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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
114
EDP1066 is an orally administered monoclonal microbial
placebo
University of Surrey Clinical Research Center
Guildford, Surrey, United Kingdom
MAC Clinical Research
Barnsley, United Kingdom
MAC Clinical Research
Cannock, United Kingdom
Royal Liverpool Clinical Research Unit
Liverpool, United Kingdom
Safety and tolerability measured through Adverse Events (AEs)
Number of participants with AEs by seriousness and relationship to treatment
Time frame: Day 1 to Day 60
Safety and tolerability measured through lab measurements
Number of participants with clinically significant change from baseline (Day 0) in laboratory values
Time frame: Day 0 to Day 60
Safety and tolerability measured through ECG
Number of participants with clinically relevant changes from baseline (Day 0) ECG parameters
Time frame: Day 0 to Day 60
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
Time frame: Day 1 to Day 60
GI safety measurement through biomarker analysis
GI safety measurement through fecal calprotectin analysis
Time frame: Day 1 to Day 60
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).
Time frame: Day 0 to Day 60
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MAC Clinical Research
Manchester, United Kingdom
Medicines Evaluation Unit Ltd., The Langley Building, Wythenshawe Hospital
Manchester, United Kingdom
MAC Clinical Research
Stockton-on-Tees, United Kingdom
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).
Time frame: Day 0 to Day 60