A Phase 2 study of EDP1815 in mild to moderate plaque psoriasis
Research type
Research Study
Full title
A Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Cohort, Dose-Ranging Study Investigating the Effect of EDP1815 in the Treatment of Mild to Moderate Plaque Psoriasis
IRAS ID
279517
Contact name
Hawys Thomas
Contact email
Sponsor organisation
Evelo Biosciences Inc.
Eudract number
2019-004901-28
Duration of Study in the UK
0 years, 10 months, 17 days
Research summary
Psoriasis is a long-term (chronic) scaling disease of the skin. It appears as red, raised scaly patches known as plaques. Any part of the skin surface may be involved but the plaques most commonly appear on the elbows, knees and scalp. Current treatments for mild to moderate psoriasis include creams and ointments.
The study drug EDP1815 is a monoclonal microbial, a medicine given orally that interacts and changes the immune system through interactions with human cells in the gut.
The evidence available so far suggests EDP1815 is very well tolerated. A previous study with EDP1815, involving healthy volunteers as well as 20 participants with psoriasis showed clinical responses on the (psoriatic) lesion severity score (LSS) and psoriasis area and severity index (PASI) at Day 28. There was also continued improvement in the response at Day 42 and the safety profile of EDP1815 was similar to placebo, with no SAEs or AEs of severe intensity.
This study will evaluate the efficacy of EDP1815 for the treatment of psoriasis following daily dosing for 16 weeks. Participants will be randomly assigned in a 1:1:1 ratio to 1 of 3 parallel dose cohorts within which 60 participants will be randomly assigned in a 3:1 ratio to receive either EDP1815 or matching placebo once daily for 16 weeks. They will then enter a will enter a 4-week post-treatment follow-up period. The maximum planned duration for each participant will be 24 weeks.
Study procedures will include analysis of blood, urine, vital signs, physical examinations, skin plaque biopsies, photographs of skin plaques and questionnaires.
This study is sponsored by Evelo Biosciences Inc. Approximately 180 participants will take part in the study globally, of which approximately 70 are expected in the UK.
REC name
East Midlands - Nottingham 2 Research Ethics Committee
REC reference
20/EM/0086
Date of REC Opinion
31 Mar 2020
REC opinion
Favourable Opinion