Atopic Dermatitis
Conditions
Keywords
Mild Atopic Dermatitis, Moderate Atopic Dermatitis, Severe Atopic Dermatitis, Mild Eczema, Moderate Eczema, Severe Eczema
Brief summary
This is an Open-Label Extension (OLE) study to evaluate the long-term safety, tolerability, and efficacy of EDP1815 in participants with mild, moderate, and severe atopic dermatitis who have completed the treatment period of a prior clinical study (parent study) with EDP1815. The current parent study of this protocol is the EDP1815-207 study; A Phase 2, Multicenter, Double-Blind, Placebo-Controlled, Multiple-Cohort Study Investigating the Effect of EDP1815 in Participants for the Treatment of Mild, Moderate and Severe Atopic Dermatitis.
Detailed description
Atopic dermatitis (atopic eczema) is a very common type of skin disease. It typically causes red, dry, and itchy skin and may have a significant impact on quality of life. Rashes may appear on the arms and behind the knees, or anywhere else on the body. While there are existing therapies, there is currently no cure for atopic dermatitis. This study is an Open Label Extension (OLE) study to the first parent study; i.e., the EDP1815-207 study (NCT05121480). The total number of participants will be dependent on the number of participants who elect and are eligible to participate in the Open Label Extension study following participation in EDP1815-207. All participants in this study will be treated with EDP1815, regardless of the treatment assignment in the EDP1815-207 study. There will be no placebo drug administered in this study. To minimize bias, during dosing in EDP1815-208, investigators and participants will continue to be blinded to participants' treatment allocation in the parent study whilst it is ongoing. Participants in this study will be treated with EDP1815 for up to 36 weeks, followed by a follow-up visit at approximately 4 weeks after the end of treatment. The maximum study duration is up to 40 weeks for all participants. The participants may move directly from the parent study into the open label treatment phase without a break in study treatment, or within 7 days of completing the treatment period of the parent study. If the participants move directly into this study without a break in treatment from the parent study, the Day -1 visit should be performed at the same time as the end of treatment visit of the parent study. The primary endpoint of safety and tolerability will be measured using the incidence and rate per 100 patient-years of treatment-emergent adverse events during the 36-week treatment period and the 4-week follow-up period of this study; and during the treatment period of this study and the parent study. TEAEs will be defined as all events starting after first dose of study drug, and on or before 28 days after last dose for each participant. All TEAEs will be included in the assessments of incidences and rates, regardless of compliance with study medication, use of other medications or deviations from the study protocol. The secondary endpoint of efficacy will be measured using the Eczema Area and Severity Index (EASI) Score. Additionally, the Investigator's Global Assessment (IGA), percentage of Body Surface Area (BSA), Product of the IGA and BSA (IGA\*BSA), the SCORing Atopic Dermatitis (SCORAD), the Dermatology Life Quality Index (DLQI), the Peak Pruritus Numerical Rating Scale (PP-NRS), the Sleep Disturbance Numerical Rating Scale (SD-NRS), the Patient Oriented Eczema Measure (POEM) and the Atopic Dermatitis Control Tool (ADCT) will also be measured throughout the study. The number of courses of treatment with rescue therapies; and with antibiotic treatment due to skin infection, per participant, will also be measured.
Interventions
DRUGEDP1815
EDP1815 is an orally administered, pharmaceutical preparation of a single strain of bacteria
Sponsors
Evelo Biosciences, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Open Label Extension Study.
Eligibility
Sex/Gender
ALL
Age
18 Years to 76 Years
Healthy volunteers
No
Inclusion criteria
1. Must have provided informed consent. 2. Must have completed the treatment period in a parent study of EDP1815 in atopic dermatitis and complied with the parent protocol. 3. Must agree to use emollients. 4. Must continue to follow contraception criteria.
Exclusion criteria
1. Participants who are currently enrolled in another investigational drug study or plans to receive another investigational drug during this study. 2. Have any other conditions, which would make the participant unsuitable for inclusion or could interfere with the participant participating in or completing the study. 3. Use of phototherapy, a biologic agent, or a systemic immunosuppressive agent that could affect AD, including systemic corticosteroids, within 7 days prior to Day -1, unless used as a rescue treatment as part of the parent study protocol. 4. Use of topical atopic dermatitis therapies, including topical corticosteroids, topical calcineurin inhibitors, topical PDE-4 inhibitors, and topical JAK inhibitors, within 7 days prior to enrolling in the study, unless used as a rescue treatment as part of the EDP1815-207 protocol. 5. Has received live or live-attenuated vaccination prior to enrollment or intends to have such a vaccination during the study. 6. Hypersensitivity to P histicola or to any of the excipients. 7. Unwillingness to comply with study procedures, including follow-up, as specified by this protocol, or unwillingness to cooperate fully with the Investigator.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence and Rate Per 100 Patient-years of Treatment-emergent Adverse Events | 40 weeks | The long-term safety and tolerability of EDP1815 in the treatment of atopic dermatitis will be measured by evaluating the incidence and rate per 100 patient-years of treatment-emergent adverse events during the 36-week treatment period and the 4-week follow-up period of this study, and during the treatment period of this study and the relevant parent study. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Achieving EASI-75 | 40 weeks | The efficacy of long-term treatment with EDP1815 in the treatment of Atopic Dermatitis will be measured using the following EASI endpoints: • Percentage of participants achieving EASI-75 |
| Percentage of Participants Achieving EASI-90 | 40 weeks | The efficacy of long-term treatment with EDP1815 in the treatment of Atopic Dermatitis will be measured using the following EASI endpoints: • Percentage of participants achieving EASI-90 |
| Mean Absolute Change From Baseline in EASI Score | 40 weeks | The efficacy of long-term treatment with EDP1815 in the treatment of Atopic Dermatitis will be measured using the following EASI endpoints: • Mean absolute change from baseline in EASI Score |
| Mean Percentage Change From Baseline in EASI Score | 40 weeks | The efficacy of long-term treatment with EDP1815 in the treatment of Atopic Dermatitis will be measured using the following EASI endpoints: • Mean percentage change from baseline in EASI Score |
| Percentage of Participants Achieving IGA of 0 or 1 With a ≥2 Point Improvement From Baseline | 40 weeks | The efficacy of long-term treatment with EDP1815 in the treatment of Atopic Dermatitis will be measured using the following IGA endpoints: • Percentage of participants achieving IGA of 0 or 1 with a ≥2 point improvement from baseline |
| Percentage of Participants Achieving IGA of 0 or 1 | 40 weeks | The efficacy of long-term treatment with EDP1815 in the treatment of Atopic Dermatitis will be measured using the following IGA endpoints: • Percentage of participants achieving IGA of 0 or 1 |
| Percentage of Participants Achieving IGA of 0 | 40 weeks | The efficacy of long-term treatment with EDP1815 in the treatment of Atopic Dermatitis will be measured using the following IGA endpoints: • Percentage of participants achieving IGA of 0 |
| Mean Absolute Change From Baseline in IGA*BSA | 40 weeks | The efficacy of long-term treatment with EDP1815 in the treatment of Atopic Dermatitis will be measured using the following IGA \*BSA endpoints: • Mean absolute change from baseline in IGA\*BSA |
| Mean Percentage Change From Baseline in IGA*BSA | 40 weeks | The efficacy of long-term treatment with EDP1815 in the treatment of Atopic Dermatitis will be measured using the following IGA \*BSA endpoints: • Mean percentage change from baseline in IGA\*BSA |
| Mean Absolute Change From Baseline in BSA | 40 weeks | The efficacy of long-term treatment with EDP1815 in the treatment of Atopic Dermatitis will be measured using the following IGA \*BSA endpoints: • Mean absolute change from baseline in BSA |
| Mean Percentage Change From Baseline in BSA | 40 weeks | The efficacy of long-term treatment with EDP1815 in the treatment of Atopic Dermatitis will be measured using the following IGA \*BSA endpoints: • Mean percentage change from baseline in BSA |
| Percentage of Participants Achieving BSA-50 | 40 weeks | The efficacy of long-term treatment with EDP1815 in the treatment of Atopic Dermatitis will be measured using the following IGA \*BSA endpoints: • Percentage of participants achieving BSA-50 |
| Percentage of Participants Achieving BSA-75 | 40 weeks | The efficacy of long-term treatment with EDP1815 in the treatment of Atopic Dermatitis will be measured using the following BSA endpoints: • Percentage of participants achieving BSA-75 |
| Percentage of Participants Achieving BSA Reduction to 3% or Less | 40 weeks | The efficacy of long-term treatment with EDP1815 in the treatment of Atopic Dermatitis will be measured using the following IGA \*BSA endpoints: • Percentage of participants achieving BSA reduction to 3% or less |
| Mean Absolute Change From Baseline in SCORAD | 40 weeks | The efficacy of long-term treatment with EDP1815 in the treatment of Atopic Dermatitis will be measured using the following SCORAD endpoints: • Mean absolute change from baseline in SCORAD |
| Mean Percentage Change From Baseline in SCORAD | 40 weeks | The efficacy of long-term treatment with EDP1815 in the treatment of Atopic Dermatitis will be measured using the following SCORAD endpoints: • Mean percentage change from baseline in SCORAD |
| Percentage of Participants Achieving EASI-50 | 40 weeks | The efficacy of long-term treatment with EDP1815 in the treatment of Atopic Dermatitis will be measured using the following EASI endpoints: • Percentage of participants achieving EASI-50 |
| Percentage of Participants Achieving SCORAD-75 | 40 weeks | The efficacy of long-term treatment with EDP1815 in the treatment of Atopic Dermatitis will be measured using the following SCORAD endpoints: • Percentage of participants achieving SCORAD-75 |
| Mean Absolute Change From Baseline in DLQI | 40 weeks | The efficacy of long-term treatment with EDP1815 in the treatment of Atopic Dermatitis will be measured using the following DLQI endpoints: • Mean absolute change from baseline in DLQI |
| Mean Percentage Change From Baseline in DLQI | 40 weeks | The efficacy of long-term treatment with EDP1815 in the treatment of Atopic Dermatitis will be measured using the following DLQI endpoints: • Mean percentage change from baseline in DLQI |
| Percentage of Participants Achieving a Reduction of ≥4 in the DLQI, of Those With a Score of ≥4 at Baseline | 40 weeks | The efficacy of long-term treatment with EDP1815 in the treatment of Atopic Dermatitis will be measured using the following DLQI endpoints: • Percentage of participants achieving a reduction of ≥4 in the DLQI, of those with a score of ≥4 at baseline |
| Mean Absolute Change From Baseline in PP-NRS | 40 weeks | The efficacy of long-term treatment with EDP1815 in the treatment of Atopic Dermatitis will be measured using the following PP-NRS endpoints: • Mean absolute change from baseline in PP-NRS |
| Percentage of Participants Achieving a Reduction of ≥2 in the PP-NRS, of Those With a Score of ≥2 at Baseline | 40 weeks | The efficacy of long-term treatment with EDP1815 in the treatment of Atopic Dermatitis will be measured using the following PP-NRS endpoints: • Percentage of participants achieving a reduction of ≥2 in the PP-NRS, of those with a score of ≥2 at baseline |
| Percentage of Participants Achieving a Reduction of ≥4 in the PP-NRS, of Those With a Score of ≥4 at Baseline | 40 weeks | The efficacy of long-term treatment with EDP1815 in the treatment of Atopic Dermatitis will be measured using the following PP-NRS endpoints: • Percentage of participants achieving a reduction of ≥4 in the PP-NRS, of those with a score of ≥4 at baseline |
| Mean Absolute Change From Baseline in SD-NRS | 40 weeks | The efficacy of long-term treatment with EDP1815 in the treatment of Atopic Dermatitis will be measured using the following SD-NRS endpoints: • Mean absolute change from baseline in SD-NRS |
| Percentage of Participants Achieving a Reduction of ≥2 in the SD NRS, of Those With a Score of ≥2 at Baseline | 40 weeks | The efficacy of long-term treatment with EDP1815 in the treatment of Atopic Dermatitis will be measured using the following SD-NRS endpoints: • Percentage of participants achieving a reduction of ≥2 in the SD NRS, of those with a score of ≥2 at baseline |
| Mean Absolute Change From Baseline in Patient Oriented Eczema Measure (POEM) | 40 weeks | The efficacy of long-term treatment with EDP1815 in the treatment of Atopic Dermatitis will be measured using the following POEM endpoints: • Mean absolute change from baseline in Patient Oriented Eczema Measure (POEM) |
| Mean Percentage Change From Baseline in Patient Oriented Eczema Measure (POEM) | 40 weeks | The efficacy of long-term treatment with EDP1815 in the treatment of Atopic Dermatitis will be measured using the following POEM endpoints: • Mean percentage change from baseline in Patient Oriented Eczema Measure (POEM) |
| Percentage of Participants Achieving a Reduction of ≥4 in the POEM Score, of Those With a Score of ≥4 at Baseline | 40 weeks | The efficacy of long-term treatment with EDP1815 in the treatment of Atopic Dermatitis will be measured using the following POEM endpoints: • Percentage of participants achieving a reduction of ≥4 in the POEM score, of those with a score of ≥4 at baseline |
| Number of Courses Per Patient-year of Any Rescue Medication (Not Including Antibacterial Therapy) | 40 weeks | The efficacy of long-term treatment with EDP1815 in the treatment of Atopic Dermatitis will be measured using the following Rescue therapy use endpoints: • Number of courses per patient-year of any rescue medication (not including antibacterial therapy) |
| Number of Courses Per Patient-year of Topical Corticosteroids of Any Potency | 40 weeks | The efficacy of long-term treatment with EDP1815 in the treatment of Atopic Dermatitis will be measured using the following Rescue therapy use endpoints: • Number of courses per patient-year of topical corticosteroids of any potency |
| Number of Courses Per Patient-year of Topical Tacrolimus (0.1%), Topical Pimecrolimus (1%) or Grade VII Topical Corticosteroid | 40 weeks | The efficacy of long-term treatment with EDP1815 in the treatment of Atopic Dermatitis will be measured using the following Rescue therapy use endpoints: • Number of courses per patient-year of topical tacrolimus (0.1%), topical pimecrolimus (1%) or grade VII topical corticosteroid |
| Number of Courses Per Patient Year of Moderate Potency (Grade IV and V) Topical Steroids | 40 weeks | The efficacy of long-term treatment with EDP1815 in the treatment of Atopic Dermatitis will be measured using the following Rescue therapy use endpoints: • Number of courses per patient year of moderate potency (grade IV and V) topical steroids |
| Percentage of Participants Achieving SCORAD-50 | 40 weeks | The efficacy of long-term treatment with EDP1815 in the treatment of Atopic Dermatitis will be measured using the following SCORAD endpoints: • Percentage of participants achieving SCORAD-50 |
Countries
Australia, Bulgaria, Canada, Germany, Poland, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Group 1 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. | 104 |
| Group 2 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. | 102 |
| Group 3 Participants with mild, moderate or severe Atopic Dermatitis who received 1 capsule (8.0 x 10\^10 total cells) of EDP1815 (an orally administered, pharmaceutical preparation of a single strain of bacteria) once daily. | 79 |
| Total | 285 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Adverse Event | 1 | 3 | 0 |
| Overall Study | Adverse Event - Parent Study | 1 | 0 | 0 |
| Overall Study | Lack of Efficacy | 8 | 5 | 3 |
| Overall Study | Lost to Follow-up | 2 | 2 | 0 |
| Overall Study | Non-Compliance | 1 | 1 | 1 |
| Overall Study | Other than Reasons Listed | 2 | 1 | 0 |
| Overall Study | Physician Decision | 1 | 0 | 0 |
| Overall Study | Pregnancy | 1 | 0 | 0 |
| Overall Study | Treatment Failure | 0 | 1 | 0 |
| Overall Study | Trial Termination by Sponsor | 78 | 83 | 65 |
| Overall Study | Withdrawal by Subject | 9 | 6 | 10 |
Baseline characteristics
| Characteristic | Group 1 | Group 2 | Group 3 | Total |
|---|---|---|---|---|
| Age, Continuous | 40.0 years STANDARD_DEVIATION 16.28 | 40.6 years STANDARD_DEVIATION 14.05 | 39.4 years STANDARD_DEVIATION 14.66 | 40.0 years STANDARD_DEVIATION 15.02 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 6 Participants | 3 Participants | 4 Participants | 13 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 97 Participants | 98 Participants | 74 Participants | 269 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 1 Participants | 1 Participants | 1 Participants | 3 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 11 Participants | 12 Participants | 10 Participants | 33 Participants |
| Race (NIH/OMB) Black or African American | 7 Participants | 9 Participants | 10 Participants | 26 Participants |
| Race (NIH/OMB) More than one race | 3 Participants | 3 Participants | 2 Participants | 8 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 1 Participants | 0 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants | 1 Participants | 1 Participants | 3 Participants |
| Race (NIH/OMB) White | 81 Participants | 77 Participants | 56 Participants | 214 Participants |
| Region of Enrollment Australia | 4 participants | 4 participants | 1 participants | 9 participants |
| Region of Enrollment Bulgaria | 18 participants | 16 participants | 7 participants | 41 participants |
| Region of Enrollment Canada | 19 participants | 22 participants | 20 participants | 61 participants |
| Region of Enrollment Germany | 8 participants | 10 participants | 3 participants | 21 participants |
| Region of Enrollment Poland | 30 participants | 25 participants | 29 participants | 84 participants |
| Region of Enrollment United States | 25 participants | 25 participants | 19 participants | 69 participants |
| Sex: Female, Male Female | 53 Participants | 49 Participants | 45 Participants | 147 Participants |
| Sex: Female, Male Male | 51 Participants | 53 Participants | 34 Participants | 138 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 104 | 0 / 102 | 0 / 79 |
| other Total, other adverse events | 26 / 104 | 20 / 102 | 5 / 79 |
| serious Total, serious adverse events | 0 / 104 | 1 / 102 | 1 / 79 |
Outcome results
Primary
Incidence and Rate Per 100 Patient-years of Treatment-emergent Adverse Events
The long-term safety and tolerability of EDP1815 in the treatment of atopic dermatitis will be measured by evaluating the incidence and rate per 100 patient-years of treatment-emergent adverse events during the 36-week treatment period and the 4-week follow-up period of this study, and during the treatment period of this study and the relevant parent study.
Time frame: 40 weeks
Population: No participants reached the Week 40 timepoint for inclusion in the analysis as the study was terminated (halted early) as Parent Study (NCT05121480) did not meet the primary endpoint.
Secondary
Mean Absolute Change From Baseline in BSA
The efficacy of long-term treatment with EDP1815 in the treatment of Atopic Dermatitis will be measured using the following IGA \*BSA endpoints: • Mean absolute change from baseline in BSA
Time frame: 40 weeks
Population: No participants reached the Week 40 timepoint for inclusion in the analysis as the study was terminated (halted early) as Parent Study (NCT05121480) did not meet the primary endpoint.
Secondary
Mean Absolute Change From Baseline in DLQI
The efficacy of long-term treatment with EDP1815 in the treatment of Atopic Dermatitis will be measured using the following DLQI endpoints: • Mean absolute change from baseline in DLQI
Time frame: 40 weeks
Population: No participants reached the Week 40 timepoint for inclusion in the analysis as the study was terminated (halted early) as Parent Study (NCT05121480) did not meet the primary endpoint.
Secondary
Mean Absolute Change From Baseline in EASI Score
The efficacy of long-term treatment with EDP1815 in the treatment of Atopic Dermatitis will be measured using the following EASI endpoints: • Mean absolute change from baseline in EASI Score
Time frame: 40 weeks
Population: No participants reached the Week 40 timepoint for inclusion in the analysis as the study was terminated (halted early) as Parent Study (NCT05121480) did not meet the primary endpoint.
Secondary
Mean Absolute Change From Baseline in IGA*BSA
The efficacy of long-term treatment with EDP1815 in the treatment of Atopic Dermatitis will be measured using the following IGA \*BSA endpoints: • Mean absolute change from baseline in IGA\*BSA
Time frame: 40 weeks
Population: No participants reached the Week 40 timepoint for inclusion in the analysis as the study was terminated (halted early) as Parent Study (NCT05121480) did not meet the primary endpoint.
Secondary
Mean Absolute Change From Baseline in Patient Oriented Eczema Measure (POEM)
The efficacy of long-term treatment with EDP1815 in the treatment of Atopic Dermatitis will be measured using the following POEM endpoints: • Mean absolute change from baseline in Patient Oriented Eczema Measure (POEM)
Time frame: 40 weeks
Population: No participants reached the Week 40 timepoint for inclusion in the analysis as the study was terminated (halted early) as Parent Study (NCT05121480) did not meet the primary endpoint.
Secondary
Mean Absolute Change From Baseline in PP-NRS
The efficacy of long-term treatment with EDP1815 in the treatment of Atopic Dermatitis will be measured using the following PP-NRS endpoints: • Mean absolute change from baseline in PP-NRS
Time frame: 40 weeks
Population: No participants reached the Week 40 timepoint for inclusion in the analysis as the study was terminated (halted early) as Parent Study (NCT05121480) did not meet the primary endpoint.
Secondary
Mean Absolute Change From Baseline in SCORAD
The efficacy of long-term treatment with EDP1815 in the treatment of Atopic Dermatitis will be measured using the following SCORAD endpoints: • Mean absolute change from baseline in SCORAD
Time frame: 40 weeks
Population: No participants reached the Week 40 timepoint for inclusion in the analysis as the study was terminated (halted early) as Parent Study (NCT05121480) did not meet the primary endpoint.
Secondary
Mean Absolute Change From Baseline in SD-NRS
The efficacy of long-term treatment with EDP1815 in the treatment of Atopic Dermatitis will be measured using the following SD-NRS endpoints: • Mean absolute change from baseline in SD-NRS
Time frame: 40 weeks
Population: No participants reached the Week 40 timepoint for inclusion in the analysis as the study was terminated (halted early) as Parent Study (NCT05121480) did not meet the primary endpoint.
Secondary
Mean Percentage Change From Baseline in BSA
The efficacy of long-term treatment with EDP1815 in the treatment of Atopic Dermatitis will be measured using the following IGA \*BSA endpoints: • Mean percentage change from baseline in BSA
Time frame: 40 weeks
Population: No participants reached the Week 40 timepoint for inclusion in the analysis as the study was terminated (halted early) as Parent Study (NCT05121480) did not meet the primary endpoint.
Secondary
Mean Percentage Change From Baseline in DLQI
The efficacy of long-term treatment with EDP1815 in the treatment of Atopic Dermatitis will be measured using the following DLQI endpoints: • Mean percentage change from baseline in DLQI
Time frame: 40 weeks
Population: No participants reached the Week 40 timepoint for inclusion in the analysis as the study was terminated (halted early) as Parent Study (NCT05121480) did not meet the primary endpoint.
Secondary
Mean Percentage Change From Baseline in EASI Score
The efficacy of long-term treatment with EDP1815 in the treatment of Atopic Dermatitis will be measured using the following EASI endpoints: • Mean percentage change from baseline in EASI Score
Time frame: 40 weeks
Population: No participants reached the Week 40 timepoint for inclusion in the analysis as the study was terminated (halted early) as Parent Study (NCT05121480) did not meet the primary endpoint.
Secondary
Mean Percentage Change From Baseline in IGA*BSA
The efficacy of long-term treatment with EDP1815 in the treatment of Atopic Dermatitis will be measured using the following IGA \*BSA endpoints: • Mean percentage change from baseline in IGA\*BSA
Time frame: 40 weeks
Population: No participants reached the Week 40 timepoint for inclusion in the analysis as the study was terminated (halted early) as Parent Study (NCT05121480) did not meet the primary endpoint.
Secondary
Mean Percentage Change From Baseline in Patient Oriented Eczema Measure (POEM)
The efficacy of long-term treatment with EDP1815 in the treatment of Atopic Dermatitis will be measured using the following POEM endpoints: • Mean percentage change from baseline in Patient Oriented Eczema Measure (POEM)
Time frame: 40 weeks
Population: No participants reached the Week 40 timepoint for inclusion in the analysis as the study was terminated (halted early) as Parent Study (NCT05121480) did not meet the primary endpoint.
Secondary
Mean Percentage Change From Baseline in SCORAD
The efficacy of long-term treatment with EDP1815 in the treatment of Atopic Dermatitis will be measured using the following SCORAD endpoints: • Mean percentage change from baseline in SCORAD
Time frame: 40 weeks
Population: No participants reached the Week 40 timepoint for inclusion in the analysis as the study was terminated (halted early) as Parent Study (NCT05121480) did not meet the primary endpoint.
Secondary
Number of Courses Per Patient-year of Any Rescue Medication (Not Including Antibacterial Therapy)
The efficacy of long-term treatment with EDP1815 in the treatment of Atopic Dermatitis will be measured using the following Rescue therapy use endpoints: • Number of courses per patient-year of any rescue medication (not including antibacterial therapy)
Time frame: 40 weeks
Population: No participants reached the Week 40 timepoint for inclusion in the analysis as the study was terminated (halted early) as Parent Study (NCT05121480) did not meet the primary endpoint.
Secondary
Number of Courses Per Patient Year of Moderate Potency (Grade IV and V) Topical Steroids
The efficacy of long-term treatment with EDP1815 in the treatment of Atopic Dermatitis will be measured using the following Rescue therapy use endpoints: • Number of courses per patient year of moderate potency (grade IV and V) topical steroids
Time frame: 40 weeks
Population: No participants reached the Week 40 timepoint for inclusion in the analysis as the study was terminated (halted early) as Parent Study (NCT05121480) did not meet the primary endpoint.
Secondary
Number of Courses Per Patient-year of Topical Corticosteroids of Any Potency
The efficacy of long-term treatment with EDP1815 in the treatment of Atopic Dermatitis will be measured using the following Rescue therapy use endpoints: • Number of courses per patient-year of topical corticosteroids of any potency
Time frame: 40 weeks
Population: No participants reached the Week 40 timepoint for inclusion in the analysis as the study was terminated (halted early) as Parent Study (NCT05121480) did not meet the primary endpoint.
Secondary
Number of Courses Per Patient-year of Topical Tacrolimus (0.1%), Topical Pimecrolimus (1%) or Grade VII Topical Corticosteroid
The efficacy of long-term treatment with EDP1815 in the treatment of Atopic Dermatitis will be measured using the following Rescue therapy use endpoints: • Number of courses per patient-year of topical tacrolimus (0.1%), topical pimecrolimus (1%) or grade VII topical corticosteroid
Time frame: 40 weeks
Population: No participants reached the Week 40 timepoint for inclusion in the analysis as the study was terminated (halted early) as Parent Study (NCT05121480) did not meet the primary endpoint.
Secondary
Percentage of Participants Achieving a Reduction of ≥2 in the PP-NRS, of Those With a Score of ≥2 at Baseline
The efficacy of long-term treatment with EDP1815 in the treatment of Atopic Dermatitis will be measured using the following PP-NRS endpoints: • Percentage of participants achieving a reduction of ≥2 in the PP-NRS, of those with a score of ≥2 at baseline
Time frame: 40 weeks
Population: No participants reached the Week 40 timepoint for inclusion in the analysis as the study was terminated (halted early) as Parent Study (NCT05121480) did not meet the primary endpoint.
Secondary
Percentage of Participants Achieving a Reduction of ≥2 in the SD NRS, of Those With a Score of ≥2 at Baseline
The efficacy of long-term treatment with EDP1815 in the treatment of Atopic Dermatitis will be measured using the following SD-NRS endpoints: • Percentage of participants achieving a reduction of ≥2 in the SD NRS, of those with a score of ≥2 at baseline
Time frame: 40 weeks
Population: No participants reached the Week 40 timepoint for inclusion in the analysis as the study was terminated (halted early) as Parent Study (NCT05121480) did not meet the primary endpoint.
Secondary
Percentage of Participants Achieving a Reduction of ≥4 in the DLQI, of Those With a Score of ≥4 at Baseline
The efficacy of long-term treatment with EDP1815 in the treatment of Atopic Dermatitis will be measured using the following DLQI endpoints: • Percentage of participants achieving a reduction of ≥4 in the DLQI, of those with a score of ≥4 at baseline
Time frame: 40 weeks
Population: No participants reached the Week 40 timepoint for inclusion in the analysis as the study was terminated (halted early) as Parent Study (NCT05121480) did not meet the primary endpoint.
Secondary
Percentage of Participants Achieving a Reduction of ≥4 in the POEM Score, of Those With a Score of ≥4 at Baseline
The efficacy of long-term treatment with EDP1815 in the treatment of Atopic Dermatitis will be measured using the following POEM endpoints: • Percentage of participants achieving a reduction of ≥4 in the POEM score, of those with a score of ≥4 at baseline
Time frame: 40 weeks
Population: No participants reached the Week 40 timepoint for inclusion in the analysis as the study was terminated (halted early) as Parent Study (NCT05121480) did not meet the primary endpoint.
Secondary
Percentage of Participants Achieving a Reduction of ≥4 in the PP-NRS, of Those With a Score of ≥4 at Baseline
The efficacy of long-term treatment with EDP1815 in the treatment of Atopic Dermatitis will be measured using the following PP-NRS endpoints: • Percentage of participants achieving a reduction of ≥4 in the PP-NRS, of those with a score of ≥4 at baseline
Time frame: 40 weeks
Population: No participants reached the Week 40 timepoint for inclusion in the analysis as the study was terminated (halted early) as Parent Study (NCT05121480) did not meet the primary endpoint.
Secondary
Percentage of Participants Achieving BSA-50
The efficacy of long-term treatment with EDP1815 in the treatment of Atopic Dermatitis will be measured using the following IGA \*BSA endpoints: • Percentage of participants achieving BSA-50
Time frame: 40 weeks
Population: No participants reached the Week 40 timepoint for inclusion in the analysis as the study was terminated (halted early) as Parent Study (NCT05121480) did not meet the primary endpoint.
Secondary
Percentage of Participants Achieving BSA-75
The efficacy of long-term treatment with EDP1815 in the treatment of Atopic Dermatitis will be measured using the following BSA endpoints: • Percentage of participants achieving BSA-75
Time frame: 40 weeks
Population: No participants reached the Week 40 timepoint for inclusion in the analysis as the study was terminated (halted early) as Parent Study (NCT05121480) did not meet the primary endpoint.
Secondary
Percentage of Participants Achieving BSA Reduction to 3% or Less
The efficacy of long-term treatment with EDP1815 in the treatment of Atopic Dermatitis will be measured using the following IGA \*BSA endpoints: • Percentage of participants achieving BSA reduction to 3% or less
Time frame: 40 weeks
Population: No participants reached the Week 40 timepoint for inclusion in the analysis as the study was terminated (halted early) as Parent Study (NCT05121480) did not meet the primary endpoint.
Secondary
Percentage of Participants Achieving EASI-50
The efficacy of long-term treatment with EDP1815 in the treatment of Atopic Dermatitis will be measured using the following EASI endpoints: • Percentage of participants achieving EASI-50
Time frame: 40 weeks
Population: No participants reached the Week 40 timepoint for inclusion in the analysis as the study was terminated (halted early) as Parent Study (NCT05121480) did not meet the primary endpoint.
Secondary
Percentage of Participants Achieving EASI-75
The efficacy of long-term treatment with EDP1815 in the treatment of Atopic Dermatitis will be measured using the following EASI endpoints: • Percentage of participants achieving EASI-75
Time frame: 40 weeks
Population: No participants reached the Week 40 timepoint for inclusion in the analysis as the study was terminated (halted early) as Parent Study (NCT05121480) did not meet the primary endpoint.
Secondary
Percentage of Participants Achieving EASI-90
The efficacy of long-term treatment with EDP1815 in the treatment of Atopic Dermatitis will be measured using the following EASI endpoints: • Percentage of participants achieving EASI-90
Time frame: 40 weeks
Population: No participants reached the Week 40 timepoint for inclusion in the analysis as the study was terminated (halted early) as Parent Study (NCT05121480) did not meet the primary endpoint.
Secondary
Percentage of Participants Achieving IGA of 0
The efficacy of long-term treatment with EDP1815 in the treatment of Atopic Dermatitis will be measured using the following IGA endpoints: • Percentage of participants achieving IGA of 0
Time frame: 40 weeks
Population: No participants reached the Week 40 timepoint for inclusion in the analysis as the study was terminated (halted early) as Parent Study (NCT05121480) did not meet the primary endpoint.
Secondary
Percentage of Participants Achieving IGA of 0 or 1
The efficacy of long-term treatment with EDP1815 in the treatment of Atopic Dermatitis will be measured using the following IGA endpoints: • Percentage of participants achieving IGA of 0 or 1
Time frame: 40 weeks
Population: No participants reached the Week 40 timepoint for inclusion in the analysis as the study was terminated (halted early) as Parent Study (NCT05121480) did not meet the primary endpoint.
Secondary
Percentage of Participants Achieving IGA of 0 or 1 With a ≥2 Point Improvement From Baseline
The efficacy of long-term treatment with EDP1815 in the treatment of Atopic Dermatitis will be measured using the following IGA endpoints: • Percentage of participants achieving IGA of 0 or 1 with a ≥2 point improvement from baseline
Time frame: 40 weeks
Population: No participants reached the Week 40 timepoint for inclusion in the analysis as the study was terminated (halted early) as Parent Study (NCT05121480) did not meet the primary endpoint.
Secondary
Percentage of Participants Achieving SCORAD-50
The efficacy of long-term treatment with EDP1815 in the treatment of Atopic Dermatitis will be measured using the following SCORAD endpoints: • Percentage of participants achieving SCORAD-50
Time frame: 40 weeks
Population: No participants reached the Week 40 timepoint for inclusion in the analysis as the study was terminated (halted early) as Parent Study (NCT05121480) did not meet the primary endpoint.
Secondary
Percentage of Participants Achieving SCORAD-75
The efficacy of long-term treatment with EDP1815 in the treatment of Atopic Dermatitis will be measured using the following SCORAD endpoints: • Percentage of participants achieving SCORAD-75
Time frame: 40 weeks
Population: No participants reached the Week 40 timepoint for inclusion in the analysis as the study was terminated (halted early) as Parent Study (NCT05121480) did not meet the primary endpoint.