E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Mild, moderate, and severe atopic dermatitis |
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E.1.1.1 | Medical condition in easily understood language |
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E.1.1.2 | Therapeutic area | Diseases [C] - Skin and Connective Tissue Diseases [C17] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 21.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10003639 |
E.1.2 | Term | Atopic dermatitis |
E.1.2 | System Organ Class | 100000004858 |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
Evaluate the long-term safety and tolerability of EDP1815 in the treatment of atopic dermatitis. |
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E.2.2 | Secondary objectives of the trial |
Evaluate the efficacy of long-term treatment with EDP1815 in the treatment of atopic dermatitis. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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. |
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E.4 | Principal 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. |
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E.5 End points |
E.5.1 | 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 |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
36-week treatment and 4-week follow up period |
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E.5.2 | 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. |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
Throughout the entire study duration. |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | Yes |
E.8.1.7.1 | Other trial design description |
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E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 3 |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 7 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 20 |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
Australia |
Canada |
United States |
Poland |
Bulgaria |
Germany |
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E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 1 |
E.8.9.1 | In the Member State concerned months | 3 |
E.8.9.1 | In the Member State concerned days | 12 |
E.8.9.2 | In all countries concerned by the trial years | 1 |
E.8.9.2 | In all countries concerned by the trial months | 5 |