Trial Outcomes & Findings for A Phase 2 Study Investigating the Effect of EDP1815 in the Treatment of Mild to Moderate Plaque Psoriasis (NCT NCT04603027)

Results Overview

The Psoriasis Area and Severity Index Score (PASI) is a physician assessment that combines the assessment of the severity of and area affected by psoriasis into a single score in the range 0 (no disease) to 72 (maximal disease).The efficacy of EDP1815 will be measured using the mean percentage change in PASI from baseline to week 16.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

249 participants

Primary outcome timeframe

16 weeks

Results posted on

2022-12-19

Participant Flow

Participant milestones

Participant milestones
Measure	Cohort 1 Active 50 subjects with mild to moderate psoriasis on EDP1815 Dose = 0.8 x 10\^11 cells, capsule, once daily, 16 weeks	Cohort 1 Placebo 25 subjects with mild to moderate psoriasis on placebo Dose = 0.8 x 10\^11 cells, capsule, once daily, 16 weeks	Cohort 2 Active 50 subjects with mild to moderate psoriasis on EDP1815 Dose = 3.2 x 10\^11 cells, capsule, once daily, 16 weeks	Cohort 2 Placebo 50 subjects with mild to moderate psoriasis on placebo Dose = 3.2 x 10\^11 cells, capsule, once daily, 16 weeks	Cohort 3 Active 25 subjects with mild to moderate psoriasis on EDP1815 Dose = 8.0 x 10\^11 cells, capsule, once daily, 16 weeks	Cohort 3 Placebo 25 subjects with mild to moderate psoriasis on placebo Dose = 8.0 x 10\^11 cells, capsule, once daily, 16 weeks
Overall Study STARTED	56	28	55	27	55	28
Overall Study COMPLETED	40	20	48	26	42	22
Overall Study NOT COMPLETED	16	8	7	1	13	6

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

A Phase 2 Study Investigating the Effect of EDP1815 in the Treatment of Mild to Moderate Plaque Psoriasis

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Cohort 1 Active n=56 Participants At least 50 subjects with mild to moderate psoriasis on EDP1815 Dose = 0.8 x 10\^11 cells, capsule, once daily, 16 weeks	Cohort 1 Placebo n=28 Participants At least 25 subjects with mild to moderate psoriasis on placebo Dose = 0.8 x 10\^11 cells, capsule, once daily, 16 weeks	Cohort 2 Active n=55 Participants At least 50 subjects with mild to moderate psoriasis on EDP1815 Dose = 3.2 x 10\^11 cells, capsule, once daily, 16 weeks	Cohort 2 Placebo n=27 Participants At least 25 subjects with mild to moderate psoriasis on placebo Dose = 3.2 x 10\^11 cells, capsule, once daily, 16 weeks	Cohort 3 Active n=55 Participants At least 50 subjects with mild to moderate psoriasis on EDP1815 Dose = 8.0 x 10\^11 cells, capsule, once daily, 16 weeks	Cohort 3 Placebo n=28 Participants AT least 25 subjects with mild to moderate psoriasis on placebo. Dose = 8.0 x 10\^11 cells, capsule, once daily, 16 weeks	Total n=249 Participants Total of all reporting groups
Age, Continuous	44.0 years n=5 Participants	41.5 years n=7 Participants	42.0 years n=5 Participants	49.0 years n=4 Participants	44.0 years n=21 Participants	41.5 years n=8 Participants	43.0 years n=8 Participants
Sex: Female, Male Female	22 Participants n=5 Participants	13 Participants n=7 Participants	24 Participants n=5 Participants	6 Participants n=4 Participants	13 Participants n=21 Participants	14 Participants n=8 Participants	92 Participants n=8 Participants
Sex: Female, Male Male	34 Participants n=5 Participants	15 Participants n=7 Participants	31 Participants n=5 Participants	21 Participants n=4 Participants	42 Participants n=21 Participants	14 Participants n=8 Participants	157 Participants n=8 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	3 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants	1 Participants n=4 Participants	0 Participants n=21 Participants	1 Participants n=8 Participants	7 Participants n=8 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	53 Participants n=5 Participants	27 Participants n=7 Participants	54 Participants n=5 Participants	26 Participants n=4 Participants	55 Participants n=21 Participants	26 Participants n=8 Participants	241 Participants n=8 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	1 Participants n=8 Participants	1 Participants n=8 Participants
Region of Enrollment Hungary	3 participants n=5 Participants	1 participants n=7 Participants	5 participants n=5 Participants	1 participants n=4 Participants	2 participants n=21 Participants	1 participants n=8 Participants	13 participants n=8 Participants
Region of Enrollment United States	7 participants n=5 Participants	3 participants n=7 Participants	4 participants n=5 Participants	2 participants n=4 Participants	5 participants n=21 Participants	2 participants n=8 Participants	23 participants n=8 Participants
Region of Enrollment Poland	31 participants n=5 Participants	14 participants n=7 Participants	28 participants n=5 Participants	12 participants n=4 Participants	28 participants n=21 Participants	17 participants n=8 Participants	130 participants n=8 Participants
Region of Enrollment United Kingdom	15 participants n=5 Participants	10 participants n=7 Participants	18 participants n=5 Participants	12 participants n=4 Participants	20 participants n=21 Participants	8 participants n=8 Participants	83 participants n=8 Participants

PRIMARY outcome

Timeframe: 16 weeks

The Psoriasis Area and Severity Index Score (PASI) is a physician assessment that combines the assessment of the severity of and area affected by psoriasis into a single score in the range 0 (no disease) to 72 (maximal disease).The efficacy of EDP1815 will be measured using the mean percentage change in PASI from baseline to week 16.

Outcome measures

Outcome measures
Measure	All Placebo n=66 Participants 75 subjects with mild to moderate psoriasis on placebo, any dose	Cohort 1 Active n=37 Participants 50 subjects with mild to moderate psoriasis on EDP1815 Dose = 0.8 x 10\^11 cells, capsule, once daily, 16 weeks	Cohort 2 Active n=47 Participants 50 subjects with mild to moderate psoriasis on EDP1815 Dose = 3.2 x 10\^11 cells, capsule, once daily, 16 weeks	Cohort 3 Active n=40 Participants 50 subjects with mild to moderate psoriasis on EDP1815 Dose = 8.0 x 10\^11 cells, capsule, once daily, 16 weeks
Mean Percentage Change in PASI	-14.39 percentage of change Interval -22.66 to -5.52	-20.37 percentage of change Interval -31.65 to -9.47	-22.73 percentage of change Interval -33.08 to -11.88	-23.49 percentage of change Interval -34.18 to -12.12

SECONDARY outcome

Timeframe: 12 weeks

The Psoriasis Area and Severity Index Score (PASI) is a physician assessment that combines the assessment of the severity of and area affected by psoriasis into a single score in the range 0 (no disease) to 72 (maximal disease). The efficacy of EDP1815 will be measured using the mean percentage change from baseline in PASI from baseline at weeks 4, 8, and 12.

Outcome measures

Outcome measures
Measure	All Placebo n=71 Participants 75 subjects with mild to moderate psoriasis on placebo, any dose	Cohort 1 Active n=43 Participants 50 subjects with mild to moderate psoriasis on EDP1815 Dose = 0.8 x 10\^11 cells, capsule, once daily, 16 weeks	Cohort 2 Active n=48 Participants 50 subjects with mild to moderate psoriasis on EDP1815 Dose = 3.2 x 10\^11 cells, capsule, once daily, 16 weeks	Cohort 3 Active n=44 Participants 50 subjects with mild to moderate psoriasis on EDP1815 Dose = 8.0 x 10\^11 cells, capsule, once daily, 16 weeks
Mean Percentage Change in PASI	-19.24 percentage of change Interval -26.17 to -11.57	-21.84 percentage of change Interval -31.85 to -12.91	-22.57 percentage of change Interval -31.32 to -13.05	-19.13 percentage of change Interval -28.77 to -9.83

SECONDARY outcome

Timeframe: 16 weeks

The Psoriasis Area and Severity Index Score (PASI) is a physician assessment that combines the assessment of the severity of and area affected by psoriasis into a single score in the range 0 (no disease) to 72 (maximal disease). The efficacy of EDP1815 will be measured using the mean absolute change from baseline in PASI from baseline at weeks 4, 8, 12, and 16.

Outcome measures

Outcome measures
Measure	All Placebo n=66 Participants 75 subjects with mild to moderate psoriasis on placebo, any dose	Cohort 1 Active n=37 Participants 50 subjects with mild to moderate psoriasis on EDP1815 Dose = 0.8 x 10\^11 cells, capsule, once daily, 16 weeks	Cohort 2 Active n=47 Participants 50 subjects with mild to moderate psoriasis on EDP1815 Dose = 3.2 x 10\^11 cells, capsule, once daily, 16 weeks	Cohort 3 Active n=40 Participants 50 subjects with mild to moderate psoriasis on EDP1815 Dose = 8.0 x 10\^11 cells, capsule, once daily, 16 weeks
Mean Absolute Change in PASI	-1.16 score on a scale Interval -1.87 to -0.41	-1.85 score on a scale Interval -2.74 to -0.91	-1.88 score on a scale Interval -2.77 to -1.04	-1.97 score on a scale Interval -2.92 to -1.08

SECONDARY outcome

Timeframe: 16 weeks

The efficacy of EDP1815 will be measured using the achievement of PASI-50 at weeks 4, 8, 12, and 16. PASI-50 is defined by at least a 50% reduction from baseline in the PASI score.

Outcome measures

Outcome measures
Measure	All Placebo n=66 Participants 75 subjects with mild to moderate psoriasis on placebo, any dose	Cohort 1 Active n=37 Participants 50 subjects with mild to moderate psoriasis on EDP1815 Dose = 0.8 x 10\^11 cells, capsule, once daily, 16 weeks	Cohort 2 Active n=47 Participants 50 subjects with mild to moderate psoriasis on EDP1815 Dose = 3.2 x 10\^11 cells, capsule, once daily, 16 weeks	Cohort 3 Active n=40 Participants 50 subjects with mild to moderate psoriasis on EDP1815 Dose = 8.0 x 10\^11 cells, capsule, once daily, 16 weeks
Achievement of PASI-50	8 Participants	11 Participants	15 Participants	10 Participants

SECONDARY outcome

Timeframe: 20 weeks

The efficacy of EDP1815 will be measured using the time to first achievement of PASI-50

Outcome measures

Outcome measures
Measure	All Placebo n=83 Participants 75 subjects with mild to moderate psoriasis on placebo, any dose	Cohort 1 Active n=56 Participants 50 subjects with mild to moderate psoriasis on EDP1815 Dose = 0.8 x 10\^11 cells, capsule, once daily, 16 weeks	Cohort 2 Active n=55 Participants 50 subjects with mild to moderate psoriasis on EDP1815 Dose = 3.2 x 10\^11 cells, capsule, once daily, 16 weeks	Cohort 3 Active n=55 Participants 50 subjects with mild to moderate psoriasis on EDP1815 Dose = 8.0 x 10\^11 cells, capsule, once daily, 16 weeks
Time to First Achievement of PASI-50	160 days Interval 160.0 to Insufficient number of participants with event.	NA days Insufficient number of participants with event.	NA days Insufficient number of participants with event.	146 days Interval 146.0 to 154.0

SECONDARY outcome

Timeframe: 16 weeks

The efficacy of EDP1815 will be measured using the achievement of PASI-75 at week 16. PASI-75 response is defined by at least a 75% reduction from baseline in the PASI score.

Outcome measures

Outcome measures
Measure	All Placebo n=66 Participants 75 subjects with mild to moderate psoriasis on placebo, any dose	Cohort 1 Active n=37 Participants 50 subjects with mild to moderate psoriasis on EDP1815 Dose = 0.8 x 10\^11 cells, capsule, once daily, 16 weeks	Cohort 2 Active n=47 Participants 50 subjects with mild to moderate psoriasis on EDP1815 Dose = 3.2 x 10\^11 cells, capsule, once daily, 16 weeks	Cohort 3 Active n=40 Participants 50 subjects with mild to moderate psoriasis on EDP1815 Dose = 8.0 x 10\^11 cells, capsule, once daily, 16 weeks
Achievement of PASI-75	2 Participants	2 Participants	4 Participants	4 Participants

SECONDARY outcome

Timeframe: 16 weeks

The efficacy of EDP1815 will be measured using the achievement of PASI-90 at week 16.PASI-90 response is defined by at least a 90% reduction from baseline in the PASI score.

Outcome measures

Outcome measures
Measure	All Placebo n=66 Participants 75 subjects with mild to moderate psoriasis on placebo, any dose	Cohort 1 Active n=37 Participants 50 subjects with mild to moderate psoriasis on EDP1815 Dose = 0.8 x 10\^11 cells, capsule, once daily, 16 weeks	Cohort 2 Active n=47 Participants 50 subjects with mild to moderate psoriasis on EDP1815 Dose = 3.2 x 10\^11 cells, capsule, once daily, 16 weeks	Cohort 3 Active n=40 Participants 50 subjects with mild to moderate psoriasis on EDP1815 Dose = 8.0 x 10\^11 cells, capsule, once daily, 16 weeks
Achievement of PASI-90	0 Participants	2 Participants	2 Participants	0 Participants

SECONDARY outcome

Timeframe: 16 weeks

The efficacy of EDP1815 will be measured using the achievement of PASI-100 at week 16. PASI-100 response is defined as achieving a complete resolution of all disease.

Outcome measures

Outcome measures
Measure	All Placebo n=66 Participants 75 subjects with mild to moderate psoriasis on placebo, any dose	Cohort 1 Active n=37 Participants 50 subjects with mild to moderate psoriasis on EDP1815 Dose = 0.8 x 10\^11 cells, capsule, once daily, 16 weeks	Cohort 2 Active n=47 Participants 50 subjects with mild to moderate psoriasis on EDP1815 Dose = 3.2 x 10\^11 cells, capsule, once daily, 16 weeks	Cohort 3 Active n=40 Participants 50 subjects with mild to moderate psoriasis on EDP1815 Dose = 8.0 x 10\^11 cells, capsule, once daily, 16 weeks
Achievement of PASI-100	0 Participants	0 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: 16 weeks

The efficacy of EDP1815 will be measured using the achievement of PGA of 0 or 1 with a ≥2-point improvement from baseline at Week 16 \[PGA = Physician's Global Assessment\]. The National Psoriasis Foundation Psoriasis Score version of a PGA is calculated by averaging the total body erythema, induration, and desquamation scores. Erythema, induration, and desquamation will be scored on a 6-point scale, ranging from 0 (clear) to 5 (severe): the total PGA score is defined as the average of the erythema, induration, and desquamation scores. PGA score of 0 or 1 is defined as clear or almost clear of psoriasis.

Outcome measures

Outcome measures
Measure	All Placebo n=66 Participants 75 subjects with mild to moderate psoriasis on placebo, any dose	Cohort 1 Active n=37 Participants 50 subjects with mild to moderate psoriasis on EDP1815 Dose = 0.8 x 10\^11 cells, capsule, once daily, 16 weeks	Cohort 2 Active n=47 Participants 50 subjects with mild to moderate psoriasis on EDP1815 Dose = 3.2 x 10\^11 cells, capsule, once daily, 16 weeks	Cohort 3 Active n=40 Participants 50 subjects with mild to moderate psoriasis on EDP1815 Dose = 8.0 x 10\^11 cells, capsule, once daily, 16 weeks
Achievement of PGA of 0 or 1 With a ≥2-point Improvement From Baseline	4 Participants	4 Participants	5 Participants	5 Participants

SECONDARY outcome

Timeframe: 16 weeks

The efficacy of EDP1815 will be measured using the achievement of PGA of 0 at Week 16 \[PGA = Physician's Global Assessment\]. The National Psoriasis Foundation Psoriasis Score version of a PGA is calculated by averaging the total body erythema, induration, and desquamation scores. Erythema, induration, and desquamation will be scored on a 6-point scale, ranging from 0 (clear) to 5 (severe): the total PGA score is defined as the average of the erythema, induration, and desquamation scores. PGA score of 0 or 1 is defined as clear or almost clear of psoriasis. A PGA 0 is defined as clear or no signs of psoriasis.

Outcome measures

Outcome measures
Measure	All Placebo n=66 Participants 75 subjects with mild to moderate psoriasis on placebo, any dose	Cohort 1 Active n=37 Participants 50 subjects with mild to moderate psoriasis on EDP1815 Dose = 0.8 x 10\^11 cells, capsule, once daily, 16 weeks	Cohort 2 Active n=47 Participants 50 subjects with mild to moderate psoriasis on EDP1815 Dose = 3.2 x 10\^11 cells, capsule, once daily, 16 weeks	Cohort 3 Active n=40 Participants 50 subjects with mild to moderate psoriasis on EDP1815 Dose = 8.0 x 10\^11 cells, capsule, once daily, 16 weeks
Achievement of PGA of 0	1 Participants	0 Participants	0 Participants	1 Participants

SECONDARY outcome

Timeframe: 16 weeks

\[PGA = Physician's Global Assessment, BSA = Body Surface Area\]. The National Psoriasis Foundation Psoriasis Score version of a static Physicians Global Asessment (PGA) is calculated by averaging the total body erythema, induration, and desquamation scores. Erythema, induration, and desquamation will be scored on a 6-point scale, ranging from 0 (clear) to 5 (severe): the total PGA score is defined as the average of the erythema, induration, and desquamation scores. Body surface area (BSA) measures the total area of the body affected by psoriasis. Psoriasis that occurs on less than 5 percent of the BSA is considered mild to moderate psoriasis. Psoriasis affecting more than 5 percent of the BSA is considered moderate to severe psoriasis. The efficacy of EDP1815 will be measured using the mean percentage change from baseline in PGA x BSA at Weeks 4, 8, 12, and 16.

Outcome measures

Outcome measures
Measure	All Placebo n=66 Participants 75 subjects with mild to moderate psoriasis on placebo, any dose	Cohort 1 Active n=37 Participants 50 subjects with mild to moderate psoriasis on EDP1815 Dose = 0.8 x 10\^11 cells, capsule, once daily, 16 weeks	Cohort 2 Active n=47 Participants 50 subjects with mild to moderate psoriasis on EDP1815 Dose = 3.2 x 10\^11 cells, capsule, once daily, 16 weeks	Cohort 3 Active n=40 Participants 50 subjects with mild to moderate psoriasis on EDP1815 Dose = 8.0 x 10\^11 cells, capsule, once daily, 16 weeks
Mean Percentage Change in PGAxBSA	-0.05 percentage of change Interval -13.65 to 12.74	-9.13 percentage of change Interval -25.84 to 7.91	-3.04 percentage of change Interval -19.15 to 12.26	-17.16 percentage of change Interval -33.23 to -1.18

SECONDARY outcome

Timeframe: 16 weeks

\[PGA = Physician's Global Assessment, BSA = Body Surface Area\]. The National Psoriasis Foundation Psoriasis Score version of a static Physicians Global Asessment (PGA) is calculated by averaging the total body erythema, induration, and desquamation scores. Erythema, induration, and desquamation will be scored on a 6-point scale, ranging from 0 (clear) to 5 (severe): the total PGA score is defined as the average of the erythema, induration, and desquamation scores. Body surface area (BSA) measures the total area of the body affected by psoriasis. Psoriasis that occurs on less than 5 percent of the BSA is considered mild to moderate psoriasis. Psoriasis affecting more than 5 percent of the BSA is considered moderate to severe psoriasis. The efficacy of EDP1815 will be measured using the mean absolute change from baseline in PGA x BSA at Weeks 4, 8, 12, and 16.

Outcome measures

Outcome measures
Measure	All Placebo n=66 Participants 75 subjects with mild to moderate psoriasis on placebo, any dose	Cohort 1 Active n=37 Participants 50 subjects with mild to moderate psoriasis on EDP1815 Dose = 0.8 x 10\^11 cells, capsule, once daily, 16 weeks	Cohort 2 Active n=47 Participants 50 subjects with mild to moderate psoriasis on EDP1815 Dose = 3.2 x 10\^11 cells, capsule, once daily, 16 weeks	Cohort 3 Active n=40 Participants 50 subjects with mild to moderate psoriasis on EDP1815 Dose = 8.0 x 10\^11 cells, capsule, once daily, 16 weeks
Mean Absolute Change in PGAxBSA	-0.01 score on a scale Interval -2.68 to 2.41	-2.67 score on a scale Interval -5.77 to 0.6	-0.84 score on a scale Interval -3.93 to 2.06	-3.54 score on a scale Interval -6.58 to -0.29

SECONDARY outcome

Timeframe: 16 weeks

The LSS is used to score the severity of psoriasis plaques. The dimensions of scaling, erythema, and plaque elevation are each scored on a scale from 0 (clear) to 4 (very severe), and the total LSS is the numerical sum of the 3-dimensional scores. The efficacy of EDP1815 will be measured using the mean percentage change from baseline in LSS (Lesion Severity Score) at Weeks 4, 8, 12, and 16.

Outcome measures

Outcome measures
Measure	All Placebo n=66 Participants 75 subjects with mild to moderate psoriasis on placebo, any dose	Cohort 1 Active n=36 Participants 50 subjects with mild to moderate psoriasis on EDP1815 Dose = 0.8 x 10\^11 cells, capsule, once daily, 16 weeks	Cohort 2 Active n=46 Participants 50 subjects with mild to moderate psoriasis on EDP1815 Dose = 3.2 x 10\^11 cells, capsule, once daily, 16 weeks	Cohort 3 Active n=39 Participants 50 subjects with mild to moderate psoriasis on EDP1815 Dose = 8.0 x 10\^11 cells, capsule, once daily, 16 weeks
Mean Percentage Change in LSS	-14.11 percentage of change Interval -22.19 to -5.99	-21.06 percentage of change Interval -31.72 to -10.02	-16.46 percentage of change Interval -26.62 to -6.82	-16.16 percentage of change Interval -26.65 to -5.18

SECONDARY outcome

Timeframe: 16 weeks

The LSS is used to score the severity of psoriasis plaques. The dimensions of scaling, erythema, and plaque elevation are each scored on a scale from 0 (clear) to 4 (very severe), and the total LSS is the numerical sum of the 3-dimensional scores.The efficacy of EDP1815 will be measured using the mean absolute change from baseline in LSS (Lesion Severity Score) at Weeks 4, 8, 12, and 16.

Outcome measures

Outcome measures
Measure	All Placebo n=66 Participants 75 subjects with mild to moderate psoriasis on placebo, any dose	Cohort 1 Active n=36 Participants 50 subjects with mild to moderate psoriasis on EDP1815 Dose = 0.8 x 10\^11 cells, capsule, once daily, 16 weeks	Cohort 2 Active n=46 Participants 50 subjects with mild to moderate psoriasis on EDP1815 Dose = 3.2 x 10\^11 cells, capsule, once daily, 16 weeks	Cohort 3 Active n=39 Participants 50 subjects with mild to moderate psoriasis on EDP1815 Dose = 8.0 x 10\^11 cells, capsule, once daily, 16 weeks
Mean Absolute Change in LSS	-1.13 score on a scale Interval -1.62 to -0.67	-1.37 score on a scale Interval -1.97 to -0.71	-1.08 score on a scale Interval -1.7 to -0.49	-1.03 score on a scale Interval -1.66 to -0.4

SECONDARY outcome

Timeframe: 16 weeks

The DLQI is a patient reported outcomes instrument for assessing the impact of dermatologic conditions on patients' quality of life. The higher the score the more the impact on quality of life. The efficacy of EDP1815 will be measured using mean percentage change from baseline in Dermatology Life Quality Index (DLQI) at Weeks 4, 8, 12, and 16.

Outcome measures

Outcome measures
Measure	All Placebo n=64 Participants 75 subjects with mild to moderate psoriasis on placebo, any dose	Cohort 1 Active n=37 Participants 50 subjects with mild to moderate psoriasis on EDP1815 Dose = 0.8 x 10\^11 cells, capsule, once daily, 16 weeks	Cohort 2 Active n=47 Participants 50 subjects with mild to moderate psoriasis on EDP1815 Dose = 3.2 x 10\^11 cells, capsule, once daily, 16 weeks	Cohort 3 Active n=40 Participants 50 subjects with mild to moderate psoriasis on EDP1815 Dose = 8.0 x 10\^11 cells, capsule, once daily, 16 weeks
Mean Percentage Change in DLQI	-26.45 percentage of change Interval -41.2 to -10.72	-23.46 percentage of change Interval -42.34 to -4.39	-28.94 percentage of change Interval -46.16 to -9.79	-13.09 percentage of change Interval -32.2 to 5.38

SECONDARY outcome

Timeframe: 16 weeks

The DLQI is a patient reported outcomes instrument for assessing the impact of dermatologic conditions on patients' quality of life. There are 10 questions each scored 0-3, the higher the score the more the impact on quality of life (Total score range 0-30; 0 = no impact, 30 = greatest impact).The efficacy of EDP1815 will be measured using the mean absolute change from baseline in Dermatology Life Quality Index (DLQI) at Weeks 4, 8, 12, and 16

Outcome measures

Outcome measures
Measure	All Placebo n=66 Participants 75 subjects with mild to moderate psoriasis on placebo, any dose	Cohort 1 Active n=37 Participants 50 subjects with mild to moderate psoriasis on EDP1815 Dose = 0.8 x 10\^11 cells, capsule, once daily, 16 weeks	Cohort 2 Active n=47 Participants 50 subjects with mild to moderate psoriasis on EDP1815 Dose = 3.2 x 10\^11 cells, capsule, once daily, 16 weeks	Cohort 3 Active n=40 Participants 50 subjects with mild to moderate psoriasis on EDP1815 Dose = 8.0 x 10\^11 cells, capsule, once daily, 16 weeks
Mean Absolute Change in DLQI	-2.42 score on a scale Interval -3.5 to -1.38	-1.80 score on a scale Interval -3.19 to -0.51	-2.63 score on a scale Interval -3.9 to -1.38	-2.50 score on a scale Interval -3.91 to -1.18

SECONDARY outcome

Timeframe: 16 weeks

The mNAPSI is a tool for physicians to evaluate the severity of nail bed psoriasis and nail matrix psoriasis by area of involvement in the nail unit. The higher the score the more severe the nail bed psoriasis. The efficacy of EDP1815 will be measured using the mean percentage change in mNAPSI total score (modified Nail Psoriasis Severity Index) from baseline at Weeks 4, 8, 12, and 16

Outcome measures

Outcome measures
Measure	All Placebo n=35 Participants 75 subjects with mild to moderate psoriasis on placebo, any dose	Cohort 1 Active n=12 Participants 50 subjects with mild to moderate psoriasis on EDP1815 Dose = 0.8 x 10\^11 cells, capsule, once daily, 16 weeks	Cohort 2 Active n=23 Participants 50 subjects with mild to moderate psoriasis on EDP1815 Dose = 3.2 x 10\^11 cells, capsule, once daily, 16 weeks	Cohort 3 Active n=25 Participants 50 subjects with mild to moderate psoriasis on EDP1815 Dose = 8.0 x 10\^11 cells, capsule, once daily, 16 weeks
Mean Percentage Change in mNAPSI	-5.28 percentage of change Interval -35.93 to 29.58	8.43 percentage of change Interval -44.63 to 60.13	68.41 percentage of change Interval 25.97 to 109.34	3.13 percentage of change Interval -37.13 to 41.16

SECONDARY outcome

Timeframe: 16 weeks

The mNAPSI is a tool for physicians to evaluate the severity of nail bed psoriasis and nail matrix psoriasis by area of involvement in the nail unit. Each fingernail is rated for the presence and severity of seven features to give a total fingernail score of 0-13 (0= no involvement, 13 = greatest involvement). The total mNAPSI score is the sum of the 10 fingernail scores (range 0-130; 0= no involvement, 130= greatest involvement).The higher the score the more severe the nail bed psoriasis. The efficacy of EDP1815 will be measured using the mean absolute change in mNAPSI total score (modified Nail Psoriasis Severity Index) from baseline at Weeks 4, 8, 12, and 16

Outcome measures

Outcome measures
Measure	All Placebo n=35 Participants 75 subjects with mild to moderate psoriasis on placebo, any dose	Cohort 1 Active n=12 Participants 50 subjects with mild to moderate psoriasis on EDP1815 Dose = 0.8 x 10\^11 cells, capsule, once daily, 16 weeks	Cohort 2 Active n=23 Participants 50 subjects with mild to moderate psoriasis on EDP1815 Dose = 3.2 x 10\^11 cells, capsule, once daily, 16 weeks	Cohort 3 Active n=25 Participants 50 subjects with mild to moderate psoriasis on EDP1815 Dose = 8.0 x 10\^11 cells, capsule, once daily, 16 weeks
Mean Absolute Change in mNAPSI	-1.22 score on a scale Interval -4.7 to 2.33	-0.97 score on a scale Interval -6.44 to 4.89	1.13 score on a scale Interval -3.43 to 5.65	-0.14 score on a scale Interval -4.47 to 3.99

SECONDARY outcome

Timeframe: 40 weeks

The efficacy of EDP1815 will be measured by calculating the cumulative incidence of partial relapse at Weeks 20, 24, 28, and 40 for participants who were classified as responders at week 16. Partial relapse is defined as a loss of the PASI-50 response after week 16 and after cessation of study treatment, or commencing a new treatment for psoriasis.

Outcome measures

Outcome measures
Measure	All Placebo n=9 Participants 75 subjects with mild to moderate psoriasis on placebo, any dose	Cohort 1 Active n=12 Participants 50 subjects with mild to moderate psoriasis on EDP1815 Dose = 0.8 x 10\^11 cells, capsule, once daily, 16 weeks	Cohort 2 Active n=16 Participants 50 subjects with mild to moderate psoriasis on EDP1815 Dose = 3.2 x 10\^11 cells, capsule, once daily, 16 weeks	Cohort 3 Active n=10 Participants 50 subjects with mild to moderate psoriasis on EDP1815 Dose = 8.0 x 10\^11 cells, capsule, once daily, 16 weeks
Cumulative Incidence of Partial Relapse	4 Participants	4 Participants	8 Participants	2 Participants

SECONDARY outcome

Timeframe: 40 weeks

The efficacy of EDP1815 will be measured by calculating the cumulative incidence of complete relapse at Weeks 20, 24, 28, and 40 in participants who were considered as responders at week 16. Relapse is defined as an increase in the severity of the psoriasis as measured by PASI to the baseline value or greater, or commencement of a new treatment for psoriasis.

Outcome measures

Outcome measures
Measure	All Placebo n=9 Participants 75 subjects with mild to moderate psoriasis on placebo, any dose	Cohort 1 Active n=12 Participants 50 subjects with mild to moderate psoriasis on EDP1815 Dose = 0.8 x 10\^11 cells, capsule, once daily, 16 weeks	Cohort 2 Active n=16 Participants 50 subjects with mild to moderate psoriasis on EDP1815 Dose = 3.2 x 10\^11 cells, capsule, once daily, 16 weeks	Cohort 3 Active n=10 Participants 50 subjects with mild to moderate psoriasis on EDP1815 Dose = 8.0 x 10\^11 cells, capsule, once daily, 16 weeks
Cumulative Incidence of Complete Relapse	0 Participants	1 Participants	2 Participants	1 Participants

SECONDARY outcome

Timeframe: 40 weeks

The efficacy of EDP1815 will be measured by calculating the cumulative incidence of rebound at Weeks 20, 24, 28, and 40 in participants with at least one PASI assessment after the end of treatment. Rebound is defined as an increase in the severity of the psoriasis as measured by PASI to 125% of baseline score or above, or onset of new pustular/erythrodermic psoriasis, within 3 months of cessation of study treatment.

Outcome measures

Outcome measures
Measure	All Placebo n=64 Participants 75 subjects with mild to moderate psoriasis on placebo, any dose	Cohort 1 Active n=37 Participants 50 subjects with mild to moderate psoriasis on EDP1815 Dose = 0.8 x 10\^11 cells, capsule, once daily, 16 weeks	Cohort 2 Active n=43 Participants 50 subjects with mild to moderate psoriasis on EDP1815 Dose = 3.2 x 10\^11 cells, capsule, once daily, 16 weeks	Cohort 3 Active n=45 Participants 50 subjects with mild to moderate psoriasis on EDP1815 Dose = 8.0 x 10\^11 cells, capsule, once daily, 16 weeks
Cumulative Incidence of Rebound	7 Participants	6 Participants	3 Participants	1 Participants

Adverse Events

All Placebo

Serious events: 0 serious events

Other events: 22 other events

Deaths: 0 deaths

Cohort 1 Active

Serious events: 1 serious events

Other events: 21 other events

Deaths: 0 deaths

Cohort 2 Active

Serious events: 0 serious events

Other events: 21 other events

Deaths: 0 deaths

Cohort 3 Active

Serious events: 1 serious events

Other events: 25 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	All Placebo n=83 participants at risk 75 subjects with mild to moderate psoriasis on placebo, any dose	Cohort 1 Active n=56 participants at risk 50 subjects with mild to moderate psoriasis on EDP1815 Dose = 0.8 x 10\^11 cells, capsule, once daily, 16 weeks	Cohort 2 Active n=55 participants at risk 50 subjects with mild to moderate psoriasis on EDP1815 Dose = 3.2 x 10\^11 cells, capsule, once daily, 16 weeks	Cohort 3 Active n=55 participants at risk 50 subjects with mild to moderate psoriasis on EDP1815 Dose = 8.0 x 10\^11 cells, capsule, once daily, 16 weeks
Infections and infestations COVID-19 Pneumonia	0.00% 0/83 • Adverse event (AE) data were collected over a period of 20 weeks.	1.8% 1/56 • Number of events 1 • Adverse event (AE) data were collected over a period of 20 weeks.	0.00% 0/55 • Adverse event (AE) data were collected over a period of 20 weeks.	0.00% 0/55 • Adverse event (AE) data were collected over a period of 20 weeks.
Gastrointestinal disorders Peptic Ulcer Hemorrhage	0.00% 0/83 • Adverse event (AE) data were collected over a period of 20 weeks.	0.00% 0/56 • Adverse event (AE) data were collected over a period of 20 weeks.	0.00% 0/55 • Adverse event (AE) data were collected over a period of 20 weeks.	1.8% 1/55 • Number of events 1 • Adverse event (AE) data were collected over a period of 20 weeks.

Other adverse events

Other adverse events
Measure	All Placebo n=83 participants at risk 75 subjects with mild to moderate psoriasis on placebo, any dose	Cohort 1 Active n=56 participants at risk 50 subjects with mild to moderate psoriasis on EDP1815 Dose = 0.8 x 10\^11 cells, capsule, once daily, 16 weeks	Cohort 2 Active n=55 participants at risk 50 subjects with mild to moderate psoriasis on EDP1815 Dose = 3.2 x 10\^11 cells, capsule, once daily, 16 weeks	Cohort 3 Active n=55 participants at risk 50 subjects with mild to moderate psoriasis on EDP1815 Dose = 8.0 x 10\^11 cells, capsule, once daily, 16 weeks
Infections and infestations COVID-19	4.8% 4/83 • Number of events 4 • Adverse event (AE) data were collected over a period of 20 weeks.	3.6% 2/56 • Number of events 2 • Adverse event (AE) data were collected over a period of 20 weeks.	5.5% 3/55 • Number of events 3 • Adverse event (AE) data were collected over a period of 20 weeks.	1.8% 1/55 • Number of events 1 • Adverse event (AE) data were collected over a period of 20 weeks.
Infections and infestations Viral Upper Respiratory Tract Infection	0.00% 0/83 • Adverse event (AE) data were collected over a period of 20 weeks.	3.6% 2/56 • Number of events 2 • Adverse event (AE) data were collected over a period of 20 weeks.	5.5% 3/55 • Number of events 3 • Adverse event (AE) data were collected over a period of 20 weeks.	1.8% 1/55 • Number of events 1 • Adverse event (AE) data were collected over a period of 20 weeks.
Infections and infestations Upper Respiratory Tract Infection	1.2% 1/83 • Number of events 1 • Adverse event (AE) data were collected over a period of 20 weeks.	7.1% 4/56 • Number of events 5 • Adverse event (AE) data were collected over a period of 20 weeks.	0.00% 0/55 • Adverse event (AE) data were collected over a period of 20 weeks.	9.1% 5/55 • Number of events 6 • Adverse event (AE) data were collected over a period of 20 weeks.
Nervous system disorders Headache	10.8% 9/83 • Number of events 15 • Adverse event (AE) data were collected over a period of 20 weeks.	12.5% 7/56 • Number of events 20 • Adverse event (AE) data were collected over a period of 20 weeks.	5.5% 3/55 • Number of events 5 • Adverse event (AE) data were collected over a period of 20 weeks.	9.1% 5/55 • Number of events 8 • Adverse event (AE) data were collected over a period of 20 weeks.
Gastrointestinal disorders Diarrhea	6.0% 5/83 • Number of events 6 • Adverse event (AE) data were collected over a period of 20 weeks.	3.6% 2/56 • Number of events 2 • Adverse event (AE) data were collected over a period of 20 weeks.	1.8% 1/55 • Number of events 1 • Adverse event (AE) data were collected over a period of 20 weeks.	7.3% 4/55 • Number of events 6 • Adverse event (AE) data were collected over a period of 20 weeks.
Gastrointestinal disorders Abdominal Pain	2.4% 2/83 • Number of events 2 • Adverse event (AE) data were collected over a period of 20 weeks.	1.8% 1/56 • Number of events 2 • Adverse event (AE) data were collected over a period of 20 weeks.	5.5% 3/55 • Number of events 4 • Adverse event (AE) data were collected over a period of 20 weeks.	3.6% 2/55 • Number of events 2 • Adverse event (AE) data were collected over a period of 20 weeks.
Gastrointestinal disorders Dyspepsia	2.4% 2/83 • Number of events 2 • Adverse event (AE) data were collected over a period of 20 weeks.	0.00% 0/56 • Adverse event (AE) data were collected over a period of 20 weeks.	7.3% 4/55 • Number of events 7 • Adverse event (AE) data were collected over a period of 20 weeks.	3.6% 2/55 • Number of events 2 • Adverse event (AE) data were collected over a period of 20 weeks.
Gastrointestinal disorders Flatulence	0.00% 0/83 • Adverse event (AE) data were collected over a period of 20 weeks.	0.00% 0/56 • Adverse event (AE) data were collected over a period of 20 weeks.	5.5% 3/55 • Number of events 3 • Adverse event (AE) data were collected over a period of 20 weeks.	1.8% 1/55 • Number of events 1 • Adverse event (AE) data were collected over a period of 20 weeks.
Skin and subcutaneous tissue disorders Rash	0.00% 0/83 • Adverse event (AE) data were collected over a period of 20 weeks.	1.8% 1/56 • Number of events 1 • Adverse event (AE) data were collected over a period of 20 weeks.	0.00% 0/55 • Adverse event (AE) data were collected over a period of 20 weeks.	5.5% 3/55 • Number of events 3 • Adverse event (AE) data were collected over a period of 20 weeks.
Injury, poisoning and procedural complications Vaccination Complication	3.6% 3/83 • Number of events 3 • Adverse event (AE) data were collected over a period of 20 weeks.	3.6% 2/56 • Number of events 2 • Adverse event (AE) data were collected over a period of 20 weeks.	1.8% 1/55 • Number of events 1 • Adverse event (AE) data were collected over a period of 20 weeks.	9.1% 5/55 • Number of events 5 • Adverse event (AE) data were collected over a period of 20 weeks.

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