Back to resultsA Study of EDP1066 in Healthy Participants and Participants With Mild to Moderate Psoriasis and Atopic Dermatitis
Primary Purpose
Psoriasis, Atopic Dermatitis
Status
Completed
Phase
Phase 1
Locations
United Kingdom
Study Type
Interventional
Intervention
EDP1066
Placebo oral capsule
Sponsored by
About this trial
This is an interventional treatment trial for Psoriasis
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
- 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
Sites / Locations
- University of Surrey Clinical Research Center
- MAC Clinical Research
- MAC Clinical Research
- Royal Liverpool Clinical Research Unit
- MAC Clinical Research
- Medicines Evaluation Unit Ltd., The Langley Building, Wythenshawe Hospital
- MAC Clinical Research
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm 6
Arm 7
Arm 8
Arm 9
Arm Type
Other
Other
Other
Other
Other
Other
Other
Other
Other
Arm Label
Cohort 1
Cohort 2
Cohort 3
Cohort 4
Cohort 5
Cohort 6
Cohort 7
Cohort 8
Cohort 9
Arm Description
12 healthy volunteers; 8 on EDP1066, 4 on placebo. Dose=up to a maximum of 66 mg, capsule, once daily, 15 days
12 healthy volunteers; 8 on EDP1066, 4 on placebo. Dose=up to a maximum of 660 mg, capsule, once daily, 15 days
12 healthy volunteers; 8 on EDP1066, 4 on placebo. Dose=up to a maximum of 3.3 g, capsule, once daily, 15 days
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
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
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
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
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
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
Outcomes
Primary Outcome Measures
Safety and tolerability measured through Adverse Events (AEs)
Number of participants with AEs by seriousness and relationship to treatment
Safety and tolerability measured through lab measurements
Number of participants with clinically significant change from baseline (Day 0) in laboratory values
Safety and tolerability measured through ECG
Number of participants with clinically relevant changes from baseline (Day 0) ECG parameters
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
GI safety measurement through biomarker analysis
GI safety measurement through fecal calprotectin analysis
Secondary Outcome Measures
Clinical improvement in subjects with mild to moderate psoriasis
Change from baseline (Day 0) Psoriasis-area-and-severity index score (PASI) in response to EDP1066, measured on a scale of 0 to 6 (where 0 is most favorable and 6 is least favorable).
Clinical improvement in subjects with mild to moderate atopic dermatitis
Change from baseline (Day 0) Eczema-area-and-severity index score (EASI) in response to EDP1066, measured on a scale of 0 to 6 (where 0 is most favorable and 6 is least favorable).
Full Information
NCT ID
NCT03542994
First Posted
April 24, 2018
Last Updated
November 8, 2021
Sponsor
Evelo Biosciences, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT03542994
Brief Title
A Study of EDP1066 in Healthy Participants and Participants With Mild to Moderate Psoriasis and Atopic Dermatitis
Official Title
A Phase 1a/1b Randomized Double-blind Placebo-controlled Single and Multiple Ascending Dose Study of EDP1066 in Healthy Participants and Participants With Mild to Moderate Psoriasis and Atopic Dermatitis
Study Type
Interventional
2. Study Status
Record Verification Date
November 2021
Overall Recruitment Status
Completed
Study Start Date
April 24, 2019 (Actual)
Primary Completion Date
January 3, 2020 (Actual)
Study Completion Date
January 3, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Evelo Biosciences, Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
Detailed Description
This will be a randomized, double-blind, placebo-controlled clinical study with dose escalations to assess safety, tolerability, and pharmacodynamic effect of EDP1066. Since this clinical study is the first study in humans, the participants will be healthy volunteers or subjects with mild to moderate psoriasis or atopic dermatitis who are otherwise well. Investigation of EDP1066 in this patient population provides an opportunity to gain pharmacodynamic information using a range of tissue biopsies and composite clinical endpoints.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Psoriasis, Atopic Dermatitis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Sequential Assignment
Model Description
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.
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
114 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Cohort 1
Arm Type
Other
Arm Description
12 healthy volunteers; 8 on EDP1066, 4 on placebo. Dose=up to a maximum of 66 mg, capsule, once daily, 15 days
Arm Title
Cohort 2
Arm Type
Other
Arm Description
12 healthy volunteers; 8 on EDP1066, 4 on placebo. Dose=up to a maximum of 660 mg, capsule, once daily, 15 days
Arm Title
Cohort 3
Arm Type
Other
Arm Description
12 healthy volunteers; 8 on EDP1066, 4 on placebo. Dose=up to a maximum of 3.3 g, capsule, once daily, 15 days
Arm Title
Cohort 4
Arm Type
Other
Arm Description
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
Arm Title
Cohort 5
Arm Type
Other
Arm Description
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
Arm Title
Cohort 6
Arm Type
Other
Arm Description
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
Arm Title
Cohort 7
Arm Type
Other
Arm Description
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
Arm Title
Cohort 8
Arm Type
Other
Arm Description
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
Arm Title
Cohort 9
Arm Type
Other
Arm Description
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
Intervention Type
Other
Intervention Name(s)
EDP1066
Intervention Description
EDP1066 is an orally administered monoclonal microbial
Intervention Type
Drug
Intervention Name(s)
Placebo oral capsule
Intervention Description
placebo
Primary Outcome Measure Information:
Title
Safety and tolerability measured through Adverse Events (AEs)
Description
Number of participants with AEs by seriousness and relationship to treatment
Time Frame
Day 1 to Day 60
Title
Safety and tolerability measured through lab measurements
Description
Number of participants with clinically significant change from baseline (Day 0) in laboratory values
Time Frame
Day 0 to Day 60
Title
Safety and tolerability measured through ECG
Description
Number of participants with clinically relevant changes from baseline (Day 0) ECG parameters
Time Frame
Day 0 to Day 60
Title
Safety and tolerability measured through physical examination
Description
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
Time Frame
Day 1 to Day 60
Title
GI safety measurement through biomarker analysis
Description
GI safety measurement through fecal calprotectin analysis
Time Frame
Day 1 to Day 60
Secondary Outcome Measure Information:
Title
Clinical improvement in subjects with mild to moderate psoriasis
Description
Change from baseline (Day 0) Psoriasis-area-and-severity index score (PASI) in response to EDP1066, measured on a scale of 0 to 6 (where 0 is most favorable and 6 is least favorable).
Time Frame
Day 0 to Day 60
Title
Clinical improvement in subjects with mild to moderate atopic dermatitis
Description
Change from baseline (Day 0) Eczema-area-and-severity index score (EASI) in response to EDP1066, measured on a scale of 0 to 6 (where 0 is most favorable and 6 is least favorable).
Time Frame
Day 0 to Day 60
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Duncan McHale, MD, PhD
Organizational Affiliation
Evelo Biosciences
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Daryl Bendel, MBChB, MBA
Organizational Affiliation
University of Surrey
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Giuseppe Fiore, MD
Organizational Affiliation
Medicines Evaluation Unit Ltd
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Aliya Asher, MD
Organizational Affiliation
MAC Clinical Research
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Richard Fitzgerald, MD
Organizational Affiliation
Royal Liverpool Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Surrey Clinical Research Center
City
Guildford
State/Province
Surrey
ZIP/Postal Code
GU2 7XP
Country
United Kingdom
Facility Name
MAC Clinical Research
City
Barnsley
ZIP/Postal Code
S75 3DL
Country
United Kingdom
Facility Name
MAC Clinical Research
City
Cannock
ZIP/Postal Code
WS11 0BN
Country
United Kingdom
Facility Name
Royal Liverpool Clinical Research Unit
City
Liverpool
ZIP/Postal Code
L78XP
Country
United Kingdom
Facility Name
MAC Clinical Research
City
Manchester
ZIP/Postal Code
M13 9NQ
Country
United Kingdom
Facility Name
Medicines Evaluation Unit Ltd., The Langley Building, Wythenshawe Hospital
City
Manchester
ZIP/Postal Code
M23 9QZ
Country
United Kingdom
Facility Name
MAC Clinical Research
City
Stockton-on-Tees
ZIP/Postal Code
TS17 6EW
Country
United Kingdom
12. IPD Sharing Statement
Learn more about this trial
A Study of EDP1066 in Healthy Participants and Participants With Mild to Moderate Psoriasis and Atopic Dermatitis
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