← Back to Search

Immunomodulator

EDP1815 for Atopic Dermatitis

Phase 2

Waitlist Available

Led By Ben Ehst, 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

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 40 weeks

Awards & highlights

Study Summary

This trial is an extension of a previous study to see how safe and effective the EDP1815 drug is in the long term for treating atopic dermatitis.

Eligible Conditions

Atopic Dermatitis

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 40 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~40 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 40 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

Incidence and Rate Per 100 Patient-years of Treatment-emergent Adverse Events

Secondary outcome measures

Mean Absolute Change From Baseline in BSA

Mean Absolute Change From Baseline in DLQI

Mean Absolute Change From Baseline in EASI Score

+31 more

Side effects data

From 2021 Phase 2 trial • 249 Patients • NCT04603027

Vaccination Complication

Upper Respiratory Tract Infection

Headache

Diarrhea

Rash

Abdominal Pain

Dyspepsia

COVID-19

Peptic Ulcer Hemorrhage

Viral Upper Respiratory Tract Infection

Flatulence

100%

80%

60%

40%

20%

Study treatment Arm

All Placebo

Cohort 3 Active

Cohort 2 Active

Cohort 1 Active

Trial Design

3Treatment groups

Experimental Treatment

Group I: Group 3 (8.0x10^10 total cells of EDP1815, 1 capsule once daily)Experimental Treatment1 Intervention

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)

Group II: Group 2 (6.4x10^11 total cells of EDP1815, 2 capsules once daily)Experimental Treatment1 Intervention

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)

Group III: Group 1 (1.6x10^11 total cells of EDP1815, 2 capsules once daily)Experimental Treatment1 Intervention

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)

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

EDP1815

2020

Completed Phase 3

~1370

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Evelo Biosciences, Inc.Lead Sponsor

10 Previous Clinical Trials

1,219 Total Patients Enrolled

Douglas Maslin, MDStudy DirectorEvelo Biosciences

1 Previous Clinical Trials

16 Total Patients Enrolled

Ben Ehst, PhDPrincipal InvestigatorOregon Medical Research Center

Frequently Asked Questions

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

Does this research study offer enrollment for individuals of twenty and older?

"This clinical trial only accepts participants aged 18 to 76 in accordance with its stipulated requirements."

Answered by AI

Has EDP1815 earned authorization from the FDA?

"Our team at Power determined EDP1815's safety to be a 2 due to the fact that this is Phase 2 trial, thus there is proof of its security but no evidence for efficacy."

Answered by AI

Are there certain types of participants that are desirable for this research?

"This clinical trial is taking in 300 participants with eczema, aged 18 to 76. To be accepted into the study, candidates must have given informed consent, completed a parent-study called EDP1815 and followed its protocol on atopic dermatitis treatment; additionally they must agree to use emollients as well as adhere to contraception criteria."

Answered by AI

In what institutions is the experiment taking place?

"Eligible patients can join this clinical trial at USA 123 in Fremont, California, CAN-107 in Richmond Hill, Georgia and CAN-103 in Surrey, Indiana as well as 35 other medical centres."

Answered by AI

Is this research initiative presently accepting volunteers?

"Correct. Open clinicaltrials.gov records reveal that this trial is not actively enrolling patients, having been initially made available on June 6th 2022 and lastly modified on the 27th of the same month. Nonetheless, there are 236 other trials currently admitting participants in various locations across America."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Long-Term Extension Trial in Participants With Atopic Dermatitis Who Participated in Previous EDP1815 Trials

2022. "A Long-Term Extension Trial in Participants With Atopic Dermatitis Who Participated in Previous EDP1815 Trials". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05439941.