A Long-Term Extension Trial in Participants With Atopic Dermatitis Who Participated in Previous EDP1815 Trials
Condition: Atopic Dermatitis
MeSH terms: Dermatitis, Atopic; Dermatitis; Eczema
Intervention: EDP1815
Intervention description: EDP1815 is an orally administered, pharmaceutical preparation of a single strain of bacteria
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Open Label Extension Study.
Masking: None (Open Label)
Enrollment: 287.0
Sex: All
Minimum age: 18 Years
Maximum age: 76 Years
Healthy volunteers: No
Keywords: Mild Atopic Dermatitis; Moderate Atopic Dermatitis; Severe Atopic Dermatitis; Mild Eczema; Moderate Eczema; Severe Eczema

Summary:

      This is an Open-Label Extension (OLE) study to evaluate the long-term safety, tolerability,
      and efficacy of EDP1815 in participants with mild, moderate, and severe atopic dermatitis who
      have completed the treatment period of a prior clinical study ("parent study") with EDP1815.

      The current parent study of this protocol is the EDP1815-207 study; A Phase 2, Multicenter,
      Double-Blind, Placebo-Controlled, Multiple-Cohort Study Investigating the Effect of EDP1815
      in Participants for the Treatment of Mild, Moderate and Severe Atopic Dermatitis.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Must have provided informed consent.

          2. Must have completed the treatment period in a parent study of EDP1815 in atopic
             dermatitis and complied with the parent protocol.

          3. Must agree to use emollients.

          4. Must continue to follow contraception criteria.

        Exclusion Criteria:

          1. Participants who are currently enrolled in another investigational drug study or plans
             to receive another investigational drug during this study.

          2. Have any other conditions, which would make the participant unsuitable for inclusion
             or could interfere with the participant participating in or completing the study.

          3. Use of phototherapy, a biologic agent, or a systemic immunosuppressive agent that
             could affect AD, including systemic corticosteroids, within 7 days prior to Day -1,
             unless used as a rescue treatment as part of the parent study protocol.

          4. Use of topical atopic dermatitis therapies, including topical corticosteroids, topical
             calcineurin inhibitors, topical PDE-4 inhibitors, and topical JAK inhibitors, within 7
             days prior to enrolling in the study, unless used as a rescue treatment as part of the
             EDP1815-207 protocol.

          5. Has received live or live-attenuated vaccination prior to enrollment or intends to
             have such a vaccination during the study.

          6. Hypersensitivity to P histicola or to any of the excipients.

          7. Unwillingness to comply with study procedures, including follow-up, as specified by
             this protocol, or unwillingness to cooperate fully with the Investigator.