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

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ClinicalTrials.gov Identifier: NCT03542994
Recruitment Status : Recruiting
First Posted : June 1, 2018
Last Update Posted : July 6, 2018
Sponsor:
Information provided by (Responsible Party):
Evelo Biosciences, Inc.

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.

Condition or disease Intervention/treatment Phase
Psoriasis Atopic Dermatitis Other: EDP1066 Drug: Placebo oral capsule Phase 1

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 96 participants
Allocation: Randomized
Intervention Model: Sequential Assignment
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 6 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.
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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
Actual Study Start Date : April 24, 2018
Estimated Primary Completion Date : June 30, 2019
Estimated Study Completion Date : June 30, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eczema Psoriasis

Arm Intervention/treatment
Cohort 1
12 healthy volunteers; 8 on EDP1066, 4 on placebo. Dose=up to a maximum of 66 mg, capsule, once daily, 15 days
Other: EDP1066
EDP1066 is an orally administered monoclonal microbial

Drug: Placebo oral capsule
placebo

Cohort 2
12 healthy volunteers; 8 on EDP1066, 4 on placebo. Dose=up to a maximum of 660 mg, capsule, once daily, 15 days
Other: EDP1066
EDP1066 is an orally administered monoclonal microbial

Drug: Placebo oral capsule
placebo

Cohort 3
12 healthy volunteers; 8 on EDP1066, 4 on placebo. Dose=up to a maximum of 3.3 g, capsule, once daily, 15 days
Other: EDP1066
EDP1066 is an orally administered monoclonal microbial

Drug: Placebo oral capsule
placebo

Cohort 4
12 subjects with mild to moderate psoriasis; 8 on EDP1066, 4 on placebo. Dose=up to a maximum of 660 mg, capsule, once daily, 29 days
Other: EDP1066
EDP1066 is an orally administered monoclonal microbial

Drug: Placebo oral capsule
placebo

Cohort 5
24 subjects with mild to moderate psoriasis; 16 on EDP1066, 8 on placebo. Dose=up to a maximum of 3.3 g, capsule, once daily, 29 days
Other: EDP1066
EDP1066 is an orally administered monoclonal microbial

Drug: Placebo oral capsule
placebo

Cohort 6

24 subjects with mild to moderate atopic dermatitis; 16 on EDP1066, 8 on placebo.

Dose=up to a maximum of 3.3 g, capsule, once daily, 29 days

Other: EDP1066
EDP1066 is an orally administered monoclonal microbial

Drug: Placebo oral capsule
placebo




Primary Outcome Measures :
  1. Safety and tolerability measured through Adverse Events (AEs) [ Time Frame: Day 1 to Day 60 ]
    Number of participants with AEs by seriousness and relationship to treatment

  2. Safety and tolerability measured through lab measurements [ Time Frame: Day 0 to Day 60 ]
    Number of participants with clinically significant change from baseline (Day 0) in laboratory values

  3. Safety and tolerability measured through ECG [ Time Frame: Day 0 to Day 60 ]
    Number of participants with clinically relevant changes from baseline (Day 0) ECG parameters

  4. Safety and tolerability measured through physical examination [ Time Frame: 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


  5. GI safety measurement through biomarker analysis [ Time Frame: Day 1 to Day 60 ]
    GI safety measurement through fecal calprotectin analysis


Secondary Outcome Measures :
  1. Clinical improvement in subjects with mild to moderate psoriasis [ Time Frame: 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).

  2. Clinical improvement in subjects with mild to moderate atopic dermatitis [ Time Frame: 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).



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03542994


Contacts
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Contact: Suzanne Bird +44 (0) 1483 683 797 s.bird@surrey.ac.uk

Locations
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United Kingdom
University of Surrey Clinical Research Center Recruiting
Guildford, Surrey, United Kingdom, GU2 7XP
Contact: Suzanne Bird    +44 (0) 1483 683 797    s.bird@surrey.ac.uk   
Medicines Evaluation Unit Ltd., The Langley Building, Wythenshawe Hospital Not yet recruiting
Manchester, United Kingdom, M23 9QZ
Contact: Simon Pearson    +44(0)161 946 4077    spearson@meu.org.uk   
Sponsors and Collaborators
Evelo Biosciences, Inc.
Investigators
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Study Director: Duncan McHale, MD, PhD Evelo Biosciences
Principal Investigator: Daryl Bendel, MBChB, MBA University of Surrey
Principal Investigator: Giuseppe Fiore, MD Medicines Evaluation Unit Ltd

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Responsible Party: Evelo Biosciences, Inc.
ClinicalTrials.gov Identifier: NCT03542994     History of Changes
Other Study ID Numbers: EDP1066-001
2017-004337-90 ( EudraCT Number )
First Posted: June 1, 2018    Key Record Dates
Last Update Posted: July 6, 2018
Last Verified: July 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Psoriasis
Dermatitis
Dermatitis, Atopic
Eczema
Skin Diseases, Papulosquamous
Skin Diseases
Skin Diseases, Genetic
Genetic Diseases, Inborn
Skin Diseases, Eczematous
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases