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A Study of EDP1066 in Healthy Participants and Participants With Mild to Moderate Psoriasis and Atopic Dermatitis

NCT ID: NCT03542994

Last Updated: 2021-11-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

114 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-04-24

Study Completion Date

2020-01-03

Brief Summary

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Evelo will investigate the safety and tolerability of EDP1066 and its potential to be a medicinal product in healthy volunteers and individuals with mild to moderate psoriasis and atopic dermatitis.

Detailed Description

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This will be a randomized, double-blind, placebo-controlled clinical study with dose escalations to assess safety, tolerability, and pharmacodynamic effect of EDP1066. 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 EDP1066 in this patient population provides an opportunity to gain pharmacodynamic information using a range of tissue biopsies and composite clinical endpoints.

Conditions

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Psoriasis Atopic Dermatitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SEQUENTIAL

The study is a double-blind dose escalation cohort study in healthy volunteers and participants with either mild to moderate psoriasis or mild to moderate atopic dermatitis. The study consists of 9 cohorts and will test doses of EDP1066 versus placebo. The safety and tolerability of EDP1066 will be tested in participants with psoriasis and atopic dermatitis alongside pharmacodynamic effects on the systemic immune system and observation of any clinical effects.
Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Cohort 1

12 healthy volunteers; 8 on EDP1066, 4 on placebo. Dose=up to a maximum of 66 mg, capsule, once daily, 15 days

Group Type OTHER

EDP1066

Intervention Type OTHER

EDP1066 is an orally administered monoclonal microbial

Placebo oral capsule

Intervention Type DRUG

placebo

Cohort 2

12 healthy volunteers; 8 on EDP1066, 4 on placebo. Dose=up to a maximum of 660 mg, capsule, once daily, 15 days

Group Type OTHER

EDP1066

Intervention Type OTHER

EDP1066 is an orally administered monoclonal microbial

Placebo oral capsule

Intervention Type DRUG

placebo

Cohort 3

12 healthy volunteers; 8 on EDP1066, 4 on placebo. Dose=up to a maximum of 3.3 g, capsule, once daily, 15 days

Group Type OTHER

EDP1066

Intervention Type OTHER

EDP1066 is an orally administered monoclonal microbial

Placebo oral capsule

Intervention Type DRUG

placebo

Cohort 4

12 subjects with mild to moderate psoriasis; 8 on EDP1066, 4 on placebo. Dose=up to a maximum of 660 mg, capsule, once daily, 29 days

Group Type OTHER

EDP1066

Intervention Type OTHER

EDP1066 is an orally administered monoclonal microbial

Placebo oral capsule

Intervention Type DRUG

placebo

Cohort 5

24 subjects with mild to moderate psoriasis; 16 on EDP1066, 8 on placebo. Dose=up to a maximum of 3.3 g, capsule, once daily, 29 days

Group Type OTHER

EDP1066

Intervention Type OTHER

EDP1066 is an orally administered monoclonal microbial

Placebo oral capsule

Intervention Type DRUG

placebo

Cohort 6

up to 24 subjects with mild to moderate atopic dermatitis; 16 on EDP1066, 8 on placebo.

Dose=up to a maximum of 660 mg, capsule, once daily, 29 days

Group Type OTHER

EDP1066

Intervention Type OTHER

EDP1066 is an orally administered monoclonal microbial

Placebo oral capsule

Intervention Type DRUG

placebo

Cohort 7

up to 24 subjects with mild to moderate atopic dermatitis; 16 on EDP1066, 8 on placebo.

Dose=up to a maximum of 3.3 g, capsule, once daily, 29 days

Group Type OTHER

EDP1066

Intervention Type OTHER

EDP1066 is an orally administered monoclonal microbial

Placebo oral capsule

Intervention Type DRUG

placebo

Cohort 8

up to 24 subjects with mild to moderate psoriasis; 16 on EDP1066, 8 on placebo. Dose=up to a maximum of 3.3g, capsule, once daily, 29 days

Group Type OTHER

EDP1066

Intervention Type OTHER

EDP1066 is an orally administered monoclonal microbial

Placebo oral capsule

Intervention Type DRUG

placebo

Cohort 9

up to 24 subjects with mild to moderate atopic dermatitis; 16 on EDP1066, 8 on placebo.

Dose=up to a maximum of 3.3 g, capsule, once daily, 29 days

Group Type OTHER

EDP1066

Intervention Type OTHER

EDP1066 is an orally administered monoclonal microbial

Placebo oral capsule

Intervention Type DRUG

placebo

Interventions

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EDP1066

EDP1066 is an orally administered monoclonal microbial

Intervention Type OTHER

Placebo oral capsule

placebo

Intervention Type DRUG

Eligibility Criteria

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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 ≤ 5% 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 2 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:

a. 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 b. 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
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Evelo Biosciences, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Duncan McHale, MD, PhD

Role: STUDY_DIRECTOR

Evelo Biosciences

Daryl Bendel, MBChB, MBA

Role: PRINCIPAL_INVESTIGATOR

University of Surrey

Giuseppe Fiore, MD

Role: PRINCIPAL_INVESTIGATOR

Medicines Evaluation Unit Ltd

Aliya Asher, MD

Role: PRINCIPAL_INVESTIGATOR

MAC Clinical Research

Richard Fitzgerald, MD

Role: PRINCIPAL_INVESTIGATOR

Royal Liverpool Hospital

Locations

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University of Surrey Clinical Research Center

Guildford, Surrey, United Kingdom

Site Status

MAC Clinical Research

Barnsley, , United Kingdom

Site Status

MAC Clinical Research

Cannock, , United Kingdom

Site Status

Royal Liverpool Clinical Research Unit

Liverpool, , United Kingdom

Site Status

MAC Clinical Research

Manchester, , United Kingdom

Site Status

Medicines Evaluation Unit Ltd., The Langley Building, Wythenshawe Hospital

Manchester, , United Kingdom

Site Status

MAC Clinical Research

Stockton-on-Tees, , United Kingdom

Site Status

Countries

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United Kingdom

Other Identifiers

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2017-004337-90

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

EDP1066-001

Identifier Type: -

Identifier Source: org_study_id