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
Study type: Interventional
Phase: Phase 2

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.
    

Detailed description: 
      Atopic dermatitis (atopic eczema) is a very common type of skin disease. It typically causes
      red, dry, and itchy skin and may have a significant impact on quality of life. Rashes may
      appear on the arms and behind the knees, or anywhere else on the body. While there are
      existing therapies, there is currently no cure for atopic dermatitis.

      This is a randomized, double blind, placebo controlled, parallel group, Phase 2 study to
      evaluate the efficacy and safety of EDP1815 in adult participants 18 to ≤75 years of age with
      mild, moderate, and severe atopic dermatitis (AD).

      Participants will be screened within 28 days prior to the first dose of study intervention to
      confirm study eligibility. Subjects must have mild, moderate, or severe AD involving at least
      5% Body Surface Area (BSA); an Investigator Global Assessment (IGA) score of 2, 3, or 4; and
      an Eczema Area Severity Index (EASI) of at least 6 at screening and Day 1.

      All participants must agree to use a background therapy (per protocol) twice daily for at
      least 14 days prior to Day 1 in order to be considered eligible for the study.

      Approximately 405 participants will be randomized to receive either EDP1815 or placebo (295
      to EDP1815: 110 to placebo) and treated for 16 weeks. Participants in Cohorts 1, 2, & 3 will
      be randomized in a 3:1 ratio (225 to EDP1815: 75 to placebo). Participants in Cohort 4 will
      be randomized in a 2:1 ratio (70 to EDP1815: 35 to placebo). Cohorts 1, 2 & 3 will be run
      concurrently, and Cohort 4 recruitment will commence after enrollment for Cohorts 1, 2, & 3
      are completed.

      Randomization will be stratified by baseline disease severity (mild [IGA = 2], moderate [IGA
      = 3] or severe [IGA = 4] AD). The investigational product will be administered either once or
      twice daily for 16 weeks. Background emollient (moisturizer) therapy must continue at least
      twice daily for the duration of the treatment and follow-up periods. Topical rescue therapy
      is allowed during the treatment period per protocol.

      The primary efficacy endpoint is achievement of an EASI-50 response at Week 16. Secondary
      efficacy endpoints will look at EASI, IGA, BSA, SCORAD, DLQI, Pruritus-NRS, Sleep
      Disturbance-NRS, POEM, and the need for rescue therapy at Weeks 4, 8, 12 and 16 (unless
      otherwise specified in the protocol). Safety and efficacy assessments will be conducted at
      the investigator site by a clinical assessor blinded to treatment assignment. Scheduled
      clinic study visits for all subjects will occur at Screening, Day 1, Week 2, Week 4, Week 8,
      Week 12, Week 16 (end of treatment) and Week 20 (post-treatment follow-up). Participants
      discontinuing early from the study will undergo a 28-day follow-up period, where possible.

      At the end of the 16-week study treatment, qualified participants completing the study will
      have the option to enter an open label study.
    

Intervention name(s): EDP1815; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): EDP1815 is an orally administered, pharmaceutical preparation of a single strain of bacteria; Placebo oral capsule
Other intervention name(s): Prevotella histicola
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)
Primary purpose: Treatment
Keywords: Mild Atopic Dermatitis; Moderate Atopic Dermatitis; Severe Atopic Dermatitis; Mild Eczema; Moderate Eczema; Severe Eczema