- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03542994
A Study of EDP1066 in Healthy Participants and Participants With Mild to Moderate Psoriasis and Atopic Dermatitis
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 Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Phase 1
Contacts and Locations
Study Locations
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-
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Barnsley, United Kingdom, S75 3DL
- MAC Clinical Research
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Cannock, United Kingdom, WS11 0BN
- MAC Clinical Research
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Liverpool, United Kingdom, L78XP
- Royal Liverpool Clinical Research Unit
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Manchester, United Kingdom, M13 9NQ
- MAC Clinical Research
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Manchester, United Kingdom, M23 9QZ
- Medicines Evaluation Unit Ltd., The Langley Building, Wythenshawe Hospital
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Stockton-on-Tees, United Kingdom, TS17 6EW
- MAC Clinical Research
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Surrey
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Guildford, Surrey, United Kingdom, GU2 7XP
- University of Surrey Clinical Research Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: SEQUENTIAL
- Masking: DOUBLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
OTHER: Cohort 1
12 healthy volunteers; 8 on EDP1066, 4 on placebo.
Dose=up to a maximum of 66 mg, capsule, once daily, 15 days
|
placebo
EDP1066 is an orally administered monoclonal microbial
|
OTHER: Cohort 2
12 healthy volunteers; 8 on EDP1066, 4 on placebo.
Dose=up to a maximum of 660 mg, capsule, once daily, 15 days
|
placebo
EDP1066 is an orally administered monoclonal microbial
|
OTHER: Cohort 3
12 healthy volunteers; 8 on EDP1066, 4 on placebo.
Dose=up to a maximum of 3.3 g, capsule, once daily, 15 days
|
placebo
EDP1066 is an orally administered monoclonal microbial
|
OTHER: Cohort 4
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
|
placebo
EDP1066 is an orally administered monoclonal microbial
|
OTHER: Cohort 5
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
|
placebo
EDP1066 is an orally administered monoclonal microbial
|
OTHER: Cohort 6
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 |
placebo
EDP1066 is an orally administered monoclonal microbial
|
OTHER: Cohort 7
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 |
placebo
EDP1066 is an orally administered monoclonal microbial
|
OTHER: Cohort 8
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
|
placebo
EDP1066 is an orally administered monoclonal microbial
|
OTHER: Cohort 9
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 |
placebo
EDP1066 is an orally administered monoclonal microbial
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Safety and tolerability measured through Adverse Events (AEs)
Time Frame: Day 1 to Day 60
|
Number of participants with AEs by seriousness and relationship to treatment
|
Day 1 to Day 60
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Safety and tolerability measured through lab measurements
Time Frame: Day 0 to Day 60
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Number of participants with clinically significant change from baseline (Day 0) in laboratory values
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Day 0 to Day 60
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Safety and tolerability measured through ECG
Time Frame: Day 0 to Day 60
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Number of participants with clinically relevant changes from baseline (Day 0) ECG parameters
|
Day 0 to Day 60
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Safety and tolerability measured through physical examination
Time Frame: Day 1 to Day 60
|
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 |
Day 1 to Day 60
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GI safety measurement through biomarker analysis
Time Frame: Day 1 to Day 60
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GI safety measurement through fecal calprotectin analysis
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Day 1 to Day 60
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Clinical improvement in subjects with mild to moderate psoriasis
Time Frame: Day 0 to Day 60
|
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).
|
Day 0 to Day 60
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Clinical improvement in subjects with mild to moderate atopic dermatitis
Time Frame: Day 0 to Day 60
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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).
|
Day 0 to Day 60
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: Duncan McHale, MD, PhD, Evelo Biosciences
- Principal Investigator: Daryl Bendel, MBChB, MBA, University of Surrey
- Principal Investigator: Giuseppe Fiore, MD, Medicines Evaluation Unit Ltd
- Principal Investigator: Aliya Asher, MD, MAC Clinical Research
- Principal Investigator: Richard Fitzgerald, MD, Royal Liverpool Hospital
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- EDP1066-001
- 2017-004337-90 (EUDRACT_NUMBER)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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