Clinical trial NCT05682222: 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
Overall status: COMPLETED
Phase: PHASE1
Conditions: KLH and Imiquimod Induced Skin Inflammation in Healthy Volunteers
Lead sponsor: Evelo Biosciences, Inc.
Sponsor class: INDUSTRY
First posted: 2023-01-12
Enrollment: 38
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Intervention 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.
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: KLH-induced immune reaction.
timeFrame: At 24 hours after Day 57 intradermal re-challenge.
Secondary outcomes:
measure: KLH-induced immune reaction - basal flow.
timeFrame: At 4 hours, 48 hours and 72 hours after Day 57 intradermal re-challenge.
measure: KLH-induced immune reaction - flare.
timeFrame: At 4 hours, 24 hours, 48 hours and 72 hours after Day 57 intradermal re-challenge.
measure: KLH-induced immune reaction - erythema.
timeFrame: At 4 hours, 24 hours, 48 hours and 72 hours after Day 57 intradermal re-challenge.
measure: IMQ-induced immune reaction - basal flow.
timeFrame: At 24 hours, 48 hours and 72 hours after Day 57 initiation of IMQ challenge.
measure: IMQ-induced immune reaction - flare.
timeFrame: At 24 hours, 48 hours and 72 hours after Day 57 initiation of IMQ challenge.
measure: IMQ-induced immune reaction - erythema.
timeFrame: At 24 hours, 48 hours and 72 hours after Day 57 initiation of IMQ challenge.
measure: Specific B-cell response to KLH.
timeFrame: After Day 57 intradermal re-challenge.
measure: Serious adverse event (SAE) and adverse event (AE) incidents.
timeFrame: Up to Day 74.
measure: Number of participants with blood laboratory safety abnormalities.
timeFrame: Up to Day 74.
measure: Number of participants with urinary laboratory safety abnormalities.
timeFrame: Up to Day 74.
measure: Number of participants with electrocardiogram (ECG) abnormalities.
timeFrame: Up to Day 74.
measure: Number of participants with vital signs abnormalities.
timeFrame: Up to Day 74.
measure: Number of participants with physical examination abnormalities.
timeFrame: Up to Day 74.
Other outcomes:
Locations:
city: Leiden
country: Netherlands
facility: Centre for Human Drug Research
Study officials:
References: