Autoimmune disease
Conditions
Interventions
Cohort 1: EDP1815, 1 capsule QD, 8x10^10 cells per capsule (EC1)
Cohort 2: EDP1815, 1 capsule QD, 8x10^10 cells per capsule (EC2)
Cohort 3: EDP2939, 1 capsule QD, 3.9x10^12 EV per capsule (EC2).
Coho
Sponsors
Evelo Biosciences
Eligibility
Age
18 Years to 64 Years
Inclusion criteria
Inclusion criteria: 1. Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol. Obtained prior to any screening procedures and in accordance with national, local, institutional guidelines. 2. Age >= 18 years to 45 years, inclusive. 3. Participant has a body mass index of >= 18 kg/m2 to
Exclusion criteria
Exclusion criteria: 9. The participant has used Aldara® (imiquimod cream) within 3 weeks prior to the baseline visit or plans to use it during the course of the study. 10. Previous known exposure to Immucothel® or KLH. 12. The participant has a history of hypersensitivity or allergies to Prevotella (or Prevotella containing probiotics) including any associated excipients for EDP1815 or EDP2939, or has a history of hypersensitivity or allergies to placebo capsule/powder (magnesium stearate, microcrystalline cellulose, colloidal silicon dioxide, hydroxypropylmethylcellulose, or mannitol) or to the hard capsule shells (hydroxylpropylmethylcellulose and titanium dioxide), or has a known allergy against Alhydrogel®, or has a known allergy against Aldara® (imiquimod cream). 16. The participant has any current and / or recurrent pathologically, clinically significant skin condition at the treatment area (i.e., atopic dermatitis), including tattoos. Treatment area includes the forearms and back. 19. History of pathological scar formation (keloid, hypertrophic scar) or keloids or surgical scars in the target treatment area that in the opinion of the investigator, would limit or interfere with dosing and/or measurement in the trial. 20. Diagnosed with psoriasis. 21. History of skin cancer (basal cell carcinoma, squamous cell carcinoma, melanoma). 22. Tanning due to sunbathing, excessive sun exposure or a tanning booth within 3 weeks before start of treatment (Day 1) and for the duration of the study. 23. History of Schistosomiasis (infection with Schistosoma parasite).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| • KLH-induced immune reaction, after intradermal re-challenge, measured as basal flow (LSCI) at 24 hours (h). | — |
Secondary
| Measure | Time frame |
|---|---|
| • KLH-induced immune reaction, after intradermal re-challenge, measured as basal flow (LSCI) at 4h, 48h and 72h. • KLH-induced immune reaction, after intradermal re-challenge, measured as flare (LSCI) at 4h, 24h, 48h and 72h. • KLH-induced immune reaction, after intradermal re-challenge, measured as erythema (multispectral imaging) at 4h, 24h, 48h and 72h. • Specific B-cell response to KLH, measured as anti-KLH IgM and IgG • IMQ-induced immune reaction, measured as basal flow (LSCI) at 24h, 48h and 72h. • IMQ-induced immune reaction, measured as flare (LSCI) at 24h, 48h and 72h. • IMQ-induced immune reaction, measured as erythema (multispectral imaging) at 24h, 48h and 72h. • Serious adverse event (SAE) and adverse event (AE) incidents • Clinical safety laboratory measurements • Electrocardiogram (ECG) measurements • Vital sign measurements • Physical examination • Gut microbiota composition in stool samples - 16S RNA sequencing | — |
Countries
Netherlands
Outcome results
None listed