Clinical trial NCT03542994: A Study of EDP1066 in Healthy Participants and Participants With Mild to Moderate Psoriasis and Atopic Dermatitis
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Psoriasis
Atopic Dermatitis
Lead sponsor: Evelo Biosciences, Inc.
Sponsor class: INDUSTRY
First posted: 2018-06-01
Enrollment: 114
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
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.
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Safety and tolerability measured through Adverse Events (AEs)
timeFrame: Day 1 to Day 60
measure: Safety and tolerability measured through lab measurements
timeFrame: Day 0 to Day 60
measure: Safety and tolerability measured through ECG
timeFrame: Day 0 to Day 60
measure: Safety and tolerability measured through physical examination
timeFrame: Day 1 to Day 60
measure: GI safety measurement through biomarker analysis
timeFrame: Day 1 to Day 60
Secondary outcomes:
measure: Clinical improvement in subjects with mild to moderate psoriasis
timeFrame: Day 0 to Day 60
measure: Clinical improvement in subjects with mild to moderate atopic dermatitis
timeFrame: Day 0 to Day 60
Other outcomes:
Locations:
city: Guildford
country: United Kingdom
facility: University of Surrey Clinical Research Center
state: Surrey
city: Barnsley
country: United Kingdom
facility: MAC Clinical Research
city: Cannock
country: United Kingdom
facility: MAC Clinical Research
city: Liverpool
country: United Kingdom
facility: Royal Liverpool Clinical Research Unit
city: Manchester
country: United Kingdom
facility: MAC Clinical Research
city: Manchester
country: United Kingdom
facility: Medicines Evaluation Unit Ltd., The Langley Building, Wythenshawe Hospital
city: Stockton-on-Tees
country: United Kingdom
facility: MAC Clinical Research
Study officials:
affiliation: Evelo Biosciences
name: Duncan McHale, MD, PhD
role: STUDY_DIRECTOR
affiliation: University of Surrey
name: Daryl Bendel, MBChB, MBA
role: PRINCIPAL_INVESTIGATOR
affiliation: Medicines Evaluation Unit Ltd
name: Giuseppe Fiore, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: MAC Clinical Research
name: Aliya Asher, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Royal Liverpool Hospital
name: Richard Fitzgerald, MD
role: PRINCIPAL_INVESTIGATOR
References: