A Study Investigating the Effect of EDP1815 in the Treatment of Mild, Moderate and Severe Atopic Dermatitis
Condition: Atopic Dermatitis
MeSH terms: Dermatitis, Atopic; Dermatitis; Eczema
Intervention: EDP1815; Placebo
Intervention description: EDP1815 is an orally administered, pharmaceutical preparation of a single strain of bacteria; Placebo oral capsule
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Cohorts 1, 2 & 3 will be run concurrently, and Cohort 4 recruitment will commence after enrollment for Cohorts 1, 2, & 3 are completed. Randomization to Cohort 4 will not start before randomization to Cohorts 1, 2 & 3 have completed.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 421.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: Mild Atopic Dermatitis; Moderate Atopic Dermatitis; Severe Atopic Dermatitis; Mild Eczema; Moderate Eczema; Severe Eczema

Summary:

      The purpose of this research study is to determine whether the study drug, EDP1815, is safe
      and effective in the treatment of atopic dermatitis compared with placebo. The study will
      look at different doses of the study drug, and whether there are differences when the drug is
      given once daily or twice daily.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Provide written informed consent.

          -  Must meet age criteria.

          -  Must have a diagnosis of atopic dermatitis (AD)for at least 6 months.

          -  Must have severity of atopic dermatitis meeting the below criteria at both Screening
             and Day 1:

               -  An IGA of 2, 3 or 4 on the vIGA scale, and;

               -  A BSA of ≥5%, and;

               -  An EASI score of ≥6.

          -  Must agree to use emollients.

          -  Must meet contraception requirements.

        Exclusion Criteria:

          -  Have been in a clinical trial for EDP1815 prior to signing of ICF.

          -  Use of phototherapy or tanning beds; systemic medications/treatments that could affect
             AD or its symptoms including immunosuppressive therapy (e.g., oral or injectable
             corticosteroids, methotrexate, azathioprine, cyclosporine, mycophenolate mofetil, JAK
             inhibitors, tacrolimus, and/or leukotriene inhibitor) within 4 weeks of randomization.

          -  Treatment with topical agents that could affect atopic dermatitis, including topical
             corticosteroids, topical calcineurin inhibitors (e.g., tacrolimus or pimecrolimus), or
             topical PDE-4 inhibitor (e.g., crisaborole) within 14 days prior to randomization.

          -  Clinically significant abnormalities in screening laboratory values that in the
             opinion of the Investigator would make a participant unsuitable for inclusion in the
             study. One retest is permitted within the 28-day screening window.

          -  Hypersensitivity to P histicola or to any of the excipients.

          -  Unwillingness to comply with study procedures, including follow-up, as specified by
             this protocol, or unwillingness to cooperate fully with the Investigator.

          -  Have any other conditions, which, in the opinion of the Investigator or Sponsor, would
             make the participant unsuitable for inclusion or could interfere with the participant
             participating in or completing the study.