A Phase 1 interventional study of EDP1815 and Placebo oral capsule in Psoriasis and Atopic Dermatitis, sponsored by Evelo Biosciences, Inc.. Completed at 9 sites in United Kingdom. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-01-10.
Sponsored by Evelo Biosciences, Inc. · Phase 1, Interventional, and Treatment
Evelo will investigate the safety and tolerability of EDP1815 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 EDP1815. 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 EDP1815 in this patient population provides an opportunity to gain pharmacodynamic information using a range of tissue biopsies and composite clinical endpoints.
1,419 studies on the registry are indexed under Dermatitis, Atopic; 258 are open to participants now.
This study's enrollment of 204 is above the median of 83 across 1,125 interventional studies indexed under Dermatitis, Atopic.
Browse Dermatitis, Atopic studies →Evelo Biosciences, Inc. is the lead sponsor of 10 studies on the registry; none are open to participants now.
Of its 5 completed or terminated interventional studies of FDA-regulated products, 4 (80%) have results posted.
Counted across the registry records on this site, refreshed daily.
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:
Mild to moderate atopic dermatitis:
Exclusion Criteria:
Participant has renal or liver impairment, defined as:
12 healthy volunteers; 8 on EDP1815, 4 on placebo. Dose=1/10th of HED, capsule, once daily, 15 days
Drug: EDP1815 · Drug: Placebo oral capsule
12 healthy volunteers; 8 on EDP1815, 4 on placebo. Dose= 1 x HED, capsule, once daily, 15 days
Drug: EDP1815 · Drug: Placebo oral capsule
12 subjects with mild to moderate psoriasis; 8 on EDP1815, 4 on placebo. Dose= 1 x HED, capsule, once daily, 29 days
Drug: EDP1815 · Drug: Placebo oral capsule
24 subjects with mild to moderate psoriasis; 16 on EDP1815, 8 on placebo. Dose= 5 x HED capsule, once daily, 29 days
Drug: EDP1815 · Drug: Placebo oral capsule
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
Drug: EDP1815 · Drug: Placebo oral capsule
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.
Drug: EDP1815 · Drug: Placebo oral capsule
24 subjects with mild to moderate atopic dermatitis; 16 on EDP1815, 8 on placebo. Dose= 5 x HED, capsule, once daily, 56 days
Drug: EDP1815 · Drug: Placebo oral capsule
24 subjects with mild to moderate psoriasis; 16 on EDP1815, 8 on placebo. Dose= 8 x HED, tablet, once daily, 56 days
Drug: EDP1815 · Drug: Placebo oral tablet
24 subjects with mild to moderate psoriasis; 16 on EDP1815, 8 on placebo. Dose= 2 x HED, capsule, once daily, 56 days
Drug: EDP1815 · Drug: Placebo oral capsule
24 subjects with mild to moderate atopic dermatitis; 16 on EDP1815, 8 on placebo. Dose= 4 x HED, capsule, once daily, 56 days
Drug: EDP1815 · Drug: Placebo oral capsule
EDP1815 is an orally administered monoclonal microbial
Placebo
Placebo
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 70
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 70
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 70
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 0 to Day 60
GI safety measurement through biomarker analysis
GI safety measurement through fecal calprotectin analysis
Time frame: Day 0 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 EDP1815, measured on a scale of 0 to 6 (where 0 is most favorable and 6 is least favorable).
Time frame: Day 0 to Day 70
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 EDP1815, measured on a scale of 0 to 6 (where 0 is most favorable and 6 is least favorable).
Time frame: Day 0 to Day 70
Plan to share: No
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This study is completed, as verified in Jan 2022. You cannot join it, but the record below documents what was studied.
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Evelo Biosciences, Inc.