Skip to main content
OpenTrials
Completed

NCT Number: NCT05682222

Evaluation of the Immunopharmacology of EDP1815 and EDP2939

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

KLH and Imiquimod Induced Skin Inflammation in Healthy Volunteers

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Centre for Human Drug Research

Leiden, 2333 CL, Netherlands

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

EDP2939

Drug

EDP2939 is a pharmaceutical preparation of extracellular vesicles.

Placebo oral capsule

Drug

Placebo.

Primary outcomes

  1. KLH-induced immune reaction.

    Time frame: At 24 hours after Day 57 intradermal re-challenge.

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

Secondary outcomes

  1. KLH-induced immune reaction - basal flow.

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

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

  2. KLH-induced immune reaction - flare.

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

    This will be measured as flare (AU) by LSCI.

  3. KLH-induced immune reaction - erythema.

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

    This will be measured as erythema (AU) by multispectral imaging.

  4. IMQ-induced immune reaction - basal flow.

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

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

  5. IMQ-induced immune reaction - flare.

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

    This will be measured as flare (AU) by LSCI.

  6. IMQ-induced immune reaction - erythema.

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

    This will be measured as erythema (AU) by multispectral imaging.

  7. Specific B-cell response to KLH.

    Time frame: After Day 57 intradermal re-challenge.

    This will be measured as anti-KLH IgM and IgG (% of baseline concentration).

  8. Serious adverse event (SAE) and adverse event (AE) incidents.

    Time frame: Up to Day 74.

    SAEs and AEs assessed by: type, frequency, severity and treatment-relatedness of the event.

  9. Number of participants with blood laboratory safety abnormalities.

    Time frame: Up to Day 74.

  10. Number of participants with urinary laboratory safety abnormalities.

    Time frame: Up to Day 74.

  11. Number of participants with electrocardiogram (ECG) abnormalities.

    Time frame: Up to Day 74.

  12. Number of participants with vital signs abnormalities.

    Time frame: Up to Day 74.

  13. Number of participants with physical examination abnormalities.

    Time frame: Up to Day 74.

Sponsors and collaborators

Lead sponsor

Evelo Biosciences, Inc.

Industry

Registry information

Official study title

A Phase 1, Randomized, Double-blind, Placebo-controlled, Multiple Dose Platform Study Investigating the Immunopharmacology of EDP1815 and EDP2939.

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Jan 12, 2023
Registry last updated
May 19, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.