Mild, moderate, and severe atopic dermatitis MedDRA version: 21.1 Level: LLT Classification code 10003639 Term: Atopic dermatitis System Organ Class: 100000004858
Conditions
Sponsors
EVELO Biosciences Inc
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Must have given written informed consent (signed and dated) and any authorizations required by local law and be able to comply with all study requirements. 2. Must have completed the treatment period in a parent study of EDP1815 in the treatment of atopic dermatitis and complied with the protocol to the satisfaction of the investigator 3. All participants must agree to continue the use of a bland additive-free, sodium lauryl sulfate (SLS)-free, and fragrance-free emollient cream, gel, or ointment at least twice daily (or more, as needed) throughout the study. 4. Continue to meet the following contraception criteria: i. Male participants: i. A male participant must agree to use contraception during their participation in this study and for a period of 90 days after the last dose and refrain from donating sperm during this period. ii. Female participants: i. A female participant is eligible to participate if she is not pregnant, not breastfeeding, and at least 1 of the following conditions applies: 1. Not a WOCBP or 2. A WOCBP who continues to follow the contraceptive guidance provided in the parent study during participation in this study, including (if applicable) 7 days prior to the first dose, and for at least 1 complete menstrual cycle (=30 days) after the last dose. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 177 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 48
Exclusion criteria
Exclusion criteria: 1. Participants who are currently enrolled in another investigational drug study or plans to receive another investigational agent during this study. 2. 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. 3. Treatment with 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. Treatment with topical atopic dermatitis therapies, including topical corticosteroids, topical calcineurin inhibitors, topical PDE-4 inhibitors, and topical JAK inhibitors, within 7 days prior to Day -1, unless used as a rescue treatment as part of the EDP1815-207 protocol. 5. Has received live or live-attenuated vaccination within 7 days prior to Day -1 or intends to have such a vaccination during the study. Non-live and non-replicating vaccines are permitted. 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Evaluate the long-term safety and tolerability of EDP1815 in the treatment of atopic dermatitis.;Secondary Objective: Evaluate the efficacy of long-term treatment with EDP1815 in the treatment of atopic dermatitis.;Primary end point(s): The incidence and rate per 100 patient-years of treatment emergent adverse events (TEAEs) during the 36-week treatment and 4-week follow-up period;Timepoint(s) of evaluation of this end point: 36-week treatment and 4-week follow up period | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): The Eczema Area and Severity Index (EASI) Score will be utilized to measure the efficacy of EDP1815 in the treatment of atopic dermatitis. In addition to EASI, the Investigator’s Global Assessment (IGA), percentage of Body Surface Area (BSA), Product of the IGA and BSA (IGA*BSA), the SCORing Atopic Dermatitis (SCORAD), the Dermatology Life Quality Index (DLQI), the Peak Pruritus Numerical Rating Scale (PP-NRS), the Sleep Disturbance Numerical Rating Scale (SD-NRS), the Patient Oriented Eczema Measure (POEM) and the Atopic Dermatitis Control Tool (ADCT) will be measured throughout the study. The number of courses of treatment with rescue therapies; and with antibiotic treatment due to skin infection, per participant, will also be measured.;Timepoint(s) of evaluation of this end point: Throughout the entire study duration. | — |
Countries
Australia, Bulgaria, Canada, Germany, Poland, United States
Contacts
Public ContactStefania Saveri
PPD - Project Delivery
Outcome results
None listed