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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
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Scientific title
A Long-Term Extension Trial in Participants With Atopic Dermatitis Who Participated in Previous Phase 2 And 3 EDP1815 Trials
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Secondary ID [1]
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0
2022-000284-48
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Secondary ID [2]
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0
EDP1815-208
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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
0
0
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Dermatological conditions
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Skin
0
0
0
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
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
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Intervention code [1]
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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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Incidence and Rate Per 100 Patient-years of Treatment-emergent Adverse Events
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Assessment method [1]
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The long-term safety and tolerability of EDP1815 in the treatment of atopic dermatitis will be measured by evaluating the incidence and rate per 100 patient-years of treatment-emergent adverse events during the 36-week treatment period and the 4-week follow-up period of this study, and during the treatment period of this study and the relevant parent study.
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Timepoint [1]
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0
40 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 long-term treatment with EDP1815 in the treatment of Atopic Dermatitis will be measured using the following EASI endpoints:
• Percentage of participants achieving EASI-50
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Timepoint [1]
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0
40 weeks
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Secondary outcome [2]
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0
Percentage of Participants Achieving EASI-75
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Assessment method [2]
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0
The efficacy of long-term treatment with EDP1815 in the treatment of Atopic Dermatitis will be measured using the following EASI endpoints:
• Percentage of participants achieving EASI-75
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Timepoint [2]
0
0
40 weeks
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Secondary outcome [3]
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0
Percentage of Participants Achieving EASI-90
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Assessment method [3]
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0
The efficacy of long-term treatment with EDP1815 in the treatment of Atopic Dermatitis will be measured using the following EASI endpoints:
• Percentage of participants achieving EASI-90
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Timepoint [3]
0
0
40 weeks
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Secondary outcome [4]
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0
Mean Absolute Change From Baseline in EASI Score
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Assessment method [4]
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0
The efficacy of long-term treatment with EDP1815 in the treatment of Atopic Dermatitis will be measured using the following EASI endpoints:
• Mean absolute change from baseline in EASI Score
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Timepoint [4]
0
0
40 weeks
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Secondary outcome [5]
0
0
Mean Percentage Change From Baseline in EASI Score
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Assessment method [5]
0
0
The efficacy of long-term treatment with EDP1815 in the treatment of Atopic Dermatitis will be measured using the following EASI endpoints:
• Mean percentage change from baseline in EASI Score
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Timepoint [5]
0
0
40 weeks
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Secondary outcome [6]
0
0
Percentage of Participants Achieving IGA of 0 or 1 With a =2 Point Improvement From Baseline
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Assessment method [6]
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0
The efficacy of long-term treatment with EDP1815 in the treatment of Atopic Dermatitis will be measured using the following IGA endpoints:
• Percentage of participants achieving IGA of 0 or 1 with a =2 point improvement from baseline
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Timepoint [6]
0
0
40 weeks
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Secondary outcome [7]
0
0
Percentage of Participants Achieving IGA of 0 or 1
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Assessment method [7]
0
0
The efficacy of long-term treatment with EDP1815 in the treatment of Atopic Dermatitis will be measured using the following IGA endpoints:
• Percentage of participants achieving IGA of 0 or 1
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Timepoint [7]
0
0
40 weeks
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Secondary outcome [8]
0
0
Percentage of Participants Achieving IGA of 0
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Assessment method [8]
0
0
The efficacy of long-term treatment with EDP1815 in the treatment of Atopic Dermatitis will be measured using the following IGA endpoints:
• Percentage of participants achieving IGA of 0
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Timepoint [8]
0
0
40 weeks
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Secondary outcome [9]
0
0
Mean Absolute Change From Baseline in IGA*BSA
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Assessment method [9]
0
0
The efficacy of long-term treatment with EDP1815 in the treatment of Atopic Dermatitis will be measured using the following IGA \*BSA endpoints:
• Mean absolute change from baseline in IGA\*BSA
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Timepoint [9]
0
0
40 weeks
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Secondary outcome [10]
0
0
Mean Percentage Change From Baseline in IGA*BSA
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Assessment method [10]
0
0
The efficacy of long-term treatment with EDP1815 in the treatment of Atopic Dermatitis will be measured using the following IGA \*BSA endpoints:
• Mean percentage change from baseline in IGA\*BSA
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Timepoint [10]
0
0
40 weeks
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Secondary outcome [11]
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0
Mean Absolute Change From Baseline in BSA
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Assessment method [11]
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The efficacy of long-term treatment with EDP1815 in the treatment of Atopic Dermatitis will be measured using the following IGA \*BSA endpoints:
• Mean absolute change from baseline in BSA
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Timepoint [11]
0
0
40 weeks
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Secondary outcome [12]
0
0
Mean Percentage Change From Baseline in BSA
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Assessment method [12]
0
0
The efficacy of long-term treatment with EDP1815 in the treatment of Atopic Dermatitis will be measured using the following IGA \*BSA endpoints:
• Mean percentage change from baseline in BSA
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Timepoint [12]
0
0
40 weeks
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Secondary outcome [13]
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0
Percentage of Participants Achieving BSA-50
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Assessment method [13]
0
0
The efficacy of long-term treatment with EDP1815 in the treatment of Atopic Dermatitis will be measured using the following IGA \*BSA endpoints:
• Percentage of participants achieving BSA-50
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Timepoint [13]
0
0
40 weeks
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Secondary outcome [14]
0
0
Percentage of Participants Achieving BSA-75
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Assessment method [14]
0
0
The efficacy of long-term treatment with EDP1815 in the treatment of Atopic Dermatitis will be measured using the following BSA endpoints:
• Percentage of participants achieving BSA-75
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Timepoint [14]
0
0
40 weeks
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Secondary outcome [15]
0
0
Percentage of Participants Achieving BSA Reduction to 3% or Less
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Assessment method [15]
0
0
The efficacy of long-term treatment with EDP1815 in the treatment of Atopic Dermatitis will be measured using the following IGA \*BSA endpoints:
• Percentage of participants achieving BSA reduction to 3% or less
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Timepoint [15]
0
0
40 weeks
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Secondary outcome [16]
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0
Mean Absolute Change From Baseline in SCORAD
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Assessment method [16]
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0
The efficacy of long-term treatment with EDP1815 in the treatment of Atopic Dermatitis will be measured using the following SCORAD endpoints:
• Mean absolute change from baseline in SCORAD
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Timepoint [16]
0
0
40 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 long-term treatment with EDP1815 in the treatment of Atopic Dermatitis will be measured using the following SCORAD endpoints:
• Mean percentage change from baseline in SCORAD
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Timepoint [17]
0
0
40 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 long-term treatment with EDP1815 in the treatment of Atopic Dermatitis will be measured using the following SCORAD endpoints:
• Percentage of participants achieving SCORAD-50
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Timepoint [18]
0
0
40 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 long-term treatment with EDP1815 in the treatment of Atopic Dermatitis will be measured using the following SCORAD endpoints:
• Percentage of participants achieving SCORAD-75
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Timepoint [19]
0
0
40 weeks
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Secondary outcome [20]
0
0
Mean Absolute Change From Baseline in DLQI
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Assessment method [20]
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0
The efficacy of long-term treatment with EDP1815 in the treatment of Atopic Dermatitis will be measured using the following DLQI endpoints:
• Mean absolute change from baseline in DLQI
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Timepoint [20]
0
0
40 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 long-term treatment with EDP1815 in the treatment of Atopic Dermatitis will be measured using the following DLQI endpoints:
• Mean percentage change from baseline in DLQI
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Timepoint [21]
0
0
40 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]
0
0
The efficacy of long-term treatment with EDP1815 in the treatment of Atopic Dermatitis will be measured using the following DLQI endpoints:
• Percentage of participants achieving a reduction of =4 in the DLQI, of those with a score of =4 at baseline
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Timepoint [22]
0
0
40 weeks
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Secondary outcome [23]
0
0
Mean Absolute Change From Baseline in PP-NRS
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Assessment method [23]
0
0
The efficacy of long-term treatment with EDP1815 in the treatment of Atopic Dermatitis will be measured using the following PP-NRS endpoints:
• Mean absolute change from baseline in PP-NRS
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Timepoint [23]
0
0
40 weeks
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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
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Assessment method [24]
0
0
The efficacy of long-term treatment with EDP1815 in the treatment of Atopic Dermatitis will be measured using the following PP-NRS endpoints:
• Percentage of participants achieving a reduction of =2 in the PP-NRS, of those with a score of =2 at baseline
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Timepoint [24]
0
0
40 weeks
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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
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Assessment method [25]
0
0
The efficacy of long-term treatment with EDP1815 in the treatment of Atopic Dermatitis will be measured using the following PP-NRS endpoints:
• Percentage of participants achieving a reduction of =4 in the PP-NRS, of those with a score of =4 at baseline
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Timepoint [25]
0
0
40 weeks
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Secondary outcome [26]
0
0
Mean Absolute Change From Baseline in SD-NRS
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Assessment method [26]
0
0
The efficacy of long-term treatment with EDP1815 in the treatment of Atopic Dermatitis will be measured using the following SD-NRS endpoints:
• Mean absolute change from baseline in SD-NRS
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Timepoint [26]
0
0
40 weeks
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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
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Assessment method [27]
0
0
The efficacy of long-term treatment with EDP1815 in the treatment of Atopic Dermatitis will be measured using the following SD-NRS endpoints:
• Percentage of participants achieving a reduction of =2 in the SD NRS, of those with a score of =2 at baseline
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Timepoint [27]
0
0
40 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]
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0
The efficacy of long-term treatment with EDP1815 in the treatment of Atopic Dermatitis will be measured using the following POEM endpoints:
• Mean absolute change from baseline in Patient Oriented Eczema Measure (POEM)
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Timepoint [28]
0
0
40 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 long-term treatment with EDP1815 in the treatment of Atopic Dermatitis will be measured using the following POEM endpoints:
• Mean percentage change from baseline in Patient Oriented Eczema Measure (POEM)
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Timepoint [29]
0
0
40 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 long-term treatment with EDP1815 in the treatment of Atopic Dermatitis will be measured using the following POEM endpoints:
• 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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Timepoint [30]
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0
40 weeks
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Secondary outcome [31]
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Number of Courses Per Patient-year of Any Rescue Medication (Not Including Antibacterial Therapy)
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Assessment method [31]
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The efficacy of long-term treatment with EDP1815 in the treatment of Atopic Dermatitis will be measured using the following Rescue therapy use endpoints:
• Number of courses per patient-year of any rescue medication (not including antibacterial therapy)
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Timepoint [31]
0
0
40 weeks
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Secondary outcome [32]
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0
Number of Courses Per Patient-year of Topical Corticosteroids of Any Potency
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Assessment method [32]
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The efficacy of long-term treatment with EDP1815 in the treatment of Atopic Dermatitis will be measured using the following Rescue therapy use endpoints:
• Number of courses per patient-year of topical corticosteroids of any potency
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Timepoint [32]
0
0
40 weeks
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Secondary outcome [33]
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0
Number of Courses Per Patient-year of Topical Tacrolimus (0.1%), Topical Pimecrolimus (1%) or Grade VII Topical Corticosteroid
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Assessment method [33]
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The efficacy of long-term treatment with EDP1815 in the treatment of Atopic Dermatitis will be measured using the following Rescue therapy use endpoints:
• Number of courses per patient-year of topical tacrolimus (0.1%), topical pimecrolimus
(1%) or grade VII topical corticosteroid
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Timepoint [33]
0
0
40 weeks
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Secondary outcome [34]
0
0
Number of Courses Per Patient Year of Moderate Potency (Grade IV and V) Topical Steroids
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Assessment method [34]
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The efficacy of long-term treatment with EDP1815 in the treatment of Atopic Dermatitis will be measured using the following Rescue therapy use endpoints:
• Number of courses per patient year of moderate potency (grade IV and V) topical steroids
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Timepoint [34]
0
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40 weeks
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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.
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Minimum age
18
Years
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Maximum age
76
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
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.
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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
Open (masking not used)
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Who is / are masked / blinded?
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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
Stopped early
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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
6/06/2022
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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
7/06/2023
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Sample size
Target
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Accrual to date
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Final
287
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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
Indiana
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Country [5]
0
0
United States of America
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State/province [5]
0
0
Kentucky
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Country [6]
0
0
United States of America
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State/province [6]
0
0
Louisiana
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Country [7]
0
0
United States of America
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State/province [7]
0
0
Maryland
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Country [8]
0
0
United States of America
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State/province [8]
0
0
Ohio
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Country [9]
0
0
United States of America
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State/province [9]
0
0
Oregon
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Country [10]
0
0
United States of America
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State/province [10]
0
0
Tennessee
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Country [11]
0
0
United States of America
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State/province [11]
0
0
Texas
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Country [12]
0
0
United States of America
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State/province [12]
0
0
Washington
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Country [13]
0
0
Bulgaria
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State/province [13]
0
0
Pleven
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Country [14]
0
0
Bulgaria
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State/province [14]
0
0
Sevlievo
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Country [15]
0
0
Bulgaria
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State/province [15]
0
0
Sofia
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Country [16]
0
0
Canada
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State/province [16]
0
0
Barrie
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Country [17]
0
0
Canada
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State/province [17]
0
0
Edmonton
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Country [18]
0
0
Canada
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State/province [18]
0
0
Markham
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Country [19]
0
0
Canada
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State/province [19]
0
0
Mississauga
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Country [20]
0
0
Canada
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State/province [20]
0
0
Ottawa
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Country [21]
0
0
Canada
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State/province [21]
0
0
Richmond Hill
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Country [22]
0
0
Canada
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State/province [22]
0
0
Surrey
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Country [23]
0
0
Canada
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State/province [23]
0
0
Waterloo
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Country [24]
0
0
Canada
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State/province [24]
0
0
Winnipeg
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Country [25]
0
0
Germany
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State/province [25]
0
0
Berlin
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Country [26]
0
0
Germany
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State/province [26]
0
0
Erlangen
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Country [27]
0
0
Germany
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State/province [27]
0
0
Frankfurt am Main
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Country [28]
0
0
Germany
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State/province [28]
0
0
Gera
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Country [29]
0
0
Germany
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State/province [29]
0
0
Hamburg
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Country [30]
0
0
Germany
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State/province [30]
0
0
Heidelberg
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Country [31]
0
0
Poland
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State/province [31]
0
0
Gdansk
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Country [32]
0
0
Poland
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State/province [32]
0
0
Gdynia
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Country [33]
0
0
Poland
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State/province [33]
0
0
Katowice
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Country [34]
0
0
Poland
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State/province [34]
0
0
Lublin
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Country [35]
0
0
Poland
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State/province [35]
0
0
Warszawa
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Country [36]
0
0
Poland
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State/province [36]
0
0
Wroclaw
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Country [37]
0
0
Poland
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State/province [37]
0
0
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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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief summary
This is an Open-Label Extension (OLE) study to evaluate the long-term safety, tolerability, and efficacy of EDP1815 in participants with mild, moderate, and severe atopic dermatitis who have completed the treatment period of a prior clinical study ("parent study") with EDP1815. The current parent study of this protocol is the EDP1815-207 study; 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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Trial website
https://clinicaltrials.gov/study/NCT05439941
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Douglas Maslin, MD
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Evelo Biosciences
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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/41/NCT05439941/Prot_000.pdf
Statistical analysis plan
https://cdn.clinicaltrials.gov/large-docs/41/NCT05439941/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/NCT05439941