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    Clinical Trial Results:
    A Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Cohort, Dose-Ranging Study Investigating the Effect of EDP1815 in the Treatment of Mild to Moderate Plaque Psoriasis

    Summary
    EudraCT number
    		 2019-004901-28
    Trial protocol
    		 GB   PL   HU  
    Global end of trial date
    10 Nov 2021

    Results information
    Results version number
    		 v1(current)
    This version publication date
    11 Sep 2022
    First version publication date
    11 Sep 2022
    Other versions

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    EDP1815-201
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Other trial identifiers
    		 IND number: 19576
    Sponsors
    Sponsor organisation name
    Evelo Biosciences Inc.
    Sponsor organisation address
    620 Memorial Drive, Suite 500, Cambridge, United States, MA 02139
    Public contact
    Stuart Abel, Evelo Biosciences Inc., +44 (0)779 626 8347, clinicaltrials@evelobio.com
    Scientific contact
    Stuart Abel, Evelo Biosciences Inc., +44 (0)779 626 8347, clinicaltrials@evelobio.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    20 Mar 2022
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    10 Nov 2021
    Global end of trial reached?
    Yes
    Global end of trial date
    10 Nov 2021
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    Evaluate the safety and efficacy of 3 different doses of EDP1815 for the treatment of psoriasis following daily dosing for 16 weeks.
    Protection of trial subjects
    The study was performed in accordance with the ethical principles that have their origin in the Declaration of Helsinki, ICH GCP, and all applicable country and local regulations. A written informed consent was obtained from each participant before entering the study or performing any nonroutine procedure. Each prospective participant or his or her legal guardian was given a full explanation of the study, was allowed to read the approved ICF, and had any questions answered.
    Background therapy
    		 There wasn’t any background therapy. All prior and concomitant medications were listed.
    Evidence for comparator
    		 This was placebo-controlled study.
    Actual start date of recruitment
    21 Sep 2020
    Long term follow-up planned
    Yes
    Long term follow-up rationale
    		 Safety, Efficacy
    Long term follow-up duration
    		 6 Months
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    United States: 23
    Country: Number of subjects enrolled
    Poland: 130
    Country: Number of subjects enrolled
    United Kingdom: 83
    Country: Number of subjects enrolled
    Hungary: 13
    Worldwide total number of subjects
    249
    EEA total number of subjects
    143
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    0
    Infants and toddlers (28 days-23 months)
    0
    Children (2-11 years)
    0
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    235
    From 65 to 84 years
    14
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Subjects who met all of the inclusion and none of the exclusion criteria were enrolled into the study. A total of 249 subjects were randomly assigned in 1:1:1 ratio to one of the 3 parallel cohorts: Cohort 1: 0.8 × 10^11 cells of EDP1815 or placebo; Cohort 2: 3.2 × 10^11 cells of EDP1815 or placebo; Cohort 3: 8.0 × 10^11 cells of EDP1815 or placebo

    Pre-assignment
    Screening details
    		 Study comprised a screening period of up to 4 weeks. Participants were allowed into the study if they were between the ages of 18 and 70 years (inclusive) with a documented diagnosis of mild to moderate plaque psoriasis for ≥6 months and agreed to follow contraceptive guidance.

    Period 1
    Period 1 title
    Treatment period - Week 20 (Part A)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Monitor, Data analyst, Carer, Assessor
    Blinding implementation details
    This was a double-blind study. Part A of the study comprised a screening period of up to 4 weeks, a baseline visit, a treatment period of 16 weeks (8 planned study site visits), and a follow-up visit at Week 20 (4 weeks after cessation of dosing).

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Cohort 1: EDP1815 1 Capsule
    Arm description
    		 One capsule of EDP1815
    Arm type
    		 Experimental

    Investigational medicinal product name
    EDP1815 1 capsule
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    1 capsule EDP1815 self-administered orally once daily. EDP1815 PIC contained 0.8 x 10^11 cells of Prevotella histicola. 56 subjects were treated with the EDP1815 versus 28 subject treated with placebo.

    Arm title
    		 Cohort 2: EDP1815 4 Capsules
    Arm description
    		 Four capsules of EDP1815
    Arm type
    		 Experimental

    Investigational medicinal product name
    EDP1815 4 capsules
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    4 capsules EDP1815 self-administered orally once daily. Total daily dose was 3.2 x 10^11 cells of Prevotella histicola. 55 patients were treated with EDP1815 versus 27 were treated with placebo.

    Arm title
    		 Cohort 3: EDP1815 10 Capsules
    Arm description
    		 Ten capsules of EDP1815
    Arm type
    		 Experimental

    Investigational medicinal product name
    EDP1815 10 capsules
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    10 capsules EDP1815 self-administered orally once daily. Total daily dose was 8.0 x 10^11 cells of Prevotella histicola. 55 patients were treated with EDP1815 versus 28 treated with placebo.

    Arm title
    		 Placebo
    Arm description
    		 EDP1815 matching placebo administered once daily as 1, 4 or 10 capsules.
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    1, 4 or 10 capsules Placebo self-administered orally once daily. Placebo was identical in appearance to EDP1815 but did not contain Prevotella histicola or any other bacteria.

    Number of subjects in period 1
    		Cohort 1: EDP1815 1 Capsule Cohort 2: EDP1815 4 Capsules Cohort 3: EDP1815 10 Capsules Placebo
    Started
    56
    55
    55
    83
    Completed
    36
    45
    41
    64
    Not completed
    20
    10
    14
    19
         Consent withdrawn by subject
    4
    3
    4
    3
         Other
    1
    1
    -
    -
         Pregnancy
    -
    1
    -
    -
         Adverse event
    2
    1
    -
    3
         Treatment failure removal by the investigator
    4
    2
    3
    6
         Use of nonpermitted concurrent therapy
    -
    -
    -
    1
         Lost to follow-up
    1
    -
    3
    3
         Lack of efficacy
    8
    2
    4
    3
    Period 2
    Period 2 title
    Follow-up period - Week 40 (Part B)
    Is this the baseline period?
    		 No
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Monitor, Data analyst, Carer, Assessor
    Blinding implementation details
    This was double-blind study. Part B of the study was designed to assess the durability of treatment response and incidence of rebound of psoriasis following cessation of dosing with follow-up to Week 40 (24 weeks after cessation of dosing). Participants who completed Part A of the study without confirmation of treatment failure or rebound were permitted to enter Part B of the study. No treatment was conducted during part B.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Cohort 1: EDP1815 1 Capsule
    Arm description
    		 One capsule of EDP1815 was administrated in Cohort 1.
    Arm type
    		 Experimental

    Investigational medicinal product name
    EDP1815 1 capsule
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    Part A dosage and administration: 1 capsule EDP1815 self-administered orally once daily. EDP1815 PIC contained 0.8 x 10*11 cells of Prevotella histicola.

    Arm title
    		 Cohort 2: EDP1815 4 Capsules
    Arm description
    		 Four capsules of EDP1815 were administrated in Cohort 2.
    Arm type
    		 Experimental

    Investigational medicinal product name
    EDP1815 4 capsules
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    Part A dosage and administration: 4 capsules EDP1815 self-administered orally once daily. Total daily dose was 3.2 x 10*10 cells of Prevotella histicola.

    Arm title
    		 Cohort 3: EDP1815 10 Capsules
    Arm description
    		 Ten capsules of EDP1815 were administrated in Cohort 3.
    Arm type
    		 Experimental

    Investigational medicinal product name
    EDP1815 10 capsules
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    Part A dosage and administration: 10 capsules EDP1815 self-administered orally once daily. Total daily dose was 8.0 x 10*10 cells of Prevotella histicola.

    Arm title
    		 Placebo
    Arm description
    		 EDP1815 matching placebo administered once daily as 1, 4 or 10 capsules.
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    Part A dosage and administration: 1, 4 or 10 capsules Placebo self-administered orally once daily. Placebo was identical in appearance to EDP1815 but did not contain Prevotella histicola or any other bacteria.

    Number of subjects in period 2 [1]
    		Cohort 1: EDP1815 1 Capsule Cohort 2: EDP1815 4 Capsules Cohort 3: EDP1815 10 Capsules Placebo
    Started
    23
    31
    29
    41
    Completed
    22
    25
    25
    37
    Not completed
    1
    6
    4
    4
         Consent withdrawn by subject
    1
    3
    3
    2
         Other
    -
    1
    -
    1
         Lost to follow-up
    -
    2
    1
    1
    Notes
    [1] - The number of subjects starting the period is not consistent with the number completing the preceding period. It is expected the number of subjects starting the subsequent period will be the same as the number completing the preceding period.
    Justification: 249 subjects started Treatment period (Part A), 186 subjects completed Part A and 124 subjects entered into Follow up period (Part B).

    Baseline characteristics

    		 Close Top of page
    Baseline characteristics reporting groups
    Reporting group title
    Cohort 1: EDP1815 1 Capsule
    Reporting group description
    		 One capsule of EDP1815

    Reporting group title
    Cohort 2: EDP1815 4 Capsules
    Reporting group description
    		 Four capsules of EDP1815

    Reporting group title
    Cohort 3: EDP1815 10 Capsules
    Reporting group description
    		 Ten capsules of EDP1815

    Reporting group title
    Placebo
    Reporting group description
    		 EDP1815 matching placebo administered once daily as 1, 4 or 10 capsules.

    Reporting group values
    		 Cohort 1: EDP1815 1 Capsule Cohort 2: EDP1815 4 Capsules Cohort 3: EDP1815 10 Capsules Placebo Total
    Number of subjects
    		 56 55 55 83 249
    Age categorical
    Units: Subjects
        Adults (18-64 years)
    		 52 53 51 79 235
        From 65-84 years
    		 4 2 4 4 14
    Age continuous
    Units: years
        median (full range (min-max))
    		 44.0 (18 to 69) 42.0 (19 to 67) 44.0 (23 to 70) 44.0 (19 to 68) -
    Gender categorical
    Units: Subjects
        Female
    		 22 24 13 33 92
        Male
    		 34 31 42 50 157
    Subject analysis sets

    Subject analysis set title
    mITT set
    Subject analysis set type
    		 Modified intention-to-treat
    Subject analysis set description
    The mITT set consisted of all participants who were randomized to treatment and who received at least 1 dose of study treatment. Participants who withdrew from the study before the end of Week 4 and were replaced were included in this analysis set. All analyses using the mITT grouped participants according to randomized treatment. The mITT set was the primary population of interest for the efficacy analyses.

    Subject analysis set title
    Safety set
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    The safety set consisted of all participants who received any study drug. All analyses using the safety set grouped participants according to treatment received. If participants received multiple treatments during the study, they were assigned to treatment group in the following manner: • If a participant received both active EDP1815 and placebo treatments, they were assigned to the active treatment group. • If a participant received 2 or more different active dose levels, they were assigned to the highest dose they received. The safety set was used for all safety data presentations.

    Subject analysis sets values
    		 mITT set Safety set
    Number of subjects
    249
    249
    Age categorical
    Units: Subjects
        Adults (18-64 years)
    237
    237
        From 65-84 years
    14
    14
    Age continuous
    Units: years
        median (full range (min-max))
    43.0 (18 to 70)
    43.0 (18 to 70)
    Gender categorical
    Units: Subjects
        Female
    92
    92
        Male
    157
    157

    End points

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    End points reporting groups
    Reporting group title
    Cohort 1: EDP1815 1 Capsule
    Reporting group description
    		 One capsule of EDP1815

    Reporting group title
    Cohort 2: EDP1815 4 Capsules
    Reporting group description
    		 Four capsules of EDP1815

    Reporting group title
    Cohort 3: EDP1815 10 Capsules
    Reporting group description
    		 Ten capsules of EDP1815

    Reporting group title
    Placebo
    Reporting group description
    		 EDP1815 matching placebo administered once daily as 1, 4 or 10 capsules.
    Reporting group title
    Cohort 1: EDP1815 1 Capsule
    Reporting group description
    		 One capsule of EDP1815 was administrated in Cohort 1.

    Reporting group title
    Cohort 2: EDP1815 4 Capsules
    Reporting group description
    		 Four capsules of EDP1815 were administrated in Cohort 2.

    Reporting group title
    Cohort 3: EDP1815 10 Capsules
    Reporting group description
    		 Ten capsules of EDP1815 were administrated in Cohort 3.

    Reporting group title
    Placebo
    Reporting group description
    		 EDP1815 matching placebo administered once daily as 1, 4 or 10 capsules.

    Subject analysis set title
    mITT set
    Subject analysis set type
    		 Modified intention-to-treat
    Subject analysis set description
    The mITT set consisted of all participants who were randomized to treatment and who received at least 1 dose of study treatment. Participants who withdrew from the study before the end of Week 4 and were replaced were included in this analysis set. All analyses using the mITT grouped participants according to randomized treatment. The mITT set was the primary population of interest for the efficacy analyses.

    Subject analysis set title
    Safety set
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    The safety set consisted of all participants who received any study drug. All analyses using the safety set grouped participants according to treatment received. If participants received multiple treatments during the study, they were assigned to treatment group in the following manner: • If a participant received both active EDP1815 and placebo treatments, they were assigned to the active treatment group. • If a participant received 2 or more different active dose levels, they were assigned to the highest dose they received. The safety set was used for all safety data presentations.

    Primary: Analysis of Percentage Change from Baseline in PASI Score – Bayesian MMRM

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    End point title
    		 Analysis of Percentage Change from Baseline in PASI Score – Bayesian MMRM
    End point description
    The primary efficacy endpoint was percentage change in PASI score from baseline at Week 16.
    End point type
    Primary
    End point timeframe
    At week 16
    End point values
    		 Cohort 1: EDP1815 1 Capsule Cohort 2: EDP1815 4 Capsules Cohort 3: EDP1815 10 Capsules Placebo
    Number of subjects analysed
    55
    54
    54
    82
    Units: percent
    number (confidence interval 95%)
        Percentage change from baseline (Posterior mean)
    -20.37 (-31.65 to -9.47)
    -22.73 (-33.08 to -11.88)
    -23.49 (-34.18 to -12.12)
    -14.39 (-22.66 to -5.52)
    Statistical analysis title
    		 Statistical Analysis - Cohort 1 vs Placebo
    Statistical analysis description
    Performed using a Bayesian Mixed Model for Repeated Measures (MMRM) analysis with parameters for treatment*visit and baseline*visit and baseline BMI. Non-informative priors following a normal distribution with mean of 0 and a SD of 1000 were used for all parameters. After a burn-in of 10,000 samples, 100,000 MCMC samples were generated with a thin of 20 to leave 5000 retained samples for the analysis.
    Comparison groups
    Cohort 1: EDP1815 1 Capsule v Placebo
    Number of subjects included in analysis
    137
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [1]
    P-value
    		 = 0.799 [2]
    Method
    		 Bayesian MMRM
    Parameter type
    		 Posterior mean
    Point estimate
    -5.99
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -20.28
         upper limit
    		 7.12
    Notes
    [1] - All post-baseline visits were included in the model but only the Week 16 results are shown here. All four treatment groups were included into the same model and pairwise treatment differences between each active treatment group and the pooled placebo group were estimated using the posterior mean difference and 95% credible interval.
    [2] - Posterior probability of superiority over placebo.
    Statistical analysis title
    		 Statistical Analysis - Cohort 2 vs Placebo
    Statistical analysis description
    Performed using a Bayesian Mixed Model for Repeated Measures (MMRM) analysis with parameters for treatment*visit and baseline*visit and baseline BMI. Non-informative priors following a normal distribution with mean of 0 and a SD of 1000 were used for all parameters. After a burn-in of 10,000 samples, 100,000 MCMC samples were generated with a thin of 20 to leave 5000 retained samples for the analysis.
    Comparison groups
    Placebo v Cohort 2: EDP1815 4 Capsules
    Number of subjects included in analysis
    136
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [3]
    P-value
    		 = 0.887 [4]
    Method
    		 Bayesian MMRM
    Parameter type
    		 Posterior mean
    Point estimate
    -8.35
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -22.07
         upper limit
    		 5.04
    Notes
    [3] - All post-baseline visits were included in the model but only the Week 16 results are shown here. All four treatment groups were included into the same model and pairwise treatment differences between each active treatment group and the pooled placebo group were estimated using the posterior mean difference and 95% credible interval.
    [4] - Posterior probability of superiority over placebo.
    Statistical analysis title
    		 Statistical Analysis - Cohort 3 vs Placebo
    Statistical analysis description
    Performed using a Bayesian Mixed Model for Repeated Measures (MMRM) analysis with parameters for treatment*visit and baseline*visit and baseline BMI. Non-informative priors following a normal distribution with mean of 0 and a SD of 1000 were used for all parameters. After a burn-in of 10,000 samples, 100,000 MCMC samples were generated with a thin of 20 to leave 5000 retained samples for the analysis.
    Comparison groups
    Placebo v Cohort 3: EDP1815 10 Capsules
    Number of subjects included in analysis
    136
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [5]
    P-value
    		 = 0.897 [6]
    Method
    		 Bayesian MMRM
    Parameter type
    		 Posterior mean
    Point estimate
    -9.1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -23.22
         upper limit
    		 4.65
    Notes
    [5] - All post-baseline visits were included in the model but only the Week 16 results are shown here. All four treatment groups were included into the same model and pairwise treatment differences between each active treatment group and the pooled placebo group were estimated using the posterior mean difference and 95% credible interval.
    [6] - Posterior probability of superiority over placebo.

    Secondary: Summary and Analysis of PASI-50 Response - GLMM

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    End point title
    		 Summary and Analysis of PASI-50 Response - GLMM
    End point description
    Analysis of treatment with EDP1815 (1 capsule and 4 capsules) in the proportion of participants achieving PASI-50 at Week 16 compared to placebo.
    End point type
    Secondary
    End point timeframe
    At week 16
    End point values
    		 Cohort 1: EDP1815 1 Capsule Cohort 2: EDP1815 4 Capsules Cohort 3: EDP1815 10 Capsules Placebo
    Number of subjects analysed
    37
    47
    40
    66
    Units: percent
    number (confidence interval 95%)
        Responders (%)
    29.7 (15.9 to 47.0)
    31.9 (19.1 to 47.1)
    25.0 (12.7 to 41.2)
    12.1 (5.4 to 22.5)
    Statistical analysis title
    		 Statistical Analysis - Cohort 1 vs Placebo
    Statistical analysis description
    Generalised linear mixed model (GLMM) with a logit link function. Treatment, visit, baseline PASI score, and baseline BMI terms included in the model as fixed effects together with treatment visit and baseline PASI score visit interactions. An unstructured covariance structure was used. All post-baseline visits were included in the model but only the Week 16 results are shown here.
    Comparison groups
    Cohort 1: EDP1815 1 Capsule v Placebo
    Number of subjects included in analysis
    103
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [7]
    P-value
    		 = 0.048
    Method
    		 Generalised linear mixed model (GLMM)
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    2.64
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.01
         upper limit
    		 6.94
    Notes
    [7] - All four treatment groups were included into the same model and pairwise odds ratios for each active treatment group compared to placebo were estimated with 95% confidence interval.
    Statistical analysis title
    		 Statistical Analysis - Cohort 2 vs Placebo
    Statistical analysis description
    Generalised linear mixed model (GLMM) with a logit link function. Treatment, visit, baseline PASI score, and baseline BMI terms included in the model as fixed effects together with treatment visit and baseline PASI score visit interactions. An unstructured covariance structure was used. All post-baseline visits were included in the model but only the Week 16 results are shown here.
    Comparison groups
    Placebo v Cohort 2: EDP1815 4 Capsules
    Number of subjects included in analysis
    113
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [8]
    P-value
    		 = 0.022
    Method
    		 Generalised linear mixed model (GLMM)
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    2.93
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.17
         upper limit
    		 7.37
    Notes
    [8] - All four treatment groups were included into the same model and pairwise odds ratios for each active treatment group compared to placebo were estimated with 95% confidence interval.
    Statistical analysis title
    		 Statistical Analysis - Cohort 3 vs Placebo
    Statistical analysis description
    Generalised linear mixed model (GLMM) with a logit link function. Treatment, visit, baseline PASI score, and baseline BMI terms included in the model as fixed effects together with treatment visit and baseline PASI score visit interactions. An unstructured covariance structure was used. All post-baseline visits were included in the model but only the Week 16 results are shown here.
    Comparison groups
    Placebo v Cohort 3: EDP1815 10 Capsules
    Number of subjects included in analysis
    106
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [9]
    P-value
    		 = 0.285
    Method
    		 Generalised linear mixed model (GLMM)
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    1.73
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.63
         upper limit
    		 4.7
    Notes
    [9] - All four treatment groups were included into the same model and pairwise odds ratios for each active treatment group compared to placebo were estimated with 95% confidence interval.

    Secondary: Cumulative Incidence of Partial Relapse in the Week 16 Responders Population

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    End point title
    		 Cumulative Incidence of Partial Relapse in the Week 16 Responders Population
    End point description
    Cumulative Incidence of Partial Relapse was measured at week 20, 24, 28, 40. Partial relapse was the event of interest and was defined, after the Week 16 visit, as loss of PASI-50 response after cessation of study treatment or the participant began a new treatment for psoriasis.
    End point type
    Secondary
    End point timeframe
    At week 20, 24, 28, 40
    End point values
    		 Cohort 1: EDP1815 1 Capsule Cohort 2: EDP1815 4 Capsules Cohort 3: EDP1815 10 Capsules Placebo
    Number of subjects analysed
    12
    16
    10
    9
    Units: percent
    number (confidence interval 95%)
        Incidence of participants with event – Week 20
    16.7 (2.1 to 48.4)
    33.3 (11.8 to 61.6)
    0 (0 to 30.8)
    11.1 (0.3 to 48.2)
        Incidence of participants with event – Week 24
    33.3 (9.9 to 65.1)
    40.0 (16.3 to 67.7)
    10.0 (0.3 to 44.5)
    11.1 (0.3 to 48.2)
        Incidence of participants with event – Week 28
    33.3 (9.9 to 65.1)
    53.3 (26.6 to 78.7)
    20.0 (2.5 to 55.6)
    33.3 (7.5 to 70.1)
        Incidence of participants with event – Week 40
    33.3 (9.9 to 65.1)
    53.3 (26.6 to 78.7)
    20.0 (2.5 to 55.6)
    44.4 (13.7 to 78.8)
    No statistical analyses for this end point

    Secondary: Cumulative Incidence of Relapse in the Week 16 Responders Population

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    End point title
    		 Cumulative Incidence of Relapse in the Week 16 Responders Population
    End point description
    Cumulative Incidence of Relapse was measured at week 20, 24, 28, 40. Relapse was the event of interest and was defined, after the Week 16 visit, as an increase in PASI score to the baseline value or greater or the participant began a new treatment for psoriasis.
    End point type
    Secondary
    End point timeframe
    At week 20, 24, 28 and 40
    End point values
    		 Cohort 1: EDP1815 1 Capsule Cohort 2: EDP1815 4 Capsules Cohort 3: EDP1815 10 Capsules Placebo
    Number of subjects analysed
    12
    16
    10
    9
    Units: percent
    number (confidence interval 95%)
        Incidence of participants with event – Week 20
    0 (0 to 26.5)
    0 (0 to 21.8)
    0 (0 to 30.8)
    0 (0 to 33.6)
        Incidence of participants with event – Week 24
    0 (0 to 26.5)
    6.7 (0.2 to 31.9)
    10.0 (0.3 to 44.5)
    0 (0 to 33.6)
        Incidence of participants with event – Week 28
    0 (0 to 26.5)
    13.3 (1.7 to 40.5)
    10.0 (0.3 to 44.5)
    0 (0 to 33.6)
        Incidence of participants with event – Week 40
    8.3 (0.2 to 38.5)
    13.3 (1.7 to 40.5)
    10.0 (0.3 to 44.5)
    0 (0 to 33.6)
    No statistical analyses for this end point

    Secondary: Cumulative Incidence of Rebound in the mITT Population

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    End point title
    		 Cumulative Incidence of Rebound in the mITT Population
    End point description
    Cumulative Incidence of Rebound has been measured on or before Week 20/Follow-up, at week 24 and 28 in the mITT Population. Rebound was the event of interest and was defined as an increase in PASI score to 125% of baseline value or above or onset of new pustular/erythrodermic psoriasis on or before the Week 28 visit.
    End point type
    Secondary
    End point timeframe
    On or before Week 20, at week 24 and 28
    End point values
    		 Cohort 1: EDP1815 1 Capsule Cohort 2: EDP1815 4 Capsules Cohort 3: EDP1815 10 Capsules Placebo
    Number of subjects analysed
    23
    31
    29
    41
    Units: percent
    number (confidence interval 95%)
        Incidence of participants with event – Week 20
    8.1 (1.7 to 21.9)
    4.7 (0.6 to 15.8)
    2.2 (0.1 to 11.8)
    6.3 (1.7 to 15.2)
        Incidence of participants with event – Week 24
    13.5 (4.5 to 28.8)
    4.7 (0.6 to 15.8)
    2.2 (0.1 to 11.8)
    7.8 (2.6 to 17.3)
        Incidence of participants with event – Week 28
    16.2 (6.2 to 32.0)
    7.0 (1.5 to 19.1)
    2.2 (0.1 to 11.8)
    10.9 (4.5 to 21.2)
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    During the whole study period.
    Adverse event reporting additional description
    TEAE is defined as an adverse event with onset date and time on or after the date and time of the first dose of study drug.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    23.0
    Reporting groups
    Reporting group title
    Cohort 1: EDP1815 1 Capsule
    Reporting group description
    		 One capsule of EDP1815 was administrated in Cohort 1.

    Reporting group title
    Cohort 2: EDP1815 4 Capsules
    Reporting group description
    		 Four capsules of EDP1815 were administrated in Cohort 2.

    Reporting group title
    Cohort 3: EDP1815 10 Capsules
    Reporting group description
    		 Ten capsules of EDP1815 were administrated in Cohort 3.

    Reporting group title
    Placebo
    Reporting group description
    		 EDP1815 matching placebo administered once daily as 1, 4 or 10 capsules.

    Serious adverse events
    		 Cohort 1: EDP1815 1 Capsule Cohort 2: EDP1815 4 Capsules Cohort 3: EDP1815 10 Capsules Placebo
    Total subjects affected by serious adverse events
         subjects affected / exposed
    1 / 56 (1.79%)
    0 / 55 (0.00%)
    1 / 55 (1.82%)
    0 / 83 (0.00%)
         number of deaths (all causes)
    0
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    0
    Gastrointestinal disorders
    Peptic ulcer haemorrhage
         subjects affected / exposed
    0 / 56 (0.00%)
    0 / 55 (0.00%)
    1 / 55 (1.82%)
    0 / 83 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    COVID-19 pneumonia
         subjects affected / exposed
    1 / 56 (1.79%)
    0 / 55 (0.00%)
    0 / 55 (0.00%)
    0 / 83 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Cohort 1: EDP1815 1 Capsule Cohort 2: EDP1815 4 Capsules Cohort 3: EDP1815 10 Capsules Placebo
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    21 / 56 (37.50%)
    21 / 55 (38.18%)
    25 / 55 (45.45%)
    26 / 83 (31.33%)
    Injury, poisoning and procedural complications
    Vaccination complication
         subjects affected / exposed
    2 / 56 (3.57%)
    1 / 55 (1.82%)
    5 / 55 (9.09%)
    3 / 83 (3.61%)
         occurrences all number
    2
    1
    5
    3
    Nervous system disorders
    Headache
         subjects affected / exposed
    7 / 56 (12.50%)
    3 / 55 (5.45%)
    5 / 55 (9.09%)
    9 / 83 (10.84%)
         occurrences all number
    20
    5
    8
    15
    Gastrointestinal disorders
    Diarrhoea
         subjects affected / exposed
    2 / 56 (3.57%)
    1 / 55 (1.82%)
    4 / 55 (7.27%)
    5 / 83 (6.02%)
         occurrences all number
    2
    1
    6
    6
    Abdominal pain
         subjects affected / exposed
    1 / 56 (1.79%)
    3 / 55 (5.45%)
    2 / 55 (3.64%)
    2 / 83 (2.41%)
         occurrences all number
    2
    4
    2
    2
    Dyspepsia
         subjects affected / exposed
    0 / 56 (0.00%)
    4 / 55 (7.27%)
    2 / 55 (3.64%)
    2 / 83 (2.41%)
         occurrences all number
    0
    7
    2
    2
    Flatulence
         subjects affected / exposed
    0 / 56 (0.00%)
    3 / 55 (5.45%)
    1 / 55 (1.82%)
    0 / 83 (0.00%)
         occurrences all number
    0
    3
    1
    0
    Skin and subcutaneous tissue disorders
    Rash
         subjects affected / exposed
    1 / 56 (1.79%)
    0 / 55 (0.00%)
    3 / 55 (5.45%)
    0 / 83 (0.00%)
         occurrences all number
    1
    0
    3
    0
    Infections and infestations
    COVID-19
         subjects affected / exposed
    2 / 56 (3.57%)
    3 / 55 (5.45%)
    1 / 55 (1.82%)
    4 / 83 (4.82%)
         occurrences all number
    2
    3
    1
    4
    Viral upper respiratory tract infection
         subjects affected / exposed
    2 / 56 (3.57%)
    3 / 55 (5.45%)
    1 / 55 (1.82%)
    0 / 83 (0.00%)
         occurrences all number
    2
    3
    1
    0
    Upper respiratory tract infection
         subjects affected / exposed
    4 / 56 (7.14%)
    0 / 55 (0.00%)
    1 / 55 (1.82%)
    1 / 83 (1.20%)
         occurrences all number
    5
    0
    1
    1

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    26 May 2020
    The first participant was enrolled under Protocol Amendment 3, dated 26 May 2020.
    17 Nov 2020
    The following is a summary of the major changes implemented with Protocol Amendment 4, dated 17 Nov 2020: • Local Amendment 3.1 (Hungary specific) was included. • Post-treatment follow-up was extended for a maximum of up to 6 months. • One secondary and 1 exploratory objective were added. • Definitions of response, relapse, and rebound based on PASI score were added. • Statistical analyses, endpoints, and supportive analyses were updated. • Skin plaque biopsy description was added. • Instructions for participants on withholding emollients or moisturizers were added. • 1,25-dihydroxy vitamin D3 and its analogs were removed from exclusion criterion #8. • Exclusion criterion #21 was clarified. • Pre- and probiotic use was clarified. • Allowed and prohibited vaccines were updated. • Eligibility confirmation at baseline/Visit 2 was clarified to be based on screening laboratory results. • The maximum allowed dose (overdose management) was clarified. • Clarification on data blinding was added. • “On the morning of the visit” ECGs and vital signs were changed to “on the day of the visit” in footnotes of the SoA. • The ideal size of lesion area for digital photography was updated.

    Interruptions (globally)
    Were there any global interruptions to the trial? No

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported
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