Study in Healthy Participants and Participants With Moderate Atopic Dermatitis & Optionally, Moderate Psoriasis, and/or Mild Asthma

Evelo Biosciences, Inc.52 enrolled

Overview

This Phase 1 study will investigate the safety and tolerability of EDP1867 in healthy volunteers, participants with atopic dermatitis, and, optionally, in participants with psoriasis and/or asthma.

This is a phase 1a/1b, first in human, participant and investigator-blind sponsor-unblinded randomized placebo-controlled multiple dose study of EDP1867 in healthy volunteers and participants with moderate atopic dermatitis and, optionally, moderate psoriasis, and/or mild asthma. This study has been designed to investigate the clinical safety and tolerability of EDP1867 in healthy volunteers, participants with atopic dermatitis, and, optionally, in participants with psoriasis and/or asthma.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Atopic Dermatitis Psoriasis Asthma

Interventions

EDP1867DRUG

EDP1867 is an orally administered, pharmaceutical preparation of a single strain of bacteria

PlaceboDRUG

Placebo oral capsule

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 YearsHealthy volunteers:

Medical Language ↔ Plain English

Key Inclusion Criteria: 1. Age ≥ 18 years to 65 years. 2. Participant has a body mass index of ≥ 18 kg/m2 to ≤ 35 kg/m2. 3. Participants who are overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, and ECG monitoring at Screening and at Baseline. Additional Inclusion Criteria for Participants with Moderate Atopic Dermatitis 4. Participant has moderate atopic dermatitis with a minimum of 5% and a maximum of 40% BSA involvement, and an IGA score of 2 or 3. 5. Participant has had a confirmed diagnosis of atopic dermatitis for at least 6 months. 6. All participants must be using an emollient and should continue to use this once daily (or more, as needed) for at least 14 days prior to randomisation, and must continue this treatment once daily (or more, as needed) throughout the study. Additional Inclusion Criteria for Participants with Moderate Psoriasis 7. Participant has moderate plaque psoriasis with plaque covering BSA of ≥3% and ≤10% and meets both of the following additional criteria: 1. PASI score of ≥6 and ≤15, and 2. PGA score of 2 or 3. 8. Participant has a confirmed diagnosis of plaque psoriasis for at least 6 months. Additional Inclusion Criteria for Participants with Mild Asthma 9. Participant has a diagnosis of stable asthma for at least six months 10. FeNO of ≥40ppb. 11. FEV1 ≥70% of predicted normal. Key Exclusion Criteria: 1. 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 (non-live vaccines are permitted). 2. Participant requires treatment with an anti-inflammatory drug during the study period. 3. Participant has an active infection (e.g. sepsis, pneumonia, abscess) or has had an infection requiring antibiotic treatment within 6 weeks prior to study intervention administration. 4. Participant has renal or liver impairment 5. Participant has active neoplastic disease or history of neoplastic disease within 5 years of Screening 6. Participant has undergone major surgery within 4 weeks prior to Screening. 7. Any known cardiac abnormality 8. Participant has a known history of human immunodeficiency virus (HIV) 9. Known, active hepatitis A, hepatitis B (HBV), or hepatitis C (HCV) infection 10. Participant with any type of GI tract disease 11. Participants with a history of any serious psychiatric condition; or on therapy for any psychiatric condition 12. The participant has taken any over-the-counter (OTC) or prescription medication, within 14 days prior to baseline (Day -1); or anticipates an inability to abstain from these products for the duration of the study period 13. The participant has a significant history of drug abuse or regular use of illicit drugs or a history of alcohol abuse within 1 year prior to Screening or has tested positive for drugs of abuse or alcohol at Screening or at baseline. 14. The participant has had an acute, clinically significant illness within 30 days prior to the first dose of study intervention. Additional Exclusion Criteria for Participants with Atopic Dermatitis 15. Participant is receiving systemic immunosuppressive or non-biologic atopic dermatitis therapy or has received such therapy within 4 weeks prior to Screening. 16. Participant has received treatment with biologic agents within 12 months prior to first dose. 17. Participant continues to use topical medications, other than emollients, that could affect atopic dermatitis 2 weeks prior to the start of dosing. 18. Participant intends to continue to use sunbeds and/or increase their sun exposure significantly from their normal lifestyle Additional Exclusion Criteria for Participants with Psoriasis 19. Psoriasis restricted to scalp, palm, and/or soles only. 20. Non-plaque type of psoriasis 21. Participant is receiving systemic immunosuppressive or nonbiologic psoriasis therapy or has received such therapy within 4 weeks prior to Screening 22. Participant has received treatment with biologic agents within 12 months prior to first dose. 23. Participant continues to use topical medications that could affect psoriasis within 2 weeks prior to the start of dosing 24. Participant intends to continue to use sunbeds and/or increase their sun exposure significantly from their normal lifestyle Additional Exclusion Criteria for Participants with Asthma 25. History of life-threatening asthma, or a visit to the emergency department for asthma in the 6 months prior to screening, or exacerbation requiring oral corticosteroids within the previous 3 months. 26. Smoker or nicotine user within the 3 months prior to screening; or a previous smoker with a greater than 10 pack year history. 27. Other significant non-reversible pulmonary disease 28. Use of the following medicines within the specified time-frame prior to screening: 1. Long-acting inhaled β2-agonists: 8 weeks. Note: short-acting inhaled β2-agonists are permitted as required. 2. Anti-IgE therapy: 6 months 3. Inhaled corticosteroids: 8 weeks 4. Oral or Injected corticosteroids: 8 weeks 5. Intranasal or topical steroids: 4 weeks 6. Leukotriene antagonists: 2 weeks 7. Long-acting muscarinic antagonist: 8 weeks 8. Xanthines (excluding caffeine), anticholinergics, cromoglycates: 1 week.

Locations (7)

MAC Clinical Research Manchester

Manchester, Greater Manchester, United Kingdom

Medicines Evaluation Unit (MEU)

Manchester, Greater Manchester, United Kingdom

MAC Clinical Research

Blackpool, Lancashire, United Kingdom

MAC Clinical Research

Liverpool, Merseyside, United Kingdom

Outcomes

Primary Outcomes

Safety and tolerability measured through Adverse Events (AEs)

Number of participants with AEs by seriousness and relationship to treatment

Time frame: 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

Time frame: Day 1 to Day 70

Safety and tolerability measured through ECG

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

Time frame: Day 1 to Day 70

Safety and tolerability measured through physical examination

Physical examination will include, at a minimum, assessments of the cardiovascular, respiratory, oral cavity, GI and neurological systems. Height and weight will also be measured and recorded. Number of participants with clinically relevant changes from baseline (Day 0) physical examination parameters

Time frame: Day 1 to Day 70

Safety and tolerability measured through vital signs

Blood pressure, pulse rate, respiratory rate, oxygen saturations and temperature will be assessed. Number of participants with clinically relevant changes in vital signs from baseline (Day 0)

Time frame: Day 1 to Day 70

Secondary Outcomes

Change in EASI score

The clinical improvement in subjects with atopic dermatitis will be measured using the change from baseline in EASI (Eczema Area and Severity Index) score

Time frame: Day 1 to Day 70

Percentage change in EASI score

Data from ClinicalTrials.gov

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MAC Clinical Research

Cannock, South Staffordshire, United Kingdom

MAC Clinical Research

Stockton-on-Tees, Teeside, United Kingdom

MAC Clinical Research

Leeds, West Yorkshire, United Kingdom

The clinical improvement in subjects with atopic dermatitis will be measured using the percentage change from baseline in EASI (Eczema Area and Severity Index) score

Time frame: Day 1 to Day 70

Change in SCORAD score

The clinical improvement in subjects with atopic dermatitis will be measured using the change from baseline in SCORAD (SCORing Atopic Dermatitis) score

Time frame: Day 1 to Day 70

Percentage change in SCORAD score

The clinical improvement in subjects with atopic dermatitis will be measured using the percentage change from baseline in SCORAD (SCORing Atopic Dermatitis) score

Time frame: Day 1 to Day 70

Change in BSA

The clinical improvement in subjects with atopic dermatitis will be measured using the change from baseline in BSA (Body Surface Area)

Time frame: Day 1 to Day 70

Percentage change in BSA

The clinical improvement in subjects with atopic dermatitis will be measured using the percentage change from baseline in BSA (Body Surface Area)

Time frame: Day 1 to Day 70

Change in IGA x BSA

The clinical improvement in subjects with atopic dermatitis will be measured using the change from baseline in IGA x BSA \[IGA = Investigator's Global Assessment, BSA = Body Surface Area\]

Time frame: Day 1 to Day 70

Percentage change in IGA x BSA

The clinical improvement in subjects with atopic dermatitis will be measured using the percentage change from baseline in IGA x BSA \[IGA = Investigator's Global Assessment, BSA = Body Surface Area\]

Time frame: Day 1 to Day 70

Change in DLQI score

The clinical improvement in subjects with atopic dermatitis will be measured using the change from baseline in DLQI (Dermatology Life Quality Index) score

Time frame: Day 1 to Day 70

Change in POEM score

The clinical improvement in subjects with atopic dermatitis will be measured using the change from baseline in POEM (Patient-Oriented Eczema Measure) score

Time frame: Day 1 to Day 70

Change in Pruritis NRS average itch score

The clinical improvement in subjects with atopic dermatitis will be measured using the change from baseline in Pruritis NRS (Numerical Rating Scale) average itch score

Time frame: Day 1 to Day 70

Change in Pruritis NRS worst itch score

The clinical improvement in subjects with atopic dermatitis will be measured using the change from baseline in Pruritis NRS (Numerical Rating Scale) worst itch score

Time frame: Day 1 to Day 70

Achievement of EASI-50

The clinical improvement in subjects with atopic dermatitis will be measured using achievement of EASI-50 at day 70

Time frame: Day 1 to Day 70

Achievement of EASI-75

The clinical improvement in subjects with atopic dermatitis will be measured using achievement of EASI-75 at day 70

Time frame: Day 1 to Day 70

Achievement of IGA 0 or 1

The clinical improvement in subjects with atopic dermatitis will be measured using achievement of IGA 0 or 1 at day 70

Time frame: Day 1 to Day 70

Change in PASI score

The clinical improvement in subjects with psoriasis will be measured using change from baseline in PASI score (Psoriasis Area and Severity Index Score)

Time frame: Day 1 to Day 70

Percentage change in PASI score

The clinical improvement in subjects with psoriasis will be measured using percentage change from baseline in PASI score (Psoriasis Area and Severity Index Score)

Time frame: Day 1 to Day 70

Change in LSS

The clinical improvement in subjects with psoriasis will be measured using change from baseline in LSS (Lesion Severity Score)

Time frame: Day 1 to Day 70

Change in BSA

The clinical improvement in subjects with psoriasis will be measured using change from baseline in BSA (Body Surface Area)

Time frame: Day 1 to Day 70

Percentage change in BSA

The clinical improvement in subjects with psoriasis will be measured using percentage change from baseline in BSA (Body Surface Area)

Time frame: Day 1 to Day 70

Change in PGA x BSA

The clinical improvement in subjects with psoriasis will be measured using change from baseline in PGA x BSA \[PGA= Physician's Global Assessment; BSA = Body Surface Area)

Time frame: Day 1 to Day 70

Percentage change in PGA x BSA

The clinical improvement in subjects with psoriasis will be measured using percentage change from baseline in PGA x BSA \[PGA= Physician's Global Assessment; BSA = Body Surface Area)

Time frame: Day 1 to Day 70

Change in DLQI

The clinical improvement in subjects with psoriasis will be measured using change from baseline in DLQI (Dermatology Life Quality Index) score

Time frame: Day 1 to Day 70

Achievement of PASI-50

The clinical improvement in subjects with psoriasis will be measured using achievement of PASI-50 at Day 70

Time frame: Day 1 to Day 70

Achievement of PASI-75

The clinical improvement in subjects with psoriasis will be measured using achievement of PASI-75 at Day 70

Time frame: Day 1 to Day 70

Achievement of PGA of 0 or 1

The clinical improvement in subjects with psoriasis will be measured using achievement of PGA of 0 or 1 at Day 70

Time frame: Day 1 to Day 70

Change in FeNO

The clinical improvement in subjects with asthma will be measured using change from baseline in FeNO (Fractional exhaled Nitric Oxide)

Time frame: Day 1 to Day 70

Percentage change in FeNO

The clinical improvement in subjects with asthma will be measured using percentage change from baseline in FeNO

Time frame: Day 1 to Day 70

Change in FEV1

The clinical improvement in subjects with asthma will be measured using change from baseline in FEV1 (Forced Expiratory Volume)

Time frame: Day 1 to Day 70

Percentage change in FEV1

The clinical improvement in subjects with asthma will be measured using percentage change from baseline in FEV1 (Forced Expiratory Volume)

Time frame: Day 1 to Day 70

Change in FVC

The clinical improvement in subjects with asthma will be measured using change from baseline in FVC (Forced Vital Capacity)

Time frame: Day 1 to Day 70

Percentage change in FVC

The clinical improvement in subjects with asthma will be measured using percentage change from baseline in FVC (Forced Vital Capacity)

Time frame: Day 1 to Day 70

Change in FEV1/FVC ratio

The clinical improvement in subjects with asthma will be measured using change from baseline in FEV1/FVC ratio

Time frame: Day 1 to Day 70

Percentage change in FEV1/FVC ratio

The clinical improvement in subjects with asthma will be measured using percentage change from baseline in FEV1/FVC ratio

Time frame: Day 1 to Day 70

Change in PEF

The clinical improvement in subjects with asthma will be measured using change from baseline in PEF (Peak Expiratory Flow)

Time frame: Day 1 to Day 70

Percentage change in PEF

The clinical improvement in subjects with asthma will be measured using percentage change from baseline in PEF (Peak Expiratory Flow)

Time frame: Day 1 to Day 70

Change in number of exacerbations

The clinical improvement in subjects with asthma will be measured using change from baseline in number of exacerbations across the treatment period

Time frame: Day 1 to Day 56

Occurrence of any exacerbation

The clinical improvement in subjects with asthma will be measured using the occurrence of any exacerbation during the treatment period

Time frame: Day 1 to Day 56

Number of puffs of SABA medication

The clinical improvement in subjects with asthma will be measured using the number of puffs of SABA medication used in the 7 days prior to Day 28 and Day 56

Time frame: Day 1 to Day 56

Use of any SABA medication

The clinical improvement in subjects with asthma will be measured using the occurrence of use of any SABA medication during the treatment period

Time frame: Day 1 to Day 56