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

NCT03542994 | Completed Phase 1 DMC

• 2 other identifiers: EDP1066-0012017-004337-90
• Study Type: interventional
• Target: 114
• Locations: 1 country
• Sites: 7

Brief Summary

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.

Conditions

Psoriasis; Atopic 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 60

• 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 60

• Safety and tolerability measured through ECG

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

  Day 0 to Day 60

• 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 1 to Day 60

• GI safety measurement through biomarker analysis

  GI safety measurement through fecal calprotectin analysis

  Day 1 to Day 60

Secondary Outcomes (2)

• Clinical improvement in subjects with mild to moderate psoriasis

  Day 0 to Day 60

• Clinical improvement in subjects with mild to moderate atopic dermatitis

  Day 0 to Day 60

Study Arms (9)

Cohort 1

OTHER

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

Other: EDP1066; Drug: Placebo oral capsule

Cohort 2

OTHER

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

Other: EDP1066; Drug: Placebo oral capsule

Cohort 3

OTHER

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

Other: EDP1066; Drug: Placebo oral capsule

Cohort 4

OTHER

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

Other: EDP1066; Drug: Placebo oral capsule

Cohort 5

OTHER

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

Other: EDP1066; Drug: Placebo oral capsule

Cohort 6

OTHER

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

Other: EDP1066; Drug: Placebo oral capsule

Cohort 7

OTHER

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

Other: EDP1066; Drug: Placebo oral capsule

Cohort 8

OTHER

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

Other: EDP1066; Drug: Placebo oral capsule

Cohort 9

OTHER

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

Other: EDP1066; Drug: Placebo oral capsule

Interventions

EDP1066 OTHER

EDP1066 is an orally administered monoclonal microbial

Cohort 1; Cohort 2; Cohort 3; Cohort 4; Cohort 5; Cohort 6; Cohort 7; Cohort 8; Cohort 9

Placebo oral capsule DRUG

placebo

Cohort 1; Cohort 2; Cohort 3; Cohort 4; Cohort 5; Cohort 6; Cohort 7; Cohort 8; Cohort 9

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

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 ≤ 5% 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 2 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:
• 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

Sponsors & Collaborators

• Evelo Biosciences, Inc.: lead

Study Sites (7)

University of Surrey Clinical Research Center

Guildford, Surrey, GU2 7XP, United Kingdom

Location

MAC Clinical Research

Barnsley, S75 3DL, United Kingdom

Location

MAC Clinical Research

Cannock, WS11 0BN, United Kingdom

Location

Royal Liverpool Clinical Research Unit

Liverpool, L78XP, United Kingdom

Location

MAC Clinical Research

Manchester, M13 9NQ, United Kingdom

Location

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

Manchester, M23 9QZ, United Kingdom

Location

MAC Clinical Research

Stockton-on-Tees, TS17 6EW, United Kingdom

Location

MeSH Terms

Conditions

Psoriasis; Dermatitis, Atopic

Condition Hierarchy (Ancestors)

Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Dermatitis; Skin Diseases, Eczematous; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• Duncan McHale, MD, PhD

  Evelo Biosciences

  STUDY DIRECTOR

• Daryl Bendel, MBChB, MBA

  University of Surrey

  PRINCIPAL INVESTIGATOR

• Giuseppe Fiore, MD

  Medicines Evaluation Unit Ltd

  PRINCIPAL INVESTIGATOR

• Aliya Asher, MD

  MAC Clinical Research

  PRINCIPAL INVESTIGATOR

• Richard Fitzgerald, MD

  Royal Liverpool Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

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 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.

Study Record Dates

• First Submitted: April 24, 2018
• First Posted: June 1, 2018
• Study Start: April 24, 2019
• Primary Completion: January 3, 2020
• Study Completion: January 3, 2020
• Last Updated: November 9, 2021

Record last verified: 2021-11

Locations

GB (7)