NCT03733353

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
204

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Nov 2018

Typical duration for phase_1

Geographic Reach
1 country

9 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 5, 2018

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 7, 2018

Completed
12 days until next milestone

Study Start

First participant enrolled

November 19, 2018

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 29, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 29, 2021

Completed
Last Updated

January 10, 2022

Status Verified

January 1, 2022

Enrollment Period

2.9 years

First QC Date

November 5, 2018

Last Update Submit

January 6, 2022

Conditions

PsoriasisAtopic Dermatitis

Outcome Measures

Primary Outcomes (5)

  • Safety and tolerability measured through Adverse Events (AEs)

    Number of participants with AEs by seriousness and relationship to treatment

    Day 1 to Day 70

  • Safety and tolerability measured through lab measurements

    Number of participants with clinically significant change from baseline (Day 0) in laboratory values

    Day 0 to Day 70

  • Safety and tolerability measured through ECG

    Number of participants with clinically relevant changes from baseline (Day 0) ECG parameters

    Day 0 to Day 70

  • Safety and tolerability measured through physical examination

    Physical examination of stool samples based on the Bristol Stool Scale (Types 3 and 4 are ideal stool): Type 1: Separate hard lumps, like nuts (hard to pass); Type 2: Sausage-shaped, but lumpy; Type 3: Like a sausage but with cracks on its surface; Type 4: Like a sausage or snake, smooth and soft; Type 5: Soft blobs with clear cut edges (easy to pass); Type 6: Fluffy pieces with ragged edges, a mushy stool; Type 7: Watery, no solid pieces, entirely liquid

    Day 0 to Day 60

  • GI safety measurement through biomarker analysis

    GI safety measurement through fecal calprotectin analysis

    Day 0 to Day 60

Secondary Outcomes (2)

  • Clinical improvement in subjects with mild to moderate psoriasis

    Day 0 to Day 70

  • Clinical improvement in subjects with mild to moderate atopic dermatitis

    Day 0 to Day 70

Study Arms (10)

Cohort 1

OTHER

12 healthy volunteers; 8 on EDP1815, 4 on placebo. Dose=1/10th of HED, capsule, once daily, 15 days

Drug: EDP1815Drug: Placebo oral capsule

Cohort 2

OTHER

12 healthy volunteers; 8 on EDP1815, 4 on placebo. Dose= 1 x HED, capsule, once daily, 15 days

Drug: EDP1815Drug: Placebo oral capsule

Cohort 3

OTHER

12 subjects with mild to moderate psoriasis; 8 on EDP1815, 4 on placebo. Dose= 1 x HED, capsule, once daily, 29 days

Drug: EDP1815Drug: Placebo oral capsule

Cohort 4

OTHER

24 subjects with mild to moderate psoriasis; 16 on EDP1815, 8 on placebo. Dose= 5 x HED capsule, once daily, 29 days

Drug: EDP1815Drug: Placebo oral capsule

Cohort 5

OTHER

24 subjects with mild to moderate atopic dermatitis; 16 on EDP1815, 8 on placebo. Dose= 5 x HED, mini-tablets in capsule, once daily, 29 days

Drug: EDP1815Drug: Placebo oral capsule

Cohort 6

OTHER

24 subjects with mild to moderate psoriasis; 16 on EDP1815, 8 on placebo. Dose=5 x HED, mini-tablets in capsule, once daily, 29 days.

Drug: EDP1815Drug: Placebo oral capsule

Cohort 7

OTHER

24 subjects with mild to moderate atopic dermatitis; 16 on EDP1815, 8 on placebo. Dose= 5 x HED, capsule, once daily, 56 days

Drug: EDP1815Drug: Placebo oral capsule

Cohort 8

OTHER

24 subjects with mild to moderate psoriasis; 16 on EDP1815, 8 on placebo. Dose= 8 x HED, tablet, once daily, 56 days

Drug: EDP1815Drug: Placebo oral tablet

Cohort 9

OTHER

24 subjects with mild to moderate psoriasis; 16 on EDP1815, 8 on placebo. Dose= 2 x HED, capsule, once daily, 56 days

Drug: EDP1815Drug: Placebo oral capsule

Cohort 10

OTHER

24 subjects with mild to moderate atopic dermatitis; 16 on EDP1815, 8 on placebo. Dose= 4 x HED, capsule, once daily, 56 days

Drug: EDP1815Drug: Placebo oral capsule

Interventions

EDP1815DRUG

EDP1815 is an orally administered monoclonal microbial

Cohort 1Cohort 10Cohort 2Cohort 3Cohort 4Cohort 5Cohort 6Cohort 7Cohort 8Cohort 9
Placebo oral capsuleDRUG

Placebo

Cohort 1Cohort 10Cohort 2Cohort 3Cohort 4Cohort 5Cohort 6Cohort 7Cohort 9
Placebo oral tabletDRUG

Placebo

Cohort 8

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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:
  • 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).
  • Participant has a minimum of 2 psoriatic lesions with at least 1 plaque in a site suitable for biopsy.
  • Mild to moderate atopic dermatitis:
  • Mild to moderate atopic dermatitis with a minimum of 3% to a maximum of 15% BSA involvement.
  • Participant has had a confirmed diagnosis of mild to moderate atopic dermatitis for at least 6 months (IGA score of 2 or 3).
  • Participant has a minimum of 2 atopic dermatitis lesions with at least 1 in a site suitable for biopsy.

You may not qualify if:

  • 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.
  • 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.
  • Participant has received any investigational drug or experimental procedure within 90 days or 5 half-lives, whichever is longer, prior to study intervention administration.
  • 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).
  • 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.
  • Participant has renal or liver impairment, defined as:
  • 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
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (9)

UK-8

Barnsley, United Kingdom

Location

UK-7

Blackpool, United Kingdom

Location

UK-3

Cannock, United Kingdom

Location

UK-4

Leeds, United Kingdom

Location

UK-5

Liverpool, United Kingdom

Location

UK-1

London, United Kingdom

Location

UK-2

Manchester, United Kingdom

Location

UK-6

Manchester, United Kingdom

Location

UK-9

Stockton-on-Tees, United Kingdom

Location

Related Publications (1)

  • Itano A, Maslin D, Ramani K, Mehraei G, Carpenter N, Cormack T, Saghari M, Moerland M, Troy E, Caffry W, Wardwell-Scott L, Abel S, McHale D, Bodmer M. Clinical translation of anti-inflammatory effects of Prevotella histicola in Th1, Th2, and Th17 inflammation. Front Med (Lausanne). 2023 May 5;10:1070433. doi: 10.3389/fmed.2023.1070433. eCollection 2023.

    PMID: 37215725DERIVED

MeSH Terms

Conditions

PsoriasisDermatitis, Atopic

Condition Hierarchy (Ancestors)

Skin Diseases, PapulosquamousSkin DiseasesSkin and Connective Tissue DiseasesSkin Diseases, GeneticGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesDermatitisSkin Diseases, EczematousHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Study Officials

  • Duncan McHale, MD, PhD

    Evelo Biosciences, Inc.

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
SEQUENTIAL
Model Details: 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 10 cohorts and will test doses of EDP1815 versus placebo. The safety and tolerability of EDP1815 will be tested in participants with psoriasis and atopic dermatitis alongside pharmacodynamic effects on the systemic immune system and observation of any clinical effects.
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 5, 2018

First Posted

November 7, 2018

Study Start

November 19, 2018

Primary Completion

October 29, 2021

Study Completion

October 29, 2021

Last Updated

January 10, 2022

Record last verified: 2022-01

Data Sharing

IPD Sharing
Will not share

Locations

GB(9)