Back to resultsEvaluation of the Immunopharmacology of EDP1815 and EDP2939
Primary Purpose
KLH and Imiquimod Induced Skin Inflammation in Healthy Volunteers
Status
Completed
Phase
Phase 1
Locations
Netherlands
Study Type
Interventional
Intervention
EDP1815
EDP2939
Placebo oral capsule
Sponsored by
About this trial
This is an interventional treatment trial for KLH and Imiquimod Induced Skin Inflammation in Healthy Volunteers
Eligibility Criteria
Key Inclusion Criteria: Capable of giving signed informed consent, and willing to comply with requirements of the study. Age 18 years to 45 years, inclusive. Body mass index of 18 to 35 kg/m2, inclusive. Caucasian. Healthy based on medical history, physical examination, blood pressure, ECG and blood and urine laboratory tests. Key Exclusion Criteria: Use of Aldara® (imiquimod cream) within 3 weeks prior to the study. Has previously received Immucothel® or KLH. Allergy to Alhydrogel® or Aldara® (imiquimod cream). Current or recurrent skin diseases affecting the arms or back, or extensive tattoos in these areas. Previous diagnosis of psoriasis. History of pathological scar formation (e.g. keloid scar). History of skin cancer (basal cell carcinoma, squamous cell carcinoma, melanoma). Significant bowel disease (e.g. inflammatory bowel disease, coeliac disease) Currently has an infection or has needed antibiotics within 6 weeks before the study. Current smoker of more than 5 cigarettes per day Tanning due to sunbathing, excessive sun exposure or a tanning booth within 3 weeks before start of the study History of Schistosomiasis.
Sites / Locations
- Centre for Human Drug Research
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Other
Other
Other
Other
Arm Label
Cohort 1
Cohort 2
Cohort 3
Cohort 4
Arm Description
EDP1815 or placebo in capsule A, dosed for 60 days. Randomization is 2:1 active:placebo.
EDP1815 or placebo in capsule B, dosed for 60 days. Randomization is 2:1 active:placebo.
EDP2939 lower dose or placebo in capsule B, dosed for 60 days. Randomization is 2:1 active:placebo.
EDP2939 higher dose or placebo in capsule B, dosed for 60 days. Randomization is 2:1 active:placebo.
Outcomes
Primary Outcome Measures
KLH-induced immune reaction.
This will be measured as basal flow (arbitrary units, AU) by LSCI.
Secondary Outcome Measures
KLH-induced immune reaction - basal flow.
This will be measured as basal flow (AU) by LSCI.
KLH-induced immune reaction - flare.
This will be measured as flare (AU) by LSCI.
KLH-induced immune reaction - erythema.
This will be measured as erythema (AU) by multispectral imaging.
IMQ-induced immune reaction - basal flow.
This will be measured as basal flow (AU) by LSCI.
IMQ-induced immune reaction - flare.
This will be measured as flare (AU) by LSCI.
IMQ-induced immune reaction - erythema.
This will be measured as erythema (AU) by multispectral imaging.
Specific B-cell response to KLH.
This will be measured as anti-KLH IgM and IgG (% of baseline concentration).
Serious adverse event (SAE) and adverse event (AE) incidents.
SAEs and AEs assessed by: type, frequency, severity and treatment-relatedness of the event.
Number of participants with blood laboratory safety abnormalities.
Number of participants with urinary laboratory safety abnormalities.
Number of participants with electrocardiogram (ECG) abnormalities.
Number of participants with vital signs abnormalities.
Number of participants with physical examination abnormalities.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05682222
Brief Title
Evaluation of the Immunopharmacology of EDP1815 and EDP2939
Official Title
A Phase 1, Randomized, Double-blind, Placebo-controlled, Multiple Dose Platform Study Investigating the Immunopharmacology of EDP1815 and EDP2939.
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
June 27, 2022 (Actual)
Primary Completion Date
October 14, 2022 (Actual)
Study Completion Date
October 14, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Evelo Biosciences, Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
A single-center, randomized, double-blind, placebo-controlled, multiple dose platform trial.
Detailed Description
This study will evaluate the pharmacodynamic effects of multiple doses of EDP1815 and EDP2939 on immunological responses to keyhole limpet hemocyanin (KLH) and imiquimod (IMQ) dermal challenges in healthy volunteers.
EDP1815 is an essentially non-live, specific strain of Prevotella histicola, a natural human commensal organism. EDP2939 is a pharmaceutical preparation of microbial extracellular vesicles.
Four cohorts of volunteers (n=18 per cohort) will be studied using different capsule formulations and doses, administered for 60 days. Volunteers will be immunised with intramuscular KLH. Intradermal KLH re-challenge and topical IMQ challenge will commence on Day 57 with serial pharmacodynamic assessments to Day 60. Responses will be evaluated using dermal imaging (laser speckled contrast imaging; LSCI, and multi-spectral photography), as well as dermal and systemic immunological biomarkers.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
KLH and Imiquimod Induced Skin Inflammation in Healthy Volunteers
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Sequential Assignment
Model Description
This is a single-center, randomized, double-blind, placebo-controlled, platform trial to evaluate the effects of EDP1815 and EDP2939 on the systemic immune system, using intradermal KLH and topical IMQ skin challenges. A total of at least 72 healthy volunteers will be divided into 4 cohorts.
Masking
ParticipantInvestigator
Masking Description
Double-blind
Allocation
Randomized
Enrollment
38 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Cohort 1
Arm Type
Other
Arm Description
EDP1815 or placebo in capsule A, dosed for 60 days. Randomization is 2:1 active:placebo.
Arm Title
Cohort 2
Arm Type
Other
Arm Description
EDP1815 or placebo in capsule B, dosed for 60 days. Randomization is 2:1 active:placebo.
Arm Title
Cohort 3
Arm Type
Other
Arm Description
EDP2939 lower dose or placebo in capsule B, dosed for 60 days. Randomization is 2:1 active:placebo.
Arm Title
Cohort 4
Arm Type
Other
Arm Description
EDP2939 higher dose or placebo in capsule B, dosed for 60 days. Randomization is 2:1 active:placebo.
Intervention Type
Drug
Intervention Name(s)
EDP1815
Intervention Description
EDP1815 is an essentially non-viable, non-replicating pharmaceutical preparation of a single strain of Prevotella histicola, a naturally occurring human commensal microbe.
Intervention Type
Drug
Intervention Name(s)
EDP2939
Intervention Description
EDP2939 is a pharmaceutical preparation of extracellular vesicles.
Intervention Type
Drug
Intervention Name(s)
Placebo oral capsule
Intervention Description
Placebo.
Primary Outcome Measure Information:
Title
KLH-induced immune reaction.
Description
This will be measured as basal flow (arbitrary units, AU) by LSCI.
Time Frame
At 24 hours after Day 57 intradermal re-challenge.
Secondary Outcome Measure Information:
Title
KLH-induced immune reaction - basal flow.
Description
This will be measured as basal flow (AU) by LSCI.
Time Frame
At 4 hours, 48 hours and 72 hours after Day 57 intradermal re-challenge.
Title
KLH-induced immune reaction - flare.
Description
This will be measured as flare (AU) by LSCI.
Time Frame
At 4 hours, 24 hours, 48 hours and 72 hours after Day 57 intradermal re-challenge.
Title
KLH-induced immune reaction - erythema.
Description
This will be measured as erythema (AU) by multispectral imaging.
Time Frame
At 4 hours, 24 hours, 48 hours and 72 hours after Day 57 intradermal re-challenge.
Title
IMQ-induced immune reaction - basal flow.
Description
This will be measured as basal flow (AU) by LSCI.
Time Frame
At 24 hours, 48 hours and 72 hours after Day 57 initiation of IMQ challenge.
Title
IMQ-induced immune reaction - flare.
Description
This will be measured as flare (AU) by LSCI.
Time Frame
At 24 hours, 48 hours and 72 hours after Day 57 initiation of IMQ challenge.
Title
IMQ-induced immune reaction - erythema.
Description
This will be measured as erythema (AU) by multispectral imaging.
Time Frame
At 24 hours, 48 hours and 72 hours after Day 57 initiation of IMQ challenge.
Title
Specific B-cell response to KLH.
Description
This will be measured as anti-KLH IgM and IgG (% of baseline concentration).
Time Frame
After Day 57 intradermal re-challenge.
Title
Serious adverse event (SAE) and adverse event (AE) incidents.
Description
SAEs and AEs assessed by: type, frequency, severity and treatment-relatedness of the event.
Time Frame
Up to Day 74.
Title
Number of participants with blood laboratory safety abnormalities.
Time Frame
Up to Day 74.
Title
Number of participants with urinary laboratory safety abnormalities.
Time Frame
Up to Day 74.
Title
Number of participants with electrocardiogram (ECG) abnormalities.
Time Frame
Up to Day 74.
Title
Number of participants with vital signs abnormalities.
Time Frame
Up to Day 74.
Title
Number of participants with physical examination abnormalities.
Time Frame
Up to Day 74.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Key Inclusion Criteria:
Capable of giving signed informed consent, and willing to comply with requirements of the study.
Age 18 years to 45 years, inclusive.
Body mass index of 18 to 35 kg/m2, inclusive.
Caucasian.
Healthy based on medical history, physical examination, blood pressure, ECG and blood and urine laboratory tests.
Key Exclusion Criteria:
Use of Aldara® (imiquimod cream) within 3 weeks prior to the study.
Has previously received Immucothel® or KLH.
Allergy to Alhydrogel® or Aldara® (imiquimod cream).
Current or recurrent skin diseases affecting the arms or back, or extensive tattoos in these areas.
Previous diagnosis of psoriasis.
History of pathological scar formation (e.g. keloid scar).
History of skin cancer (basal cell carcinoma, squamous cell carcinoma, melanoma).
Significant bowel disease (e.g. inflammatory bowel disease, coeliac disease)
Currently has an infection or has needed antibiotics within 6 weeks before the study.
Current smoker of more than 5 cigarettes per day
Tanning due to sunbathing, excessive sun exposure or a tanning booth within 3 weeks before start of the study
History of Schistosomiasis.
Facility Information:
Facility Name
Centre for Human Drug Research
City
Leiden
ZIP/Postal Code
2333 CL
Country
Netherlands
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Evaluation of the Immunopharmacology of EDP1815 and EDP2939
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