Atopic Dermatitis, Psoriasis
Conditions
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.
Interventions
OTHEREDP1066
EDP1066 is an orally administered monoclonal microbial
DRUGPlacebo oral capsule
placebo
Sponsors
Evelo Biosciences, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Intervention 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.
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
Yes
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: 1. 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). 2. Participant has a minimum of 2 psoriatic lesions with at least 1 plaque in a site suitable for biopsy. Mild to moderate atopic dermatitis: 1. Mild to moderate atopic dermatitis with a minimum of 3% to a maximum of 15% BSA involvement. 2. Participant has had a confirmed diagnosis of mild to moderate atopic dermatitis for at least 6 months IGA score of 2 or 3. 3. Participant has a minimum of 2 atopic dermatitis lesions with at least 1 in a site suitable for biopsy.
Exclusion criteria
1. 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. 2. 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. 3. Participant has received any investigational drug or experimental procedure within 90 days or 5 half-lives, whichever is longer, prior to study intervention administration. 4. 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). 5. 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. 6. 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety and tolerability measured through lab measurements | Day 0 to Day 60 | Number of participants with clinically significant change from baseline (Day 0) in laboratory values |
| Safety and tolerability measured through physical examination | 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 |
| GI safety measurement through biomarker analysis | Day 1 to Day 60 | GI safety measurement through fecal calprotectin analysis |
| Safety and tolerability measured through Adverse Events (AEs) | Day 1 to Day 60 | Number of participants with AEs by seriousness and relationship to treatment |
| Safety and tolerability measured through ECG | Day 0 to Day 60 | Number of participants with clinically relevant changes from baseline (Day 0) ECG parameters |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Clinical improvement in subjects with mild to moderate atopic dermatitis | Day 0 to Day 60 | 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). |
| Clinical improvement in subjects with mild to moderate psoriasis | 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). |
Countries
United Kingdom
Outcome results
None listed