NCT03733353

A Study of EDP1815 in Healthy Participants and Participants With Mild to Moderate Psoriasis and Atopic Dermatitis

A Phase 1 Randomized Double-Blind Placebo-controlled Single and Multiple Ascending Dose Study of EDP1815 in Healthy Participants and Participants With Mild to Moderate Psoriasis or Atopic Dermatitis

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 204 (actual)
• Sponsor: Evelo Biosciences, Inc. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

Evelo will investigate the safety and tolerability of EDP1815 and its potential to be a medicinal product in healthy volunteers and individuals with mild to moderate psoriasis and atopic dermatitis.

Detailed description

This will be a randomized, double-blind, placebo-controlled clinical study with dose escalations to assess safety, tolerability, and pharmacodynamic effect of EDP1815. Since this clinical study is the first study in humans, the participants will be healthy volunteers or subjects with mild to moderate psoriasis or atopic dermatitis who are otherwise well. Investigation of EDP1815 in this patient population provides an opportunity to gain pharmacodynamic information using a range of tissue biopsies and composite clinical endpoints.

Conditions

• Psoriasis
• Atopic Dermatitis

Interventions

Type	Name	Description
DRUG	EDP1815	EDP1815 is an orally administered monoclonal microbial
DRUG	Placebo oral capsule	Placebo
DRUG	Placebo oral tablet	Placebo

Timeline

• Start date: 2018-11-19
• Primary completion: 2021-10-29
• Completion: 2021-10-29
• First posted: 2018-11-07
• Last updated: 2022-01-10

Locations

9 sites across 1 country: United Kingdom