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

Asthma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04927195
• Other study ID #: EDP1867-101
• Status: Completed
• Phase: Phase 1
• Start date: February 23, 2021
• Est. completion date: February 28, 2022

Study information

• Verified date: March 2022
• Source: Evelo Biosciences, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 52
• Est. completion date: February 28, 2022
• Est. primary completion date: February 28, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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 ß2-agonists: 8 weeks. Note: short-acting inhaled ß2-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.

Related Conditions & MeSH terms

• Asthma
• Atopic Dermatitis
• Dermatitis
• Dermatitis, Atopic
• Eczema
• Psoriasis

Intervention

Drug:
• EDP1867
EDP1867 is an orally administered, pharmaceutical preparation of a single strain of bacteria
• Placebo
Placebo oral capsule

Locations

Country	Name	City	State
United Kingdom	MAC Clinical Research	Blackpool	Lancashire
United Kingdom	MAC Clinical Research	Cannock	South Staffordshire
United Kingdom	MAC Clinical Research	Leeds	West Yorkshire
United Kingdom	MAC Clinical Research	Liverpool	Merseyside
United Kingdom	MAC Clinical Research Manchester	Manchester	Greater Manchester
United Kingdom	Medicines Evaluation Unit (MEU)	Manchester	Greater Manchester
United Kingdom	MAC Clinical Research	Stockton-On-Tees	Teeside

Sponsors (1)

Lead Sponsor	Collaborator
Evelo Biosciences, Inc.

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety and tolerability measured through Adverse Events (AEs)	Number of participants with AEs by seriousness and relationship to treatment	Day 1 to Day 70
Primary	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
Primary	Safety and tolerability measured through ECG	Number of participants with clinically relevant changes from baseline (Day 0) ECG parameters	Day 1 to Day 70
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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