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

NCT05439941 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 287

Last updated 2023-09-07

Study results available
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Summary

This is an Open-Label Extension (OLE) study to evaluate the long-term safety, tolerability, and efficacy of EDP1815 in participants with mild, moderate, and severe atopic dermatitis who have completed the treatment period of a prior clinical study ("parent study") with EDP1815.

The current parent study of this protocol is the EDP1815-207 study; A Phase 2, Multicenter, Double-Blind, Placebo-Controlled, Multiple-Cohort Study Investigating the Effect of EDP1815 in Participants for the Treatment of Mild, Moderate and Severe Atopic Dermatitis.

Conditions

Interventions

DRUG

EDP1815

EDP1815 is an orally administered, pharmaceutical preparation of a single strain of bacteria

Sponsors & Collaborators

  • Evelo Biosciences, Inc.

    lead INDUSTRY

Principal Investigators

  • Douglas Maslin, MD · Evelo Biosciences

  • Ben Ehst, PhD · Oregon Medical Research Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
76 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-06-06
Primary Completion
2023-05-25
Completion
2023-06-07
FDA Drug
Yes

Countries

  • United States
  • Australia
  • Bulgaria
  • Canada
  • Germany
  • Poland

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05439941 on ClinicalTrials.gov