Outcome
| Type |
Measure |
Description |
Time frame |
Safety issue |
| 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. |
16 weeks |
|
| 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. |
4, 8 and 12 weeks |
|
| 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. |
4, 8, 12, and 16 weeks |
|
| 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. |
4, 8, 12, and 16 weeks |
|
| 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. |
4, 8, 12, and 16 weeks |
|
| 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. |
4, 8, 12, and 16 weeks |
|
| 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 |
4, 8, 12, and 16 weeks |
|
| 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 |
4, 8, 12, and 16 weeks |
|
| 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 |
16 weeks |
|
| 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. |
4, 8, 12, and 16 weeks |
|
| 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. |
4, 8, 12, and 16 weeks |
|
| 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. |
4, 8, 12, and 16 weeks |
|
| 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. |
4, 8, 12, and 16 weeks |
|
| 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 |
4, 8, 12, and 16 weeks |
|
| 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 |
4, 8, 12, and 16 weeks |
|
| 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 |
4, 8, 12, and 16 weeks |
|
| 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. |
4, 8, 12, and 16 weeks |
|
| 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. |
4, 8, 12, and 16 weeks |
|
| 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 |
4, 8, 12, and 16 weeks |
|
| 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 |
4, 8, 12, and 16 weeks |
|
| 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. |
4, 8, 12, and 16 weeks |
|
| 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. |
4, 8, 12, and 16 weeks |
|
| 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. |
16 weeks |
|
| 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. |
4, 8, 12, and 16 weeks |
|
| 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. |
4, 8, 12, and 16 weeks |
|
| 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. |
16 weeks |
|
| 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. |
4, 8, 12, and 16 weeks |
|
| 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. |
16 weeks |
|
| 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. |
4, 8, 12, and 16 weeks |
|
| 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. |
4, 8, 12, and 16 weeks |
|
| 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. |
16 weeks |
|
| 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 |
4, 8, 12, and 16 weeks |
|
| 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 |
16 weeks |
|
| 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 |
4, 8, 12, and 16 weeks |
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