A Study of EDP1815 in Healthy Participants and Participants With Mild to Moderate Psoriasis and Atopic Dermatitis
NCT ID: NCT03733353
Last Updated: 2022-01-10
Study Results
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Basic Information
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COMPLETED
PHASE1
204 participants
INTERVENTIONAL
2018-11-19
2021-10-29
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
SEQUENTIAL
TREATMENT
DOUBLE
Study Groups
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Cohort 1
12 healthy volunteers; 8 on EDP1815, 4 on placebo. Dose=1/10th of HED, capsule, once daily, 15 days
EDP1815
EDP1815 is an orally administered monoclonal microbial
Placebo oral capsule
Placebo
Cohort 2
12 healthy volunteers; 8 on EDP1815, 4 on placebo. Dose= 1 x HED, capsule, once daily, 15 days
EDP1815
EDP1815 is an orally administered monoclonal microbial
Placebo oral capsule
Placebo
Cohort 3
12 subjects with mild to moderate psoriasis; 8 on EDP1815, 4 on placebo. Dose= 1 x HED, capsule, once daily, 29 days
EDP1815
EDP1815 is an orally administered monoclonal microbial
Placebo oral capsule
Placebo
Cohort 4
24 subjects with mild to moderate psoriasis; 16 on EDP1815, 8 on placebo. Dose= 5 x HED capsule, once daily, 29 days
EDP1815
EDP1815 is an orally administered monoclonal microbial
Placebo oral capsule
Placebo
Cohort 5
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
EDP1815
EDP1815 is an orally administered monoclonal microbial
Placebo oral capsule
Placebo
Cohort 6
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.
EDP1815
EDP1815 is an orally administered monoclonal microbial
Placebo oral capsule
Placebo
Cohort 7
24 subjects with mild to moderate atopic dermatitis; 16 on EDP1815, 8 on placebo. Dose= 5 x HED, capsule, once daily, 56 days
EDP1815
EDP1815 is an orally administered monoclonal microbial
Placebo oral capsule
Placebo
Cohort 8
24 subjects with mild to moderate psoriasis; 16 on EDP1815, 8 on placebo. Dose= 8 x HED, tablet, once daily, 56 days
EDP1815
EDP1815 is an orally administered monoclonal microbial
Placebo oral tablet
Placebo
Cohort 9
24 subjects with mild to moderate psoriasis; 16 on EDP1815, 8 on placebo. Dose= 2 x HED, capsule, once daily, 56 days
EDP1815
EDP1815 is an orally administered monoclonal microbial
Placebo oral capsule
Placebo
Cohort 10
24 subjects with mild to moderate atopic dermatitis; 16 on EDP1815, 8 on placebo. Dose= 4 x HED, capsule, once daily, 56 days
EDP1815
EDP1815 is an orally administered monoclonal microbial
Placebo oral capsule
Placebo
Interventions
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EDP1815
EDP1815 is an orally administered monoclonal microbial
Placebo oral capsule
Placebo
Placebo oral tablet
Placebo
Eligibility Criteria
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Inclusion Criteria
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:
1. 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).
2. Participant has a minimum of 2 psoriatic lesions with at least 1 plaque in a site suitable for biopsy.
Mild to moderate atopic dermatitis:
1. Mild to moderate atopic dermatitis with a minimum of 3% to a maximum of 15% BSA involvement.
2. Participant has had a confirmed diagnosis of mild to moderate atopic dermatitis for at least 6 months (IGA score of 2 or 3).
3. Participant has a minimum of 2 atopic dermatitis lesions with at least 1 in a site suitable for biopsy.
Exclusion Criteria
2. 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.
3. Participant has received any investigational drug or experimental procedure within 90 days or 5 half-lives, whichever is longer, prior to study intervention administration.
4. 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).
5. 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.
6. Participant has renal or liver impairment, defined as:
1. 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
2. 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
18 Years
65 Years
ALL
Yes
Sponsors
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Evelo Biosciences, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Duncan McHale, MD, PhD
Role: STUDY_DIRECTOR
Evelo Biosciences, Inc.
Locations
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UK-8
Barnsley, , United Kingdom
UK-7
Blackpool, , United Kingdom
UK-3
Cannock, , United Kingdom
UK-4
Leeds, , United Kingdom
UK-5
Liverpool, , United Kingdom
UK-1
London, , United Kingdom
UK-2
Manchester, , United Kingdom
UK-6
Manchester, , United Kingdom
UK-9
Stockton-on-Tees, , United Kingdom
Countries
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References
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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.
Other Identifiers
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2018-002807-32
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
EDP1815-101
Identifier Type: -
Identifier Source: org_study_id
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