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| ID | Type | Description | Link |
|---|---|---|---|
| 2022-000284-48 | EudraCT Number |
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Parent Study (NCT05121480) did not meet the primary endpoint.
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 (1.6x10^11 total cells of EDP1815, 2 capsules once daily) | Experimental | EDP1815-207 Cohort 1 participants will receive 1.6x10^11 total cells of EDP1815 in EDP1815-208 administered as 2 capsules once daily. (Group 1) |
|
| Group 2 (6.4x10^11 total cells of EDP1815, 2 capsules once daily) | Experimental | EDP1815-207 Cohort 2 participants will receive 6.4x10^11 total cells of EDP1815 in EDP1815-208 administered as 2 capsules once daily. (Group 2) |
|
| Group 3 (8.0x10^10 total cells of EDP1815, 1 capsule once daily) | Experimental | EDP1815-207 Cohort 4 participants will receive 8.0x10^10 total cells of EDP1815 in EDP1815-208 administered as 1 capsule once daily. (Group 3) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| EDP1815 | Drug | EDP1815 is an orally administered, pharmaceutical preparation of a single strain of bacteria |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 40 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 40 weeks |
| Percentage of Participants Achieving EASI-75 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Douglas Maslin, MD | Evelo Biosciences | Study Director |
| Ben Ehst, PhD | Oregon Medical Research Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| USA-131 | Birmingham | Alabama | 35244 | United States | ||
| USA 112 |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | Group 2 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | May 16, 2022 | Jun 8, 2023 |
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Open Label Extension Study.
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|
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 |
| 40 weeks |
| Percentage of Participants Achieving EASI-90 | The efficacy of long-term treatment with EDP1815 in the treatment of Atopic Dermatitis will be measured using the following EASI endpoints: • Percentage of participants achieving EASI-90 | 40 weeks |
| Mean Absolute Change From Baseline in EASI Score | The efficacy of long-term treatment with EDP1815 in the treatment of Atopic Dermatitis will be measured using the following EASI endpoints: • Mean absolute change from baseline in EASI Score | 40 weeks |
| Mean Percentage Change From Baseline in EASI Score | The efficacy of long-term treatment with EDP1815 in the treatment of Atopic Dermatitis will be measured using the following EASI endpoints: • Mean percentage change from baseline in EASI Score | 40 weeks |
| Percentage of Participants Achieving IGA of 0 or 1 With a ≥2 Point Improvement From Baseline | The efficacy of long-term treatment with EDP1815 in the treatment of Atopic Dermatitis will be measured using the following IGA endpoints: • Percentage of participants achieving IGA of 0 or 1 with a ≥2 point improvement from baseline | 40 weeks |
| Percentage of Participants Achieving IGA of 0 or 1 | The efficacy of long-term treatment with EDP1815 in the treatment of Atopic Dermatitis will be measured using the following IGA endpoints: • Percentage of participants achieving IGA of 0 or 1 | 40 weeks |
| Percentage of Participants Achieving IGA of 0 | The efficacy of long-term treatment with EDP1815 in the treatment of Atopic Dermatitis will be measured using the following IGA endpoints: • Percentage of participants achieving IGA of 0 | 40 weeks |
| Mean Absolute Change From Baseline in IGA*BSA | The efficacy of long-term treatment with EDP1815 in the treatment of Atopic Dermatitis will be measured using the following IGA *BSA endpoints: • Mean absolute change from baseline in IGA*BSA | 40 weeks |
| Mean Percentage Change From Baseline in IGA*BSA | The efficacy of long-term treatment with EDP1815 in the treatment of Atopic Dermatitis will be measured using the following IGA *BSA endpoints: • Mean percentage change from baseline in IGA*BSA | 40 weeks |
| Mean Absolute Change From Baseline in BSA | The efficacy of long-term treatment with EDP1815 in the treatment of Atopic Dermatitis will be measured using the following IGA *BSA endpoints: • Mean absolute change from baseline in BSA | 40 weeks |
| Mean Percentage Change From Baseline in BSA | The efficacy of long-term treatment with EDP1815 in the treatment of Atopic Dermatitis will be measured using the following IGA *BSA endpoints: • Mean percentage change from baseline in BSA | 40 weeks |
| Percentage of Participants Achieving BSA-50 | The efficacy of long-term treatment with EDP1815 in the treatment of Atopic Dermatitis will be measured using the following IGA *BSA endpoints: • Percentage of participants achieving BSA-50 | 40 weeks |
| Percentage of Participants Achieving BSA-75 | The efficacy of long-term treatment with EDP1815 in the treatment of Atopic Dermatitis will be measured using the following BSA endpoints: • Percentage of participants achieving BSA-75 | 40 weeks |
| Percentage of Participants Achieving BSA Reduction to 3% or Less | The efficacy of long-term treatment with EDP1815 in the treatment of Atopic Dermatitis will be measured using the following IGA *BSA endpoints: • Percentage of participants achieving BSA reduction to 3% or less | 40 weeks |
| Mean Absolute Change From Baseline in SCORAD | The efficacy of long-term treatment with EDP1815 in the treatment of Atopic Dermatitis will be measured using the following SCORAD endpoints: • Mean absolute change from baseline in SCORAD | 40 weeks |
| Mean Percentage Change From Baseline in SCORAD | The efficacy of long-term treatment with EDP1815 in the treatment of Atopic Dermatitis will be measured using the following SCORAD endpoints: • Mean percentage change from baseline in SCORAD | 40 weeks |
| Percentage of Participants Achieving SCORAD-50 | The efficacy of long-term treatment with EDP1815 in the treatment of Atopic Dermatitis will be measured using the following SCORAD endpoints: • Percentage of participants achieving SCORAD-50 | 40 weeks |
| Percentage of Participants Achieving SCORAD-75 | The efficacy of long-term treatment with EDP1815 in the treatment of Atopic Dermatitis will be measured using the following SCORAD endpoints: • Percentage of participants achieving SCORAD-75 | 40 weeks |
| Mean Absolute Change From Baseline in DLQI | The efficacy of long-term treatment with EDP1815 in the treatment of Atopic Dermatitis will be measured using the following DLQI endpoints: • Mean absolute change from baseline in DLQI | 40 weeks |
| Mean Percentage Change From Baseline in DLQI | The efficacy of long-term treatment with EDP1815 in the treatment of Atopic Dermatitis will be measured using the following DLQI endpoints: • Mean percentage change from baseline in DLQI | 40 weeks |
| Percentage of Participants Achieving a Reduction of ≥4 in the DLQI, of Those With a Score of ≥4 at Baseline | The efficacy of long-term treatment with EDP1815 in the treatment of Atopic Dermatitis will be measured using the following DLQI endpoints: • Percentage of participants achieving a reduction of ≥4 in the DLQI, of those with a score of ≥4 at baseline | 40 weeks |
| Mean Absolute Change From Baseline in PP-NRS | The efficacy of long-term treatment with EDP1815 in the treatment of Atopic Dermatitis will be measured using the following PP-NRS endpoints: • Mean absolute change from baseline in PP-NRS | 40 weeks |
| Percentage of Participants Achieving a Reduction of ≥2 in the PP-NRS, of Those With a Score of ≥2 at Baseline | The efficacy of long-term treatment with EDP1815 in the treatment of Atopic Dermatitis will be measured using the following PP-NRS endpoints: • Percentage of participants achieving a reduction of ≥2 in the PP-NRS, of those with a score of ≥2 at baseline | 40 weeks |
| Percentage of Participants Achieving a Reduction of ≥4 in the PP-NRS, of Those With a Score of ≥4 at Baseline | The efficacy of long-term treatment with EDP1815 in the treatment of Atopic Dermatitis will be measured using the following PP-NRS endpoints: • Percentage of participants achieving a reduction of ≥4 in the PP-NRS, of those with a score of ≥4 at baseline | 40 weeks |
| Mean Absolute Change From Baseline in SD-NRS | The efficacy of long-term treatment with EDP1815 in the treatment of Atopic Dermatitis will be measured using the following SD-NRS endpoints: • Mean absolute change from baseline in SD-NRS | 40 weeks |
| Percentage of Participants Achieving a Reduction of ≥2 in the SD NRS, of Those With a Score of ≥2 at Baseline | The efficacy of long-term treatment with EDP1815 in the treatment of Atopic Dermatitis will be measured using the following SD-NRS endpoints: • Percentage of participants achieving a reduction of ≥2 in the SD NRS, of those with a score of ≥2 at baseline | 40 weeks |
| Mean Absolute Change From Baseline in Patient Oriented Eczema Measure (POEM) | The efficacy of long-term treatment with EDP1815 in the treatment of Atopic Dermatitis will be measured using the following POEM endpoints: • Mean absolute change from baseline in Patient Oriented Eczema Measure (POEM) | 40 weeks |
| Mean Percentage Change From Baseline in Patient Oriented Eczema Measure (POEM) | The efficacy of long-term treatment with EDP1815 in the treatment of Atopic Dermatitis will be measured using the following POEM endpoints: • Mean percentage change from baseline in Patient Oriented Eczema Measure (POEM) | 40 weeks |
| Percentage of Participants Achieving a Reduction of ≥4 in the POEM Score, of Those With a Score of ≥4 at Baseline | The efficacy of long-term treatment with EDP1815 in the treatment of Atopic Dermatitis will be measured using the following POEM endpoints: • Percentage of participants achieving a reduction of ≥4 in the POEM score, of those with a score of ≥4 at baseline | 40 weeks |
| Number of Courses Per Patient-year of Any Rescue Medication (Not Including Antibacterial Therapy) | The efficacy of long-term treatment with EDP1815 in the treatment of Atopic Dermatitis will be measured using the following Rescue therapy use endpoints: • Number of courses per patient-year of any rescue medication (not including antibacterial therapy) | 40 weeks |
| Number of Courses Per Patient-year of Topical Corticosteroids of Any Potency | The efficacy of long-term treatment with EDP1815 in the treatment of Atopic Dermatitis will be measured using the following Rescue therapy use endpoints: • Number of courses per patient-year of topical corticosteroids of any potency | 40 weeks |
| Number of Courses Per Patient-year of Topical Tacrolimus (0.1%), Topical Pimecrolimus (1%) or Grade VII Topical Corticosteroid | The efficacy of long-term treatment with EDP1815 in the treatment of Atopic Dermatitis will be measured using the following Rescue therapy use endpoints: • Number of courses per patient-year of topical tacrolimus (0.1%), topical pimecrolimus (1%) or grade VII topical corticosteroid | 40 weeks |
| Number of Courses Per Patient Year of Moderate Potency (Grade IV and V) Topical Steroids | The efficacy of long-term treatment with EDP1815 in the treatment of Atopic Dermatitis will be measured using the following Rescue therapy use endpoints: • Number of courses per patient year of moderate potency (grade IV and V) topical steroids | 40 weeks |
| Fountain Valley |
| California |
| 92708 |
| United States |
| USA 123 | Fremont | California | 94538 | United States |
| USA -101 | Fort Lauderdale | Florida | 33308 | United States |
| USA-124 | Jacksonville | Florida | 32216 | United States |
| USA-108 | Miami | Florida | 33165 | United States |
| USA-120 | Miami | Florida | 33175 | United States |
| USA-105 | Miramar | Florida | 33027 | United States |
| USA-102 | Orlando | Florida | 32801 | United States |
| USA-115 | Sweetwater | Florida | 33172 | United States |
| USA-106 | Tampa | Florida | 33613 | United States |
| USA-126 | Tampa | Florida | 33613 | United States |
| USA-111 | Clarksville | Indiana | 47129 | United States |
| USA-116 | Louisville | Kentucky | 40241 | United States |
| USA-119 | Baton Rouge | Louisiana | 70806 | United States |
| USA-109 | Metairie | Louisiana | 70006 | United States |
| USA-125 | Silver Spring | Maryland | 20902 | United States |
| USA-121 | Columbus | Ohio | 43221 | United States |
| USA-128 | Concord | Ohio | 44077 | United States |
| USA-104 | Portland | Oregon | 97239 | United States |
| USA-127 | Memphis | Tennessee | 38119 | United States |
| USA-117 | Frisco | Texas | 75034 | United States |
| USA-110 | Pflugerville | Texas | 78660 | United States |
| USA-113 | Bellevue | Washington | 98004 | United States |
| AUS-102 | Carlton | Australia |
| AUS-104 | Kogarah | Australia |
| AUS-101 | Melbourne | Australia |
| AUS-106 | Woolloongabba | Australia |
| BGR-105 | Pleven | Bulgaria |
| BGR-104 | Sevlievo | Bulgaria |
| BGR-101 | Sofia | Bulgaria |
| BGR-103 | Sofia | Bulgaria |
| CAN-109 | Barrie | Canada |
| CAN-108 | Edmonton | Canada |
| CAN-105 | Markham | Canada |
| CAN-104 | Mississauga | Canada |
| CAN-101 | Ottawa | Canada |
| CAN-107 | Richmond Hill | Canada |
| CAN-103 | Surrey | Canada |
| CAN-106 | Waterloo | Canada |
| CAN-111 | Winnipeg | Canada |
| DEU-105 | Berlin | Germany |
| DEU-106 | Erlangen | Germany |
| DEU-102 | Frankfurt am Main | Germany |
| DEU-104 | Gera | Germany |
| DEU-101 | Hamburg | Germany |
| DEU-103 | Heidelberg | Germany |
| POL-104 | Gdansk | Poland |
| POL-106 | Gdynia | Poland |
| POL-107 | Katowice | Poland |
| POL-105 | Lodz | Poland |
| POL-101 | Lublin | Poland |
| POL-102 | Warsaw | Poland |
| POL-103 | Wroclaw | Poland |
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. |
| FG002 | 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. |
| COMPLETED |
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| NOT COMPLETED |
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|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 | 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. |
| BG002 | 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. |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Number | participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | 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. | Posted | 40 weeks |
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| 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 | 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. | Posted | 40 weeks |
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| 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 | 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. | Posted | 40 weeks |
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| 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 | 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. | Posted | 40 weeks |
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| 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 | 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. | Posted | 40 weeks |
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| 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 | 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. | Posted | 40 weeks |
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| 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 | 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. | Posted | 40 weeks |
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| 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 | 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. | Posted | 40 weeks |
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| 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 | 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. | Posted | 40 weeks |
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| 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 | 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. | Posted | 40 weeks |
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| 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 | 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. | Posted | 40 weeks |
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| 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 | 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. | Posted | 40 weeks |
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| 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 | 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. | Posted | 40 weeks |
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| 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 | 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. | Posted | 40 weeks |
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| 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 | 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. | Posted | 40 weeks |
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| 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 | 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. | Posted | 40 weeks |
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| 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 | 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. | Posted | 40 weeks |
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| 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 | 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. | Posted | 40 weeks |
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| 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 | 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. | Posted | 40 weeks |
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| 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 | 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. | Posted | 40 weeks |
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| 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 | 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. | Posted | 40 weeks |
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| 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 | 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. | Posted | 40 weeks |
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| 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 | 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. | Posted | 40 weeks |
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| 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 | 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. | Posted | 40 weeks |
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| 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 | 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. | Posted | 40 weeks |
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| 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 | 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. | Posted | 40 weeks |
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| 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 | 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. | Posted | 40 weeks |
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| 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 | 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. | Posted | 40 weeks |
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| 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) | 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. | Posted | 40 weeks |
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| 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) | 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. | Posted | 40 weeks |
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| 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 | 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. | Posted | 40 weeks |
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| 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) | 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. | Posted | 40 weeks |
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| 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 | 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. | Posted | 40 weeks |
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| 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 | 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. | Posted | 40 weeks |
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| 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 | 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. | Posted | 40 weeks |
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Adverse events (AEs) were collected from informed consent, during the treatment period (110 days on average) and through an additional 28 days after taking their last dose of study drug.
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. | 0 | 104 | 0 | 104 | 26 | 104 |
| EG001 | 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. | 0 | 102 | 1 | 102 | 20 | 102 |
| EG002 | 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. | 0 | 79 | 1 | 79 | 5 | 79 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hypertension Exacerbation | Vascular disorders | MedDRA 25.1 | Systematic Assessment |
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| Abortion Spontaneous | Pregnancy, puerperium and perinatal conditions | MedDRA 25.1 | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nasopharyngitis | Infections and infestations | MedDRA 25.1 | Systematic Assessment |
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| Upper respiratory tract infection | Infections and infestations | MedDRA 25.1 | Systematic Assessment |
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| COVID-19 | Infections and infestations | MedDRA 25.1 | Systematic Assessment |
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| Dermatitis atopic | Skin and subcutaneous tissue disorders | MedDRA 25.1 | Systematic Assessment |
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After completion of the study, the data may be considered for reporting at a scientific meeting or for publication in a scientific journal. The sponsor has final approved authority over publication of the study data.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Duncan McHale, MBBS, MRCP, PhD | Evelo Biosciences, Inc | +447500128938 | duncan@evelobio.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jun 7, 2023 | Jun 12, 2023 | SAP_001.pdf |
Not provided
| ID | Term |
|---|---|
| D003876 | Dermatitis, Atopic |
| D004485 | Eczema |
| ID | Term |
|---|---|
| D012873 | Skin Diseases, Genetic |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D003872 | Dermatitis |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D017443 | Skin Diseases, Eczematous |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
Not provided
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| Male |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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| United States |
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| Poland |
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| Australia |
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| Bulgaria |
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| Germany |
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