A Study of EDP1066 in Healthy Participants and Participants With Mild to Moderate Psoriasis and Atopic Dermatitis

Psoriasis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03542994
• Other study ID #: EDP1066-001
• Secondary ID: 2017-004337-90
• Status: Completed
• Phase: Phase 1
• Start date: April 24, 2019
• Est. completion date: January 3, 2020

Study information

• Verified date: November 2021
• Source: Evelo Biosciences, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 114
• Est. completion date: January 3, 2020
• Est. primary completion date: January 3, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Atopic Dermatitis
• Dermatitis
• Dermatitis, Atopic
• Eczema
• Psoriasis

Intervention

Other:
• EDP1066
EDP1066 is an orally administered monoclonal microbial

Drug:
• Placebo oral capsule
placebo

Locations

Country	Name	City	State
United Kingdom	MAC Clinical Research	Barnsley
United Kingdom	MAC Clinical Research	Cannock
United Kingdom	University of Surrey Clinical Research Center	Guildford	Surrey
United Kingdom	Royal Liverpool Clinical Research Unit	Liverpool
United Kingdom	MAC Clinical Research	Manchester
United Kingdom	Medicines Evaluation Unit Ltd., The Langley Building, Wythenshawe Hospital	Manchester
United Kingdom	MAC Clinical Research	Stockton-on-Tees

Sponsors (1)

Lead Sponsor	Collaborator
Evelo Biosciences, Inc.

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety and tolerability measured through Adverse Events (AEs)	Number of participants with AEs by seriousness and relationship to treatment	Day 1 to Day 60
Primary	Safety and tolerability measured through lab measurements	Number of participants with clinically significant change from baseline (Day 0) in laboratory values	Day 0 to Day 60
Primary	Safety and tolerability measured through ECG	Number of participants with clinically relevant changes from baseline (Day 0) ECG parameters	Day 0 to Day 60
Primary	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	Day 1 to Day 60
Primary	GI safety measurement through biomarker analysis	GI safety measurement through fecal calprotectin analysis	Day 1 to Day 60
Secondary	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).	Day 0 to Day 60
Secondary	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).	Day 0 to Day 60