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

A Ph1a/1b, First in Human, Participant and Investigator-blind Sponsor-unblinded Randomized Placebo-controlled Multiple Dose Study of EDP1867 in Healthy Volunteers & Participants With Moderate Atopic Dermatitis & Optionally, Moderate Psoriasis, and/or Mild Asthma

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.

Study Overview

• Status: Completed
• Conditions: Psoriasis; Asthma; Atopic Dermatitis
• Intervention / Treatment: Drug: Placebo; Drug: EDP1867

Detailed Description

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
• Enrollment (Actual): 52
• Phase: Phase 1

Contacts and Locations

Study Locations

• United Kingdom
  • Greater Manchester
    • Manchester, Greater Manchester, United Kingdom, M13 9NQ
      • MAC Clinical Research Manchester
    • Manchester, Greater Manchester, United Kingdom, M23 9QZ
      • Medicines Evaluation Unit (MEU)
  • Lancashire
    • Blackpool, Lancashire, United Kingdom, FY2 0JH
      • MAC Clinical Research
  • Merseyside
    • Liverpool, Merseyside, United Kingdom, L34 1BH
      • MAC Clinical Research
  • South Staffordshire
    • Cannock, South Staffordshire, United Kingdom, WS11 0BN
      • MAC Clinical Research
  • Teeside
    • Stockton-On-Tees, Teeside, United Kingdom, TS17 6EW
      • MAC Clinical Research
  • West Yorkshire
    • Leeds, West Yorkshire, United Kingdom, LS10 1DU
      • MAC Clinical Research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

5

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Cohort 1; 12 healthy volunteers; 8 on EDP1867, 4 on placebo. Dose = upto 7.5 x 10^11 cells, capsules, once daily, 14 days total	Drug: Placebo; Placebo oral capsule; Drug: EDP1867; EDP1867 is an orally administered, pharmaceutical preparation of a single strain of bacteria
Experimental: Cohort 2; 12 healthy volunteers; 8 on EDP1867, 4 on placebo. Dose = upto 1.5 x 10^12 cells, capsules, once daily, 14 days total	Drug: Placebo; Placebo oral capsule; Drug: EDP1867; EDP1867 is an orally administered, pharmaceutical preparation of a single strain of bacteria
Experimental: Cohort 3; 24 subjects with moderate atopic dermatitis; 16 on EDP1867, 8 on placebo. Dose = 7.5 x 10^11 cells, capsules, once daily, 56 days	Drug: Placebo; Placebo oral capsule; Drug: EDP1867; EDP1867 is an orally administered, pharmaceutical preparation of a single strain of bacteria
Experimental: Cohort 4; 24 subjects with moderate psoriasis; 16 on EDP1867, 8 on placebo. Dose = 7.5 x 10^11 cells, capsules, once daily, 56 days	Drug: Placebo; Placebo oral capsule; Drug: EDP1867; EDP1867 is an orally administered, pharmaceutical preparation of a single strain of bacteria
Experimental: Cohort 5; 24 subjects with mild asthma; 16 on EDP1867, 8 on placebo. Dose = 7.5 x 10^11 cells, capsules, once daily, 56 days	Drug: Placebo; Placebo oral capsule; Drug: EDP1867; EDP1867 is an orally administered, pharmaceutical preparation of a single strain of bacteria

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 1 to Day 70
Safety and tolerability measured through ECG	Number of participants with clinically relevant changes from baseline (Day 0) ECG parameters	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	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)	Day 1 to Day 70

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Day 1 to Day 70
Percentage change in EASI score	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	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	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	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)	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)	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]	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]	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	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	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	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	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	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	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	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)	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)	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)	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)	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)	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)	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)	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	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	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	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	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)	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	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)	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)	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)	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)	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	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	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)	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)	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	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	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	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	Day 1 to Day 56

Collaborators and Investigators

• Sponsor: Evelo Biosciences, Inc.
• Investigators: Principal Investigator: Pui Man Leung, MBChB MRCP FFPM DPM, MAC Clinical Research

Study record dates

Study Major Dates

• Study Start (Actual): February 23, 2021
• Primary Completion (Actual): February 28, 2022
• Study Completion (Actual): February 28, 2022

Study Registration Dates

• First Submitted: April 15, 2021
• First Submitted That Met QC Criteria: June 8, 2021
• First Posted (Actual): June 15, 2021

Study Record Updates

• Last Update Posted (Actual): October 7, 2022
• Last Update Submitted That Met QC Criteria: October 6, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Respiratory Tract Diseases; Immune System Diseases; Lung Diseases; Hypersensitivity, Immediate; Bronchial Diseases; Genetic Diseases, Inborn; Skin Diseases, Genetic; Skin Diseases, Papulosquamous; Lung Diseases, Obstructive; Respiratory Hypersensitivity; Hypersensitivity; Skin Diseases, Eczematous; Psoriasis; Asthma; Dermatitis; Eczema; Dermatitis, Atopic
• Other Study ID Numbers: EDP1867-101

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No