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

NCT ID: NCT04603027

Last Updated: 2022-12-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 249 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-09-21
• Study Completion Date: 2021-12-06

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.

Detailed Description

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Cohort 1

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

Group Type: EXPERIMENTAL

EDP1815

Intervention Type: DRUG

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

Placebo

Intervention Type: DRUG

Placebo oral capsule

Cohort 2

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

Group Type: EXPERIMENTAL

EDP1815

Intervention Type: DRUG

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

Placebo

Intervention Type: DRUG

Placebo oral capsule

Cohort 3

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

Group Type: EXPERIMENTAL

EDP1815

Intervention Type: DRUG

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

Placebo

Intervention Type: DRUG

Placebo oral capsule

Interventions

EDP1815

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

Intervention Type: DRUG

Placebo

Placebo oral capsule

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Males or females ≥18 and ≤70 years old at the time of informed consent.

2. A documented diagnosis of plaque psoriasis for ≥6 months.

3. 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:

1. PASI score of ≥6 and ≤15, and

2. PGA score of 2 or 3.

Exclusion Criteria

1. Have a diagnosis of non-plaque psoriasis.

2. Plaque psoriasis restricted to scalp, palms, and soles only.

3. 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.

4. 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).

5. If prior biologic therapy and responsive, participants must have been off therapy for at least 12 months prior to first administration of study drug.

6. 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.

7. 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.

8. 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.

9. Gastrointestinal tract disease (eg, short-bowel syndrome, diarrhea-predominant irritable bowel syndrome) that could interfere with GI delivery and transit time.

10. Active inflammatory bowel disease.

11. Active infection requiring systemic antiviral or antimicrobial therapy that will not be completed prior to Day 1 (Visit 2).

12. Have received live or live attenuated replicating vaccine within 6 weeks prior to screening or intend to have such a vaccination during the study.

13. Clinically significant abnormalities in screening laboratory values that would render a participant unsuitable for inclusion (per investigator judgment).

14. Known history of or positive test for HIV, or active infection with hepatitis C or chronic hepatitis B.

15. 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]).

16. 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.

17. Hypersensitivity to P histicola or to any of the excipients.

18. Active untreated mental or psychiatric disorder. Participants who are on stable dosing of medication for a mental or psychiatric disorder for at least 6 months before screening and whose treating physicians consider them to be mentally stable may be enrolled.

19. Any major or minor GI surgery within 6 months of screening.

20. Any major surgery within 6 months of screening.

21. Malignancy within 5 years, except for basal or squamous cell carcinoma of the skin or carcinoma in situ of the cervix that has been successfully treated.

22. Treatment with another investigational drug, biological agent, or device within 1 month of screening, or 5 half-lives of investigational agent, whichever is longer.

23. Initiating any OTC or prescription medication including vitamins, herbal supplements and nutraceuticals (eg, supplements including high doses of probiotics and prebiotics as usually found in capsules/tablets/powders), except acetaminophen/paracetamol and anti-histamines, within 14 days prior to baseline or anticipates change in dosage for the duration of the study period. Note that probiotic and prebiotic foods that contain low doses are allowed (eg, yoghurt, kefir, kombucha, however, supplements containing high doses of probiotics and prebiotics are not allowed at any point during the study.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Evelo Biosciences, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Benjamin Ehst, MD PhD

Role: PRINCIPAL_INVESTIGATOR

Oregon Medical Research Center

Douglas Maslin, MPhil MBBS

Role: STUDY_DIRECTOR

Evelo Biosciences

Locations

Synexus Clinical Research US, Inc. - Santa Rosa

Santa Rosa, California, United States

Synexus Clinical Research US, Inc. - Orlando

Orlando, Florida, United States

Synexus Clinical Research US, Inc. - St. Petersburg

St. Petersburg, Florida, United States

ForCare Clinical Research

Tampa, Florida, United States

Synexus Clinical Research US, Inc. - The Villages

The Villages, Florida, United States

Synexus Clinical Research US, Inc. - Cincinnati

Cincinnati, Ohio, United States

Oregon Medical Research Center PC

Portland, Oregon, United States

Synexus Clinical Research US, Inc. - Anderson

Anderson, South Carolina, United States

Synexus Budapest - Magyarország Egészségügyi Szolgáltató Kft

Budapest, , Hungary

Synexus Zalaegerszeg Magyarország Egészségügyi Kft

Zalaegerszeg, , Hungary

Synexus - Poznan

Poznan, Greater Poland Voivodeship, Poland

Synexus - Wroclaw

Wroclaw, Lower Silesian Voivodeship, Poland

Synexus - Gdansk

Gdansk, Pomeranian Voivodeship, Poland

Synexus - Gdynia

Gdynia, Pomeranian Voivodeship, Poland

Synexus - Czestochowa

Częstochowa, , Poland

Synexus - Katowice

Katowice, , Poland

Synexus - Lodz

Lodz, , Poland

Synexus - Warszawa

Warsaw, , Poland

Synexus - Thames Valley Clinical Research Centre

Reading, Berkshire, United Kingdom

MAC Clinical Research

Blackpool, Lancashire, United Kingdom

Synexus - Lancashire Clinical Research Centre

Chorley, Lancashire, United Kingdom

Synexus - Merseyside Clinical Research Centre

Waterloo, Liverpool, United Kingdom

Medicine Evaluation Unit

Wythenshawe, Manchester, United Kingdom

MAC Clinical Research

Stockton-on-Tees, North Yorkshire, United Kingdom

MAC Clinical Research

Cannock, Staffordshire, United Kingdom

Synexus - Wales Clinical Research Centre

Cardiff, Wales, United Kingdom

MAC Clinical Research

Leeds, West Yorkshire, United Kingdom

Synexus - Scotland Clinical Research Centre

Glasgow, , United Kingdom

Synexus - Manchester Clinical Research Centre

Manchester, , United Kingdom

Countries

United States; Hungary; Poland; United Kingdom

References

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.

Reference Type: DERIVED

PMID: 38813388 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

EDP1815-201

Identifier Type: -

Identifier Source: org_study_id