Status:
TERMINATED
A Long-Term Extension Trial in Participants With Atopic Dermatitis Who Participated in Previous EDP1815 Trials
Lead Sponsor:
Evelo Biosciences, Inc.
Conditions:
Atopic Dermatitis
Eligibility:
All Genders
18-76 years
Phase:
PHASE2
Brief 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...
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 arm...
Eligibility Criteria
Inclusion
- Must have provided informed consent.
- Must have completed the treatment period in a parent study of EDP1815 in atopic dermatitis and complied with the parent protocol.
- Must agree to use emollients.
- Must continue to follow contraception criteria.
Exclusion
- Participants who are currently enrolled in another investigational drug study or plans to receive another investigational drug during this study.
- Have any other conditions, which would make the participant unsuitable for inclusion or could interfere with the participant participating in or completing the study.
- 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.
- 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.
- Has received live or live-attenuated vaccination prior to enrollment or intends to have such a vaccination during the study.
- 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.
Key Trial Info
Start Date :
June 6 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 7 2023
Estimated Enrollment :
287 Patients enrolled
Trial Details
Trial ID
NCT05439941
Start Date
June 6 2022
End Date
June 7 2023
Last Update
September 7 2023
Active Locations (54)
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1
USA-131
Birmingham, Alabama, United States, 35244
2
USA 112
Fountain Valley, California, United States, 92708
3
USA 123
Fremont, California, United States, 94538
4
USA -101
Fort Lauderdale, Florida, United States, 33308