A study to test the effect of experimental drugs EDP1815 and EDP2939 on skin inflammation in healthy volunteers after KLH and imiquimod challenge

Phase 1

Completed

Conditions: KLH and imiquimod induced skin inflammation in healthy volunteers
Skin and Connective Tissue Diseases

Registration Number: ISRCTN29254828

Lead Sponsor: Evelo Biosciences

Brief Summary: 2024 Results article in https://pubmed.ncbi.nlm.nih.gov/38748319/ (added 24/05/2024)

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: All

Target Recruitment: 38

Inclusion Criteria

1. Capable of giving signed informed consent, and willing to comply with requirements of the study
2. Age 18 years to 45 years, inclusive
3. Body mass index of 18 to 35 kg/m2, inclusive
4. Caucasian
5. Healthy based on medical history, physical examination, blood pressure, ECG and blood and urine laboratory tests

Exclusion Criteria

1. Use of Aldara® (imiquimod cream) within 3 weeks prior to the study
2. Has previously received Immucothel® or KLH
3. Allergy to Alhydrogel® or Aldara® (imiquimod cream)
4. Current or recurrent skin diseases affecting the arms or back, or extensive tattoos in these areas
5. Previous diagnosis of psoriasis
6. History of pathological scar formation (e.g. keloid scar)
7. History of skin cancer (basal cell carcinoma, squamous cell carcinoma, melanoma)
8. Significant bowel disease (e.g. inflammatory bowel disease, coeliac disease)
9. Currently has an infection or has needed antibiotics within 6 weeks before the study
10. Current smoker of more than 5 cigarettes per day
11. Tanning due to sunbathing, excessive sun exposure or a tanning booth within 3 weeks before the start of the study
12. History of schistosomiasis (infection with Schistosoma parasite)

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
KLH-induced immune reaction after intradermal re-challenge, measured as basal flow (laser speckle contrast imaging [LSCI]) at 24 h

Secondary Outcome Measures

Name	Time	Method
1. KLH-induced immune reaction after intradermal re-challenge, measured as basal flow (LSCI) at 4 h, 48 h and 72 h<br>2. KLH-induced immune reaction after intradermal re-challenge, measured as flare (LSCI) at 4 h, 24 h, 48 h and 72 h<br>3. KLH-induced immune reaction after intradermal re-challenge, measured as erythema (multispectral imaging) at 4 h, 24 h, 48 h and 72 h<br>4. Specific B-cell response to KLH, measured as anti-KLH IgM and IgG at 1, 22, 36 and 57 days<br>5. IMQ-induced immune reaction, measured as basal flow (LSCI) at 24 h, 48 h and 72 h<br>6. IMQ-induced immune reaction, measured as flare (LSCI) at 24 h, 48 h and 72 h<br>7. IMQ-induced immune reaction, measured as erythema (multispectral imaging) at 24 h, 48 h and 72 h