EDP1815 for Eczema

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Eczema+3 More
EDP1815 - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This trial will test whether EDP1815 is safe and effective for treating atopic dermatitis. Different doses will be compared, as well as once-daily and twice-daily administration.

Eligible Conditions
  • Eczema
  • Dermatitis

Treatment Effectiveness

Effectiveness Progress

1 of 3

Other trials for Eczema

Study Objectives

1 Primary · 33 Secondary · Reporting Duration: 4, 8, 12, and 16 weeks

16 weeks
Achievement of EASI-50
Percentage of Participants Achieving vIGA of 0
Percentage of Participants achieving a reduction of ≥2 in SD-NRS score, of those with a score of ≥2 at baseline
Percentage of Participants achieving a reduction of ≥4 in the DLQI, of those with a score of ≥4 at baseline
Percentage of Participants achieving a reduction of ≥4 in the POEM score, of those with a score of ≥4 at baseline
Percentage of Participants achieving a reduction of ≥4 in the worst PR-NRS, of those with a score of ≥4 at baseline
Week 12
Percentage of participants achieving EASI-50
Week 16
Mean absolute change from baseline in BSA
Mean absolute change from baseline in Patient Oriented Eczema Measure (POEM)
Mean absolute change from baseline in SCORing Atopic Dermatitis (SCORAD)
Mean absolute change from baseline in the Dermatology Quality of Life Index (DLQI)
Mean absolute change from baseline in the Sleep Disturbance Numerical Rating Scale (SD-NRS) score
Mean absolute change from baseline in worst Pruritus Numerical Rating Scale (PR-NRS)
Mean absolute change in EASI
Mean absolute change in vIGA*BSA (body surface area)
Mean percentage change from baseline in BSA
Mean percentage change from baseline in DLQI
Mean percentage change from baseline in Patient Oriented Eczema Measure (POEM)
Mean percentage change from baseline in SCORAD
Mean percentage change in EASI
Mean percentage change in vIGA*BSA
Number of courses of rescue therapy per Participant
Number of days of treatment with rescue therapy per Participant
Percentage of Participants Achieving BSA reduction to 3% BSA or less
Percentage of Participants Achieving BSA-50
Percentage of Participants Achieving BSA-75
Percentage of Participants Achieving Investigator's Global Assessment (vIGA) of 0 or 1 with a ≥2 Point Improvement
Percentage of Participants Achieving SCORAD-50
Percentage of Participants Achieving SCORAD-75
Percentage of Participants Achieving vIGA of 0 or 1
Percentage of Participants achieving a reduction of ≥2 in the worst Pruritus-NRS, of those with a score of ≥2 at baseline
Percentage of participants achieving EASI-75
Percentage of participants achieving EASI-90
Proportion of participants not requiring rescue therapy

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Other trials for Eczema

Trial Design

4 Treatment Groups

Cohort 4
1 of 4
Cohort 1
1 of 4
Cohort 3
1 of 4
Cohort 2
1 of 4
Experimental Treatment

405 Total Participants · 4 Treatment Groups

Primary Treatment: EDP1815 · Has Placebo Group · Phase 2

Cohort 4Experimental Group · 2 Interventions: EDP1815, Placebo · Intervention Types: Drug, Drug
Cohort 1Experimental Group · 2 Interventions: EDP1815, Placebo · Intervention Types: Drug, Drug
Cohort 3Experimental Group · 2 Interventions: EDP1815, Placebo · Intervention Types: Drug, Drug
Cohort 2Experimental Group · 2 Interventions: EDP1815, Placebo · Intervention Types: Drug, Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
EDP1815
2018
Completed Phase 2
~430
Placebo
1995
Completed Phase 3
~2670

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 4, 8, 12, and 16 weeks

Who is running the clinical trial?

Evelo Biosciences, Inc.Lead Sponsor
8 Previous Clinical Trials
1,028 Total Patients Enrolled
4 Trials studying Eczema
670 Patients Enrolled for Eczema
Benjamin Ehst, MD, PhDPrincipal InvestigatorOregon Medical Research Center
Douglas Maslin, MPhil, MBBSStudy DirectorEvelo Biosciences, Inc.
Yanislav Mihaylov, MDStudy DirectorEvelo Biosciences, Inc.
1 Previous Clinical Trials
300 Total Patients Enrolled
1 Trials studying Eczema
300 Patients Enrolled for Eczema

Eligibility Criteria

Age 18+ · All Participants · 8 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You have given informed consent.
You have a score of ≥6 on the EASI questionnaire.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 23rd, 2021

Last Reviewed: October 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.

Who else is applying?

What state do they live in?
North Carolina100.0%
How old are they?
18 - 65100.0%
What site did they apply to?
USA-103100.0%
What portion of applicants met pre-screening criteria?
Met criteria100.0%