Adults 18 to 75, any sex, with Atopic Dermatitis. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Achievement of EASI-50Primary· 16 weeks
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.
Group
Value
95% CI
Cohorts 1-3 - Placebo
38
Cohort 1 - Active
27
Cohort 2 - Active
25
Cohort 3 - Active
23
Cohort 4 - Placebo
17
Cohort 4 - Active
25
Percentage of Participants Achieving EASI-50Secondary· 4, 8 and 12 weeks
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.
Week 4
Group
Value
95% CI
Cohorts 1-3 - Placebo
20
Cohort 1 - Active
18
Cohort 2 - Active
14
Cohort 3 - Active
18
Cohort 4 - Placebo
8
Cohort 4 - Active
23
Week 8
Group
Value
95% CI
Cohorts 1-3 - Placebo
23
Cohort 1 - Active
29
Cohort 2 - Active
21
Cohort 3 - Active
22
Cohort 4 - Placebo
16
Cohort 4 - Active
27
Week 12
Group
Value
95% CI
Cohorts 1-3 - Placebo
26
Cohort 1 - Active
33
Cohort 2 - Active
21
Cohort 3 - Active
24
Cohort 4 - Placebo
17
Cohort 4 - Active
24
Percentage of Participants Achieving EASI-75Secondary· 4, 8, 12, and 16 weeks
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.
Week 4
Group
Value
95% CI
Cohorts 1-3 - Placebo
1
Cohort 1 - Active
9
Cohort 2 - Active
4
Cohort 3 - Active
6
Cohort 4 - Placebo
2
Cohort 4 - Active
7
Week 8
Group
Value
95% CI
Cohorts 1-3 - Placebo
5
Cohort 1 - Active
11
Cohort 2 - Active
11
Cohort 3 - Active
9
Cohort 4 - Placebo
9
Cohort 4 - Active
11
Week 12
Group
Value
95% CI
Cohorts 1-3 - Placebo
11
Cohort 1 - Active
13
Cohort 2 - Active
8
Cohort 3 - Active
13
Cohort 4 - Placebo
10
Cohort 4 - Active
15
Week 16
Group
Value
95% CI
Cohorts 1-3 - Placebo
22
Cohort 1 - Active
13
Cohort 2 - Active
9
Cohort 3 - Active
13
Cohort 4 - Placebo
9
Cohort 4 - Active
11
Percentage of Participants Achieving EASI-90Secondary· 4, 8, 12, and 16 weeks
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.
Week 4
Group
Value
95% CI
Cohorts 1-3 - Placebo
0
Cohort 1 - Active
3
Cohort 2 - Active
1
Cohort 3 - Active
1
Cohort 4 - Placebo
0
Cohort 4 - Active
1
Week 8
Group
Value
95% CI
Cohorts 1-3 - Placebo
1
Cohort 1 - Active
3
Cohort 2 - Active
3
Cohort 3 - Active
4
Cohort 4 - Placebo
2
Cohort 4 - Active
4
Week 12
Group
Value
95% CI
Cohorts 1-3 - Placebo
6
Cohort 1 - Active
5
Cohort 2 - Active
5
Cohort 3 - Active
3
Cohort 4 - Placebo
4
Cohort 4 - Active
7
Week 16
Group
Value
95% CI
Cohorts 1-3 - Placebo
8
Cohort 1 - Active
3
Cohort 2 - Active
5
Cohort 3 - Active
6
Cohort 4 - Placebo
1
Cohort 4 - Active
4
Mean Absolute Change in EASISecondary· 4, 8, 12, and 16 weeks
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.
Week 4
Group
Value
95% CI
Cohorts 1-3 - Placebo
-2.88
± 5.229
Cohort 1 - Active
-4.57
± 6.248
Cohort 2 - Active
-1.87
± 7.020
Cohort 3 - Active
-3.72
± 7.947
Cohort 4 - Placebo
-3.09
± 5.834
Cohort 4 - Active
-3.36
± 5.293
Week 8
Group
Value
95% CI
Cohorts 1-3 - Placebo
-4.30
± 5.642
Cohort 1 - Active
-5.68
± 6.823
Cohort 2 - Active
-3.05
± 8.001
Cohort 3 - Active
-4.54
± 8.930
Cohort 4 - Placebo
-5.57
± 6.665
Cohort 4 - Active
-4.22
± 5.056
Week 12
Group
Value
95% CI
Cohorts 1-3 - Placebo
-5.42
± 5.590
Cohort 1 - Active
-6.38
± 7.924
Cohort 2 - Active
-3.56
± 8.049
Cohort 3 - Active
-5.12
± 8.982
Cohort 4 - Placebo
-6.58
± 6.758
Cohort 4 - Active
-4.82
± 5.063
Week 16
Group
Value
95% CI
Cohorts 1-3 - Placebo
-6.48
± 6.360
Cohort 1 - Active
-5.83
± 7.915
Cohort 2 - Active
-4.55
± 7.897
Cohort 3 - Active
-5.11
± 9.116
Cohort 4 - Placebo
-6.99
± 6.806
Cohort 4 - Active
-4.82
± 5.480
Mean Percentage Change in EASISecondary· 4, 8, 12, and 16 weeks
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.
Week 4
Group
Value
95% CI
Cohorts 1-3 - Placebo
-20.13
± 36.926
Cohort 1 - Active
-27.36
± 38.993
Cohort 2 - Active
-13.96
± 48.008
Cohort 3 - Active
-22.80
± 40.131
Cohort 4 - Placebo
-23.30
± 35.369
Cohort 4 - Active
-27.30
± 41.493
Week 8
Group
Value
95% CI
Cohorts 1-3 - Placebo
-30.96
± 36.521
Cohort 1 - Active
-35.33
± 42.920
Cohort 2 - Active
-22.70
± 50.991
Cohort 3 - Active
-27.14
± 43.544
Cohort 4 - Placebo
-43.08
± 36.432
Cohort 4 - Active
-35.92
± 40.244
Week 12
Group
Value
95% CI
Cohorts 1-3 - Placebo
-40.05
± 38.450
Cohort 1 - Active
-38.40
± 48.605
Cohort 2 - Active
-24.69
± 49.969
Cohort 3 - Active
-31.95
± 44.916
Cohort 4 - Placebo
-44.99
± 34.922
Cohort 4 - Active
-41.28
± 40.377
Week 16
Group
Value
95% CI
Cohorts 1-3 - Placebo
-46.97
± 44.193
Cohort 1 - Active
-35.72
± 49.737
Cohort 2 - Active
-31.03
± 46.957
Cohort 3 - Active
-32.68
± 45.752
Cohort 4 - Placebo
-45.58
± 35.526
Cohort 4 - Active
-39.35
± 39.316
Percentage of Participants Achieving Investigator's Global Assessment (vIGA) of 0 or 1 With a ≥2 Point ImprovementSecondary· 4, 8, 12, and 16 weeks
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
Week 4
Group
Value
95% CI
Cohorts 1-3 - Placebo
1
Cohort 1 - Active
5
Cohort 2 - Active
3
Cohort 3 - Active
2
Cohort 4 - Placebo
2
Cohort 4 - Active
4
Week 8
Group
Value
95% CI
Cohorts 1-3 - Placebo
3
Cohort 1 - Active
5
Cohort 2 - Active
5
Cohort 3 - Active
6
Cohort 4 - Placebo
5
Cohort 4 - Active
9
Week 12
Group
Value
95% CI
Cohorts 1-3 - Placebo
6
Cohort 1 - Active
6
Cohort 2 - Active
5
Cohort 3 - Active
6
Cohort 4 - Placebo
6
Cohort 4 - Active
9
Week 16
Group
Value
95% CI
Cohorts 1-3 - Placebo
12
Cohort 1 - Active
5
Cohort 2 - Active
7
Cohort 3 - Active
10
Cohort 4 - Placebo
2
Cohort 4 - Active
7
Percentage of Participants Achieving vIGA of 0 or 1Secondary· 4, 8, 12, and 16 weeks
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
Week 4
Group
Value
95% CI
Cohorts 1-3 - Placebo
2
Cohort 1 - Active
7
Cohort 2 - Active
3
Cohort 3 - Active
4
Cohort 4 - Placebo
3
Cohort 4 - Active
8
Week 8
Group
Value
95% CI
Cohorts 1-3 - Placebo
4
Cohort 1 - Active
7
Cohort 2 - Active
5
Cohort 3 - Active
7
Cohort 4 - Placebo
8
Cohort 4 - Active
12
Week 12
Group
Value
95% CI
Cohorts 1-3 - Placebo
12
Cohort 1 - Active
10
Cohort 2 - Active
5
Cohort 3 - Active
9
Cohort 4 - Placebo
9
Cohort 4 - Active
11
Week 16
Group
Value
95% CI
Cohorts 1-3 - Placebo
19
Cohort 1 - Active
10
Cohort 2 - Active
7
Cohort 3 - Active
11
Cohort 4 - Placebo
5
Cohort 4 - Active
9
Percentage of Participants Achieving vIGA of 0Secondary· 16 weeks
The efficacy of EDP1815 will be measured by the number of participants achieving a vIGA of 0 at Week16
Group
Value
95% CI
Cohorts 1-3 - Placebo
2
Cohort 1 - Active
1
Cohort 2 - Active
2
Cohort 3 - Active
1
Cohort 4 - Placebo
0
Cohort 4 - Active
3
Mean Absolute Change in vIGA*BSASecondary· 4, 8, 12, and 16 weeks
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.
Week 4
Group
Value
95% CI
Cohorts 1-3 - Placebo
-6.47
± 27.832
Cohort 1 - Active
-15.84
± 33.960
Cohort 2 - Active
-5.96
± 40.678
Cohort 3 - Active
-10.92
± 52.802
Cohort 4 - Placebo
-11.04
± 29.770
Cohort 4 - Active
-14.07
± 30.797
Week 8
Group
Value
95% CI
Cohorts 1-3 - Placebo
-14.49
± 36.336
Cohort 1 - Active
-21.31
± 41.564
Cohort 2 - Active
-12.46
± 45.651
Cohort 3 - Active
-14.53
± 59.754
Cohort 4 - Placebo
-21.63
± 32.517
Cohort 4 - Active
-17.88
± 29.523
Week 12
Group
Value
95% CI
Cohorts 1-3 - Placebo
-20.83
± 36.619
Cohort 1 - Active
-24.85
± 58.901
Cohort 2 - Active
-10.48
± 45.919
Cohort 3 - Active
-17.26
± 60.858
Cohort 4 - Placebo
-28.91
± 40.904
Cohort 4 - Active
-19.56
± 30.250
Week 16
Group
Value
95% CI
Cohorts 1-3 - Placebo
-25.70
± 36.633
Cohort 1 - Active
-18.90
± 58.271
Cohort 2 - Active
-14.52
± 46.948
Cohort 3 - Active
-18.10
± 59.953
Cohort 4 - Placebo
-31.00
± 42.250
Cohort 4 - Active
-24.23
± 35.523
Mean Percentage Change in vIGA*BSASecondary· 4, 8, 12, and 16 weeks
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.
Week 4
Group
Value
95% CI
Cohorts 1-3 - Placebo
-14.82
± 47.171
Cohort 1 - Active
-21.83
± 47.440
Cohort 2 - Active
-9.70
± 59.410
Cohort 3 - Active
-13.26
± 75.742
Cohort 4 - Placebo
-19.01
± 49.996
Cohort 4 - Active
-25.99
± 51.487
Week 8
Group
Value
95% CI
Cohorts 1-3 - Placebo
-25.95
± 51.703
Cohort 1 - Active
-32.16
± 54.509
Cohort 2 - Active
-21.27
± 65.335
Cohort 3 - Active
-15.77
± 78.290
Cohort 4 - Placebo
-42.98
± 44.572
Cohort 4 - Active
-35.85
± 47.881
Week 12
Group
Value
95% CI
Cohorts 1-3 - Placebo
-39.10
± 50.435
Cohort 1 - Active
-33.23
± 74.662
Cohort 2 - Active
-18.83
± 68.537
Cohort 3 - Active
-23.49
± 79.946
Cohort 4 - Placebo
-43.64
± 52.832
Cohort 4 - Active
-37.27
± 51.582
Week 16
Group
Value
95% CI
Cohorts 1-3 - Placebo
-49.25
± 51.883
Cohort 1 - Active
-28.17
± 78.637
Cohort 2 - Active
-23.15
± 71.749
Cohort 3 - Active
-23.74
± 81.817
Cohort 4 - Placebo
-44.29
± 60.140
Cohort 4 - Active
-43.02
± 41.198
Mean Absolute Change From Baseline in BSASecondary· 4, 8, 12, and 16 weeks
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.
Week 4
Group
Value
95% CI
Cohorts 1-3 - Placebo
-2.06
± 7.127
Cohort 1 - Active
-3.87
± 8.429
Cohort 2 - Active
-1.81
± 10.573
Cohort 3 - Active
-3.09
± 13.025
Cohort 4 - Placebo
-2.50
± 7.886
Cohort 4 - Active
-3.43
± 7.503
Week 8
Group
Value
95% CI
Cohorts 1-3 - Placebo
-3.96
± 8.354
Cohort 1 - Active
-5.58
± 10.766
Cohort 2 - Active
-4.10
± 12.211
Cohort 3 - Active
-4.09
± 14.854
Cohort 4 - Placebo
-5.42
± 8.712
Cohort 4 - Active
-4.50
± 8.021
Week 12
Group
Value
95% CI
Cohorts 1-3 - Placebo
-5.61
± 9.432
Cohort 1 - Active
-6.79
± 14.420
Cohort 2 - Active
-3.21
± 12.990
Cohort 3 - Active
-5.13
± 15.342
Cohort 4 - Placebo
-7.96
± 11.601
Cohort 4 - Active
-5.36
± 8.550
Week 16
Group
Value
95% CI
Cohorts 1-3 - Placebo
-7.18
± 9.772
Cohort 1 - Active
-5.65
± 14.554
Cohort 2 - Active
-4.30
± 12.902
Cohort 3 - Active
-4.96
± 15.289
Cohort 4 - Placebo
-8.87
± 11.221
Cohort 4 - Active
-6.28
± 9.078
Adverse events — posted to ClinicalTrials.gov
Time frame: Adverse events (AEs) were collected after the participant signing of the informed consent form (ICF) through 16 weeks of treatment plus an additional 28 days after taking their last dose of study drug..
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
All Placebo
Serious: 1/113 (1%)
Deaths: 0/113
Cohort 1 - Active
Serious: 2/74 (3%)
Deaths: 0/74
Cohort 2 - Active
Serious: 2/74 (3%)
Deaths: 0/74
Cohort 3 - Active
Serious: 1/85 (1%)
Deaths: 0/85
Cohort 4 - Active
Serious: 0/74 (0%)
Deaths: 0/74
Serious adverse events (6 terms)
Reaction
System
All Placebo
Cohort 1 - Active
Cohort 2 - Active
Cohort 3 - Active
Cohort 4 - Active
Pneumonia
Infections and infestations
—
—
—
—
—
Dermatitis Atopic
Skin and subcutaneous tissue disorders
—
—
—
—
—
Ischaemic Stroke
Nervous system disorders
—
—
—
—
—
Hepatitis Toxic
Hepatobiliary disorders
—
—
—
—
—
Papillary Thyroid Cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
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.
Publications & conference data
4 peer-reviewed publications reference this trial (live from Europe PMC):
NCT05682222 — Evaluation of the Immunopharmacology of EDP1815 and EDP2939
· Phase 1
· completed
NCT05439941 — A Long-Term Extension Trial in Participants With Atopic Dermatitis Who Participated in Previous EDP1815 Trials
· Phase 2
· terminated
NCT04603027 — A Phase 2 Study Investigating the Effect of EDP1815 in the Treatment of Mild to Moderate Plaque Psoriasis
· Phase 2
· completed
NCT04488575 — Safety and Efficacy of EDP1815 in the Treatment of Patients Hospitalized With COVID-19 Infection
· Phase 2
· terminated
NCT04393246 — mulTi-Arm Therapeutic Study in Pre-ICu Patients Admitted With Covid-19 - Experimental Drugs and Mechanisms
· Phase 2, PHASE3
· completed
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Other Evelo Biosciences, Inc. trials
Trials by the same sponsor.
NCT05682222 — Evaluation of the Immunopharmacology of EDP1815 and EDP2939
· Phase 1
· completed
NCT05439941 — A Long-Term Extension Trial in Participants With Atopic Dermatitis Who Participated in Previous EDP1815 Trials
· Phase 2
· terminated
NCT05066373 — Scintigraphy Study to Evaluate the Gastrointestinal Behavior of EDP1815 Oral Dosage Forms
· Phase 1
· completed
NCT04927195 — Study in Healthy Participants and Participants With Moderate Atopic Dermatitis & Optionally, Moderate Psoriasis, and/or
· Phase 1
· completed
NCT04603027 — A Phase 2 Study Investigating the Effect of EDP1815 in the Treatment of Mild to Moderate Plaque Psoriasis
· Phase 2
· completed
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Evelo Biosciences, Inc.
Last refreshed: 16 August 2023
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05121480.