 Participants |
| Cohort 4 - Placebo | Percentage of Participants Achieving SCORAD-50 | Week 4 | 4 Participants |
| Cohort 4 - Active | Percentage of Participants Achieving SCORAD-50 | Week 8 | 8 Participants |
| Cohort 4 - Active | Percentage of Participants Achieving SCORAD-50 | Week 12 | 11 Participants |
| Cohort 4 - Active | Percentage of Participants Achieving SCORAD-50 | Week 16 | 12 Participants |
| Cohort 4 - Active | Percentage of Participants Achieving SCORAD-50 | Week 4 | 8 Participants |
Secondary
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
Time frame: 4, 8, 12, and 16 weeks
Population: Randomized participants who completed the SCORAD at the relevant visit or dropped out before the relevant visit for treatment-related reasons.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Cohorts 1-3 - Placebo | Percentage of Participants Achieving SCORAD-75 | Week 4 | 0 Participants |
| Cohorts 1-3 - Placebo | Percentage of Participants Achieving SCORAD-75 | Week 8 | 1 Participants |
| Cohorts 1-3 - Placebo | Percentage of Participants Achieving SCORAD-75 | Week 12 | 5 Participants |
| Cohorts 1-3 - Placebo | Percentage of Participants Achieving SCORAD-75 | Week 16 | 7 Participants |
| Cohort 1 - Active | Percentage of Participants Achieving SCORAD-75 | Week 12 | 2 Participants |
| Cohort 1 - Active | Percentage of Participants Achieving SCORAD-75 | Week 8 | 2 Participants |
| Cohort 1 - Active | Percentage of Participants Achieving SCORAD-75 | Week 4 | 1 Participants |
| Cohort 1 - Active | Percentage of Participants Achieving SCORAD-75 | Week 16 | 1 Participants |
| Cohort 2 - Active | Percentage of Participants Achieving SCORAD-75 | Week 16 | 1 Participants |
| Cohort 2 - Active | Percentage of Participants Achieving SCORAD-75 | Week 12 | 1 Participants |
| Cohort 2 - Active | Percentage of Participants Achieving SCORAD-75 | Week 8 | 0 Participants |
| Cohort 2 - Active | Percentage of Participants Achieving SCORAD-75 | Week 4 | 0 Participants |
| Cohort 3 - Active | Percentage of Participants Achieving SCORAD-75 | Week 4 | 2 Participants |
| Cohort 3 - Active | Percentage of Participants Achieving SCORAD-75 | Week 16 | 5 Participants |
| Cohort 3 - Active | Percentage of Participants Achieving SCORAD-75 | Week 8 | 5 Participants |
| Cohort 3 - Active | Percentage of Participants Achieving SCORAD-75 | Week 12 | 2 Participants |
| Cohort 4 - Placebo | Percentage of Participants Achieving SCORAD-75 | Week 12 | 1 Participants |
| Cohort 4 - Placebo | Percentage of Participants Achieving SCORAD-75 | Week 16 | 2 Participants |
| Cohort 4 - Placebo | Percentage of Participants Achieving SCORAD-75 | Week 8 | 3 Participants |
| Cohort 4 - Placebo | Percentage of Participants Achieving SCORAD-75 | Week 4 | 0 Participants |
| Cohort 4 - Active | Percentage of Participants Achieving SCORAD-75 | Week 8 | 1 Participants |
| Cohort 4 - Active | Percentage of Participants Achieving SCORAD-75 | Week 12 | 4 Participants |
| Cohort 4 - Active | Percentage of Participants Achieving SCORAD-75 | Week 16 | 4 Participants |
| Cohort 4 - Active | Percentage of Participants Achieving SCORAD-75 | Week 4 | 1 Participants |
Secondary
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
Time frame: 16 weeks
Population: Randomized participants who completed the vIGA at the relevant visit or dropped out before the relevant visit for treatment-related reasons.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Cohorts 1-3 - Placebo | Percentage of Participants Achieving vIGA of 0 | 2 Participants |
| Cohort 1 - Active | Percentage of Participants Achieving vIGA of 0 | 1 Participants |
| Cohort 2 - Active | Percentage of Participants Achieving vIGA of 0 | 2 Participants |
| Cohort 3 - Active | Percentage of Participants Achieving vIGA of 0 | 1 Participants |
| Cohort 4 - Placebo | Percentage of Participants Achieving vIGA of 0 | 0 Participants |
| Cohort 4 - Active | Percentage of Participants Achieving vIGA of 0 | 3 Participants |
Secondary
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
Time frame: 4, 8, 12, and 16 weeks
Population: Randomized participants who completed the vIGA at the relevant visit or dropped out before the relevant visit for treatment-related reasons.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Cohorts 1-3 - Placebo | Percentage of Participants Achieving vIGA of 0 or 1 | Week 4 | 2 Participants |
| Cohorts 1-3 - Placebo | Percentage of Participants Achieving vIGA of 0 or 1 | Week 16 | 19 Participants |
| Cohorts 1-3 - Placebo | Percentage of Participants Achieving vIGA of 0 or 1 | Week 12 | 12 Participants |
| Cohorts 1-3 - Placebo | Percentage of Participants Achieving vIGA of 0 or 1 | Week 8 | 4 Participants |
| Cohort 1 - Active | Percentage of Participants Achieving vIGA of 0 or 1 | Week 16 | 10 Participants |
| Cohort 1 - Active | Percentage of Participants Achieving vIGA of 0 or 1 | Week 8 | 7 Participants |
| Cohort 1 - Active | Percentage of Participants Achieving vIGA of 0 or 1 | Week 4 | 7 Participants |
| Cohort 1 - Active | Percentage of Participants Achieving vIGA of 0 or 1 | Week 12 | 10 Participants |
| Cohort 2 - Active | Percentage of Participants Achieving vIGA of 0 or 1 | Week 4 | 3 Participants |
| Cohort 2 - Active | Percentage of Participants Achieving vIGA of 0 or 1 | Week 16 | 7 Participants |
| Cohort 2 - Active | Percentage of Participants Achieving vIGA of 0 or 1 | Week 8 | 5 Participants |
| Cohort 2 - Active | Percentage of Participants Achieving vIGA of 0 or 1 | Week 12 | 5 Participants |
| Cohort 3 - Active | Percentage of Participants Achieving vIGA of 0 or 1 | Week 16 | 11 Participants |
| Cohort 3 - Active | Percentage of Participants Achieving vIGA of 0 or 1 | Week 8 | 7 Participants |
| Cohort 3 - Active | Percentage of Participants Achieving vIGA of 0 or 1 | Week 12 | 9 Participants |
| Cohort 3 - Active | Percentage of Participants Achieving vIGA of 0 or 1 | Week 4 | 4 Participants |
| Cohort 4 - Placebo | Percentage of Participants Achieving vIGA of 0 or 1 | Week 12 | 9 Participants |
| Cohort 4 - Placebo | Percentage of Participants Achieving vIGA of 0 or 1 | Week 4 | 3 Participants |
| Cohort 4 - Placebo | Percentage of Participants Achieving vIGA of 0 or 1 | Week 16 | 5 Participants |
| Cohort 4 - Placebo | Percentage of Participants Achieving vIGA of 0 or 1 | Week 8 | 8 Participants |
| Cohort 4 - Active | Percentage of Participants Achieving vIGA of 0 or 1 | Week 16 | 9 Participants |
| Cohort 4 - Active | Percentage of Participants Achieving vIGA of 0 or 1 | Week 4 | 8 Participants |
| Cohort 4 - Active | Percentage of Participants Achieving vIGA of 0 or 1 | Week 8 | 12 Participants |
| Cohort 4 - Active | Percentage of Participants Achieving vIGA of 0 or 1 | Week 12 | 11 Participants |
Secondary
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
Time frame: 4, 8, 12, and 16 weeks
Population: Participants who did not receive rescue therapy at any of the study visits were included as part of the analysis.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Cohorts 1-3 - Placebo | Proportion of Participants Not Requiring Rescue Therapy | Week 4 | 61 Participants |
| Cohorts 1-3 - Placebo | Proportion of Participants Not Requiring Rescue Therapy | Week 8 | 55 Participants |
| Cohorts 1-3 - Placebo | Proportion of Participants Not Requiring Rescue Therapy | Week 12 | 59 Participants |
| Cohorts 1-3 - Placebo | Proportion of Participants Not Requiring Rescue Therapy | Week 16 | 62 Participants |
| Cohort 1 - Active | Proportion of Participants Not Requiring Rescue Therapy | Week 12 | 55 Participants |
| Cohort 1 - Active | Proportion of Participants Not Requiring Rescue Therapy | Week 8 | 59 Participants |
| Cohort 1 - Active | Proportion of Participants Not Requiring Rescue Therapy | Week 4 | 58 Participants |
| Cohort 1 - Active | Proportion of Participants Not Requiring Rescue Therapy | Week 16 | 53 Participants |
| Cohort 2 - Active | Proportion of Participants Not Requiring Rescue Therapy | Week 16 | 51 Participants |
| Cohort 2 - Active | Proportion of Participants Not Requiring Rescue Therapy | Week 12 | 47 Participants |
| Cohort 2 - Active | Proportion of Participants Not Requiring Rescue Therapy | Week 8 | 52 Participants |
| Cohort 2 - Active | Proportion of Participants Not Requiring Rescue Therapy | Week 4 | 59 Participants |
| Cohort 3 - Active | Proportion of Participants Not Requiring Rescue Therapy | Week 4 | 58 Participants |
| Cohort 3 - Active | Proportion of Participants Not Requiring Rescue Therapy | Week 16 | 58 Participants |
| Cohort 3 - Active | Proportion of Participants Not Requiring Rescue Therapy | Week 8 | 59 Participants |
| Cohort 3 - Active | Proportion of Participants Not Requiring Rescue Therapy | Week 12 | 54 Participants |
| Cohort 4 - Placebo | Proportion of Participants Not Requiring Rescue Therapy | Week 12 | 29 Participants |
| Cohort 4 - Placebo | Proportion of Participants Not Requiring Rescue Therapy | Week 16 | 35 Participants |
| Cohort 4 - Placebo | Proportion of Participants Not Requiring Rescue Therapy | Week 8 | 32 Participants |
| Cohort 4 - Placebo | Proportion of Participants Not Requiring Rescue Therapy | Week 4 | 25 Participants |
| Cohort 4 - Active | Proportion of Participants Not Requiring Rescue Therapy | Week 8 | 50 Participants |
| Cohort 4 - Active | Proportion of Participants Not Requiring Rescue Therapy | Week 12 | 55 Participants |
| Cohort 4 - Active | Proportion of Participants Not Requiring Rescue Therapy | Week 16 | 53 Participants |
| Cohort 4 - Active | Proportion of Participants Not Requiring Rescue Therapy | Week 4 | 58 Participants |