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Also known as EDP1815 tablet, Prevotella histicola
EDP1815 · 4 trials · 4 indications
The efficacy of EDP1815 will be measured by achieving a decrease of at least 50% from baseline in Eczema Area Severity Index (EASI) score of 50 (EASI-50) at Week 16. The EASI is a validated measure of eczema severity, which considers a combination of the disease severity and body surface area affected across 4 body regions. The EASI score ranges from 0 - 72. A lower score indicates a better outcome.
The Psoriasis Area and Severity Index Score (PASI) is a physician assessment that combines the assessment of the severity of and area affected by psoriasis into a single score in the range 0 (no disease) to 72 (maximal disease).The efficacy of EDP1815 will be measured using the mean percentage change in PASI from baseline to week 16.
This will be measured as basal flow (arbitrary units, AU) by LSCI.
Number of participants with AEs by seriousness and relationship to treatment
Number of participants with clinically significant change from baseline (Day 0) in laboratory values
Number of participants with clinically relevant changes from baseline (Day 0) ECG parameters
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 fecal calprotectin analysis
| Arm | Type | Description |
|---|---|---|
| Cohort 1 | EXPERIMENTAL | 100 participants with mild, moderate or severe Atopic Dermatitis 75 participants on EDP1815 and 25 participants on matching placebo administered as 2 capsules (1.6 x 10\^11 total cells) once daily for 16 weeks |
| Cohort 2 | EXPERIMENTAL | 100 participants with mild, moderate or severe Atopic Dermatitis 75 participants on EDP1815 and 25 participants on matching placebo administered as 2 capsules (6.4 x 10\^11 total cells) once daily for 16 weeks |
| Cohort 3 | EXPERIMENTAL | 100 participants with mild, moderate or severe Atopic Dermatitis 75 participants on EDP1815 and 25 participants on matching placebo administered as 1 capsule (3.2 x 10\^11 cells) twice daily (6.4 x 10\^11 total cells) for 16 weeks |
| Cohort 4 | EXPERIMENTAL | 105 participants with mild, moderate or severe Atopic Dermatitis 70 participants on EDP1815 and 35 participants on matching placebo administered at 1 capsule (8.0x10\^10 total cells) once daily for 16 weeks |
| Cohort 5 | OTHER | 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 |
| Cohort 6 | OTHER | 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. |
| Cohort 7 | OTHER | 24 subjects with mild to moderate atopic dermatitis; 16 on EDP1815, 8 on placebo. Dose= 5 x HED, capsule, once daily, 56 days |
| Cohort 8 | OTHER | 24 subjects with mild to moderate psoriasis; 16 on EDP1815, 8 on placebo. Dose= 8 x HED, tablet, once daily, 56 days |
| Cohort 9 | OTHER | 24 subjects with mild to moderate psoriasis; 16 on EDP1815, 8 on placebo. Dose= 2 x HED, capsule, once daily, 56 days |
| Cohort 10 | OTHER | 24 subjects with mild to moderate atopic dermatitis; 16 on EDP1815, 8 on placebo. Dose= 4 x HED, capsule, once daily, 56 days |
| Name | Type | Description |
|---|---|---|
| EDP1815 | DRUG | EDP1815 is an orally administered, pharmaceutical preparation of a single strain of bacteria |
| Placebo | DRUG | Placebo oral capsule |
| EDP2939 | DRUG | EDP2939 is a pharmaceutical preparation of extracellular vesicles. |
| Placebo oral capsule | DRUG | Placebo. |
| Placebo oral tablet | DRUG | Placebo |
Inclusion Criteria: * Provide written informed consent. * Must meet age criteria. * Must have a diagnosis of atopic dermatitis (AD)for at least 6 months. * Must have severity of atopic dermatitis meeting the below criteria at both Screening and Day 1: * An IGA of 2, 3 or 4 on the vIGA scale, and...
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