Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
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.

Tracking Information
First Submitted Date  ICMJE April 24, 2018
First Posted Date  ICMJE June 1, 2018
Last Update Posted Date July 6, 2018
Actual Study Start Date  ICMJE April 24, 2018
Estimated Primary Completion Date June 30, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 30, 2018)
  • 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
  • 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
  • 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
  • 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
  • GI safety measurement through biomarker analysis [ Time Frame: Day 1 to Day 60 ]
    GI safety measurement through fecal calprotectin analysis
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03542994 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: May 30, 2018)
  • 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).
  • 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).
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study of EDP1066 in Healthy Participants and Participants With Mild to Moderate Psoriasis and Atopic Dermatitis
Official Title  ICMJE 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
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE 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
Condition  ICMJE
  • Psoriasis
  • Atopic Dermatitis
Intervention  ICMJE
  • Other: EDP1066
    EDP1066 is an orally administered monoclonal microbial
  • Drug: Placebo oral capsule
    placebo
Study Arms  ICMJE
  • Cohort 1
    12 healthy volunteers; 8 on EDP1066, 4 on placebo. Dose=up to a maximum of 66 mg, capsule, once daily, 15 days
    Interventions:
    • Other: EDP1066
    • Drug: Placebo oral capsule
  • Cohort 2
    12 healthy volunteers; 8 on EDP1066, 4 on placebo. Dose=up to a maximum of 660 mg, capsule, once daily, 15 days
    Interventions:
    • Other: EDP1066
    • Drug: Placebo oral capsule
  • 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
    Interventions:
    • Other: EDP1066
    • Drug: Placebo oral capsule
  • 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
    Interventions:
    • Other: EDP1066
    • Drug: Placebo oral capsule
  • 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
    Interventions:
    • Other: EDP1066
    • Drug: Placebo oral capsule
  • 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

    Interventions:
    • Other: EDP1066
    • Drug: Placebo oral capsule
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: May 30, 2018)
96
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 30, 2019
Estimated Primary Completion Date June 30, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 60 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Suzanne Bird +44 (0) 1483 683 797 s.bird@surrey.ac.uk
Listed Location Countries  ICMJE United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03542994
Other Study ID Numbers  ICMJE EDP1066-001
2017-004337-90 ( EudraCT Number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Evelo Biosciences, Inc.
Study Sponsor  ICMJE Evelo Biosciences, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
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
PRS Account Evelo Biosciences, Inc.
Verification Date July 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP