CRC 386 Psoriasis Study

Study Aim: The primary aim of this study is to assess safety and tolerability of the investigational product EDP1066 in healthy participants and patients with either mild-moderate psoriasis or mild-moderate atopic dermatitis (eczema). EDP1066 is a strain of the bacteria species Lactococcus lactis subsp. Cremoris. It is a naturally occurring organism commonly used in the production of a variety of food products for human consumption (including probiotic formulations, food processing and dairy manufacturing). You will be participating in the psoriasis participant group.

Participant Requirements 

Participant requirements:

You must be aged between 18 and 60

You must have been diagnosed with mild to moderate plaque-type psoriasis for at least 6 months, affecting no more than 5% of your body (excluding scalp).

You must be willing to provide skin biopsies You must be willing to have photographs. taken of affected areas

You must have at least 2 psoriatic lesions, with at least one of these suitable for biopsy.

You must not have participated in another clinical trial using investigational drug(s) within 3 months of the first treatment period.

You must have an appropriate work permit (if you are not from the EU)

You must have a Body Mass Index of  ≥ 18 kg/m2 to ≤ 35 kg/m2

If you are female you must not be pregnant, be trying to get pregnant or breastfeeding during the study. If you are male, you must not be trying to conceive with a partner.

You must be willing to provide faecal samples.

Participant has received systemic nonbiologic psoriasis therapy (methotrexate [MTX], steroids, cyclophosphamide) or psoralen plus ultraviolet A (PUVA)/ultraviolet A (UVA) phototherapy within 4 weeks prior to Screening.

 

Information 

Study Visits (All timings are approximate)

Cohort 4, 5 and 8

Visit 1 Screening – approx. 6 hours

Visits 2-10 - outpatient visits – most visits will take approximately 2 hours with some visits taking up to 6 hours. Visit 3 will take approximately 6 hours.

Visit 11 - Follow-up Visit - approx. 3 hours

The clinical team may also phone you in between visits.

Visit 
Inconvenience Allowance 

For Cohort 4, 5 and 8 Compensation – £1350

Travel Expenses – Maximum £40 per visit, determined on a zone-by-zone basis

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