Phase 2
N=421
A Study Investigating the Effect of EDP1815 in the Treatment of Mild, Moderate and Severe Atopic Dermatitis
Atopic Dermatitis
Bottom Line
View on ClinicalTrials.gov: NCT05121480 ↗Enrolled (actual)
421
Serious AEs
1.4%
Results posted
Aug 2023
Primary outcome: Primary: Achievement of EASI-50 — 38; 27; 25; 23 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- EDP1815 (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Evelo Biosciences, Inc.
- Primary completion
- Mar 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Achievement of EASI-50 |
38; 27; 25; 23; 17; 25 | — |
| SECONDARY Percentage of Participants Achieving EASI-50 |
20; 18; 14; 18; 8; 23 | — |
| SECONDARY Percentage of Participants Achieving EASI-75 |
1; 9; 4; 6; 2; 7 | — |
| SECONDARY Percentage of Participants Achieving EASI-90 |
0; 3; 1; 1; 0; 1 | — |
| SECONDARY Mean Absolute Change in EASI |
-2.88; -4.57; -1.87; -3.72; -3.09; -3.36 | — |
| SECONDARY Mean Percentage Change in EASI |
-20.13; -27.36; -13.96; -22.80; -23.30; -27.30 | — |
| SECONDARY Percentage of Participants Achieving Investigator's Global Assessment (vIGA) of 0 or 1 With a ≥2 Point Improvement |
1; 5; 3; 2; 2; 4 | — |
| SECONDARY Percentage of Participants Achieving vIGA of 0 or 1 |
2; 7; 3; 4; 3; 8 | — |
| SECONDARY Percentage of Participants Achieving vIGA of 0 |
2; 1; 2; 1; 0; 3 | — |
| SECONDARY Mean Absolute Change in vIGA*BSA |
-6.47; -15.84; -5.96; -10.92; -11.04; -14.07 | — |
| SECONDARY Mean Percentage Change in vIGA*BSA |
-14.82; -21.83; -9.70; -13.26; -19.01; -25.99 | — |
| SECONDARY Mean Absolute Change From Baseline in BSA |
-2.06; -3.87; -1.81; -3.09; -2.50; -3.43 | — |
| SECONDARY Mean Percentage Change From Baseline in BSA |
-12.70; -18.45; -7.55; -12.51; -15.29; -20.56 | — |
| SECONDARY Percentage of Participants Achieving BSA-50 |
12; 12; 12; 17; 6; 16 | — |
| SECONDARY Percentage of Participants Achieving BSA-75 |
4; 7; 2; 2; 2; 4 | — |
| SECONDARY Percentage of Participants Achieving BSA Reduction to 3% BSA or Less |
3; 5; 3; 4; 3; 8 | — |
| SECONDARY Mean Absolute Change From Baseline in SCORing Atopic Dermatitis (SCORAD) |
-7.53; -9.79; -5.03; -5.61; -9.57; -8.08 | — |
| SECONDARY Mean Percentage Change From Baseline in SCORAD |
-15.27; -17.42; -9.30; -11.94; -18.01; -16.43 | — |
| SECONDARY Percentage of Participants Achieving SCORAD-50 |
2; 10; 4; 6; 4; 8 | — |
| SECONDARY Percentage of Participants Achieving SCORAD-75 |
0; 1; 0; 2; 0; 1 | — |
| SECONDARY Mean Absolute Change From Baseline in the Dermatology Quality of Life Index (DLQI) |
-2.6; -2.7; -2.4; -2.4; -3.0; -3.1 | — |
| SECONDARY Mean Percentage Change From Baseline in DLQI |
-20.56; -21.97; -19.48; -14.35; -22.67; -10.28 | — |
| SECONDARY Percentage of Participants Achieving a Reduction of ≥4 in the DLQI, of Those With a Score of ≥4 at Baseline |
40; 24; 23; 30; 17; 24 | — |
| SECONDARY Mean Absolute Change From Baseline in Worst Pruritus Numerical Rating Scale (PR-NRS) |
-0.53; -0.45; -0.65; -0.57; -1.52; -0.72 | — |
| SECONDARY Percentage of Participants Achieving a Reduction of ≥2 in the Worst Pruritus-NRS, of Those With a Score of ≥2 at Baseline |
11; 14; 12; 11; 10; 10 | — |
| SECONDARY Percentage of Participants Achieving a Reduction of ≥4 in the Worst PR-NRS, of Those With a Score of ≥4 at Baseline |
13; 9; 5; 7; 5; 3 | — |
| SECONDARY Mean Absolute Change From Baseline in the Sleep Disturbance Numerical Rating Scale (SD-NRS) Score |
-0.36; -0.52; -0.27; -0.16; -0.93; -0.11 | — |
| SECONDARY Percentage of Participants Achieving a Reduction of ≥2 in SD-NRS Score, of Those With a Score of ≥2 at Baseline |
25; 16; 11; 13; 8; 9 | — |
| SECONDARY Mean Absolute Change From Baseline in Patient Oriented Eczema Measure (POEM) |
-2.1; -2.4; -1.6; -3.0; -3.1; -2.7 | — |
| SECONDARY Mean Percentage Change From Baseline in Patient Oriented Eczema Measure (POEM) |
-10.43; -12.19; -6.68; -17.24; -14.30; -12.84 | — |
| SECONDARY Percentage of Participants Achieving a Reduction of ≥4 in the POEM Score, of Those With a Score of ≥4 at Baseline |
41; 24; 26; 26; 20; 27 | — |
| SECONDARY Number of Courses of Rescue Therapy Per Participant |
61; 58; 59; 58; 25; 58 | — |
| SECONDARY Number of Days of Treatment With Rescue Therapy Per Participant |
54; 55; 53; 55; 25; 54 | — |
| SECONDARY Proportion of Participants Not Requiring Rescue Therapy |
61; 58; 59; 58; 25; 58 | — |
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.
Eligibility Criteria
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.
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.
Data sourced from ClinicalTrials.gov (NCT05121480). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.