Evaluation of the Immunopharmacology of EDP1815 and EDP2939

NCT05682222 | Completed Phase 1

• 1 other identifier: EDP1815-105
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

Brief Summary

A single-center, randomized, double-blind, placebo-controlled, multiple dose platform trial.

Conditions

KLH and Imiquimod Induced Skin Inflammation in Healthy Volunteers

Outcome Measures

Primary Outcomes (1)

• KLH-induced immune reaction.

  This will be measured as basal flow (arbitrary units, AU) by LSCI.

  At 24 hours after Day 57 intradermal re-challenge.

Secondary Outcomes (13)

• KLH-induced immune reaction - basal flow.

  At 4 hours, 48 hours and 72 hours after Day 57 intradermal re-challenge.

• KLH-induced immune reaction - flare.

  At 4 hours, 24 hours, 48 hours and 72 hours after Day 57 intradermal re-challenge.

• KLH-induced immune reaction - erythema.

  At 4 hours, 24 hours, 48 hours and 72 hours after Day 57 intradermal re-challenge.

• IMQ-induced immune reaction - basal flow.

  At 24 hours, 48 hours and 72 hours after Day 57 initiation of IMQ challenge.

• IMQ-induced immune reaction - flare.

  At 24 hours, 48 hours and 72 hours after Day 57 initiation of IMQ challenge.

Study Arms (4)

Cohort 1

OTHER

EDP1815 or placebo in capsule A, dosed for 60 days. Randomization is 2:1 active:placebo.

Drug: EDP1815; Drug: Placebo oral capsule

Cohort 2

OTHER

EDP1815 or placebo in capsule B, dosed for 60 days. Randomization is 2:1 active:placebo.

Drug: EDP1815; Drug: Placebo oral capsule

Cohort 3

OTHER

EDP2939 lower dose or placebo in capsule B, dosed for 60 days. Randomization is 2:1 active:placebo.

Drug: EDP2939; Drug: Placebo oral capsule

Cohort 4

OTHER

EDP2939 higher dose or placebo in capsule B, dosed for 60 days. Randomization is 2:1 active:placebo.

Drug: EDP2939; Drug: Placebo oral capsule

Interventions

EDP1815 DRUG

EDP1815 is an essentially non-viable, non-replicating pharmaceutical preparation of a single strain of Prevotella histicola, a naturally occurring human commensal microbe.

Cohort 1; Cohort 2

EDP2939 DRUG

EDP2939 is a pharmaceutical preparation of extracellular vesicles.

Cohort 3; Cohort 4

Placebo oral capsule DRUG

Placebo.

Cohort 1; Cohort 2; Cohort 3; Cohort 4

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Evelo Biosciences, Inc.: lead

Study Sites (1)

Centre for Human Drug Research

Leiden, 2333 CL, Netherlands

Location

Related Publications (1)

• Eveleens Maarse BC, Ronner MN, Jansen MAA, Niemeyer-van der Kolk T, In 't Veld AE, Klaassen ES, Ahmad S, Itano A, McHale D, Moerland M. Immunomodulating effects of the single bacterial strain therapy EDP1815 on innate and adaptive immune challenge responses - a randomized, placebo-controlled clinical trial. Immunol Res. 2024 Aug;72(4):776-787. doi: 10.1007/s12026-024-09484-7. Epub 2024 May 15.

  PMID: 38748319 DERIVED

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Double-blind
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: July 22, 2022
• First Posted: January 12, 2023
• Study Start: June 27, 2022
• Primary Completion: October 14, 2022
• Study Completion: October 14, 2022
• Last Updated: May 19, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)