A Phase 2 Study Investigating the Effect of EDP1815 in the Treatment of Mild to Moderate Plaque Psoriasis

NCT04603027 | Completed Phase 2 Results FDA Drug

• 1 other identifier: EDP1815-201
• Study Type: interventional
• Target: 249
• Locations: 4 countries
• Sites: 29

Brief Summary

This Phase 2 study has been designed to investigate the clinical safety and efficacy of EDP1815 and to identify an optimal dose in subjects with mild to moderate psoriasis.

Conditions

Psoriasis; Plaque Psoriasis

Keywords

PSO; mild psoriasis; moderate psoriasis; plaque psoriasis; psoriasis; EDP1815

Outcome Measures

Primary Outcomes (1)

• Mean Percentage Change in PASI

  The Psoriasis Area and Severity Index Score (PASI) is a physician assessment that combines the assessment of the severity of and area affected by psoriasis into a single score in the range 0 (no disease) to 72 (maximal disease).The efficacy of EDP1815 will be measured using the mean percentage change in PASI from baseline to week 16.

  16 weeks

Secondary Outcomes (20)

• Mean Percentage Change in PASI

  12 weeks

• Mean Absolute Change in PASI

  16 weeks

• Achievement of PASI-50

  16 weeks

• Time to First Achievement of PASI-50

  20 weeks

• Achievement of PASI-75

  16 weeks

Study Arms (3)

Cohort 1

EXPERIMENTAL

75 subjects with mild to moderate psoriasis; 50 on EDP1815, 25 on placebo. Dose = 0.8 x 10\^11 cells, capsule, once daily, 16 weeks

Drug: EDP1815; Drug: Placebo

Cohort 2

EXPERIMENTAL

75 subjects with mild to moderate psoriasis; 50 on EDP1815, 25 on placebo. Dose = 3.2 x 10\^11 cells, capsule, once daily, 16 weeks

Drug: EDP1815; Drug: Placebo

Cohort 3

EXPERIMENTAL

75 subjects with mild to moderate psoriasis; 50 on EDP1815, 25 on placebo. Dose = 8.0 x 10\^11 cells, capsule, once daily, 16 weeks

Drug: EDP1815; Drug: Placebo

Interventions

EDP1815 DRUG

EDP1815 is an orally administered, pharmaceutical preparation of a single strain of bacteria

Cohort 1; Cohort 2; Cohort 3

Placebo DRUG

Placebo oral capsule

Cohort 1; Cohort 2; Cohort 3

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Males or females ≥18 and ≤70 years old at the time of informed consent.
• A documented diagnosis of plaque psoriasis for ≥6 months.
• Have mild to moderate plaque psoriasis with plaque covering body surface area (BSA) of ≥3% and ≤10% and meet both of the following additional criteria:
• PASI score of ≥6 and ≤15, and
• PGA score of 2 or 3.

You may not qualify if:

• Have a diagnosis of non-plaque psoriasis.
• Plaque psoriasis restricted to scalp, palms, and soles only.
• Have received systemic immunosuppressive therapy (MTX, apremilast, azathioprine, cyclosporine, 6-thioguanine, mercaptopurine, mycophenolate mofetil, hydroxyurea, and tacrolimus) within 4 weeks of first administration of study drug.
• Unresponsive to prior use of biologics (including, but not limited to, TNFα inhibitors, natalizumab, efalizumab, anakinra or agents that modulate B cells or T cells).
• If prior biologic therapy and responsive, participants must have been off therapy for at least 12 months prior to first administration of study drug.
• Have received phototherapy or any systemic medications/treatments that could affect psoriasis or PGA evaluation (including, but not limited to oral or injectable corticosteroids, retinoids, psoralens, sulfasalazine, hydroxyurea, or fumaric acid derivatives) within 4 weeks of first administration of study drug. This includes therapeutic doses of non-steroidal anti-inflammatory drugs such as ibuprofen, although intermittent as required use as an analgesic is permitted when required. Chronic use of low dose aspirin for cardiovascular protection is permitted.
• Currently receiving lithium, antimalarials, leflunomide, or IM gold, or have received lithium, antimalarials, IM gold, or leflunomide within 4 weeks of first administration of study drug.
• Have used topical medications/treatments that could affect psoriasis or PGA evaluation (including \[but not limited to\] high- and mid-potency corticosteroids, anthralin, calcipotriene, topical vitamin D derivatives, retinoids, tazarotene, methoxsalen, trimethylpsoralens, picrolimus, and tacrolimus) within 2 weeks of the first administration of study drug. Topical unmedicated emollients and low-potency topical corticosteroids are not excluded.
• Gastrointestinal tract disease (eg, short-bowel syndrome, diarrhea-predominant irritable bowel syndrome) that could interfere with GI delivery and transit time.
• Active inflammatory bowel disease.
• Active infection requiring systemic antiviral or antimicrobial therapy that will not be completed prior to Day 1 (Visit 2).
• Have received live or live attenuated replicating vaccine within 6 weeks prior to screening or intend to have such a vaccination during the study.
• Known history of or positive test for HIV, or active infection with hepatitis C or chronic hepatitis B.
• History of clinically significant acute cardiac or cerebrovascular event within 6 months before screening (includes stroke, transient ischemic attack, and coronary heart disease \[angina pectoris, myocardial infarction, heart failure, revascularization procedures\]).
• Current acute or chronic inflammatory disease other than psoriasis or psoriatic arthritis (eg, inflammatory bowel disease, rheumatoid arthritis, systemic lupus erythematosus). If a subject is off all treatment and is disease and has been symptom free for greater than 12 months, then the inflammatory disease is considered to be in remission and they may be enrolled.

Sponsors & Collaborators

• Evelo Biosciences, Inc.: lead

Study Sites (29)

Synexus Clinical Research US, Inc. - Santa Rosa

Santa Rosa, California, 95405, United States

Location

Synexus Clinical Research US, Inc. - Orlando

Orlando, Florida, 32806, United States

Location

Synexus Clinical Research US, Inc. - St. Petersburg

St. Petersburg, Florida, 33781, United States

Location

ForCare Clinical Research

Tampa, Florida, 33624, United States

Location

Synexus Clinical Research US, Inc. - The Villages

The Villages, Florida, 32162, United States

Location

Synexus Clinical Research US, Inc. - Cincinnati

Cincinnati, Ohio, 45236, United States

Location

Oregon Medical Research Center PC

Portland, Oregon, 97223, United States

Location

Synexus Clinical Research US, Inc. - Anderson

Anderson, South Carolina, 29621, United States

Location

Synexus Budapest - Magyarország Egészségügyi Szolgáltató Kft

Budapest, 1036, Hungary

Location

Synexus Zalaegerszeg Magyarország Egészségügyi Kft

Zalaegerszeg, 8900, Hungary

Location

Synexus - Poznan

Poznan, Greater Poland Voivodeship, 60-702, Poland

Location

Synexus - Wroclaw

Wroclaw, Lower Silesian Voivodeship, 50-088, Poland

Location

Synexus - Gdansk

Gdansk, Pomeranian Voivodeship, 80-382, Poland

Location

Synexus - Gdynia

Gdynia, Pomeranian Voivodeship, 81-537, Poland

Location

Synexus - Czestochowa

Częstochowa, 42-202, Poland

Location

Synexus - Katowice

Katowice, 40-040, Poland

Location

Synexus - Lodz

Lodz, Poland

Location

Synexus - Warszawa

Warsaw, 01-192, Poland

Location

Synexus - Thames Valley Clinical Research Centre

Reading, Berkshire, RG2 0TG, United Kingdom

Location

MAC Clinical Research

Blackpool, Lancashire, FY2 0JH, United Kingdom

Location

Synexus - Lancashire Clinical Research Centre

Chorley, Lancashire, PR7 7NA, United Kingdom

Location

Synexus - Merseyside Clinical Research Centre

Waterloo, Liverpool, L22 0LG, United Kingdom

Location

Medicine Evaluation Unit

Wythenshawe, Manchester, M23 9QZ, United Kingdom

Location

MAC Clinical Research

Stockton-on-Tees, North Yorkshire, TS17 6EW, United Kingdom

Location

MAC Clinical Research

Cannock, Staffordshire, WS11 0BN, United Kingdom

Location

Synexus - Wales Clinical Research Centre

Cardiff, Wales, CF15 9SS, United Kingdom

Location

MAC Clinical Research

Leeds, West Yorkshire, LS10 1DU, United Kingdom

Location

Synexus - Scotland Clinical Research Centre

Glasgow, G20 0SP, United Kingdom

Location

Synexus - Manchester Clinical Research Centre

Manchester, M15 6SE, United Kingdom

Location

Related Publications (1)

• Ehst BD, Strober B, Blauvelt A, Maslin D, Macaro D, Carpenter N, Bodmer M, McHale D. A randomized, double-blinded, phase 2 trial of EDP1815, an oral immunomodulatory preparation of Prevotella histicola, in adults with mild-to-moderate plaque psoriasis. Front Med (Lausanne). 2024 May 15;11:1292406. doi: 10.3389/fmed.2024.1292406. eCollection 2024.

  PMID: 38813388 DERIVED

MeSH Terms

Conditions

Psoriasis

Condition Hierarchy (Ancestors)

Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases

Results Point of Contact

• Title: Duncan McHale, MBBS, MRCP, PhD
• Organization: Evelo Biosciences, Inc.

duncan@evelobio.com

+447500128938

Study Officials

• Benjamin Ehst, MD PhD

  Oregon Medical Research Center

  PRINCIPAL INVESTIGATOR

• Douglas Maslin, MPhil MBBS

  Evelo Biosciences

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: This is a multicenter, randomized, double-blind, placebo-controlled, parallel-cohort, dose-ranging study of participants with mild to moderate plaque psoriasis

Study Record Dates

• First Submitted: October 16, 2020
• First Posted: October 26, 2020
• Study Start: September 21, 2020
• Primary Completion: July 2, 2021
• Study Completion: December 6, 2021
• Last Updated: December 19, 2022
• Results First Posted: December 19, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will not share

Locations

HU (2); US (8); GB (11); PL (8)