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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

Yes
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years - 60 Years
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

General: Participant has a body mass index of ≥ 18 kg/m2 to ≤ 35 kg/m2 at Screening. Healthy Volunteers: Participants who are overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, and cardiac monitoring. Mild to moderate psoriasis: 1. Participant has had a confirmed diagnosis of mild to moderate plaque-type psoriasis for at least 6 months involving ≤ 10% of body surface area (BSA) (excluding the scalp). 2. Participant has a minimum of 2 psoriatic lesions with at least 1 plaque in a site suitable for biopsy. Mild to moderate atopic dermatitis: 1. Mild to moderate atopic dermatitis with a minimum of 3% to a maximum of 15% BSA involvement. 2. Participant has had a confirmed diagnosis of mild to moderate atopic dermatitis for at least 6 months (IGA score of 2 or 3). 3. Participant has a minimum of 2 atopic dermatitis lesions with at least 1 in a site suitable for biopsy.

Exclusion Criteria:

1. Female participant who is pregnant, or plans to become pregnant during the study, or breastfeeding, or sexually active with childbearing potential who is not using a medically accepted birth control method. 2. Participant has received live attenuated vaccination within 6 weeks prior to Screening or intends to have such a vaccination during the course of the study. 3. Participant has received any investigational drug or experimental procedure within 90 days or 5 half-lives, whichever is longer, prior to study intervention administration. 4. Participant requires treatment with an anti-inflammatory drug during the study period. Paracetamol will be permitted for use as an antipyretic and/or analgesic (maximum of 4 grams/day in any 24 hour period). 5. Participant has an active infection (e.g. sepsis, pneumonia, abscess) or has had an infection requiring antibiotic treatment within 6 weeks prior to Investigational Medicinal Product (IMP) administration. When in doubt, the investigator should confer with the Sponsor study physician. 6. Participant has renal or liver impairment, defined as: 1. For healthy volunteers: i. For women, serum creatinine level ≥ 125 μmol/L; for men, ≥ 135 μmol/L, or ii. Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≥ 1.5 x upper limit of normal (ULN), or iii. Alkaline phosphatase (ALP) and/or bilirubin > 1.5 x ULN 2. For participants with mild to moderate atopic dermatitis or psoriasis: i. For women, serum creatinine level ≥ 125 μmol/L; for men, ≥ 135 μmol/L, or ii. ALT or AST > 2 x ULN and/or bilirubin > 1.5 x ULN

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT03733353
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 1
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Evelo Biosciences, Inc.
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Duncan McHale, MD, PhD
Principal Investigator Affiliation Evelo Biosciences, Inc.
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Industry
Overall Status Recruiting
Countries United Kingdom
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Psoriasis, Atopic Dermatitis
Additional Details

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.

Arms & Interventions

Arms

Other: Cohort 1

12 healthy volunteers; 8 on EDP1815, 4 on placebo. Dose=55 mg, capsule, once daily, 15 days

Other: Cohort 2

12 healthy volunteers; 8 on EDP1815, 4 on placebo. Dose= 550 mg, capsule, once daily, 15 days

Other: Cohort 3

12 subjects with mild to moderate psoriasis; 8 on EDP1815, 4 on placebo. Dose= 550 mg, capsule, once daily, 29 days

Other: Cohort 4

24 subjects with mild to moderate psoriasis; 16 on EDP1815, 8 on placebo. Dose= 2.76 g, capsule, once daily, 29 days

Other: Cohort 5

24 subjects with mild to moderate atopic dermatitis; 16 on EDP1815, 8 on placebo. Dose= 2.76 g, capsule, once daily, 29 days

Other: Cohort 6

24 subjects with mild to moderate psoriasis; 16 on EDP1815, 8 on placebo. Dose=550 mg, capsule, once daily, 28 days.

Other: Cohort 7

24 subjects with mild to moderate atopic dermatitis; 16 on EDP1815, 8 on placebo. Dose= 550 mg, capsule, once daily, 28 days

Interventions

Drug: - EDP1815

EDP1815 is an orally administered monoclonal microbial

Drug: - Placebo oral capsule

Placebo

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

Hammersmith Medicines Research, Hammersmith, London, United Kingdom

Status

Recruiting

Address

Hammersmith Medicines Research

Hammersmith, London, NW10 7EW

Site Contact

Malcolm Boyce, MD FRCP FFPM

[email protected]

02089614130

The content provided on clinical trials is for informational purposes only and is not a substitute for medical consultation with your healthcare provider. We do not recommend or endorse any specific study and you are advised to discuss the information shown with your healthcare provider. While we believe the information presented on this website to be accurate at the time of writing, we do not guarantee that its contents are correct, complete, or applicable to any particular individual situation. We strongly encourage individuals to seek out appropriate medical advice and treatment from their physicians. We cannot guarantee the availability of any clinical trial listed and will not be responsible if you are considered ineligible to participate in a given clinical trial. We are also not liable for any injury arising as a result of participation.