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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
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
Secondary ID [1] 0 0
2021-001805-63
Secondary ID [2] 0 0
EDP1815-207
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Atopic Dermatitis 0 0
Condition category
Condition code
Skin 0 0 0 0
Dermatological conditions
Skin 0 0 0 0
Other skin conditions
Inflammatory and Immune System 0 0 0 0
Other inflammatory or immune system disorders

Intervention/exposure
Study type
Interventional
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
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Achievement of EASI-50
Timepoint [1] 0 0
16 weeks
Secondary outcome [1] 0 0
Percentage of Participants Achieving EASI-50
Timepoint [1] 0 0
4, 8 and 12 weeks
Secondary outcome [2] 0 0
Percentage of Participants Achieving EASI-75
Timepoint [2] 0 0
4, 8, 12, and 16 weeks
Secondary outcome [3] 0 0
Percentage of Participants Achieving EASI-90
Timepoint [3] 0 0
4, 8, 12, and 16 weeks
Secondary outcome [4] 0 0
Mean Absolute Change in EASI
Timepoint [4] 0 0
4, 8, 12, and 16 weeks
Secondary outcome [5] 0 0
Mean Percentage Change in EASI
Timepoint [5] 0 0
4, 8, 12, and 16 weeks
Secondary outcome [6] 0 0
Percentage of Participants Achieving Investigator's Global Assessment (vIGA) of 0 or 1 With a =2 Point Improvement
Timepoint [6] 0 0
4, 8, 12, and 16 weeks
Secondary outcome [7] 0 0
Percentage of Participants Achieving vIGA of 0 or 1
Timepoint [7] 0 0
4, 8, 12, and 16 weeks
Secondary outcome [8] 0 0
Percentage of Participants Achieving vIGA of 0
Timepoint [8] 0 0
16 weeks
Secondary outcome [9] 0 0
Mean Absolute Change in vIGA*BSA
Timepoint [9] 0 0
4, 8, 12, and 16 weeks
Secondary outcome [10] 0 0
Mean Percentage Change in vIGA*BSA
Timepoint [10] 0 0
4, 8, 12, and 16 weeks
Secondary outcome [11] 0 0
Mean Absolute Change From Baseline in BSA
Timepoint [11] 0 0
4, 8, 12, and 16 weeks
Secondary outcome [12] 0 0
Mean Percentage Change From Baseline in BSA
Timepoint [12] 0 0
4, 8, 12, and 16 weeks
Secondary outcome [13] 0 0
Percentage of Participants Achieving BSA-50
Timepoint [13] 0 0
4, 8, 12, and 16 weeks
Secondary outcome [14] 0 0
Percentage of Participants Achieving BSA-75
Timepoint [14] 0 0
4, 8, 12, and 16 weeks
Secondary outcome [15] 0 0
Percentage of Participants Achieving BSA Reduction to 3% BSA or Less
Timepoint [15] 0 0
4, 8, 12, and 16 weeks
Secondary outcome [16] 0 0
Mean Absolute Change From Baseline in SCORing Atopic Dermatitis (SCORAD)
Timepoint [16] 0 0
4, 8, 12, and 16 weeks
Secondary outcome [17] 0 0
Mean Percentage Change From Baseline in SCORAD
Timepoint [17] 0 0
4, 8, 12, and 16 weeks
Secondary outcome [18] 0 0
Percentage of Participants Achieving SCORAD-50
Timepoint [18] 0 0
4, 8, 12, and 16 weeks
Secondary outcome [19] 0 0
Percentage of Participants Achieving SCORAD-75
Timepoint [19] 0 0
4, 8, 12, and 16 weeks
Secondary outcome [20] 0 0
Mean Absolute Change From Baseline in the Dermatology Quality of Life Index (DLQI)
Timepoint [20] 0 0
4, 8, 12, and 16 weeks
Secondary outcome [21] 0 0
Mean Percentage Change From Baseline in DLQI
Timepoint [21] 0 0
4, 8, 12, and 16 weeks
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
Timepoint [22] 0 0
16 weeks
Secondary outcome [23] 0 0
Mean Absolute Change From Baseline in Worst Pruritus Numerical Rating Scale (PR-NRS)
Timepoint [23] 0 0
4, 8, 12, and 16 weeks
Secondary outcome [24] 0 0
Percentage of Participants Achieving a Reduction of =2 in the Worst Pruritus-NRS, of Those With a Score of =2 at Baseline
Timepoint [24] 0 0
4, 8, 12, and 16 weeks
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
Timepoint [25] 0 0
16 weeks
Secondary outcome [26] 0 0
Mean Absolute Change From Baseline in the Sleep Disturbance Numerical Rating Scale (SD-NRS) Score
Timepoint [26] 0 0
4, 8, 12, and 16 weeks
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
Timepoint [27] 0 0
16 weeks
Secondary outcome [28] 0 0
Mean Absolute Change From Baseline in Patient Oriented Eczema Measure (POEM)
Timepoint [28] 0 0
4, 8, 12, and 16 weeks
Secondary outcome [29] 0 0
Mean Percentage Change From Baseline in Patient Oriented Eczema Measure (POEM)
Timepoint [29] 0 0
4, 8, 12, and 16 weeks
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
Timepoint [30] 0 0
16 weeks
Secondary outcome [31] 0 0
Number of Courses of Rescue Therapy Per Participant
Timepoint [31] 0 0
4, 8, 12, and 16 weeks
Secondary outcome [32] 0 0
Number of Days of Treatment With Rescue Therapy Per Participant
Timepoint [32] 0 0
16 weeks
Secondary outcome [33] 0 0
Proportion of Participants Not Requiring Rescue Therapy
Timepoint [33] 0 0
4, 8, 12, and 16 weeks

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.
Minimum age
18 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
No
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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
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
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
31/01/2022
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
28/03/2023
Sample size
Target
Accrual to date
Final
421
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
AUS-102 - Carlton
Recruitment hospital [2] 0 0
AUS-104 - Kogarah
Recruitment hospital [3] 0 0
AUS-101 - Melbourne
Recruitment hospital [4] 0 0
AUS-106 - Woolloongabba
Recruitment postcode(s) [1] 0 0
- Carlton
Recruitment postcode(s) [2] 0 0
- Kogarah
Recruitment postcode(s) [3] 0 0
- Melbourne
Recruitment postcode(s) [4] 0 0
- Woolloongabba
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
Florida
Country [4] 0 0
United States of America
State/province [4] 0 0
Georgia
Country [5] 0 0
United States of America
State/province [5] 0 0
Indiana
Country [6] 0 0
United States of America
State/province [6] 0 0
Kentucky
Country [7] 0 0
United States of America
State/province [7] 0 0
Louisiana
Country [8] 0 0
United States of America
State/province [8] 0 0
Maryland
Country [9] 0 0
United States of America
State/province [9] 0 0
Michigan
Country [10] 0 0
United States of America
State/province [10] 0 0
Ohio
Country [11] 0 0
United States of America
State/province [11] 0 0
Oregon
Country [12] 0 0
United States of America
State/province [12] 0 0
Tennessee
Country [13] 0 0
United States of America
State/province [13] 0 0
Texas
Country [14] 0 0
United States of America
State/province [14] 0 0
Washington
Country [15] 0 0
Bulgaria
State/province [15] 0 0
Pleven
Country [16] 0 0
Bulgaria
State/province [16] 0 0
Sevlievo
Country [17] 0 0
Bulgaria
State/province [17] 0 0
Sofia
Country [18] 0 0
Canada
State/province [18] 0 0
Barrie
Country [19] 0 0
Canada
State/province [19] 0 0
Edmonton
Country [20] 0 0
Canada
State/province [20] 0 0
Markham
Country [21] 0 0
Canada
State/province [21] 0 0
Mississauga
Country [22] 0 0
Canada
State/province [22] 0 0
Ottawa
Country [23] 0 0
Canada
State/province [23] 0 0
Richmond Hill
Country [24] 0 0
Canada
State/province [24] 0 0
Surrey
Country [25] 0 0
Canada
State/province [25] 0 0
Waterloo
Country [26] 0 0
Canada
State/province [26] 0 0
Winnipeg
Country [27] 0 0
Germany
State/province [27] 0 0
Berlin
Country [28] 0 0
Germany
State/province [28] 0 0
Bochum
Country [29] 0 0
Germany
State/province [29] 0 0
Erlangen
Country [30] 0 0
Germany
State/province [30] 0 0
Frankfurt am Main
Country [31] 0 0
Germany
State/province [31] 0 0
Gera
Country [32] 0 0
Germany
State/province [32] 0 0
Hamburg
Country [33] 0 0
Germany
State/province [33] 0 0
Heidelberg
Country [34] 0 0
Poland
State/province [34] 0 0
Gdansk
Country [35] 0 0
Poland
State/province [35] 0 0
Gdynia
Country [36] 0 0
Poland
State/province [36] 0 0
Katowice
Country [37] 0 0
Poland
State/province [37] 0 0
Lublin
Country [38] 0 0
Poland
State/province [38] 0 0
Warszawa
Country [39] 0 0
Poland
State/province [39] 0 0
Wroclaw
Country [40] 0 0
Poland
State/province [40] 0 0
Lódz

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Evelo Biosciences, Inc.
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Benjamin Ehst, MD, PhD
Address 0 0
Oregon Medical Research Center
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?




Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results are available at https://clinicaltrials.gov/study/NCT05121480