Trial Outcomes & Findings for A Study Investigating the Effect of EDP1815 in the Treatment of Mild, Moderate and Severe Atopic Dermatitis (NCT NCT05121480)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

421 participants

Primary outcome timeframe

16 weeks

Results posted on

2023-08-16

Participant Flow

Participant milestones

Participant milestones
Measure	Cohort 1 - Placebo Participants with mild, moderate or severe Atopic Dermatitis who received placebo oral capsules.	Cohort 1 - Active Participants with mild, moderate or severe Atopic Dermatitis who received 2 capsules (1.6 x 10\^11 total cells) of EDP1815 (an orally administered, pharmaceutical preparation of a single strain of bacteria) once daily for 16 weeks.	Cohort 2 - Placebo Participants with mild, moderate or severe Atopic Dermatitis who received placebo oral capsules.	Cohort 2 - Active Participants with mild, moderate or severe Atopic Dermatitis who received 2 capsules (6.4 x 10\^11 total cells) of EDP1815 (an orally administered, pharmaceutical preparation of a single strain of bacteria) once daily for 16 weeks.	Cohort 3 - Placebo Participants with mild, moderate or severe Atopic Dermatitis who received placebo oral capsules.	Cohort 3 - Active Participants with mild, moderate or severe Atopic Dermatitis who received 1 capsule (3.2 x 10\^11 cells) twice daily (6.4 x 10\^11 total cells) of EDP1815 (an orally administered, pharmaceutical preparation of a single strain of bacteria) once daily for 16 weeks.	Cohort 4 - Placebo Participants with mild, moderate or severe Atopic Dermatitis who received placebo oral capsules.	Cohort 4 - Active Participants with mild, moderate or severe Atopic Dermatitis who received 1 capsule (8.0x10\^10 total cells) of EDP1815 (an orally administered, pharmaceutical preparation of a single strain of bacteria) once daily for 16 weeks.
Overall Study STARTED	25	74	25	74	25	86	38	74
Overall Study COMPLETED	19	56	22	53	20	65	36	57
Overall Study NOT COMPLETED	6	18	3	21	5	21	2	17

Reasons for withdrawal

Reasons for withdrawal
Measure	Cohort 1 - Placebo Participants with mild, moderate or severe Atopic Dermatitis who received placebo oral capsules.	Cohort 1 - Active Participants with mild, moderate or severe Atopic Dermatitis who received 2 capsules (1.6 x 10\^11 total cells) of EDP1815 (an orally administered, pharmaceutical preparation of a single strain of bacteria) once daily for 16 weeks.	Cohort 2 - Placebo Participants with mild, moderate or severe Atopic Dermatitis who received placebo oral capsules.	Cohort 2 - Active Participants with mild, moderate or severe Atopic Dermatitis who received 2 capsules (6.4 x 10\^11 total cells) of EDP1815 (an orally administered, pharmaceutical preparation of a single strain of bacteria) once daily for 16 weeks.	Cohort 3 - Placebo Participants with mild, moderate or severe Atopic Dermatitis who received placebo oral capsules.	Cohort 3 - Active Participants with mild, moderate or severe Atopic Dermatitis who received 1 capsule (3.2 x 10\^11 cells) twice daily (6.4 x 10\^11 total cells) of EDP1815 (an orally administered, pharmaceutical preparation of a single strain of bacteria) once daily for 16 weeks.	Cohort 4 - Placebo Participants with mild, moderate or severe Atopic Dermatitis who received placebo oral capsules.	Cohort 4 - Active Participants with mild, moderate or severe Atopic Dermatitis who received 1 capsule (8.0x10\^10 total cells) of EDP1815 (an orally administered, pharmaceutical preparation of a single strain of bacteria) once daily for 16 weeks.
Overall Study Lack of Efficacy	2	2	1	4	0	1	0	2
Overall Study Treatment Failure	0	2	0	1	0	0	0	0
Overall Study Adverse Event	0	1	0	5	3	2	0	4
Overall Study Withdrawal by Subject	4	9	1	8	0	9	0	4
Overall Study Non-compliance with the protocol	0	0	0	0	1	6	0	1
Overall Study Lost to Follow-up	0	4	1	3	1	1	1	4
Overall Study Physician Decision	0	0	0	0	0	1	0	1
Overall Study Other Reason	0	0	0	0	0	1	1	1

Baseline Characteristics

A Study Investigating the Effect of EDP1815 in the Treatment of Mild, Moderate and Severe Atopic Dermatitis

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Cohort 1 - Placebo n=25 Participants Participants with mild, moderate or severe Atopic Dermatitis who received placebo oral capsules.	Cohort 1 - Active n=74 Participants Participants with mild, moderate or severe Atopic Dermatitis who received 2 capsules (1.6 x 10\^11 total cells) of EDP1815 (an orally administered, pharmaceutical preparation of a single strain of bacteria) once daily for 16 weeks.	Cohort 2 - Placebo n=25 Participants Participants with mild, moderate or severe Atopic Dermatitis who received placebo oral capsules	Cohort 2 - Active n=74 Participants Participants with mild, moderate or severe Atopic Dermatitis who received 2 capsules (6.4 x 10\^11 total cells) of EDP1815 (an orally administered, pharmaceutical preparation of a single strain of bacteria) once daily for 16 weeks.	Cohort 3 - Placebo n=25 Participants Participants with mild, moderate or severe Atopic Dermatitis who received placebo oral capsules.	Cohort 3 - Active n=86 Participants Participants with mild, moderate or severe Atopic Dermatitis who received 1 capsule (3.2 x 10\^11 cells) twice daily (6.4 x 10\^11 total cells) of EDP1815 (an orally administered, pharmaceutical preparation of a single strain of bacteria) once daily for 16 weeks.	Cohort 4 - Placebo n=38 Participants Participants with mild, moderate or severe Atopic Dermatitis who received placebo oral capsules.	Cohort 4 - Active n=74 Participants Participants with mild, moderate or severe Atopic Dermatitis who received 1 capsule (8.0x10\^10 total cells) of EDP1815 (an orally administered, pharmaceutical preparation of a single strain of bacteria) once daily for 16 weeks.	Total n=421 Participants Total of all reporting groups
Age, Continuous	39.3 years STANDARD_DEVIATION 14.79 • n=93 Participants	36.1 years STANDARD_DEVIATION 16.08 • n=4 Participants	42.9 years STANDARD_DEVIATION 14.27 • n=27 Participants	37.6 years STANDARD_DEVIATION 14.38 • n=483 Participants	40.2 years STANDARD_DEVIATION 17.35 • n=36 Participants	39.6 years STANDARD_DEVIATION 14.72 • n=10 Participants	38.6 years STANDARD_DEVIATION 14.78 • n=115 Participants	42.7 years STANDARD_DEVIATION 14.97 • n=40 Participants	39.3 years STANDARD_DEVIATION 15.15 • n=8 Participants
Sex: Female, Male Female	15 Participants n=93 Participants	36 Participants n=4 Participants	16 Participants n=27 Participants	37 Participants n=483 Participants	10 Participants n=36 Participants	37 Participants n=10 Participants	19 Participants n=115 Participants	43 Participants n=40 Participants	213 Participants n=8 Participants
Sex: Female, Male Male	10 Participants n=93 Participants	38 Participants n=4 Participants	9 Participants n=27 Participants	37 Participants n=483 Participants	15 Participants n=36 Participants	49 Participants n=10 Participants	19 Participants n=115 Participants	31 Participants n=40 Participants	208 Participants n=8 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	3 Participants n=93 Participants	2 Participants n=4 Participants	2 Participants n=27 Participants	6 Participants n=483 Participants	0 Participants n=36 Participants	2 Participants n=10 Participants	3 Participants n=115 Participants	4 Participants n=40 Participants	22 Participants n=8 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	22 Participants n=93 Participants	72 Participants n=4 Participants	23 Participants n=27 Participants	68 Participants n=483 Participants	23 Participants n=36 Participants	84 Participants n=10 Participants	35 Participants n=115 Participants	69 Participants n=40 Participants	396 Participants n=8 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants	0 Participants n=483 Participants	2 Participants n=36 Participants	0 Participants n=10 Participants	0 Participants n=115 Participants	1 Participants n=40 Participants	3 Participants n=8 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants	0 Participants n=483 Participants	0 Participants n=36 Participants	0 Participants n=10 Participants	0 Participants n=115 Participants	0 Participants n=40 Participants	0 Participants n=8 Participants
Race (NIH/OMB) Asian	3 Participants n=93 Participants	9 Participants n=4 Participants	3 Participants n=27 Participants	9 Participants n=483 Participants	1 Participants n=36 Participants	8 Participants n=10 Participants	4 Participants n=115 Participants	11 Participants n=40 Participants	48 Participants n=8 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants	0 Participants n=483 Participants	0 Participants n=36 Participants	0 Participants n=10 Participants	0 Participants n=115 Participants	0 Participants n=40 Participants	0 Participants n=8 Participants
Race (NIH/OMB) Black or African American	3 Participants n=93 Participants	9 Participants n=4 Participants	4 Participants n=27 Participants	8 Participants n=483 Participants	1 Participants n=36 Participants	7 Participants n=10 Participants	5 Participants n=115 Participants	14 Participants n=40 Participants	51 Participants n=8 Participants
Race (NIH/OMB) White	19 Participants n=93 Participants	55 Participants n=4 Participants	16 Participants n=27 Participants	55 Participants n=483 Participants	22 Participants n=36 Participants	65 Participants n=10 Participants	26 Participants n=115 Participants	49 Participants n=40 Participants	307 Participants n=8 Participants
Race (NIH/OMB) More than one race	0 Participants n=93 Participants	1 Participants n=4 Participants	2 Participants n=27 Participants	1 Participants n=483 Participants	0 Participants n=36 Participants	4 Participants n=10 Participants	3 Participants n=115 Participants	0 Participants n=40 Participants	11 Participants n=8 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants	1 Participants n=483 Participants	1 Participants n=36 Participants	2 Participants n=10 Participants	0 Participants n=115 Participants	0 Participants n=40 Participants	4 Participants n=8 Participants
Region of Enrollment Canada	5 Participants n=93 Participants	11 Participants n=4 Participants	5 Participants n=27 Participants	16 Participants n=483 Participants	7 Participants n=36 Participants	13 Participants n=10 Participants	12 Participants n=115 Participants	15 Participants n=40 Participants	84 Participants n=8 Participants
Region of Enrollment United States	8 Participants n=93 Participants	19 Participants n=4 Participants	9 Participants n=27 Participants	20 Participants n=483 Participants	4 Participants n=36 Participants	24 Participants n=10 Participants	10 Participants n=115 Participants	27 Participants n=40 Participants	121 Participants n=8 Participants
Region of Enrollment Poland	8 Participants n=93 Participants	22 Participants n=4 Participants	6 Participants n=27 Participants	16 Participants n=483 Participants	6 Participants n=36 Participants	23 Participants n=10 Participants	10 Participants n=115 Participants	22 Participants n=40 Participants	113 Participants n=8 Participants
Region of Enrollment Australia	0 Participants n=93 Participants	2 Participants n=4 Participants	0 Participants n=27 Participants	1 Participants n=483 Participants	1 Participants n=36 Participants	8 Participants n=10 Participants	0 Participants n=115 Participants	2 Participants n=40 Participants	14 Participants n=8 Participants
Region of Enrollment Bulgaria	3 Participants n=93 Participants	11 Participants n=4 Participants	4 Participants n=27 Participants	12 Participants n=483 Participants	5 Participants n=36 Participants	11 Participants n=10 Participants	3 Participants n=115 Participants	6 Participants n=40 Participants	55 Participants n=8 Participants
Region of Enrollment Germany	1 Participants n=93 Participants	9 Participants n=4 Participants	1 Participants n=27 Participants	9 Participants n=483 Participants	2 Participants n=36 Participants	7 Participants n=10 Participants	3 Participants n=115 Participants	2 Participants n=40 Participants	34 Participants n=8 Participants
Baseline IGA Score IGA 2	4 Participants n=93 Participants	13 Participants n=4 Participants	4 Participants n=27 Participants	12 Participants n=483 Participants	4 Participants n=36 Participants	10 Participants n=10 Participants	7 Participants n=115 Participants	13 Participants n=40 Participants	67 Participants n=8 Participants
Baseline IGA Score IGA 3	17 Participants n=93 Participants	50 Participants n=4 Participants	17 Participants n=27 Participants	51 Participants n=483 Participants	17 Participants n=36 Participants	64 Participants n=10 Participants	26 Participants n=115 Participants	54 Participants n=40 Participants	296 Participants n=8 Participants
Baseline IGA Score IGA 4	4 Participants n=93 Participants	11 Participants n=4 Participants	4 Participants n=27 Participants	11 Participants n=483 Participants	4 Participants n=36 Participants	11 Participants n=10 Participants	5 Participants n=115 Participants	7 Participants n=40 Participants	57 Participants n=8 Participants
Baseline EASI Score	15.08 EASI Score STANDARD_DEVIATION 5.851 • n=93 Participants	16.57 EASI Score STANDARD_DEVIATION 9.420 • n=4 Participants	13.74 EASI Score STANDARD_DEVIATION 5.660 • n=27 Participants	16.25 EASI Score STANDARD_DEVIATION 8.535 • n=483 Participants	15.39 EASI Score STANDARD_DEVIATION 10.175 • n=36 Participants	18.07 EASI Score STANDARD_DEVIATION 10.905 • n=10 Participants	15.40 EASI Score STANDARD_DEVIATION 9.142 • n=115 Participants	13.30 EASI Score STANDARD_DEVIATION 8.049 • n=40 Participants	15.81 EASI Score STANDARD_DEVIATION 9.110 • n=8 Participants
Baseline BSA	19.78 percentage of BSA STANDARD_DEVIATION 12.304 • n=93 Participants	23.16 percentage of BSA STANDARD_DEVIATION 15.036 • n=4 Participants	17.92 percentage of BSA STANDARD_DEVIATION 9.939 • n=27 Participants	22.76 percentage of BSA STANDARD_DEVIATION 15.069 • n=483 Participants	21.08 percentage of BSA STANDARD_DEVIATION 17.518 • n=36 Participants	24.96 percentage of BSA STANDARD_DEVIATION 18.291 • n=10 Participants	21.86 percentage of BSA STANDARD_DEVIATION 18.053 • n=115 Participants	19.11 percentage of BSA STANDARD_DEVIATION 14.651 • n=40 Participants	22.03 percentage of BSA STANDARD_DEVIATION 15.780 • n=8 Participants
Time Since Diagnosis	20.30 years STANDARD_DEVIATION 13.308 • n=93 Participants	19.59 years STANDARD_DEVIATION 15.221 • n=4 Participants	21.82 years STANDARD_DEVIATION 18.216 • n=27 Participants	18.91 years STANDARD_DEVIATION 14.111 • n=483 Participants	20.79 years STANDARD_DEVIATION 16.586 • n=36 Participants	21.44 years STANDARD_DEVIATION 16.960 • n=10 Participants	24.93 years STANDARD_DEVIATION 16.592 • n=115 Participants	23.95 years STANDARD_DEVIATION 17.248 • n=40 Participants	21.34 years STANDARD_DEVIATION 16.057 • n=8 Participants

PRIMARY outcome

Timeframe: 16 weeks

Population: Randomized participants who completed the EASI at Week 16 or dropped out before Week 16 for treatment-related reasons.

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.

Outcome measures

Outcome measures
Measure	Cohorts 1-3 - Placebo n=68 Participants Placebo participants from Cohorts 1-3	Cohort 1 - Active n=66 Participants Mild, moderate or severe Atopic Dermatitis participants taking 2 capsules (1.6 x 10\^11 total cells) of EDP1815 once daily for 16 weeks.	Cohort 2 - Active n=66 Participants Mild, moderate or severe Atopic Dermatitis participants receiving 2 capsules (6.4 x 10\^11 total cells) of EDP1815 once daily for 16 weeks.	Cohort 3 - Active n=73 Participants Mild, moderate or severe Atopic Dermatitis participants receiving 1 capsule (3.2 x 10\^11 cells) twice daily (6.4 x 10\^11 total cells) of EDP1815 for 16 weeks.	Cohort 4 - Placebo n=38 Participants Placebo participants from Cohort 4	Cohort 4 - Active n=66 Participants Mild, moderate or severe Atopic Dermatitis participants receiving 1 capsule (8.0x10\^10 total cells) of EDP1815 once daily for 16 weeks.
Achievement of EASI-50	38 Participants	27 Participants	25 Participants	23 Participants	17 Participants	25 Participants

SECONDARY outcome

Timeframe: 4, 8 and 12 weeks

Population: Randomized participants who completed the EASI at the relevant visit or dropped out before the relevant visit for treatment-related reasons.

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.

Outcome measures

Outcome measures
Measure	Cohorts 1-3 - Placebo n=72 Participants Placebo participants from Cohorts 1-3	Cohort 1 - Active n=73 Participants Mild, moderate or severe Atopic Dermatitis participants taking 2 capsules (1.6 x 10\^11 total cells) of EDP1815 once daily for 16 weeks.	Cohort 2 - Active n=73 Participants Mild, moderate or severe Atopic Dermatitis participants receiving 2 capsules (6.4 x 10\^11 total cells) of EDP1815 once daily for 16 weeks.	Cohort 3 - Active n=81 Participants Mild, moderate or severe Atopic Dermatitis participants receiving 1 capsule (3.2 x 10\^11 cells) twice daily (6.4 x 10\^11 total cells) of EDP1815 for 16 weeks.	Cohort 4 - Placebo n=38 Participants Placebo participants from Cohort 4	Cohort 4 - Active n=72 Participants Mild, moderate or severe Atopic Dermatitis participants receiving 1 capsule (8.0x10\^10 total cells) of EDP1815 once daily for 16 weeks.
Percentage of Participants Achieving EASI-50 Week 4	20 Participants	18 Participants	14 Participants	18 Participants	8 Participants	23 Participants
Percentage of Participants Achieving EASI-50 Week 8	23 Participants	29 Participants	21 Participants	22 Participants	16 Participants	27 Participants
Percentage of Participants Achieving EASI-50 Week 12	26 Participants	33 Participants	21 Participants	24 Participants	17 Participants	24 Participants

SECONDARY outcome

Timeframe: 4, 8, 12, and 16 weeks

Population: Randomized participants who completed the EASI at the relevant visit or dropped out before the relevant visit for treatment-related reasons.

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.

Outcome measures

Outcome measures
Measure	Cohorts 1-3 - Placebo n=72 Participants Placebo participants from Cohorts 1-3	Cohort 1 - Active n=73 Participants Mild, moderate or severe Atopic Dermatitis participants taking 2 capsules (1.6 x 10\^11 total cells) of EDP1815 once daily for 16 weeks.	Cohort 2 - Active n=73 Participants Mild, moderate or severe Atopic Dermatitis participants receiving 2 capsules (6.4 x 10\^11 total cells) of EDP1815 once daily for 16 weeks.	Cohort 3 - Active n=81 Participants Mild, moderate or severe Atopic Dermatitis participants receiving 1 capsule (3.2 x 10\^11 cells) twice daily (6.4 x 10\^11 total cells) of EDP1815 for 16 weeks.	Cohort 4 - Placebo n=38 Participants Placebo participants from Cohort 4	Cohort 4 - Active n=72 Participants Mild, moderate or severe Atopic Dermatitis participants receiving 1 capsule (8.0x10\^10 total cells) of EDP1815 once daily for 16 weeks.
Percentage of Participants Achieving EASI-75 Week 4	1 Participants	9 Participants	4 Participants	6 Participants	2 Participants	7 Participants
Percentage of Participants Achieving EASI-75 Week 8	5 Participants	11 Participants	11 Participants	9 Participants	9 Participants	11 Participants
Percentage of Participants Achieving EASI-75 Week 12	11 Participants	13 Participants	8 Participants	13 Participants	10 Participants	15 Participants
Percentage of Participants Achieving EASI-75 Week 16	22 Participants	13 Participants	9 Participants	13 Participants	9 Participants	11 Participants

SECONDARY outcome

Timeframe: 4, 8, 12, and 16 weeks

Population: Randomized participants who completed the EASI at the relevant visit or dropped out before the relevant visit for treatment-related reasons.

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.

Outcome measures

Outcome measures
Measure	Cohorts 1-3 - Placebo n=72 Participants Placebo participants from Cohorts 1-3	Cohort 1 - Active n=73 Participants Mild, moderate or severe Atopic Dermatitis participants taking 2 capsules (1.6 x 10\^11 total cells) of EDP1815 once daily for 16 weeks.	Cohort 2 - Active n=73 Participants Mild, moderate or severe Atopic Dermatitis participants receiving 2 capsules (6.4 x 10\^11 total cells) of EDP1815 once daily for 16 weeks.	Cohort 3 - Active n=81 Participants Mild, moderate or severe Atopic Dermatitis participants receiving 1 capsule (3.2 x 10\^11 cells) twice daily (6.4 x 10\^11 total cells) of EDP1815 for 16 weeks.	Cohort 4 - Placebo n=38 Participants Placebo participants from Cohort 4	Cohort 4 - Active n=72 Participants Mild, moderate or severe Atopic Dermatitis participants receiving 1 capsule (8.0x10\^10 total cells) of EDP1815 once daily for 16 weeks.
Percentage of Participants Achieving EASI-90 Week 4	0 Participants	3 Participants	1 Participants	1 Participants	0 Participants	1 Participants
Percentage of Participants Achieving EASI-90 Week 8	1 Participants	3 Participants	3 Participants	4 Participants	2 Participants	4 Participants
Percentage of Participants Achieving EASI-90 Week 12	6 Participants	5 Participants	5 Participants	3 Participants	4 Participants	7 Participants
Percentage of Participants Achieving EASI-90 Week 16	8 Participants	3 Participants	5 Participants	6 Participants	1 Participants	4 Participants

SECONDARY outcome

Timeframe: 4, 8, 12, and 16 weeks

Population: Randomized participants who completed the EASI at the relevant visit or dropped out before the relevant visit for treatment-related reasons.

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.

Outcome measures

Outcome measures
Measure	Cohorts 1-3 - Placebo n=72 Participants Placebo participants from Cohorts 1-3	Cohort 1 - Active n=73 Participants Mild, moderate or severe Atopic Dermatitis participants taking 2 capsules (1.6 x 10\^11 total cells) of EDP1815 once daily for 16 weeks.	Cohort 2 - Active n=71 Participants Mild, moderate or severe Atopic Dermatitis participants receiving 2 capsules (6.4 x 10\^11 total cells) of EDP1815 once daily for 16 weeks.	Cohort 3 - Active n=76 Participants Mild, moderate or severe Atopic Dermatitis participants receiving 1 capsule (3.2 x 10\^11 cells) twice daily (6.4 x 10\^11 total cells) of EDP1815 for 16 weeks.	Cohort 4 - Placebo n=38 Participants Placebo participants from Cohort 4	Cohort 4 - Active n=69 Participants Mild, moderate or severe Atopic Dermatitis participants receiving 1 capsule (8.0x10\^10 total cells) of EDP1815 once daily for 16 weeks.
Mean Absolute Change in EASI Week 4	-2.88 score on a scale Standard Deviation 5.229	-4.57 score on a scale Standard Deviation 6.248	-1.87 score on a scale Standard Deviation 7.020	-3.72 score on a scale Standard Deviation 7.947	-3.09 score on a scale Standard Deviation 5.834	-3.36 score on a scale Standard Deviation 5.293
Mean Absolute Change in EASI Week 8	-4.30 score on a scale Standard Deviation 5.642	-5.68 score on a scale Standard Deviation 6.823	-3.05 score on a scale Standard Deviation 8.001	-4.54 score on a scale Standard Deviation 8.930	-5.57 score on a scale Standard Deviation 6.665	-4.22 score on a scale Standard Deviation 5.056
Mean Absolute Change in EASI Week 12	-5.42 score on a scale Standard Deviation 5.590	-6.38 score on a scale Standard Deviation 7.924	-3.56 score on a scale Standard Deviation 8.049	-5.12 score on a scale Standard Deviation 8.982	-6.58 score on a scale Standard Deviation 6.758	-4.82 score on a scale Standard Deviation 5.063
Mean Absolute Change in EASI Week 16	-6.48 score on a scale Standard Deviation 6.360	-5.83 score on a scale Standard Deviation 7.915	-4.55 score on a scale Standard Deviation 7.897	-5.11 score on a scale Standard Deviation 9.116	-6.99 score on a scale Standard Deviation 6.806	-4.82 score on a scale Standard Deviation 5.480

SECONDARY outcome

Timeframe: 4, 8, 12, and 16 weeks

Population: Randomized participants who completed the EASI at the relevant visit or dropped out before the relevant visit for treatment-related reasons.

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.

Outcome measures

Outcome measures
Measure	Cohorts 1-3 - Placebo n=72 Participants Placebo participants from Cohorts 1-3	Cohort 1 - Active n=73 Participants Mild, moderate or severe Atopic Dermatitis participants taking 2 capsules (1.6 x 10\^11 total cells) of EDP1815 once daily for 16 weeks.	Cohort 2 - Active n=71 Participants Mild, moderate or severe Atopic Dermatitis participants receiving 2 capsules (6.4 x 10\^11 total cells) of EDP1815 once daily for 16 weeks.	Cohort 3 - Active n=76 Participants Mild, moderate or severe Atopic Dermatitis participants receiving 1 capsule (3.2 x 10\^11 cells) twice daily (6.4 x 10\^11 total cells) of EDP1815 for 16 weeks.	Cohort 4 - Placebo n=38 Participants Placebo participants from Cohort 4	Cohort 4 - Active n=69 Participants Mild, moderate or severe Atopic Dermatitis participants receiving 1 capsule (8.0x10\^10 total cells) of EDP1815 once daily for 16 weeks.
Mean Percentage Change in EASI Week 4	-20.13 percentage change from baseline Standard Deviation 36.926	-27.36 percentage change from baseline Standard Deviation 38.993	-13.96 percentage change from baseline Standard Deviation 48.008	-22.80 percentage change from baseline Standard Deviation 40.131	-23.30 percentage change from baseline Standard Deviation 35.369	-27.30 percentage change from baseline Standard Deviation 41.493
Mean Percentage Change in EASI Week 8	-30.96 percentage change from baseline Standard Deviation 36.521	-35.33 percentage change from baseline Standard Deviation 42.920	-22.70 percentage change from baseline Standard Deviation 50.991	-27.14 percentage change from baseline Standard Deviation 43.544	-43.08 percentage change from baseline Standard Deviation 36.432	-35.92 percentage change from baseline Standard Deviation 40.244
Mean Percentage Change in EASI Week 12	-40.05 percentage change from baseline Standard Deviation 38.450	-38.40 percentage change from baseline Standard Deviation 48.605	-24.69 percentage change from baseline Standard Deviation 49.969	-31.95 percentage change from baseline Standard Deviation 44.916	-44.99 percentage change from baseline Standard Deviation 34.922	-41.28 percentage change from baseline Standard Deviation 40.377
Mean Percentage Change in EASI Week 16	-46.97 percentage change from baseline Standard Deviation 44.193	-35.72 percentage change from baseline Standard Deviation 49.737	-31.03 percentage change from baseline Standard Deviation 46.957	-32.68 percentage change from baseline Standard Deviation 45.752	-45.58 percentage change from baseline Standard Deviation 35.526	-39.35 percentage change from baseline Standard Deviation 39.316

SECONDARY outcome

Timeframe: 4, 8, 12, and 16 weeks

Population: Randomized participants who completed the vIGA at the relevant visit or dropped out before the relevant visit for treatment-related reasons.

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

Outcome measures

Outcome measures
Measure	Cohorts 1-3 - Placebo n=72 Participants Placebo participants from Cohorts 1-3	Cohort 1 - Active n=73 Participants Mild, moderate or severe Atopic Dermatitis participants taking 2 capsules (1.6 x 10\^11 total cells) of EDP1815 once daily for 16 weeks.	Cohort 2 - Active n=73 Participants Mild, moderate or severe Atopic Dermatitis participants receiving 2 capsules (6.4 x 10\^11 total cells) of EDP1815 once daily for 16 weeks.	Cohort 3 - Active n=81 Participants Mild, moderate or severe Atopic Dermatitis participants receiving 1 capsule (3.2 x 10\^11 cells) twice daily (6.4 x 10\^11 total cells) of EDP1815 for 16 weeks.	Cohort 4 - Placebo n=38 Participants Placebo participants from Cohort 4	Cohort 4 - Active n=72 Participants Mild, moderate or severe Atopic Dermatitis participants receiving 1 capsule (8.0x10\^10 total cells) of EDP1815 once daily for 16 weeks.
Percentage of Participants Achieving Investigator's Global Assessment (vIGA) of 0 or 1 With a ≥2 Point Improvement Week 8	3 Participants	5 Participants	5 Participants	6 Participants	5 Participants	9 Participants
Percentage of Participants Achieving Investigator's Global Assessment (vIGA) of 0 or 1 With a ≥2 Point Improvement Week 12	6 Participants	6 Participants	5 Participants	6 Participants	6 Participants	9 Participants
Percentage of Participants Achieving Investigator's Global Assessment (vIGA) of 0 or 1 With a ≥2 Point Improvement Week 16	12 Participants	5 Participants	7 Participants	10 Participants	2 Participants	7 Participants
Percentage of Participants Achieving Investigator's Global Assessment (vIGA) of 0 or 1 With a ≥2 Point Improvement Week 4	1 Participants	5 Participants	3 Participants	2 Participants	2 Participants	4 Participants

SECONDARY outcome

Timeframe: 4, 8, 12, and 16 weeks

Population: Randomized participants who completed the vIGA at the relevant visit or dropped out before the relevant visit for treatment-related reasons.

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

Outcome measures

Outcome measures
Measure	Cohorts 1-3 - Placebo n=72 Participants Placebo participants from Cohorts 1-3	Cohort 1 - Active n=73 Participants Mild, moderate or severe Atopic Dermatitis participants taking 2 capsules (1.6 x 10\^11 total cells) of EDP1815 once daily for 16 weeks.	Cohort 2 - Active n=73 Participants Mild, moderate or severe Atopic Dermatitis participants receiving 2 capsules (6.4 x 10\^11 total cells) of EDP1815 once daily for 16 weeks.	Cohort 3 - Active n=81 Participants Mild, moderate or severe Atopic Dermatitis participants receiving 1 capsule (3.2 x 10\^11 cells) twice daily (6.4 x 10\^11 total cells) of EDP1815 for 16 weeks.	Cohort 4 - Placebo n=38 Participants Placebo participants from Cohort 4	Cohort 4 - Active n=72 Participants Mild, moderate or severe Atopic Dermatitis participants receiving 1 capsule (8.0x10\^10 total cells) of EDP1815 once daily for 16 weeks.
Percentage of Participants Achieving vIGA of 0 or 1 Week 4	2 Participants	7 Participants	3 Participants	4 Participants	3 Participants	8 Participants
Percentage of Participants Achieving vIGA of 0 or 1 Week 8	4 Participants	7 Participants	5 Participants	7 Participants	8 Participants	12 Participants
Percentage of Participants Achieving vIGA of 0 or 1 Week 12	12 Participants	10 Participants	5 Participants	9 Participants	9 Participants	11 Participants
Percentage of Participants Achieving vIGA of 0 or 1 Week 16	19 Participants	10 Participants	7 Participants	11 Participants	5 Participants	9 Participants

SECONDARY outcome

Timeframe: 16 weeks

Population: Randomized participants who completed the vIGA at the relevant visit or dropped out before the relevant visit for treatment-related reasons.

The efficacy of EDP1815 will be measured by the number of participants achieving a vIGA of 0 at Week16

Outcome measures

Outcome measures
Measure	Cohorts 1-3 - Placebo n=68 Participants Placebo participants from Cohorts 1-3	Cohort 1 - Active n=65 Participants Mild, moderate or severe Atopic Dermatitis participants taking 2 capsules (1.6 x 10\^11 total cells) of EDP1815 once daily for 16 weeks.	Cohort 2 - Active n=66 Participants Mild, moderate or severe Atopic Dermatitis participants receiving 2 capsules (6.4 x 10\^11 total cells) of EDP1815 once daily for 16 weeks.	Cohort 3 - Active n=74 Participants Mild, moderate or severe Atopic Dermatitis participants receiving 1 capsule (3.2 x 10\^11 cells) twice daily (6.4 x 10\^11 total cells) of EDP1815 for 16 weeks.	Cohort 4 - Placebo n=38 Participants Placebo participants from Cohort 4	Cohort 4 - Active n=66 Participants Mild, moderate or severe Atopic Dermatitis participants receiving 1 capsule (8.0x10\^10 total cells) of EDP1815 once daily for 16 weeks.
Percentage of Participants Achieving vIGA of 0	2 Participants	1 Participants	2 Participants	1 Participants	0 Participants	3 Participants

SECONDARY outcome

Timeframe: 4, 8, 12, and 16 weeks

Population: Randomized participants who completed the vIGA and BSA at the relevant visit or dropped out before the relevant visit for treatment-related reasons.

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.

Outcome measures

Outcome measures
Measure	Cohorts 1-3 - Placebo n=72 Participants Placebo participants from Cohorts 1-3	Cohort 1 - Active n=73 Participants Mild, moderate or severe Atopic Dermatitis participants taking 2 capsules (1.6 x 10\^11 total cells) of EDP1815 once daily for 16 weeks.	Cohort 2 - Active n=71 Participants Mild, moderate or severe Atopic Dermatitis participants receiving 2 capsules (6.4 x 10\^11 total cells) of EDP1815 once daily for 16 weeks.	Cohort 3 - Active n=76 Participants Mild, moderate or severe Atopic Dermatitis participants receiving 1 capsule (3.2 x 10\^11 cells) twice daily (6.4 x 10\^11 total cells) of EDP1815 for 16 weeks.	Cohort 4 - Placebo n=38 Participants Placebo participants from Cohort 4	Cohort 4 - Active n=69 Participants Mild, moderate or severe Atopic Dermatitis participants receiving 1 capsule (8.0x10\^10 total cells) of EDP1815 once daily for 16 weeks.
Mean Absolute Change in vIGA*BSA Week 4	-6.47 score on a scale Standard Deviation 27.832	-15.84 score on a scale Standard Deviation 33.960	-5.96 score on a scale Standard Deviation 40.678	-10.92 score on a scale Standard Deviation 52.802	-11.04 score on a scale Standard Deviation 29.770	-14.07 score on a scale Standard Deviation 30.797
Mean Absolute Change in vIGA*BSA Week 8	-14.49 score on a scale Standard Deviation 36.336	-21.31 score on a scale Standard Deviation 41.564	-12.46 score on a scale Standard Deviation 45.651	-14.53 score on a scale Standard Deviation 59.754	-21.63 score on a scale Standard Deviation 32.517	-17.88 score on a scale Standard Deviation 29.523
Mean Absolute Change in vIGA*BSA Week 12	-20.83 score on a scale Standard Deviation 36.619	-24.85 score on a scale Standard Deviation 58.901	-10.48 score on a scale Standard Deviation 45.919	-17.26 score on a scale Standard Deviation 60.858	-28.91 score on a scale Standard Deviation 40.904	-19.56 score on a scale Standard Deviation 30.250
Mean Absolute Change in vIGA*BSA Week 16	-25.70 score on a scale Standard Deviation 36.633	-18.90 score on a scale Standard Deviation 58.271	-14.52 score on a scale Standard Deviation 46.948	-18.10 score on a scale Standard Deviation 59.953	-31.00 score on a scale Standard Deviation 42.250	-24.23 score on a scale Standard Deviation 35.523

SECONDARY outcome

Timeframe: 4, 8, 12, and 16 weeks

Population: Randomized participants who completed the vIGA and BSA at the relevant visit or dropped out before the relevant visit for treatment-related reasons.

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.

Outcome measures

Outcome measures
Measure	Cohorts 1-3 - Placebo n=72 Participants Placebo participants from Cohorts 1-3	Cohort 1 - Active n=73 Participants Mild, moderate or severe Atopic Dermatitis participants taking 2 capsules (1.6 x 10\^11 total cells) of EDP1815 once daily for 16 weeks.	Cohort 2 - Active n=71 Participants Mild, moderate or severe Atopic Dermatitis participants receiving 2 capsules (6.4 x 10\^11 total cells) of EDP1815 once daily for 16 weeks.	Cohort 3 - Active n=76 Participants Mild, moderate or severe Atopic Dermatitis participants receiving 1 capsule (3.2 x 10\^11 cells) twice daily (6.4 x 10\^11 total cells) of EDP1815 for 16 weeks.	Cohort 4 - Placebo n=38 Participants Placebo participants from Cohort 4	Cohort 4 - Active n=69 Participants Mild, moderate or severe Atopic Dermatitis participants receiving 1 capsule (8.0x10\^10 total cells) of EDP1815 once daily for 16 weeks.
Mean Percentage Change in vIGA*BSA Week 4	-14.82 percentage of change Standard Deviation 47.171	-21.83 percentage of change Standard Deviation 47.440	-9.70 percentage of change Standard Deviation 59.410	-13.26 percentage of change Standard Deviation 75.742	-19.01 percentage of change Standard Deviation 49.996	-25.99 percentage of change Standard Deviation 51.487
Mean Percentage Change in vIGA*BSA Week 8	-25.95 percentage of change Standard Deviation 51.703	-32.16 percentage of change Standard Deviation 54.509	-21.27 percentage of change Standard Deviation 65.335	-15.77 percentage of change Standard Deviation 78.290	-42.98 percentage of change Standard Deviation 44.572	-35.85 percentage of change Standard Deviation 47.881
Mean Percentage Change in vIGA*BSA Week 12	-39.10 percentage of change Standard Deviation 50.435	-33.23 percentage of change Standard Deviation 74.662	-18.83 percentage of change Standard Deviation 68.537	-23.49 percentage of change Standard Deviation 79.946	-43.64 percentage of change Standard Deviation 52.832	-37.27 percentage of change Standard Deviation 51.582
Mean Percentage Change in vIGA*BSA Week 16	-49.25 percentage of change Standard Deviation 51.883	-28.17 percentage of change Standard Deviation 78.637	-23.15 percentage of change Standard Deviation 71.749	-23.74 percentage of change Standard Deviation 81.817	-44.29 percentage of change Standard Deviation 60.140	-43.02 percentage of change Standard Deviation 41.198

SECONDARY outcome

Timeframe: 4, 8, 12, and 16 weeks

Population: Randomized participants who completed the BSA at the relevant visit or dropped out before the relevant visit for treatment-related reasons.

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.

Outcome measures

Outcome measures
Measure	Cohorts 1-3 - Placebo n=72 Participants Placebo participants from Cohorts 1-3	Cohort 1 - Active n=73 Participants Mild, moderate or severe Atopic Dermatitis participants taking 2 capsules (1.6 x 10\^11 total cells) of EDP1815 once daily for 16 weeks.	Cohort 2 - Active n=71 Participants Mild, moderate or severe Atopic Dermatitis participants receiving 2 capsules (6.4 x 10\^11 total cells) of EDP1815 once daily for 16 weeks.	Cohort 3 - Active n=76 Participants Mild, moderate or severe Atopic Dermatitis participants receiving 1 capsule (3.2 x 10\^11 cells) twice daily (6.4 x 10\^11 total cells) of EDP1815 for 16 weeks.	Cohort 4 - Placebo n=38 Participants Placebo participants from Cohort 4	Cohort 4 - Active n=69 Participants Mild, moderate or severe Atopic Dermatitis participants receiving 1 capsule (8.0x10\^10 total cells) of EDP1815 once daily for 16 weeks.
Mean Absolute Change From Baseline in BSA Week 4	-2.06 percentage of BSA Standard Deviation 7.127	-3.87 percentage of BSA Standard Deviation 8.429	-1.81 percentage of BSA Standard Deviation 10.573	-3.09 percentage of BSA Standard Deviation 13.025	-2.50 percentage of BSA Standard Deviation 7.886	-3.43 percentage of BSA Standard Deviation 7.503
Mean Absolute Change From Baseline in BSA Week 8	-3.96 percentage of BSA Standard Deviation 8.354	-5.58 percentage of BSA Standard Deviation 10.766	-4.10 percentage of BSA Standard Deviation 12.211	-4.09 percentage of BSA Standard Deviation 14.854	-5.42 percentage of BSA Standard Deviation 8.712	-4.50 percentage of BSA Standard Deviation 8.021
Mean Absolute Change From Baseline in BSA Week 12	-5.61 percentage of BSA Standard Deviation 9.432	-6.79 percentage of BSA Standard Deviation 14.420	-3.21 percentage of BSA Standard Deviation 12.990	-5.13 percentage of BSA Standard Deviation 15.342	-7.96 percentage of BSA Standard Deviation 11.601	-5.36 percentage of BSA Standard Deviation 8.550
Mean Absolute Change From Baseline in BSA Week 16	-7.18 percentage of BSA Standard Deviation 9.772	-5.65 percentage of BSA Standard Deviation 14.554	-4.30 percentage of BSA Standard Deviation 12.902	-4.96 percentage of BSA Standard Deviation 15.289	-8.87 percentage of BSA Standard Deviation 11.221	-6.28 percentage of BSA Standard Deviation 9.078

SECONDARY outcome

Timeframe: 4, 8, 12, and 16 weeks

Population: Randomized participants who completed the BSA at the relevant visit or dropped out before the relevant visit for treatment-related reasons.

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.

Outcome measures

Outcome measures
Measure	Cohorts 1-3 - Placebo n=72 Participants Placebo participants from Cohorts 1-3	Cohort 1 - Active n=73 Participants Mild, moderate or severe Atopic Dermatitis participants taking 2 capsules (1.6 x 10\^11 total cells) of EDP1815 once daily for 16 weeks.	Cohort 2 - Active n=71 Participants Mild, moderate or severe Atopic Dermatitis participants receiving 2 capsules (6.4 x 10\^11 total cells) of EDP1815 once daily for 16 weeks.	Cohort 3 - Active n=76 Participants Mild, moderate or severe Atopic Dermatitis participants receiving 1 capsule (3.2 x 10\^11 cells) twice daily (6.4 x 10\^11 total cells) of EDP1815 for 16 weeks.	Cohort 4 - Placebo n=38 Participants Placebo participants from Cohort 4	Cohort 4 - Active n=69 Participants Mild, moderate or severe Atopic Dermatitis participants receiving 1 capsule (8.0x10\^10 total cells) of EDP1815 once daily for 16 weeks.
Mean Percentage Change From Baseline in BSA Week 4	-12.70 percentage change from baseline Standard Deviation 38.657	-18.45 percentage change from baseline Standard Deviation 36.769	-7.55 percentage change from baseline Standard Deviation 48.616	-12.51 percentage change from baseline Standard Deviation 56.294	-15.29 percentage change from baseline Standard Deviation 44.347	-20.56 percentage change from baseline Standard Deviation 36.664
Mean Percentage Change From Baseline in BSA Week 8	-23.23 percentage change from baseline Standard Deviation 37.106	-27.19 percentage change from baseline Standard Deviation 44.087	-20.92 percentage change from baseline Standard Deviation 53.115	-14.54 percentage change from baseline Standard Deviation 61.187	-34.23 percentage change from baseline Standard Deviation 41.835	-28.75 percentage change from baseline Standard Deviation 40.087
Mean Percentage Change From Baseline in BSA Week 12	-31.79 percentage change from baseline Standard Deviation 45.657	-30.78 percentage change from baseline Standard Deviation 57.815	-16.34 percentage change from baseline Standard Deviation 59.085	-22.17 percentage change from baseline Standard Deviation 61.255	-39.35 percentage change from baseline Standard Deviation 46.518	-31.91 percentage change from baseline Standard Deviation 44.645
Mean Percentage Change From Baseline in BSA Week 16	-41.54 percentage change from baseline Standard Deviation 48.345	-26.73 percentage change from baseline Standard Deviation 60.521	-21.74 percentage change from baseline Standard Deviation 56.381	-20.93 percentage change from baseline Standard Deviation 63.590	-40.61 percentage change from baseline Standard Deviation 52.352	-34.81 percentage change from baseline Standard Deviation 37.995

SECONDARY outcome

Timeframe: 4, 8, 12, and 16 weeks

Population: Randomized participants who completed the BSA at the relevant visit or dropped out before the relevant visit for treatment-related reasons.

The efficacy of EDP1815 will be measured by the number of participants achieving a BSA-50 at Weeks 4, 8, 12 and 16

Outcome measures

Outcome measures
Measure	Cohorts 1-3 - Placebo n=72 Participants Placebo participants from Cohorts 1-3	Cohort 1 - Active n=73 Participants Mild, moderate or severe Atopic Dermatitis participants taking 2 capsules (1.6 x 10\^11 total cells) of EDP1815 once daily for 16 weeks.	Cohort 2 - Active n=73 Participants Mild, moderate or severe Atopic Dermatitis participants receiving 2 capsules (6.4 x 10\^11 total cells) of EDP1815 once daily for 16 weeks.	Cohort 3 - Active n=81 Participants Mild, moderate or severe Atopic Dermatitis participants receiving 1 capsule (3.2 x 10\^11 cells) twice daily (6.4 x 10\^11 total cells) of EDP1815 for 16 weeks.	Cohort 4 - Placebo n=38 Participants Placebo participants from Cohort 4	Cohort 4 - Active n=72 Participants Mild, moderate or severe Atopic Dermatitis participants receiving 1 capsule (8.0x10\^10 total cells) of EDP1815 once daily for 16 weeks.
Percentage of Participants Achieving BSA-50 Week 4	12 Participants	12 Participants	12 Participants	17 Participants	6 Participants	16 Participants
Percentage of Participants Achieving BSA-50 Week 8	19 Participants	21 Participants	21 Participants	18 Participants	15 Participants	19 Participants
Percentage of Participants Achieving BSA-50 Week 12	23 Participants	27 Participants	18 Participants	20 Participants	17 Participants	24 Participants
Percentage of Participants Achieving BSA-50 Week 16	32 Participants	23 Participants	19 Participants	18 Participants	16 Participants	20 Participants

SECONDARY outcome

Timeframe: 4, 8, 12, and 16 weeks

Population: Randomized participants who completed the BSA at the relevant visit or dropped out before the relevant visit for treatment-related reasons.

The efficacy of EDP1815 will be measured by the number of participants achieving a BSA-75 at Weeks 4, 8, 12 and 16

Outcome measures

Outcome measures
Measure	Cohorts 1-3 - Placebo n=72 Participants Placebo participants from Cohorts 1-3	Cohort 1 - Active n=73 Participants Mild, moderate or severe Atopic Dermatitis participants taking 2 capsules (1.6 x 10\^11 total cells) of EDP1815 once daily for 16 weeks.	Cohort 2 - Active n=73 Participants Mild, moderate or severe Atopic Dermatitis participants receiving 2 capsules (6.4 x 10\^11 total cells) of EDP1815 once daily for 16 weeks.	Cohort 3 - Active n=81 Participants Mild, moderate or severe Atopic Dermatitis participants receiving 1 capsule (3.2 x 10\^11 cells) twice daily (6.4 x 10\^11 total cells) of EDP1815 for 16 weeks.	Cohort 4 - Placebo n=38 Participants Placebo participants from Cohort 4	Cohort 4 - Active n=72 Participants Mild, moderate or severe Atopic Dermatitis participants receiving 1 capsule (8.0x10\^10 total cells) of EDP1815 once daily for 16 weeks.
Percentage of Participants Achieving BSA-75 Week 4	4 Participants	7 Participants	2 Participants	2 Participants	2 Participants	4 Participants
Percentage of Participants Achieving BSA-75 Week 8	3 Participants	11 Participants	6 Participants	6 Participants	6 Participants	11 Participants
Percentage of Participants Achieving BSA-75 Week 12	11 Participants	15 Participants	6 Participants	10 Participants	10 Participants	13 Participants
Percentage of Participants Achieving BSA-75 Week 16	21 Participants	12 Participants	8 Participants	13 Participants	7 Participants	12 Participants

SECONDARY outcome

Timeframe: 4, 8, 12, and 16 weeks

Population: Randomized participants who completed the BSA at the relevant visit or dropped out before the relevant visit for treatment-related reasons.

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

Outcome measures

Outcome measures
Measure	Cohorts 1-3 - Placebo n=72 Participants Placebo participants from Cohorts 1-3	Cohort 1 - Active n=73 Participants Mild, moderate or severe Atopic Dermatitis participants taking 2 capsules (1.6 x 10\^11 total cells) of EDP1815 once daily for 16 weeks.	Cohort 2 - Active n=73 Participants Mild, moderate or severe Atopic Dermatitis participants receiving 2 capsules (6.4 x 10\^11 total cells) of EDP1815 once daily for 16 weeks.	Cohort 3 - Active n=81 Participants Mild, moderate or severe Atopic Dermatitis participants receiving 1 capsule (3.2 x 10\^11 cells) twice daily (6.4 x 10\^11 total cells) of EDP1815 for 16 weeks.	Cohort 4 - Placebo n=38 Participants Placebo participants from Cohort 4	Cohort 4 - Active n=72 Participants Mild, moderate or severe Atopic Dermatitis participants receiving 1 capsule (8.0x10\^10 total cells) of EDP1815 once daily for 16 weeks.
Percentage of Participants Achieving BSA Reduction to 3% BSA or Less Week 8	2 Participants	8 Participants	7 Participants	6 Participants	10 Participants	12 Participants
Percentage of Participants Achieving BSA Reduction to 3% BSA or Less Week 4	3 Participants	5 Participants	3 Participants	4 Participants	3 Participants	8 Participants
Percentage of Participants Achieving BSA Reduction to 3% BSA or Less Week 12	12 Participants	11 Participants	5 Participants	8 Participants	8 Participants	14 Participants
Percentage of Participants Achieving BSA Reduction to 3% BSA or Less Week 16	20 Participants	12 Participants	7 Participants	10 Participants	8 Participants	10 Participants

SECONDARY outcome

Timeframe: 4, 8, 12, and 16 weeks

Population: Randomized participants who completed the SCORAD at the relevant visit or dropped out before the relevant visit for treatment-related reasons.

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.

Outcome measures

Outcome measures
Measure	Cohorts 1-3 - Placebo n=72 Participants Placebo participants from Cohorts 1-3	Cohort 1 - Active n=71 Participants Mild, moderate or severe Atopic Dermatitis participants taking 2 capsules (1.6 x 10\^11 total cells) of EDP1815 once daily for 16 weeks.	Cohort 2 - Active n=71 Participants Mild, moderate or severe Atopic Dermatitis participants receiving 2 capsules (6.4 x 10\^11 total cells) of EDP1815 once daily for 16 weeks.	Cohort 3 - Active n=76 Participants Mild, moderate or severe Atopic Dermatitis participants receiving 1 capsule (3.2 x 10\^11 cells) twice daily (6.4 x 10\^11 total cells) of EDP1815 for 16 weeks.	Cohort 4 - Placebo n=38 Participants Placebo participants from Cohort 4	Cohort 4 - Active n=71 Participants Mild, moderate or severe Atopic Dermatitis participants receiving 1 capsule (8.0x10\^10 total cells) of EDP1815 once daily for 16 weeks.
Mean Absolute Change From Baseline in SCORing Atopic Dermatitis (SCORAD) Week 4	-7.53 score on a scale Standard Deviation 10.655	-9.79 score on a scale Standard Deviation 14.561	-5.03 score on a scale Standard Deviation 12.977	-5.61 score on a scale Standard Deviation 12.761	-9.57 score on a scale Standard Deviation 13.608	-8.08 score on a scale Standard Deviation 13.525
Mean Absolute Change From Baseline in SCORing Atopic Dermatitis (SCORAD) Week 8	-10.92 score on a scale Standard Deviation 13.228	-11.82 score on a scale Standard Deviation 14.587	-9.22 score on a scale Standard Deviation 15.082	-7.45 score on a scale Standard Deviation 16.543	-14.95 score on a scale Standard Deviation 15.082	-9.22 score on a scale Standard Deviation 13.271
Mean Absolute Change From Baseline in SCORing Atopic Dermatitis (SCORAD) Week 12	-15.74 score on a scale Standard Deviation 15.335	-12.43 score on a scale Standard Deviation 16.200	-9.19 score on a scale Standard Deviation 15.339	-9.81 score on a scale Standard Deviation 15.782	-13.61 score on a scale Standard Deviation 15.179	-11.16 score on a scale Standard Deviation 14.688
Mean Absolute Change From Baseline in SCORing Atopic Dermatitis (SCORAD) Week 16	-18.47 score on a scale Standard Deviation 15.920	-12.05 score on a scale Standard Deviation 16.072	-11.80 score on a scale Standard Deviation 16.573	-11.04 score on a scale Standard Deviation 18.009	-14.58 score on a scale Standard Deviation 16.659	-11.60 score on a scale Standard Deviation 15.521

SECONDARY outcome

Timeframe: 4, 8, 12, and 16 weeks

Population: Randomized participants who completed the SCORAD at the relevant visit or dropped out before the relevant visit for treatment-related reasons.

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.

Outcome measures

Outcome measures
Measure	Cohorts 1-3 - Placebo n=72 Participants Placebo participants from Cohorts 1-3	Cohort 1 - Active n=71 Participants Mild, moderate or severe Atopic Dermatitis participants taking 2 capsules (1.6 x 10\^11 total cells) of EDP1815 once daily for 16 weeks.	Cohort 2 - Active n=71 Participants Mild, moderate or severe Atopic Dermatitis participants receiving 2 capsules (6.4 x 10\^11 total cells) of EDP1815 once daily for 16 weeks.	Cohort 3 - Active n=76 Participants Mild, moderate or severe Atopic Dermatitis participants receiving 1 capsule (3.2 x 10\^11 cells) twice daily (6.4 x 10\^11 total cells) of EDP1815 for 16 weeks.	Cohort 4 - Placebo n=38 Participants Placebo participants from Cohort 4	Cohort 4 - Active n=71 Participants Mild, moderate or severe Atopic Dermatitis participants receiving 1 capsule (8.0x10\^10 total cells) of EDP1815 once daily for 16 weeks.
Mean Percentage Change From Baseline in SCORAD Week 4	-15.27 percentage change from baseline Standard Deviation 20.788	-17.42 percentage change from baseline Standard Deviation 28.161	-9.30 percentage change from baseline Standard Deviation 27.186	-11.94 percentage change from baseline Standard Deviation 25.258	-18.01 percentage change from baseline Standard Deviation 25.219	-16.43 percentage change from baseline Standard Deviation 26.070
Mean Percentage Change From Baseline in SCORAD Week 8	-21.29 percentage change from baseline Standard Deviation 24.598	-21.74 percentage change from baseline Standard Deviation 29.649	-17.75 percentage change from baseline Standard Deviation 30.305	-14.62 percentage change from baseline Standard Deviation 32.958	-30.08 percentage change from baseline Standard Deviation 29.043	-20.06 percentage change from baseline Standard Deviation 27.947
Mean Percentage Change From Baseline in SCORAD Week 12	-30.92 percentage change from baseline Standard Deviation 28.283	-22.70 percentage change from baseline Standard Deviation 32.777	-17.69 percentage change from baseline Standard Deviation 30.135	-19.71 percentage change from baseline Standard Deviation 31.608	-27.25 percentage change from baseline Standard Deviation 30.640	-24.52 percentage change from baseline Standard Deviation 32.251
Mean Percentage Change From Baseline in SCORAD Week 16	-36.37 percentage change from baseline Standard Deviation 29.640	-21.52 percentage change from baseline Standard Deviation 33.038	-20.96 percentage change from baseline Standard Deviation 31.086	-20.42 percentage change from baseline Standard Deviation 33.785	-27.57 percentage change from baseline Standard Deviation 32.326	-24.10 percentage change from baseline Standard Deviation 32.563

SECONDARY outcome

Timeframe: 4, 8, 12, and 16 weeks

Population: Randomized participants who completed the SCORAD at the relevant visit or dropped out before the relevant visit for treatment-related reasons.

The efficacy of EDP1815 will be measured by the number of participants achieving a SCORAD-50 at Weeks 4, 8, 12 and 16

Outcome measures

Outcome measures
Measure	Cohorts 1-3 - Placebo n=72 Participants Placebo participants from Cohorts 1-3	Cohort 1 - Active n=73 Participants Mild, moderate or severe Atopic Dermatitis participants taking 2 capsules (1.6 x 10\^11 total cells) of EDP1815 once daily for 16 weeks.	Cohort 2 - Active n=73 Participants Mild, moderate or severe Atopic Dermatitis participants receiving 2 capsules (6.4 x 10\^11 total cells) of EDP1815 once daily for 16 weeks.	Cohort 3 - Active n=81 Participants Mild, moderate or severe Atopic Dermatitis participants receiving 1 capsule (3.2 x 10\^11 cells) twice daily (6.4 x 10\^11 total cells) of EDP1815 for 16 weeks.	Cohort 4 - Placebo n=38 Participants Placebo participants from Cohort 4	Cohort 4 - Active n=71 Participants Mild, moderate or severe Atopic Dermatitis participants receiving 1 capsule (8.0x10\^10 total cells) of EDP1815 once daily for 16 weeks.
Percentage of Participants Achieving SCORAD-50 Week 4	2 Participants	10 Participants	4 Participants	6 Participants	4 Participants	8 Participants
Percentage of Participants Achieving SCORAD-50 Week 8	6 Participants	12 Participants	10 Participants	9 Participants	10 Participants	8 Participants
Percentage of Participants Achieving SCORAD-50 Week 12	15 Participants	12 Participants	7 Participants	12 Participants	9 Participants	11 Participants
Percentage of Participants Achieving SCORAD-50 Week 16	21 Participants	8 Participants	9 Participants	16 Participants	10 Participants	12 Participants

SECONDARY outcome

Timeframe: 4, 8, 12, and 16 weeks

Population: Randomized participants who completed the SCORAD at the relevant visit or dropped out before the relevant visit for treatment-related reasons.

The efficacy of EDP1815 will be measured by the number of participants achieving a SCORAD-75 at Weeks 4, 8, 12 and 16

Outcome measures

Outcome measures
Measure	Cohorts 1-3 - Placebo n=72 Participants Placebo participants from Cohorts 1-3	Cohort 1 - Active n=73 Participants Mild, moderate or severe Atopic Dermatitis participants taking 2 capsules (1.6 x 10\^11 total cells) of EDP1815 once daily for 16 weeks.	Cohort 2 - Active n=73 Participants Mild, moderate or severe Atopic Dermatitis participants receiving 2 capsules (6.4 x 10\^11 total cells) of EDP1815 once daily for 16 weeks.	Cohort 3 - Active n=81 Participants Mild, moderate or severe Atopic Dermatitis participants receiving 1 capsule (3.2 x 10\^11 cells) twice daily (6.4 x 10\^11 total cells) of EDP1815 for 16 weeks.	Cohort 4 - Placebo n=38 Participants Placebo participants from Cohort 4	Cohort 4 - Active n=71 Participants Mild, moderate or severe Atopic Dermatitis participants receiving 1 capsule (8.0x10\^10 total cells) of EDP1815 once daily for 16 weeks.
Percentage of Participants Achieving SCORAD-75 Week 4	0 Participants	1 Participants	0 Participants	2 Participants	0 Participants	1 Participants
Percentage of Participants Achieving SCORAD-75 Week 8	1 Participants	2 Participants	0 Participants	5 Participants	3 Participants	1 Participants
Percentage of Participants Achieving SCORAD-75 Week 12	5 Participants	2 Participants	1 Participants	2 Participants	1 Participants	4 Participants
Percentage of Participants Achieving SCORAD-75 Week 16	7 Participants	1 Participants	1 Participants	5 Participants	2 Participants	4 Participants

SECONDARY outcome

Timeframe: 4, 8, 12, and 16 weeks

Population: Randomized participants who completed the DLQI at the relevant visit or dropped out before the relevant visit for treatment-related reasons.

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.

Outcome measures

Outcome measures
Measure	Cohorts 1-3 - Placebo n=71 Participants Placebo participants from Cohorts 1-3	Cohort 1 - Active n=72 Participants Mild, moderate or severe Atopic Dermatitis participants taking 2 capsules (1.6 x 10\^11 total cells) of EDP1815 once daily for 16 weeks.	Cohort 2 - Active n=71 Participants Mild, moderate or severe Atopic Dermatitis participants receiving 2 capsules (6.4 x 10\^11 total cells) of EDP1815 once daily for 16 weeks.	Cohort 3 - Active n=77 Participants Mild, moderate or severe Atopic Dermatitis participants receiving 1 capsule (3.2 x 10\^11 cells) twice daily (6.4 x 10\^11 total cells) of EDP1815 for 16 weeks.	Cohort 4 - Placebo n=38 Participants Placebo participants from Cohort 4	Cohort 4 - Active n=68 Participants Mild, moderate or severe Atopic Dermatitis participants receiving 1 capsule (8.0x10\^10 total cells) of EDP1815 once daily for 16 weeks.
Mean Absolute Change From Baseline in the Dermatology Quality of Life Index (DLQI) Week 8	-3.6 score on a scale Standard Deviation 5.27	-3.4 score on a scale Standard Deviation 6.40	-3.1 score on a scale Standard Deviation 5.09	-3.0 score on a scale Standard Deviation 6.39	-5.1 score on a scale Standard Deviation 6.76	-3.3 score on a scale Standard Deviation 6.55
Mean Absolute Change From Baseline in the Dermatology Quality of Life Index (DLQI) Week 4	-2.6 score on a scale Standard Deviation 4.34	-2.7 score on a scale Standard Deviation 4.93	-2.4 score on a scale Standard Deviation 4.20	-2.4 score on a scale Standard Deviation 5.61	-3.0 score on a scale Standard Deviation 5.77	-3.1 score on a scale Standard Deviation 6.03
Mean Absolute Change From Baseline in the Dermatology Quality of Life Index (DLQI) Week 12	-4.2 score on a scale Standard Deviation 5.15	-3.5 score on a scale Standard Deviation 5.75	-2.1 score on a scale Standard Deviation 4.78	-3.7 score on a scale Standard Deviation 5.74	-4.2 score on a scale Standard Deviation 6.81	-3.5 score on a scale Standard Deviation 6.95
Mean Absolute Change From Baseline in the Dermatology Quality of Life Index (DLQI) Week 16	-5.4 score on a scale Standard Deviation 5.49	-3.6 score on a scale Standard Deviation 6.47	-3.5 score on a scale Standard Deviation 5.12	-3.7 score on a scale Standard Deviation 6.49	-4.3 score on a scale Standard Deviation 5.78	-4.5 score on a scale Standard Deviation 6.76

SECONDARY outcome

Timeframe: 4, 8, 12, and 16 weeks

Population: Randomized participants who completed the DLQI at the relevant visit or dropped out before the relevant visit for treatment-related reasons.

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.

Outcome measures

Outcome measures
Measure	Cohorts 1-3 - Placebo n=71 Participants Placebo participants from Cohorts 1-3	Cohort 1 - Active n=72 Participants Mild, moderate or severe Atopic Dermatitis participants taking 2 capsules (1.6 x 10\^11 total cells) of EDP1815 once daily for 16 weeks.	Cohort 2 - Active n=71 Participants Mild, moderate or severe Atopic Dermatitis participants receiving 2 capsules (6.4 x 10\^11 total cells) of EDP1815 once daily for 16 weeks.	Cohort 3 - Active n=77 Participants Mild, moderate or severe Atopic Dermatitis participants receiving 1 capsule (3.2 x 10\^11 cells) twice daily (6.4 x 10\^11 total cells) of EDP1815 for 16 weeks.	Cohort 4 - Placebo n=37 Participants Placebo participants from Cohort 4	Cohort 4 - Active n=68 Participants Mild, moderate or severe Atopic Dermatitis participants receiving 1 capsule (8.0x10\^10 total cells) of EDP1815 once daily for 16 weeks.
Mean Percentage Change From Baseline in DLQI Week 4	-20.56 percentage change from baseline Standard Deviation 42.424	-21.97 percentage change from baseline Standard Deviation 43.095	-19.48 percentage change from baseline Standard Deviation 47.134	-14.35 percentage change from baseline Standard Deviation 76.350	-22.67 percentage change from baseline Standard Deviation 52.475	-10.28 percentage change from baseline Standard Deviation 73.896
Mean Percentage Change From Baseline in DLQI Week 8	-28.63 percentage change from baseline Standard Deviation 57.232	-27.49 percentage change from baseline Standard Deviation 46.333	-25.84 percentage change from baseline Standard Deviation 46.946	-18.56 percentage change from baseline Standard Deviation 84.619	-30.29 percentage change from baseline Standard Deviation 61.213	-12.05 percentage change from baseline Standard Deviation 79.431
Mean Percentage Change From Baseline in DLQI Week 12	-31.11 percentage change from baseline Standard Deviation 63.580	-25.89 percentage change from baseline Standard Deviation 47.527	-12.86 percentage change from baseline Standard Deviation 65.083	-27.61 percentage change from baseline Standard Deviation 76.072	-25.25 percentage change from baseline Standard Deviation 76.866	-10.44 percentage change from baseline Standard Deviation 84.857
Mean Percentage Change From Baseline in DLQI Week 16	-45.78 percentage change from baseline Standard Deviation 52.438	-20.13 percentage change from baseline Standard Deviation 67.256	-29.67 percentage change from baseline Standard Deviation 46.996	-26.63 percentage change from baseline Standard Deviation 79.367	-37.04 percentage change from baseline Standard Deviation 49.074	-17.68 percentage change from baseline Standard Deviation 82.217

SECONDARY outcome

Timeframe: 16 weeks

Population: Randomized participants who completed the DLQI at the relevant visit or dropped out before the relevant visit for treatment-related reasons.

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.

Outcome measures

Outcome measures
Measure	Cohorts 1-3 - Placebo n=61 Participants Placebo participants from Cohorts 1-3	Cohort 1 - Active n=59 Participants Mild, moderate or severe Atopic Dermatitis participants taking 2 capsules (1.6 x 10\^11 total cells) of EDP1815 once daily for 16 weeks.	Cohort 2 - Active n=61 Participants Mild, moderate or severe Atopic Dermatitis participants receiving 2 capsules (6.4 x 10\^11 total cells) of EDP1815 once daily for 16 weeks.	Cohort 3 - Active n=71 Participants Mild, moderate or severe Atopic Dermatitis participants receiving 1 capsule (3.2 x 10\^11 cells) twice daily (6.4 x 10\^11 total cells) of EDP1815 for 16 weeks.	Cohort 4 - Placebo n=34 Participants Placebo participants from Cohort 4	Cohort 4 - Active n=63 Participants Mild, moderate or severe Atopic Dermatitis participants receiving 1 capsule (8.0x10\^10 total cells) of EDP1815 once daily for 16 weeks.
Percentage of Participants Achieving a Reduction of ≥4 in the DLQI, of Those With a Score of ≥4 at Baseline	40 Participants	24 Participants	23 Participants	30 Participants	17 Participants	24 Participants

SECONDARY outcome

Timeframe: 4, 8, 12, and 16 weeks

Population: Randomized participants who completed the PP-NRS at the relevant visit or dropped out before the relevant visit for treatment-related reasons.

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.

Outcome measures

Outcome measures
Measure	Cohorts 1-3 - Placebo n=71 Participants Placebo participants from Cohorts 1-3	Cohort 1 - Active n=70 Participants Mild, moderate or severe Atopic Dermatitis participants taking 2 capsules (1.6 x 10\^11 total cells) of EDP1815 once daily for 16 weeks.	Cohort 2 - Active n=68 Participants Mild, moderate or severe Atopic Dermatitis participants receiving 2 capsules (6.4 x 10\^11 total cells) of EDP1815 once daily for 16 weeks.	Cohort 3 - Active n=72 Participants Mild, moderate or severe Atopic Dermatitis participants receiving 1 capsule (3.2 x 10\^11 cells) twice daily (6.4 x 10\^11 total cells) of EDP1815 for 16 weeks.	Cohort 4 - Placebo n=36 Participants Placebo participants from Cohort 4	Cohort 4 - Active n=63 Participants Mild, moderate or severe Atopic Dermatitis participants receiving 1 capsule (8.0x10\^10 total cells) of EDP1815 once daily for 16 weeks.
Mean Absolute Change From Baseline in Worst Pruritus Numerical Rating Scale (PR-NRS) Week 4	-0.53 score on a scale Standard Deviation 1.933	-0.45 score on a scale Standard Deviation 1.962	-0.65 score on a scale Standard Deviation 2.052	-0.57 score on a scale Standard Deviation 1.692	-1.52 score on a scale Standard Deviation 1.845	-0.72 score on a scale Standard Deviation 1.828
Mean Absolute Change From Baseline in Worst Pruritus Numerical Rating Scale (PR-NRS) Week 8	-1.18 score on a scale Standard Deviation 2.452	-1.04 score on a scale Standard Deviation 2.483	-0.83 score on a scale Standard Deviation 2.103	-1.17 score on a scale Standard Deviation 1.986	-1.97 score on a scale Standard Deviation 1.978	-0.84 score on a scale Standard Deviation 1.856
Mean Absolute Change From Baseline in Worst Pruritus Numerical Rating Scale (PR-NRS) Week 12	-1.54 score on a scale Standard Deviation 2.581	-1.24 score on a scale Standard Deviation 2.613	-0.99 score on a scale Standard Deviation 2.171	-1.34 score on a scale Standard Deviation 1.921	-1.73 score on a scale Standard Deviation 1.955	-0.95 score on a scale Standard Deviation 2.095
Mean Absolute Change From Baseline in Worst Pruritus Numerical Rating Scale (PR-NRS) Week 16	-1.84 score on a scale Standard Deviation 2.454	-1.35 score on a scale Standard Deviation 2.674	-1.00 score on a scale Standard Deviation 2.167	-1.37 score on a scale Standard Deviation 2.218	-1.91 score on a scale Standard Deviation 2.007	-1.08 score on a scale Standard Deviation 2.305

SECONDARY outcome

Timeframe: 4, 8, 12, and 16 weeks

Population: Randomized participants who completed the PP-NRS at the relevant visit or dropped out before the relevant visit for treatment-related reasons.

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.

Outcome measures

Outcome measures
Measure	Cohorts 1-3 - Placebo n=70 Participants Placebo participants from Cohorts 1-3	Cohort 1 - Active n=71 Participants Mild, moderate or severe Atopic Dermatitis participants taking 2 capsules (1.6 x 10\^11 total cells) of EDP1815 once daily for 16 weeks.	Cohort 2 - Active n=70 Participants Mild, moderate or severe Atopic Dermatitis participants receiving 2 capsules (6.4 x 10\^11 total cells) of EDP1815 once daily for 16 weeks.	Cohort 3 - Active n=78 Participants Mild, moderate or severe Atopic Dermatitis participants receiving 1 capsule (3.2 x 10\^11 cells) twice daily (6.4 x 10\^11 total cells) of EDP1815 for 16 weeks.	Cohort 4 - Placebo n=38 Participants Placebo participants from Cohort 4	Cohort 4 - Active n=67 Participants Mild, moderate or severe Atopic Dermatitis participants receiving 1 capsule (8.0x10\^10 total cells) of EDP1815 once daily for 16 weeks.
Percentage of Participants Achieving a Reduction of ≥2 in the Worst Pruritus-NRS, of Those With a Score of ≥2 at Baseline Week 4	11 Participants	14 Participants	12 Participants	11 Participants	10 Participants	10 Participants
Percentage of Participants Achieving a Reduction of ≥2 in the Worst Pruritus-NRS, of Those With a Score of ≥2 at Baseline Week 8	21 Participants	20 Participants	14 Participants	20 Participants	11 Participants	13 Participants
Percentage of Participants Achieving a Reduction of ≥2 in the Worst Pruritus-NRS, of Those With a Score of ≥2 at Baseline Week 12	25 Participants	20 Participants	15 Participants	25 Participants	10 Participants	13 Participants
Percentage of Participants Achieving a Reduction of ≥2 in the Worst Pruritus-NRS, of Those With a Score of ≥2 at Baseline Week 16	29 Participants	18 Participants	14 Participants	22 Participants	12 Participants	13 Participants

SECONDARY outcome

Timeframe: 16 weeks

Population: Randomized participants who completed the PP-NRS at the relevant visit or dropped out before the relevant visit for treatment-related reasons.

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.

Outcome measures

Outcome measures
Measure	Cohorts 1-3 - Placebo n=50 Participants Placebo participants from Cohorts 1-3	Cohort 1 - Active n=53 Participants Mild, moderate or severe Atopic Dermatitis participants taking 2 capsules (1.6 x 10\^11 total cells) of EDP1815 once daily for 16 weeks.	Cohort 2 - Active n=50 Participants Mild, moderate or severe Atopic Dermatitis participants receiving 2 capsules (6.4 x 10\^11 total cells) of EDP1815 once daily for 16 weeks.	Cohort 3 - Active n=61 Participants Mild, moderate or severe Atopic Dermatitis participants receiving 1 capsule (3.2 x 10\^11 cells) twice daily (6.4 x 10\^11 total cells) of EDP1815 for 16 weeks.	Cohort 4 - Placebo n=25 Participants Placebo participants from Cohort 4	Cohort 4 - Active n=47 Participants Mild, moderate or severe Atopic Dermatitis participants receiving 1 capsule (8.0x10\^10 total cells) of EDP1815 once daily for 16 weeks.
Percentage of Participants Achieving a Reduction of ≥4 in the Worst PR-NRS, of Those With a Score of ≥4 at Baseline	13 Participants	9 Participants	5 Participants	7 Participants	5 Participants	3 Participants

SECONDARY outcome

Timeframe: 4, 8, 12, and 16 weeks

Population: Randomized participants who completed the SD-NRS at the relevant visit or dropped out before the relevant visit for treatment-related reasons.

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.

Outcome measures

Outcome measures
Measure	Cohorts 1-3 - Placebo n=71 Participants Placebo participants from Cohorts 1-3	Cohort 1 - Active n=70 Participants Mild, moderate or severe Atopic Dermatitis participants taking 2 capsules (1.6 x 10\^11 total cells) of EDP1815 once daily for 16 weeks.	Cohort 2 - Active n=68 Participants Mild, moderate or severe Atopic Dermatitis participants receiving 2 capsules (6.4 x 10\^11 total cells) of EDP1815 once daily for 16 weeks.	Cohort 3 - Active n=72 Participants Mild, moderate or severe Atopic Dermatitis participants receiving 1 capsule (3.2 x 10\^11 cells) twice daily (6.4 x 10\^11 total cells) of EDP1815 for 16 weeks.	Cohort 4 - Placebo n=36 Participants Placebo participants from Cohort 4	Cohort 4 - Active n=63 Participants Mild, moderate or severe Atopic Dermatitis participants receiving 1 capsule (8.0x10\^10 total cells) of EDP1815 once daily for 16 weeks.
Mean Absolute Change From Baseline in the Sleep Disturbance Numerical Rating Scale (SD-NRS) Score Week 4	-0.36 score on a scale Standard Deviation 1.834	-0.52 score on a scale Standard Deviation 1.872	-0.27 score on a scale Standard Deviation 1.985	-0.16 score on a scale Standard Deviation 1.457	-0.93 score on a scale Standard Deviation 2.226	-0.11 score on a scale Standard Deviation 2.126
Mean Absolute Change From Baseline in the Sleep Disturbance Numerical Rating Scale (SD-NRS) Score Week 8	-1.09 score on a scale Standard Deviation 2.342	-0.97 score on a scale Standard Deviation 2.128	-0.56 score on a scale Standard Deviation 1.985	-0.49 score on a scale Standard Deviation 1.840	-1.28 score on a scale Standard Deviation 1.956	-0.35 score on a scale Standard Deviation 2.145
Mean Absolute Change From Baseline in the Sleep Disturbance Numerical Rating Scale (SD-NRS) Score Week 12	-1.24 score on a scale Standard Deviation 2.568	-1.06 score on a scale Standard Deviation 2.315	-0.62 score on a scale Standard Deviation 2.003	-0.58 score on a scale Standard Deviation 1.916	-1.22 score on a scale Standard Deviation 2.060	-0.42 score on a scale Standard Deviation 2.369
Mean Absolute Change From Baseline in the Sleep Disturbance Numerical Rating Scale (SD-NRS) Score Week 16	01.48 score on a scale Standard Deviation 2.457	-1.23 score on a scale Standard Deviation 2.336	-0.77 score on a scale Standard Deviation 1.936	-0.63 score on a scale Standard Deviation 1.988	-1.36 score on a scale Standard Deviation 2.102	-0.51 score on a scale Standard Deviation 2.374

SECONDARY outcome

Timeframe: 16 weeks

Population: Randomized participants who completed the SD-NRS at the relevant visit or dropped out before the relevant visit for treatment-related reasons.

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.

Outcome measures

Outcome measures
Measure	Cohorts 1-3 - Placebo n=56 Participants Placebo participants from Cohorts 1-3	Cohort 1 - Active n=54 Participants Mild, moderate or severe Atopic Dermatitis participants taking 2 capsules (1.6 x 10\^11 total cells) of EDP1815 once daily for 16 weeks.	Cohort 2 - Active n=54 Participants Mild, moderate or severe Atopic Dermatitis participants receiving 2 capsules (6.4 x 10\^11 total cells) of EDP1815 once daily for 16 weeks.	Cohort 3 - Active n=63 Participants Mild, moderate or severe Atopic Dermatitis participants receiving 1 capsule (3.2 x 10\^11 cells) twice daily (6.4 x 10\^11 total cells) of EDP1815 for 16 weeks.	Cohort 4 - Placebo n=25 Participants Placebo participants from Cohort 4	Cohort 4 - Active n=52 Participants Mild, moderate or severe Atopic Dermatitis participants receiving 1 capsule (8.0x10\^10 total cells) of EDP1815 once daily for 16 weeks.
Percentage of Participants Achieving a Reduction of ≥2 in SD-NRS Score, of Those With a Score of ≥2 at Baseline	25 Participants	16 Participants	11 Participants	13 Participants	8 Participants	9 Participants

SECONDARY outcome

Timeframe: 4, 8, 12, and 16 weeks

Population: Randomized participants who completed the POEM at the relevant visit or dropped out before the relevant visit for treatment-related reasons.

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.

Outcome measures

Outcome measures
Measure	Cohorts 1-3 - Placebo n=71 Participants Placebo participants from Cohorts 1-3	Cohort 1 - Active n=71 Participants Mild, moderate or severe Atopic Dermatitis participants taking 2 capsules (1.6 x 10\^11 total cells) of EDP1815 once daily for 16 weeks.	Cohort 2 - Active n=71 Participants Mild, moderate or severe Atopic Dermatitis participants receiving 2 capsules (6.4 x 10\^11 total cells) of EDP1815 once daily for 16 weeks.	Cohort 3 - Active n=76 Participants Mild, moderate or severe Atopic Dermatitis participants receiving 1 capsule (3.2 x 10\^11 cells) twice daily (6.4 x 10\^11 total cells) of EDP1815 for 16 weeks.	Cohort 4 - Placebo n=37 Participants Placebo participants from Cohort 4	Cohort 4 - Active n=68 Participants Mild, moderate or severe Atopic Dermatitis participants receiving 1 capsule (8.0x10\^10 total cells) of EDP1815 once daily for 16 weeks.
Mean Absolute Change From Baseline in Patient Oriented Eczema Measure (POEM) Week 4	-2.1 score on a scale Standard Deviation 5.48	-2.4 score on a scale Standard Deviation 5.75	-1.6 score on a scale Standard Deviation 5.24	-3.0 score on a scale Standard Deviation 5.57	-3.1 score on a scale Standard Deviation 5.66	-2.7 score on a scale Standard Deviation 6.37
Mean Absolute Change From Baseline in Patient Oriented Eczema Measure (POEM) Week 8	-3.7 score on a scale Standard Deviation 6.31	-3.8 score on a scale Standard Deviation 6.99	-2.9 score on a scale Standard Deviation 5.80	-3.3 score on a scale Standard Deviation 5.88	-5.4 score on a scale Standard Deviation 6.94	-3.2 score on a scale Standard Deviation 6.80
Mean Absolute Change From Baseline in Patient Oriented Eczema Measure (POEM) Week 12	-5.1 score on a scale Standard Deviation 7.30	-4.1 score on a scale Standard Deviation 7.58	-2.0 score on a scale Standard Deviation 5.44	-3.9 score on a scale Standard Deviation 6.24	-4.9 score on a scale Standard Deviation 8.38	-3.5 score on a scale Standard Deviation 7.17
Mean Absolute Change From Baseline in Patient Oriented Eczema Measure (POEM) Week 16	-6.3 score on a scale Standard Deviation 7.20	-3.7 score on a scale Standard Deviation 7.93	-3.8 score on a scale Standard Deviation 6.41	-3.8 score on a scale Standard Deviation 7.32	-5.5 score on a scale Standard Deviation 7.53	-4.3 score on a scale Standard Deviation 7.58

SECONDARY outcome

Timeframe: 4, 8, 12, and 16 weeks

Population: Randomized participants who completed the POEM at the relevant visit or dropped out before the relevant visit for treatment-related reasons.

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.

Outcome measures

Outcome measures
Measure	Cohorts 1-3 - Placebo n=75 Participants Placebo participants from Cohorts 1-3	Cohort 1 - Active n=74 Participants Mild, moderate or severe Atopic Dermatitis participants taking 2 capsules (1.6 x 10\^11 total cells) of EDP1815 once daily for 16 weeks.	Cohort 2 - Active n=74 Participants Mild, moderate or severe Atopic Dermatitis participants receiving 2 capsules (6.4 x 10\^11 total cells) of EDP1815 once daily for 16 weeks.	Cohort 3 - Active n=86 Participants Mild, moderate or severe Atopic Dermatitis participants receiving 1 capsule (3.2 x 10\^11 cells) twice daily (6.4 x 10\^11 total cells) of EDP1815 for 16 weeks.	Cohort 4 - Placebo n=38 Participants Placebo participants from Cohort 4	Cohort 4 - Active n=74 Participants Mild, moderate or severe Atopic Dermatitis participants receiving 1 capsule (8.0x10\^10 total cells) of EDP1815 once daily for 16 weeks.
Mean Percentage Change From Baseline in Patient Oriented Eczema Measure (POEM) Week 4	-10.43 percentage change from baseline Standard Deviation 35.777	-12.19 percentage change from baseline Standard Deviation 36.533	-6.68 percentage change from baseline Standard Deviation 36.687	-17.24 percentage change from baseline Standard Deviation 35.159	-14.30 percentage change from baseline Standard Deviation 42.346	-12.84 percentage change from baseline Standard Deviation 44.818
Mean Percentage Change From Baseline in Patient Oriented Eczema Measure (POEM) Week 8	-20.37 percentage change from baseline Standard Deviation 38.202	-19.07 percentage change from baseline Standard Deviation 39.531	-12.99 percentage change from baseline Standard Deviation 54.065	-20.40 percentage change from baseline Standard Deviation 36.544	-25.58 percentage change from baseline Standard Deviation 44.885	-17.22 percentage change from baseline Standard Deviation 41.533
Mean Percentage Change From Baseline in Patient Oriented Eczema Measure (POEM) Week 12	-27.85 percentage change from baseline Standard Deviation 44.630	-19.14 percentage change from baseline Standard Deviation 47.984	-5.42 percentage change from baseline Standard Deviation 61.699	-23.68 percentage change from baseline Standard Deviation 37.052	-18.28 percentage change from baseline Standard Deviation 69.762	-20.35 percentage change from baseline Standard Deviation 46.029
Mean Percentage Change From Baseline in Patient Oriented Eczema Measure (POEM) Week 16	-34.70 percentage change from baseline Standard Deviation 41.593	-13.27 percentage change from baseline Standard Deviation 54.785	-19.75 percentage change from baseline Standard Deviation 46.292	-20.97 percentage change from baseline Standard Deviation 42.685	-25.05 percentage change from baseline Standard Deviation 64.982	-21.56 percentage change from baseline Standard Deviation 47.588

SECONDARY outcome

Timeframe: 16 weeks

Population: Randomized participants who completed the POEM at the relevant visit or dropped out before the relevant visit for treatment-related reasons.

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.

Outcome measures

Outcome measures
Measure	Cohorts 1-3 - Placebo n=66 Participants Placebo participants from Cohorts 1-3	Cohort 1 - Active n=66 Participants Mild, moderate or severe Atopic Dermatitis participants taking 2 capsules (1.6 x 10\^11 total cells) of EDP1815 once daily for 16 weeks.	Cohort 2 - Active n=65 Participants Mild, moderate or severe Atopic Dermatitis participants receiving 2 capsules (6.4 x 10\^11 total cells) of EDP1815 once daily for 16 weeks.	Cohort 3 - Active n=72 Participants Mild, moderate or severe Atopic Dermatitis participants receiving 1 capsule (3.2 x 10\^11 cells) twice daily (6.4 x 10\^11 total cells) of EDP1815 for 16 weeks.	Cohort 4 - Placebo n=37 Participants Placebo participants from Cohort 4	Cohort 4 - Active n=66 Participants Mild, moderate or severe Atopic Dermatitis participants receiving 1 capsule (8.0x10\^10 total cells) of EDP1815 once daily for 16 weeks.
Percentage of Participants Achieving a Reduction of ≥4 in the POEM Score, of Those With a Score of ≥4 at Baseline	41 Participants	24 Participants	26 Participants	26 Participants	20 Participants	27 Participants

SECONDARY outcome

Timeframe: 4, 8, 12, and 16 weeks

Population: Participants who received rescue therapy at each study visit listed were included as part of the analysis.

The efficacy of EDP1815 will be measured by the number of rescue therapy courses per participant at Weeks 4, 8, 12 and 16

Outcome measures

Outcome measures
Measure	Cohorts 1-3 - Placebo n=75 Participants Placebo participants from Cohorts 1-3	Cohort 1 - Active n=74 Participants Mild, moderate or severe Atopic Dermatitis participants taking 2 capsules (1.6 x 10\^11 total cells) of EDP1815 once daily for 16 weeks.	Cohort 2 - Active n=74 Participants Mild, moderate or severe Atopic Dermatitis participants receiving 2 capsules (6.4 x 10\^11 total cells) of EDP1815 once daily for 16 weeks.	Cohort 3 - Active n=86 Participants Mild, moderate or severe Atopic Dermatitis participants receiving 1 capsule (3.2 x 10\^11 cells) twice daily (6.4 x 10\^11 total cells) of EDP1815 for 16 weeks.	Cohort 4 - Placebo n=38 Participants Placebo participants from Cohort 4	Cohort 4 - Active n=74 Participants Mild, moderate or severe Atopic Dermatitis participants receiving 1 capsule (8.0x10\^10 total cells) of EDP1815 once daily for 16 weeks.
Number of Courses of Rescue Therapy Per Participant Week 4 · 0	61 Participants	58 Participants	59 Participants	58 Participants	25 Participants	58 Participants
Number of Courses of Rescue Therapy Per Participant Week 4 · 1	5 Participants	6 Participants	5 Participants	12 Participants	6 Participants	4 Participants
Number of Courses of Rescue Therapy Per Participant Week 4 · 2	6 Participants	5 Participants	6 Participants	7 Participants	1 Participants	6 Participants
Number of Courses of Rescue Therapy Per Participant Week 4 · 3 or more	3 Participants	3 Participants	4 Participants	4 Participants	6 Participants	6 Participants
Number of Courses of Rescue Therapy Per Participant Week 8 · 0	55 Participants	59 Participants	52 Participants	59 Participants	32 Participants	50 Participants
Number of Courses of Rescue Therapy Per Participant Week 8 · 1	6 Participants	4 Participants	8 Participants	5 Participants	2 Participants	3 Participants
Number of Courses of Rescue Therapy Per Participant Week 8 · 2	6 Participants	2 Participants	5 Participants	4 Participants	1 Participants	9 Participants
Number of Courses of Rescue Therapy Per Participant Week 8 · 3 or more	1 Participants	1 Participants	1 Participants	4 Participants	3 Participants	4 Participants
Number of Courses of Rescue Therapy Per Participant Week 12 · 0	59 Participants	55 Participants	47 Participants	54 Participants	29 Participants	55 Participants
Number of Courses of Rescue Therapy Per Participant Week 12 · 1	3 Participants	3 Participants	6 Participants	6 Participants	4 Participants	4 Participants
Number of Courses of Rescue Therapy Per Participant Week 12 · 2	2 Participants	4 Participants	6 Participants	4 Participants	2 Participants	1 Participants
Number of Courses of Rescue Therapy Per Participant Week 12 · 3 or more	0 Participants	0 Participants	0 Participants	4 Participants	2 Participants	4 Participants
Number of Courses of Rescue Therapy Per Participant Week 16 · 0	62 Participants	53 Participants	51 Participants	58 Participants	35 Participants	53 Participants
Number of Courses of Rescue Therapy Per Participant Week 16 · 1	1 Participants	2 Participants	3 Participants	3 Participants	0 Participants	3 Participants
Number of Courses of Rescue Therapy Per Participant Week 16 · 2	0 Participants	0 Participants	0 Participants	2 Participants	0 Participants	1 Participants
Number of Courses of Rescue Therapy Per Participant Week 16 · 3 or more	0 Participants	0 Participants	0 Participants	1 Participants	1 Participants	1 Participants

SECONDARY outcome

Timeframe: 16 weeks

Population: All participants who received rescue therapy during the study were included as part of the analysis.

The efficacy of EDP1815 will be measured by the number of rescue therapy treatment days per participant at Weeks 1-8 and 9-16

Outcome measures

Outcome measures
Measure	Cohorts 1-3 - Placebo n=75 Participants Placebo participants from Cohorts 1-3	Cohort 1 - Active n=74 Participants Mild, moderate or severe Atopic Dermatitis participants taking 2 capsules (1.6 x 10\^11 total cells) of EDP1815 once daily for 16 weeks.	Cohort 2 - Active n=74 Participants Mild, moderate or severe Atopic Dermatitis participants receiving 2 capsules (6.4 x 10\^11 total cells) of EDP1815 once daily for 16 weeks.	Cohort 3 - Active n=86 Participants Mild, moderate or severe Atopic Dermatitis participants receiving 1 capsule (3.2 x 10\^11 cells) twice daily (6.4 x 10\^11 total cells) of EDP1815 for 16 weeks.	Cohort 4 - Placebo n=38 Participants Placebo participants from Cohort 4	Cohort 4 - Active n=74 Participants Mild, moderate or severe Atopic Dermatitis participants receiving 1 capsule (8.0x10\^10 total cells) of EDP1815 once daily for 16 weeks.
Number of Days of Treatment With Rescue Therapy Per Participant Weeks 1-8 · 0	54 Participants	55 Participants	53 Participants	55 Participants	25 Participants	54 Participants
Number of Days of Treatment With Rescue Therapy Per Participant Weeks 1-8 · 1-7	10 Participants	8 Participants	9 Participants	16 Participants	5 Participants	8 Participants
Number of Days of Treatment With Rescue Therapy Per Participant Weeks 1-8 · 8-14	9 Participants	7 Participants	7 Participants	4 Participants	5 Participants	8 Participants
Number of Days of Treatment With Rescue Therapy Per Participant Weeks 1-8 · 15-21	2 Participants	2 Participants	2 Participants	4 Participants	1 Participants	1 Participants
Number of Days of Treatment With Rescue Therapy Per Participant Weeks 1-8 · 22 or more	0 Participants	0 Participants	3 Participants	2 Participants	2 Participants	3 Participants
Number of Days of Treatment With Rescue Therapy Per Participant Week 9-16 · 0	53 Participants	51 Participants	42 Participants	50 Participants	27 Participants	48 Participants
Number of Days of Treatment With Rescue Therapy Per Participant Week 9-16 · 1-7	8 Participants	7 Participants	8 Participants	7 Participants	5 Participants	6 Participants
Number of Days of Treatment With Rescue Therapy Per Participant Week 9-16 · 8-14	2 Participants	4 Participants	9 Participants	8 Participants	4 Participants	7 Participants
Number of Days of Treatment With Rescue Therapy Per Participant Week 9-16 · 15-21	1 Participants	0 Participants	0 Participants	2 Participants	1 Participants	1 Participants
Number of Days of Treatment With Rescue Therapy Per Participant Week 9-16 · 22 or more	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants	2 Participants

SECONDARY outcome

Timeframe: 4, 8, 12, and 16 weeks

Population: Participants who did not receive rescue therapy at any of the study visits were included as part of the analysis.

The efficacy of EDP1815 will be measured by the proportion of participants not requiring rescue therapy at Weeks 4, 8, 12 and 16

Outcome measures

Outcome measures
Measure	Cohorts 1-3 - Placebo n=75 Participants Placebo participants from Cohorts 1-3	Cohort 1 - Active n=74 Participants Mild, moderate or severe Atopic Dermatitis participants taking 2 capsules (1.6 x 10\^11 total cells) of EDP1815 once daily for 16 weeks.	Cohort 2 - Active n=74 Participants Mild, moderate or severe Atopic Dermatitis participants receiving 2 capsules (6.4 x 10\^11 total cells) of EDP1815 once daily for 16 weeks.	Cohort 3 - Active n=86 Participants Mild, moderate or severe Atopic Dermatitis participants receiving 1 capsule (3.2 x 10\^11 cells) twice daily (6.4 x 10\^11 total cells) of EDP1815 for 16 weeks.	Cohort 4 - Placebo n=38 Participants Placebo participants from Cohort 4	Cohort 4 - Active n=74 Participants Mild, moderate or severe Atopic Dermatitis participants receiving 1 capsule (8.0x10\^10 total cells) of EDP1815 once daily for 16 weeks.
Proportion of Participants Not Requiring Rescue Therapy Week 16	62 Participants	53 Participants	51 Participants	58 Participants	35 Participants	53 Participants
Proportion of Participants Not Requiring Rescue Therapy Week 4	61 Participants	58 Participants	59 Participants	58 Participants	25 Participants	58 Participants
Proportion of Participants Not Requiring Rescue Therapy Week 8	55 Participants	59 Participants	52 Participants	59 Participants	32 Participants	50 Participants
Proportion of Participants Not Requiring Rescue Therapy Week 12	59 Participants	55 Participants	47 Participants	54 Participants	29 Participants	55 Participants

Adverse Events

All Placebo

Serious events: 1 serious events

Other events: 36 other events

Deaths: 0 deaths

Cohort 1 - Active

Serious events: 2 serious events

Other events: 21 other events

Deaths: 0 deaths

Cohort 2 - Active

Serious events: 2 serious events

Other events: 25 other events

Deaths: 0 deaths

Cohort 3 - Active

Serious events: 1 serious events

Other events: 31 other events

Deaths: 0 deaths

Cohort 4 - Active

Serious events: 0 serious events

Other events: 18 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	All Placebo n=113 participants at risk Placebo participants from all cohorts	Cohort 1 - Active n=74 participants at risk Mild, moderate or severe Atopic Dermatitis participants receiving 2 capsules (1.6 x 10\^11 total cells) of EDP1815 once daily for 16 weeks.	Cohort 2 - Active n=74 participants at risk Mild, moderate or severe Atopic Dermatitis participants receiving 2 capsules (6.4 x 10\^11 total cells) of EDP1815 once daily for 16 weeks.	Cohort 3 - Active n=85 participants at risk Mild, moderate or severe Atopic Dermatitis participants receiving 1 capsule (3.2 x 10\^11 cells) twice daily (6.4 x 10\^11 total cells) of EDP1815 for 16 weeks.	Cohort 4 - Active n=74 participants at risk Mild, moderate or severe Atopic Dermatitis participants receiving 1 capsule (8.0x10\^10 total cells) of EDP1815 once daily for 16 weeks.
Infections and infestations Pneumonia	0.00% 0/113 • Adverse events (AEs) were collected after the participant signing of the informed consent form (ICF) through 16 weeks of treatment plus an additional 28 days after taking their last dose of study drug.	0.00% 0/74 • Adverse events (AEs) were collected after the participant signing of the informed consent form (ICF) through 16 weeks of treatment plus an additional 28 days after taking their last dose of study drug.	1.4% 1/74 • Number of events 1 • Adverse events (AEs) were collected after the participant signing of the informed consent form (ICF) through 16 weeks of treatment plus an additional 28 days after taking their last dose of study drug.	0.00% 0/85 • Adverse events (AEs) were collected after the participant signing of the informed consent form (ICF) through 16 weeks of treatment plus an additional 28 days after taking their last dose of study drug.	0.00% 0/74 • Adverse events (AEs) were collected after the participant signing of the informed consent form (ICF) through 16 weeks of treatment plus an additional 28 days after taking their last dose of study drug.
Skin and subcutaneous tissue disorders Dermatitis Atopic	0.00% 0/113 • Adverse events (AEs) were collected after the participant signing of the informed consent form (ICF) through 16 weeks of treatment plus an additional 28 days after taking their last dose of study drug.	1.4% 1/74 • Number of events 1 • Adverse events (AEs) were collected after the participant signing of the informed consent form (ICF) through 16 weeks of treatment plus an additional 28 days after taking their last dose of study drug.	0.00% 0/74 • Adverse events (AEs) were collected after the participant signing of the informed consent form (ICF) through 16 weeks of treatment plus an additional 28 days after taking their last dose of study drug.	0.00% 0/85 • Adverse events (AEs) were collected after the participant signing of the informed consent form (ICF) through 16 weeks of treatment plus an additional 28 days after taking their last dose of study drug.	0.00% 0/74 • Adverse events (AEs) were collected after the participant signing of the informed consent form (ICF) through 16 weeks of treatment plus an additional 28 days after taking their last dose of study drug.
Nervous system disorders Ischaemic Stroke	0.00% 0/113 • Adverse events (AEs) were collected after the participant signing of the informed consent form (ICF) through 16 weeks of treatment plus an additional 28 days after taking their last dose of study drug.	0.00% 0/74 • Adverse events (AEs) were collected after the participant signing of the informed consent form (ICF) through 16 weeks of treatment plus an additional 28 days after taking their last dose of study drug.	1.4% 1/74 • Number of events 1 • Adverse events (AEs) were collected after the participant signing of the informed consent form (ICF) through 16 weeks of treatment plus an additional 28 days after taking their last dose of study drug.	0.00% 0/85 • Adverse events (AEs) were collected after the participant signing of the informed consent form (ICF) through 16 weeks of treatment plus an additional 28 days after taking their last dose of study drug.	0.00% 0/74 • Adverse events (AEs) were collected after the participant signing of the informed consent form (ICF) through 16 weeks of treatment plus an additional 28 days after taking their last dose of study drug.
Hepatobiliary disorders Hepatitis Toxic	0.00% 0/113 • Adverse events (AEs) were collected after the participant signing of the informed consent form (ICF) through 16 weeks of treatment plus an additional 28 days after taking their last dose of study drug.	1.4% 1/74 • Number of events 1 • Adverse events (AEs) were collected after the participant signing of the informed consent form (ICF) through 16 weeks of treatment plus an additional 28 days after taking their last dose of study drug.	0.00% 0/74 • Adverse events (AEs) were collected after the participant signing of the informed consent form (ICF) through 16 weeks of treatment plus an additional 28 days after taking their last dose of study drug.	0.00% 0/85 • Adverse events (AEs) were collected after the participant signing of the informed consent form (ICF) through 16 weeks of treatment plus an additional 28 days after taking their last dose of study drug.	0.00% 0/74 • Adverse events (AEs) were collected after the participant signing of the informed consent form (ICF) through 16 weeks of treatment plus an additional 28 days after taking their last dose of study drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Papillary Thyroid Cancer	0.88% 1/113 • Number of events 1 • Adverse events (AEs) were collected after the participant signing of the informed consent form (ICF) through 16 weeks of treatment plus an additional 28 days after taking their last dose of study drug.	0.00% 0/74 • Adverse events (AEs) were collected after the participant signing of the informed consent form (ICF) through 16 weeks of treatment plus an additional 28 days after taking their last dose of study drug.	0.00% 0/74 • Adverse events (AEs) were collected after the participant signing of the informed consent form (ICF) through 16 weeks of treatment plus an additional 28 days after taking their last dose of study drug.	0.00% 0/85 • Adverse events (AEs) were collected after the participant signing of the informed consent form (ICF) through 16 weeks of treatment plus an additional 28 days after taking their last dose of study drug.	0.00% 0/74 • Adverse events (AEs) were collected after the participant signing of the informed consent form (ICF) through 16 weeks of treatment plus an additional 28 days after taking their last dose of study drug.
Nervous system disorders Cerebrovascular Accident	0.00% 0/113 • Adverse events (AEs) were collected after the participant signing of the informed consent form (ICF) through 16 weeks of treatment plus an additional 28 days after taking their last dose of study drug.	0.00% 0/74 • Adverse events (AEs) were collected after the participant signing of the informed consent form (ICF) through 16 weeks of treatment plus an additional 28 days after taking their last dose of study drug.	0.00% 0/74 • Adverse events (AEs) were collected after the participant signing of the informed consent form (ICF) through 16 weeks of treatment plus an additional 28 days after taking their last dose of study drug.	1.2% 1/85 • Number of events 1 • Adverse events (AEs) were collected after the participant signing of the informed consent form (ICF) through 16 weeks of treatment plus an additional 28 days after taking their last dose of study drug.	0.00% 0/74 • Adverse events (AEs) were collected after the participant signing of the informed consent form (ICF) through 16 weeks of treatment plus an additional 28 days after taking their last dose of study drug.

Other adverse events

Other adverse events
Measure	All Placebo n=113 participants at risk Placebo participants from all cohorts	Cohort 1 - Active n=74 participants at risk Mild, moderate or severe Atopic Dermatitis participants receiving 2 capsules (1.6 x 10\^11 total cells) of EDP1815 once daily for 16 weeks.	Cohort 2 - Active n=74 participants at risk Mild, moderate or severe Atopic Dermatitis participants receiving 2 capsules (6.4 x 10\^11 total cells) of EDP1815 once daily for 16 weeks.	Cohort 3 - Active n=85 participants at risk Mild, moderate or severe Atopic Dermatitis participants receiving 1 capsule (3.2 x 10\^11 cells) twice daily (6.4 x 10\^11 total cells) of EDP1815 for 16 weeks.	Cohort 4 - Active n=74 participants at risk Mild, moderate or severe Atopic Dermatitis participants receiving 1 capsule (8.0x10\^10 total cells) of EDP1815 once daily for 16 weeks.
Infections and infestations Nasopharyngitis	2.7% 3/113 • Number of events 3 • Adverse events (AEs) were collected after the participant signing of the informed consent form (ICF) through 16 weeks of treatment plus an additional 28 days after taking their last dose of study drug.	6.8% 5/74 • Number of events 5 • Adverse events (AEs) were collected after the participant signing of the informed consent form (ICF) through 16 weeks of treatment plus an additional 28 days after taking their last dose of study drug.	6.8% 5/74 • Number of events 5 • Adverse events (AEs) were collected after the participant signing of the informed consent form (ICF) through 16 weeks of treatment plus an additional 28 days after taking their last dose of study drug.	4.7% 4/85 • Number of events 4 • Adverse events (AEs) were collected after the participant signing of the informed consent form (ICF) through 16 weeks of treatment plus an additional 28 days after taking their last dose of study drug.	2.7% 2/74 • Number of events 3 • Adverse events (AEs) were collected after the participant signing of the informed consent form (ICF) through 16 weeks of treatment plus an additional 28 days after taking their last dose of study drug.
Infections and infestations COVID-19	4.4% 5/113 • Number of events 5 • Adverse events (AEs) were collected after the participant signing of the informed consent form (ICF) through 16 weeks of treatment plus an additional 28 days after taking their last dose of study drug.	5.4% 4/74 • Number of events 4 • Adverse events (AEs) were collected after the participant signing of the informed consent form (ICF) through 16 weeks of treatment plus an additional 28 days after taking their last dose of study drug.	5.4% 4/74 • Number of events 4 • Adverse events (AEs) were collected after the participant signing of the informed consent form (ICF) through 16 weeks of treatment plus an additional 28 days after taking their last dose of study drug.	3.5% 3/85 • Number of events 3 • Adverse events (AEs) were collected after the participant signing of the informed consent form (ICF) through 16 weeks of treatment plus an additional 28 days after taking their last dose of study drug.	4.1% 3/74 • Number of events 3 • Adverse events (AEs) were collected after the participant signing of the informed consent form (ICF) through 16 weeks of treatment plus an additional 28 days after taking their last dose of study drug.
Nervous system disorders Headache	8.0% 9/113 • Number of events 9 • Adverse events (AEs) were collected after the participant signing of the informed consent form (ICF) through 16 weeks of treatment plus an additional 28 days after taking their last dose of study drug.	9.5% 7/74 • Number of events 11 • Adverse events (AEs) were collected after the participant signing of the informed consent form (ICF) through 16 weeks of treatment plus an additional 28 days after taking their last dose of study drug.	2.7% 2/74 • Number of events 2 • Adverse events (AEs) were collected after the participant signing of the informed consent form (ICF) through 16 weeks of treatment plus an additional 28 days after taking their last dose of study drug.	3.5% 3/85 • Number of events 4 • Adverse events (AEs) were collected after the participant signing of the informed consent form (ICF) through 16 weeks of treatment plus an additional 28 days after taking their last dose of study drug.	5.4% 4/74 • Number of events 4 • Adverse events (AEs) were collected after the participant signing of the informed consent form (ICF) through 16 weeks of treatment plus an additional 28 days after taking their last dose of study drug.
Gastrointestinal disorders Diarrhoea	2.7% 3/113 • Number of events 3 • Adverse events (AEs) were collected after the participant signing of the informed consent form (ICF) through 16 weeks of treatment plus an additional 28 days after taking their last dose of study drug.	2.7% 2/74 • Number of events 2 • Adverse events (AEs) were collected after the participant signing of the informed consent form (ICF) through 16 weeks of treatment plus an additional 28 days after taking their last dose of study drug.	4.1% 3/74 • Number of events 4 • Adverse events (AEs) were collected after the participant signing of the informed consent form (ICF) through 16 weeks of treatment plus an additional 28 days after taking their last dose of study drug.	5.9% 5/85 • Number of events 5 • Adverse events (AEs) were collected after the participant signing of the informed consent form (ICF) through 16 weeks of treatment plus an additional 28 days after taking their last dose of study drug.	2.7% 2/74 • Number of events 3 • Adverse events (AEs) were collected after the participant signing of the informed consent form (ICF) through 16 weeks of treatment plus an additional 28 days after taking their last dose of study drug.
Skin and subcutaneous tissue disorders Dermatitis atopic	9.7% 11/113 • Number of events 16 • Adverse events (AEs) were collected after the participant signing of the informed consent form (ICF) through 16 weeks of treatment plus an additional 28 days after taking their last dose of study drug.	9.5% 7/74 • Number of events 7 • Adverse events (AEs) were collected after the participant signing of the informed consent form (ICF) through 16 weeks of treatment plus an additional 28 days after taking their last dose of study drug.	18.9% 14/74 • Number of events 17 • Adverse events (AEs) were collected after the participant signing of the informed consent form (ICF) through 16 weeks of treatment plus an additional 28 days after taking their last dose of study drug.	16.5% 14/85 • Number of events 17 • Adverse events (AEs) were collected after the participant signing of the informed consent form (ICF) through 16 weeks of treatment plus an additional 28 days after taking their last dose of study drug.	5.4% 4/74 • Number of events 5 • Adverse events (AEs) were collected after the participant signing of the informed consent form (ICF) through 16 weeks of treatment plus an additional 28 days after taking their last dose of study drug.
Respiratory, thoracic and mediastinal disorders Upper respiratory tract infection	8.0% 9/113 • Number of events 10 • Adverse events (AEs) were collected after the participant signing of the informed consent form (ICF) through 16 weeks of treatment plus an additional 28 days after taking their last dose of study drug.	2.7% 2/74 • Number of events 3 • Adverse events (AEs) were collected after the participant signing of the informed consent form (ICF) through 16 weeks of treatment plus an additional 28 days after taking their last dose of study drug.	1.4% 1/74 • Number of events 1 • Adverse events (AEs) were collected after the participant signing of the informed consent form (ICF) through 16 weeks of treatment plus an additional 28 days after taking their last dose of study drug.	3.5% 3/85 • Number of events 3 • Adverse events (AEs) were collected after the participant signing of the informed consent form (ICF) through 16 weeks of treatment plus an additional 28 days after taking their last dose of study drug.	5.4% 4/74 • Number of events 6 • Adverse events (AEs) were collected after the participant signing of the informed consent form (ICF) through 16 weeks of treatment plus an additional 28 days after taking their last dose of study drug.

Additional Information

Duncan McHale, MBBS, MRCP, PhD

Evelo Biosciences, Inc

Phone: +447500128938

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee 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 approval authority over publication of the study data.
Publication restrictions are in place

Restriction type: OTHER