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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT05121480
Registration number
NCT05121480
Ethics application status
Date submitted
4/11/2021
Date registered
16/11/2021
Titles & IDs
Public title
A Study Investigating the Effect of EDP1815 in the Treatment of Mild, Moderate and Severe Atopic Dermatitis
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Scientific title
A Phase 2, Multicenter, Double-Blind, Placebo-Controlled, Multiple-Cohort Study Investigating the Effect of EDP1815 in Participants for the Treatment of Mild, Moderate and Severe Atopic Dermatitis
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Secondary ID [1]
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0
2021-001805-63
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Secondary ID [2]
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0
EDP1815-207
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Atopic Dermatitis
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0
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Condition category
Condition code
Skin
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0
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0
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Dermatological conditions
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Skin
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0
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0
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Other skin conditions
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Inflammatory and Immune System
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0
0
0
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Other inflammatory or immune system disorders
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - EDP1815
Treatment: Drugs - Placebo
Experimental: Cohort 1 - 100 participants with mild, moderate or severe Atopic Dermatitis 75 participants on EDP1815 and 25 participants on matching placebo administered as 2 capsules (1.6 x 10\^11 total cells) once daily for 16 weeks
Experimental: Cohort 2 - 100 participants with mild, moderate or severe Atopic Dermatitis 75 participants on EDP1815 and 25 participants on matching placebo administered as 2 capsules (6.4 x 10\^11 total cells) once daily for 16 weeks
Experimental: Cohort 3 - 100 participants with mild, moderate or severe Atopic Dermatitis 75 participants on EDP1815 and 25 participants on matching placebo administered as 1 capsule (3.2 x 10\^11 cells) twice daily (6.4 x 10\^11 total cells) for 16 weeks
Experimental: Cohort 4 - 105 participants with mild, moderate or severe Atopic Dermatitis 70 participants on EDP1815 and 35 participants on matching placebo administered at 1 capsule (8.0x10\^10 total cells) once daily for 16 weeks
Treatment: Drugs: EDP1815
EDP1815 is an orally administered, pharmaceutical preparation of a single strain of bacteria
Treatment: Drugs: Placebo
Placebo oral capsule
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Intervention code [1]
0
0
Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Achievement of EASI-50
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Assessment method [1]
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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.
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Timepoint [1]
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0
16 weeks
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Secondary outcome [1]
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0
Percentage of Participants Achieving EASI-50
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Assessment method [1]
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0
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.
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Timepoint [1]
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4, 8 and 12 weeks
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Secondary outcome [2]
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Percentage of Participants Achieving EASI-75
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Assessment method [2]
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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.
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Timepoint [2]
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4, 8, 12, and 16 weeks
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Secondary outcome [3]
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Percentage of Participants Achieving EASI-90
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Assessment method [3]
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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.
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Timepoint [3]
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4, 8, 12, and 16 weeks
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Secondary outcome [4]
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Mean Absolute Change in EASI
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Assessment method [4]
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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.
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Timepoint [4]
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0
4, 8, 12, and 16 weeks
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Secondary outcome [5]
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0
Mean Percentage Change in EASI
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Assessment method [5]
0
0
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.
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Timepoint [5]
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0
4, 8, 12, and 16 weeks
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Secondary outcome [6]
0
0
Percentage of Participants Achieving Investigator's Global Assessment (vIGA) of 0 or 1 With a =2 Point Improvement
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Assessment method [6]
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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
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Timepoint [6]
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0
4, 8, 12, and 16 weeks
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Secondary outcome [7]
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Percentage of Participants Achieving vIGA of 0 or 1
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Assessment method [7]
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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
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Timepoint [7]
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0
4, 8, 12, and 16 weeks
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Secondary outcome [8]
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Percentage of Participants Achieving vIGA of 0
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Assessment method [8]
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The efficacy of EDP1815 will be measured by the number of participants achieving a vIGA of 0 at Week16
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Timepoint [8]
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16 weeks
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Secondary outcome [9]
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Mean Absolute Change in vIGA*BSA
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Assessment method [9]
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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.
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Timepoint [9]
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4, 8, 12, and 16 weeks
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Secondary outcome [10]
0
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Mean Percentage Change in vIGA*BSA
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Assessment method [10]
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0
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.
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Timepoint [10]
0
0
4, 8, 12, and 16 weeks
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Secondary outcome [11]
0
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Mean Absolute Change From Baseline in BSA
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Assessment method [11]
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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.
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Timepoint [11]
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4, 8, 12, and 16 weeks
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Secondary outcome [12]
0
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Mean Percentage Change From Baseline in BSA
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Assessment method [12]
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0
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.
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Timepoint [12]
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4, 8, 12, and 16 weeks
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Secondary outcome [13]
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Percentage of Participants Achieving BSA-50
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Assessment method [13]
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The efficacy of EDP1815 will be measured by the number of participants achieving a BSA-50 at Weeks 4, 8, 12 and 16
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Timepoint [13]
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4, 8, 12, and 16 weeks
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Secondary outcome [14]
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0
Percentage of Participants Achieving BSA-75
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Assessment method [14]
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0
The efficacy of EDP1815 will be measured by the number of participants achieving a BSA-75 at Weeks 4, 8, 12 and 16
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Timepoint [14]
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4, 8, 12, and 16 weeks
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Secondary outcome [15]
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Percentage of Participants Achieving BSA Reduction to 3% BSA or Less
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Assessment method [15]
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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
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Timepoint [15]
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0
4, 8, 12, and 16 weeks
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Secondary outcome [16]
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Mean Absolute Change From Baseline in SCORing Atopic Dermatitis (SCORAD)
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Assessment method [16]
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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.
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Timepoint [16]
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0
4, 8, 12, and 16 weeks
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Secondary outcome [17]
0
0
Mean Percentage Change From Baseline in SCORAD
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Assessment method [17]
0
0
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.
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Timepoint [17]
0
0
4, 8, 12, and 16 weeks
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Secondary outcome [18]
0
0
Percentage of Participants Achieving SCORAD-50
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Assessment method [18]
0
0
The efficacy of EDP1815 will be measured by the number of participants achieving a SCORAD-50 at Weeks 4, 8, 12 and 16
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Timepoint [18]
0
0
4, 8, 12, and 16 weeks
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Secondary outcome [19]
0
0
Percentage of Participants Achieving SCORAD-75
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Assessment method [19]
0
0
The efficacy of EDP1815 will be measured by the number of participants achieving a SCORAD-75 at Weeks 4, 8, 12 and 16
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Timepoint [19]
0
0
4, 8, 12, and 16 weeks
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Secondary outcome [20]
0
0
Mean Absolute Change From Baseline in the Dermatology Quality of Life Index (DLQI)
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Assessment method [20]
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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.
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Timepoint [20]
0
0
4, 8, 12, and 16 weeks
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Secondary outcome [21]
0
0
Mean Percentage Change From Baseline in DLQI
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Assessment method [21]
0
0
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.
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Timepoint [21]
0
0
4, 8, 12, and 16 weeks
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Secondary outcome [22]
0
0
Percentage of Participants Achieving a Reduction of =4 in the DLQI, of Those With a Score of =4 at Baseline
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Assessment method [22]
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0
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.
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Timepoint [22]
0
0
16 weeks
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Secondary outcome [23]
0
0
Mean Absolute Change From Baseline in Worst Pruritus Numerical Rating Scale (PR-NRS)
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Assessment method [23]
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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.
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Timepoint [23]
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0
4, 8, 12, and 16 weeks
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Secondary outcome [24]
0
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Percentage of Participants Achieving a Reduction of =2 in the Worst Pruritus-NRS, of Those With a Score of =2 at Baseline
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Assessment method [24]
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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.
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Timepoint [24]
0
0
4, 8, 12, and 16 weeks
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Secondary outcome [25]
0
0
Percentage of Participants Achieving a Reduction of =4 in the Worst PR-NRS, of Those With a Score of =4 at Baseline
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Assessment method [25]
0
0
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.
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Timepoint [25]
0
0
16 weeks
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Secondary outcome [26]
0
0
Mean Absolute Change From Baseline in the Sleep Disturbance Numerical Rating Scale (SD-NRS) Score
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Assessment method [26]
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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.
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Timepoint [26]
0
0
4, 8, 12, and 16 weeks
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Secondary outcome [27]
0
0
Percentage of Participants Achieving a Reduction of =2 in SD-NRS Score, of Those With a Score of =2 at Baseline
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Assessment method [27]
0
0
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.
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Timepoint [27]
0
0
16 weeks
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Secondary outcome [28]
0
0
Mean Absolute Change From Baseline in Patient Oriented Eczema Measure (POEM)
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Assessment method [28]
0
0
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.
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Timepoint [28]
0
0
4, 8, 12, and 16 weeks
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Secondary outcome [29]
0
0
Mean Percentage Change From Baseline in Patient Oriented Eczema Measure (POEM)
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Assessment method [29]
0
0
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.
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Timepoint [29]
0
0
4, 8, 12, and 16 weeks
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Secondary outcome [30]
0
0
Percentage of Participants Achieving a Reduction of =4 in the POEM Score, of Those With a Score of =4 at Baseline
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Assessment method [30]
0
0
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.
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Timepoint [30]
0
0
16 weeks
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Secondary outcome [31]
0
0
Number of Courses of Rescue Therapy Per Participant
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Assessment method [31]
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0
The efficacy of EDP1815 will be measured by the number of rescue therapy courses per participant at Weeks 4, 8, 12 and 16
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Timepoint [31]
0
0
4, 8, 12, and 16 weeks
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Secondary outcome [32]
0
0
Number of Days of Treatment With Rescue Therapy Per Participant
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Assessment method [32]
0
0
The efficacy of EDP1815 will be measured by the number of rescue therapy treatment days per participant at Weeks 1-8 and 9-16
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Timepoint [32]
0
0
16 weeks
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Secondary outcome [33]
0
0
Proportion of Participants Not Requiring Rescue Therapy
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Assessment method [33]
0
0
The efficacy of EDP1815 will be measured by the proportion of participants not requiring rescue therapy at Weeks 4, 8, 12 and 16
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Timepoint [33]
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0
4, 8, 12, and 16 weeks
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Eligibility
Key inclusion criteria
* Provide written informed consent.
* Must meet age criteria.
* Must have a diagnosis of atopic dermatitis (AD)for at least 6 months.
* Must have severity of atopic dermatitis meeting the below criteria at both Screening and Day 1:
* An IGA of 2, 3 or 4 on the vIGA scale, and;
* A BSA of =5%, and;
* An EASI score of =6.
* Must agree to use emollients.
* Must meet contraception requirements.
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Minimum age
18
Years
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Maximum age
75
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
* Have been in a clinical trial for EDP1815 prior to signing of ICF.
* Use of phototherapy or tanning beds; systemic medications/treatments that could affect AD or its symptoms including immunosuppressive therapy (e.g., oral or injectable corticosteroids, methotrexate, azathioprine, cyclosporine, mycophenolate mofetil, JAK inhibitors, tacrolimus, and/or leukotriene inhibitor) within 4 weeks of randomization.
* Treatment with topical agents that could affect atopic dermatitis, including topical corticosteroids, topical calcineurin inhibitors (e.g., tacrolimus or pimecrolimus), or topical PDE-4 inhibitor (e.g., crisaborole) within 14 days prior to randomization.
* Clinically significant abnormalities in screening laboratory values that in the opinion of the Investigator would make a participant unsuitable for inclusion in the study. One retest is permitted within the 28-day screening window.
* Hypersensitivity to P histicola or to any of the excipients.
* Unwillingness to comply with study procedures, including follow-up, as specified by this protocol, or unwillingness to cooperate fully with the Investigator.
* Have any other conditions, which, in the opinion of the Investigator or Sponsor, would make the participant unsuitable for inclusion or could interfere with the participant participating in or completing the study.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 2
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
31/01/2022
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
28/03/2023
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Sample size
Target
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Accrual to date
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Final
421
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Recruitment in Australia
Recruitment state(s)
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Recruitment hospital [1]
0
0
AUS-102 - Carlton
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Recruitment hospital [2]
0
0
AUS-104 - Kogarah
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Recruitment hospital [3]
0
0
AUS-101 - Melbourne
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Recruitment hospital [4]
0
0
AUS-106 - Woolloongabba
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Recruitment postcode(s) [1]
0
0
- Carlton
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Recruitment postcode(s) [2]
0
0
- Kogarah
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Recruitment postcode(s) [3]
0
0
- Melbourne
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Recruitment postcode(s) [4]
0
0
- Woolloongabba
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Recruitment outside Australia
Country [1]
0
0
United States of America
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State/province [1]
0
0
Alabama
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Country [2]
0
0
United States of America
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State/province [2]
0
0
California
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Country [3]
0
0
United States of America
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State/province [3]
0
0
Florida
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Country [4]
0
0
United States of America
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State/province [4]
0
0
Georgia
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Country [5]
0
0
United States of America
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State/province [5]
0
0
Indiana
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Country [6]
0
0
United States of America
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State/province [6]
0
0
Kentucky
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Country [7]
0
0
United States of America
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State/province [7]
0
0
Louisiana
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Country [8]
0
0
United States of America
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State/province [8]
0
0
Maryland
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Country [9]
0
0
United States of America
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State/province [9]
0
0
Michigan
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Country [10]
0
0
United States of America
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State/province [10]
0
0
Ohio
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Country [11]
0
0
United States of America
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State/province [11]
0
0
Oregon
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Country [12]
0
0
United States of America
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State/province [12]
0
0
Tennessee
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Country [13]
0
0
United States of America
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State/province [13]
0
0
Texas
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Country [14]
0
0
United States of America
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State/province [14]
0
0
Washington
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Country [15]
0
0
Bulgaria
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State/province [15]
0
0
Pleven
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Country [16]
0
0
Bulgaria
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State/province [16]
0
0
Sevlievo
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Country [17]
0
0
Bulgaria
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State/province [17]
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Barrie
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Lódz
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
Evelo Biosciences, Inc.
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Ethics approval
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Summary
Brief summary
The purpose of this research study is to determine whether the study drug, EDP1815, is safe and effective in the treatment of atopic dermatitis compared with placebo. The study will look at different doses of the study drug, and whether there are differences when the drug is given once daily or twice daily.
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Trial website
https://clinicaltrials.gov/study/NCT05121480
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Public notes
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Contacts
Principal investigator
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Benjamin Ehst, MD, PhD
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Oregon Medical Research Center
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Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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No/undecided IPD sharing reason/comment
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What supporting documents are/will be available?
No Supporting Document Provided
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Other Details
Attachment
Study protocol
https://cdn.clinicaltrials.gov/large-docs/80/NCT05121480/Prot_000.pdf
Statistical analysis plan
https://cdn.clinicaltrials.gov/large-docs/80/NCT05121480/SAP_001.pdf
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results are available at
https://clinicaltrials.gov/study/NCT05121480