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EDP1815 for Atopic Dermatitis

Phase 2
Waitlist Available
Led By Benjamin Ehst, MD, PhD
Research Sponsored by Evelo Biosciences, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Must have a diagnosis of atopic dermatitis (AD)for at least 6 months.
Must agree to use emollients.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 4, 8, 12, and 16 weeks
Awards & highlights

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
  • Atopic Dermatitis

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
You must have had atopic dermatitis (a type of skin condition) for at least 6 months.
Select...
You must be willing to use moisturizing creams.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~4, 8, 12, and 16 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 4, 8, 12, and 16 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Achievement of EASI-50
Secondary outcome measures
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)
+30 more

Side effects data

From 2021 Phase 2 trial • 249 Patients • NCT04603027
13%
Headache
7%
Upper Respiratory Tract Infection
4%
Viral Upper Respiratory Tract Infection
4%
Diarrhea
4%
COVID-19
4%
Vaccination Complication
2%
Abdominal Pain
2%
Rash
2%
COVID-19 Pneumonia
100%
80%
60%
40%
20%
0%
Study treatment Arm
All Placebo
Cohort 1 Active
Cohort 3 Active
Cohort 2 Active

Trial Design

4Treatment groups
Experimental Treatment
Group I: Cohort 4Experimental Treatment2 Interventions
105 participants with mild, moderate or severe Atopic Dermatitis 70 participants on EDP1815 and 35 participants on matching placebo administered at 1 capsule (8.0x10^10 total cells) once daily for 16 weeks
Group II: Cohort 3Experimental Treatment2 Interventions
100 participants with mild, moderate or severe Atopic Dermatitis 75 participants on EDP1815 and 25 participants on matching placebo administered as 1 capsule (3.2 x 10^11 cells) twice daily (6.4 x 10^11 total cells) for 16 weeks
Group III: Cohort 2Experimental Treatment2 Interventions
100 participants with mild, moderate or severe Atopic Dermatitis 75 participants on EDP1815 and 25 participants on matching placebo administered as 2 capsules (6.4 x 10^11 total cells) once daily for 16 weeks
Group IV: Cohort 1Experimental Treatment2 Interventions
100 participants with mild, moderate or severe Atopic Dermatitis 75 participants on EDP1815 and 25 participants on matching placebo administered as 2 capsules (1.6 x 10^11 total cells) once daily for 16 weeks
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
EDP1815
2020
Completed Phase 3
~1370
Placebo
1995
Completed Phase 3
~2670

Find a Location

Who is running the clinical trial?

Evelo Biosciences, Inc.Lead Sponsor
10 Previous Clinical Trials
1,085 Total Patients Enrolled
Benjamin Ehst, MD, PhDPrincipal InvestigatorOregon Medical Research Center
Yanislav Mihaylov, MDStudy DirectorEvelo Biosciences, Inc.
1 Previous Clinical Trials
287 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is it possible for me to join this research project?

"This medical trial is inviting 405 people aged 18 to 75 who have eczema and satisfy additional conditions, such as written consent, a 6 month history of atopic dermatitis (AD), an Investigator's Global Assessment (IGA) score between 2-4 on the vIGA scale, a minimum Body Surface Area (BSA) of 5%, an Eczema Area Severity Index (EASI) above 6, agreement to use emollients, and contraception requirements."

Answered by AI

Has the Food and Drug Administration given its stamp of approval to EDP1815?

"There is some evidence indicating that EDP1815 is safe, resulting in it receiving a score of 2. Given this trial's Phase 2 designation, there are no clinical data supporting the drug's efficacy."

Answered by AI

Are there still open slots for those interested in participating in this experiment?

"As evidenced on clinicaltrials.gov, this research endeavour is no longer actively seeking participants. Initially posted in January of 2022, the most recent update to the trial's information was November 3rd of that same year. While not enrolling any new patients currently, there are numerous other medical trials which do require more volunteers at present moment."

Answered by AI

Is the age criterion for admission to this research trial above 25 years old?

"This medical trial is open to all individuals falling within the age range of 18-75. By comparison, there are 102 clinical trials for those younger than eighteen and 166 available for seniors over 65."

Answered by AI

How many sites are involved in the implementation of this trial?

"36 clinics across the United States are currently enrolling patients for this study. Ann Arbor, Concord and Fountain Valley are three of these locations; you can find a full list on our website. Choosing the clinic closest to your residence is highly encouraged to alleviate travel burdens."

Answered by AI

Who else is applying?

What state do they live in?
North Carolina
How old are they?
18 - 65
What site did they apply to?
USA-103
What portion of applicants met pre-screening criteria?
Met criteria
~137 spots leftby Mar 2025