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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05439941




Registration number
NCT05439941
Ethics application status
Date submitted
27/06/2022
Date registered
30/06/2022

Titles & IDs
Public title
A Long-Term Extension Trial in Participants With Atopic Dermatitis Who Participated in Previous EDP1815 Trials
Scientific title
A Long-Term Extension Trial in Participants With Atopic Dermatitis Who Participated in Previous Phase 2 And 3 EDP1815 Trials
Secondary ID [1] 0 0
2022-000284-48
Secondary ID [2] 0 0
EDP1815-208
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

Experimental: Group 1 (1.6x10^11 total cells of EDP1815, 2 capsules once daily) - EDP1815-207 Cohort 1 participants will receive 1.6x10\^11 total cells of EDP1815 in EDP1815-208 administered as 2 capsules once daily. (Group 1)

Experimental: Group 2 (6.4x10^11 total cells of EDP1815, 2 capsules once daily) - EDP1815-207 Cohort 2 participants will receive 6.4x10\^11 total cells of EDP1815 in EDP1815-208 administered as 2 capsules once daily. (Group 2)

Experimental: Group 3 (8.0x10^10 total cells of EDP1815, 1 capsule once daily) - EDP1815-207 Cohort 4 participants will receive 8.0x10\^10 total cells of EDP1815 in EDP1815-208 administered as 1 capsule once daily. (Group 3)


Treatment: Drugs: EDP1815
EDP1815 is an orally administered, pharmaceutical preparation of a single strain of bacteria
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Incidence and Rate Per 100 Patient-years of Treatment-emergent Adverse Events
Timepoint [1] 0 0
40 weeks
Secondary outcome [1] 0 0
Percentage of Participants Achieving EASI-50
Timepoint [1] 0 0
40 weeks
Secondary outcome [2] 0 0
Percentage of Participants Achieving EASI-75
Timepoint [2] 0 0
40 weeks
Secondary outcome [3] 0 0
Percentage of Participants Achieving EASI-90
Timepoint [3] 0 0
40 weeks
Secondary outcome [4] 0 0
Mean Absolute Change From Baseline in EASI Score
Timepoint [4] 0 0
40 weeks
Secondary outcome [5] 0 0
Mean Percentage Change From Baseline in EASI Score
Timepoint [5] 0 0
40 weeks
Secondary outcome [6] 0 0
Percentage of Participants Achieving IGA of 0 or 1 With a =2 Point Improvement From Baseline
Timepoint [6] 0 0
40 weeks
Secondary outcome [7] 0 0
Percentage of Participants Achieving IGA of 0 or 1
Timepoint [7] 0 0
40 weeks
Secondary outcome [8] 0 0
Percentage of Participants Achieving IGA of 0
Timepoint [8] 0 0
40 weeks
Secondary outcome [9] 0 0
Mean Absolute Change From Baseline in IGA*BSA
Timepoint [9] 0 0
40 weeks
Secondary outcome [10] 0 0
Mean Percentage Change From Baseline in IGA*BSA
Timepoint [10] 0 0
40 weeks
Secondary outcome [11] 0 0
Mean Absolute Change From Baseline in BSA
Timepoint [11] 0 0
40 weeks
Secondary outcome [12] 0 0
Mean Percentage Change From Baseline in BSA
Timepoint [12] 0 0
40 weeks
Secondary outcome [13] 0 0
Percentage of Participants Achieving BSA-50
Timepoint [13] 0 0
40 weeks
Secondary outcome [14] 0 0
Percentage of Participants Achieving BSA-75
Timepoint [14] 0 0
40 weeks
Secondary outcome [15] 0 0
Percentage of Participants Achieving BSA Reduction to 3% or Less
Timepoint [15] 0 0
40 weeks
Secondary outcome [16] 0 0
Mean Absolute Change From Baseline in SCORAD
Timepoint [16] 0 0
40 weeks
Secondary outcome [17] 0 0
Mean Percentage Change From Baseline in SCORAD
Timepoint [17] 0 0
40 weeks
Secondary outcome [18] 0 0
Percentage of Participants Achieving SCORAD-50
Timepoint [18] 0 0
40 weeks
Secondary outcome [19] 0 0
Percentage of Participants Achieving SCORAD-75
Timepoint [19] 0 0
40 weeks
Secondary outcome [20] 0 0
Mean Absolute Change From Baseline in DLQI
Timepoint [20] 0 0
40 weeks
Secondary outcome [21] 0 0
Mean Percentage Change From Baseline in DLQI
Timepoint [21] 0 0
40 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
40 weeks
Secondary outcome [23] 0 0
Mean Absolute Change From Baseline in PP-NRS
Timepoint [23] 0 0
40 weeks
Secondary outcome [24] 0 0
Percentage of Participants Achieving a Reduction of =2 in the PP-NRS, of Those With a Score of =2 at Baseline
Timepoint [24] 0 0
40 weeks
Secondary outcome [25] 0 0
Percentage of Participants Achieving a Reduction of =4 in the PP-NRS, of Those With a Score of =4 at Baseline
Timepoint [25] 0 0
40 weeks
Secondary outcome [26] 0 0
Mean Absolute Change From Baseline in SD-NRS
Timepoint [26] 0 0
40 weeks
Secondary outcome [27] 0 0
Percentage of Participants Achieving a Reduction of =2 in the SD NRS, of Those With a Score of =2 at Baseline
Timepoint [27] 0 0
40 weeks
Secondary outcome [28] 0 0
Mean Absolute Change From Baseline in Patient Oriented Eczema Measure (POEM)
Timepoint [28] 0 0
40 weeks
Secondary outcome [29] 0 0
Mean Percentage Change From Baseline in Patient Oriented Eczema Measure (POEM)
Timepoint [29] 0 0
40 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
40 weeks
Secondary outcome [31] 0 0
Number of Courses Per Patient-year of Any Rescue Medication (Not Including Antibacterial Therapy)
Timepoint [31] 0 0
40 weeks
Secondary outcome [32] 0 0
Number of Courses Per Patient-year of Topical Corticosteroids of Any Potency
Timepoint [32] 0 0
40 weeks
Secondary outcome [33] 0 0
Number of Courses Per Patient-year of Topical Tacrolimus (0.1%), Topical Pimecrolimus (1%) or Grade VII Topical Corticosteroid
Timepoint [33] 0 0
40 weeks
Secondary outcome [34] 0 0
Number of Courses Per Patient Year of Moderate Potency (Grade IV and V) Topical Steroids
Timepoint [34] 0 0
40 weeks

Eligibility
Key inclusion criteria
1. Must have provided informed consent.
2. Must have completed the treatment period in a parent study of EDP1815 in atopic dermatitis and complied with the parent protocol.
3. Must agree to use emollients.
4. Must continue to follow contraception criteria.
Minimum age
18 Years
Maximum age
76 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Participants who are currently enrolled in another investigational drug study or plans to receive another investigational drug during this study.
2. Have any other conditions, which would make the participant unsuitable for inclusion or could interfere with the participant participating in or completing the study.
3. Use of phototherapy, a biologic agent, or a systemic immunosuppressive agent that could affect AD, including systemic corticosteroids, within 7 days prior to Day -1, unless used as a rescue treatment as part of the parent study protocol.
4. Use of topical atopic dermatitis therapies, including topical corticosteroids, topical calcineurin inhibitors, topical PDE-4 inhibitors, and topical JAK inhibitors, within 7 days prior to enrolling in the study, unless used as a rescue treatment as part of the EDP1815-207 protocol.
5. Has received live or live-attenuated vaccination prior to enrollment or intends to have such a vaccination during the study.
6. Hypersensitivity to P histicola or to any of the excipients.
7. Unwillingness to comply with study procedures, including follow-up, as specified by this protocol, or unwillingness to cooperate fully with the Investigator.

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
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Stopped early
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
6/06/2022
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
7/06/2023
Sample size
Target
Accrual to date
Final
287
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
Indiana
Country [5] 0 0
United States of America
State/province [5] 0 0
Kentucky
Country [6] 0 0
United States of America
State/province [6] 0 0
Louisiana
Country [7] 0 0
United States of America
State/province [7] 0 0
Maryland
Country [8] 0 0
United States of America
State/province [8] 0 0
Ohio
Country [9] 0 0
United States of America
State/province [9] 0 0
Oregon
Country [10] 0 0
United States of America
State/province [10] 0 0
Tennessee
Country [11] 0 0
United States of America
State/province [11] 0 0
Texas
Country [12] 0 0
United States of America
State/province [12] 0 0
Washington
Country [13] 0 0
Bulgaria
State/province [13] 0 0
Pleven
Country [14] 0 0
Bulgaria
State/province [14] 0 0
Sevlievo
Country [15] 0 0
Bulgaria
State/province [15] 0 0
Sofia
Country [16] 0 0
Canada
State/province [16] 0 0
Barrie
Country [17] 0 0
Canada
State/province [17] 0 0
Edmonton
Country [18] 0 0
Canada
State/province [18] 0 0
Markham
Country [19] 0 0
Canada
State/province [19] 0 0
Mississauga
Country [20] 0 0
Canada
State/province [20] 0 0
Ottawa
Country [21] 0 0
Canada
State/province [21] 0 0
Richmond Hill
Country [22] 0 0
Canada
State/province [22] 0 0
Surrey
Country [23] 0 0
Canada
State/province [23] 0 0
Waterloo
Country [24] 0 0
Canada
State/province [24] 0 0
Winnipeg
Country [25] 0 0
Germany
State/province [25] 0 0
Berlin
Country [26] 0 0
Germany
State/province [26] 0 0
Erlangen
Country [27] 0 0
Germany
State/province [27] 0 0
Frankfurt am Main
Country [28] 0 0
Germany
State/province [28] 0 0
Gera
Country [29] 0 0
Germany
State/province [29] 0 0
Hamburg
Country [30] 0 0
Germany
State/province [30] 0 0
Heidelberg
Country [31] 0 0
Poland
State/province [31] 0 0
Gdansk
Country [32] 0 0
Poland
State/province [32] 0 0
Gdynia
Country [33] 0 0
Poland
State/province [33] 0 0
Katowice
Country [34] 0 0
Poland
State/province [34] 0 0
Lublin
Country [35] 0 0
Poland
State/province [35] 0 0
Warszawa
Country [36] 0 0
Poland
State/province [36] 0 0
Wroclaw
Country [37] 0 0
Poland
State/province [37] 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
Douglas Maslin, MD
Address 0 0
Evelo Biosciences
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/NCT05439941