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

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ClinicalTrials.gov Identifier: NCT04603027
Recruitment Status : Completed
First Posted : October 26, 2020
Last Update Posted : January 10, 2022
Sponsor:
Information provided by (Responsible Party):
Evelo Biosciences, Inc.

Study Description
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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.

Condition or disease Intervention/treatment Phase
Psoriasis Plaque Psoriasis Drug: EDP1815 Drug: Placebo Phase 2

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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 225 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: This is a multicenter, randomized, double-blind, placebo-controlled, parallel-cohort, dose-ranging study of participants with mild to moderate plaque psoriasis
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official 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
Actual Study Start Date : September 21, 2020
Actual Primary Completion Date : July 2, 2021
Actual Study Completion Date : December 6, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Psoriasis

Arms and Interventions
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Arm Intervention/treatment
Experimental: 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
 Drug: EDP1815
EDP1815 is an orally administered, pharmaceutical preparation of a single strain of bacteria

Drug: Placebo
Placebo oral capsule
Experimental: 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
 Drug: EDP1815
EDP1815 is an orally administered, pharmaceutical preparation of a single strain of bacteria

Drug: Placebo
Placebo oral capsule
Experimental: 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
 Drug: EDP1815
EDP1815 is an orally administered, pharmaceutical preparation of a single strain of bacteria

Drug: Placebo
Placebo oral capsule


Outcome Measures
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Primary Outcome Measures :
  1. Mean percentage change in PASI [ Time Frame: 16 weeks ]
    The efficacy of EDP1815 will be measured using the mean percentage change in Psoriasis Area and Severity Index Score (PASI) from baseline to week 16


Secondary Outcome Measures :
  1. Mean percentage change in PASI [ Time Frame: 12 weeks ]
    The efficacy of EDP1815 will be measured using the mean percentage change from baseline in Psoriasis Area and Severity Index Score (PASI) from baseline at weeks 4, 8, and 12

  2. Mean absolute change in PASI [ Time Frame: 16 weeks ]
    The efficacy of EDP1815 will be measured using the mean absolute change from baseline in Psoriasis Area and Severity Index Score (PASI) from baseline at weeks 4, 8, 12, and 16

  3. Achievement of PASI-50 [ Time Frame: 16 weeks ]
    The efficacy of EDP1815 will be measured using the achievement of PASI-50 at weeks 4, 8, 12, and 16

  4. Time to first achievement of PASI-50 [ Time Frame: 16 weeks ]
    The efficacy of EDP1815 will be measured using the time to first achievement of PASI-50

  5. Achievement of PASI-75 [ Time Frame: 16 weeks ]
    The efficacy of EDP1815 will be measured using the achievement of PASI-75 at week 16

  6. Achievement of PASI-90 [ Time Frame: 16 weeks ]
    The efficacy of EDP1815 will be measured using the achievement of PASI-90 at week 16

  7. Achievement of PASI-100 [ Time Frame: 16 weeks ]
    The efficacy of EDP1815 will be measured using the achievement of PASI-100 at week 16

  8. Achievement of PGA of 0 or 1 with a ≥2-point improvement from baseline [ Time Frame: 16 weeks ]
    The efficacy of EDP1815 will be measured using the achievement of PGA of 0 or 1 with a ≥2-point improvement from baseline at Week 16 [PGA = Physician's Global Assessment]

  9. Achievement of PGA of 0 [ Time Frame: 16 weeks ]
    The efficacy of EDP1815 will be measured using the achievement of PGA of 0 at Week 16 [PGA = Physician's Global Assessment]

  10. Mean percentage change in PGAxBSA [ Time Frame: 16 weeks ]
    The efficacy of EDP1815 will be measured using the mean percentage change from baseline in PGA x BSA at Weeks 4, 8, 12, and 16. [PGA = Physician's Global Assessment, BSA = Body Surface Area]

  11. Mean absolute change in PGAxBSA [ Time Frame: 16 weeks ]
    The efficacy of EDP1815 will be measured using the mean absolute change from baseline in PGA x BSA at Weeks 4, 8, 12, and 16. [PGA = Physician's Global Assessment, BSA = Body Surface Area]

  12. Mean percentage change in LSS [ Time Frame: 16 weeks ]
    The efficacy of EDP1815 will be measured using the mean percentage change from baseline in LSS (Lesion Severity Score) at Weeks 4, 8, 12, and 16.

  13. Mean absolute change in LSS [ Time Frame: 16 weeks ]
    The efficacy of EDP1815 will be measured using the mean absolute change from baseline in LSS (Lesion Severity Score) at Weeks 4, 8, 12, and 16.

  14. Mean percentage change in DLQI [ Time Frame: 16 weeks ]
    The efficacy of EDP1815 will be measured using mean percentage change from baseline in Dermatology Life Quality Index (DLQI) at Weeks 4, 8, 12, and 16

  15. Mean absolute change in DLQI [ Time Frame: 16 weeks ]
    The efficacy of EDP1815 will be measured using the mean absolute change from baseline in Dermatology Life Quality Index (DLQI) at Weeks 4, 8, 12, and 16

  16. Mean percentage change in mNAPSI [ Time Frame: 16 weeks ]
    The efficacy of EDP1815 will be measured using the mean percentage change in mNAPSI total score (modified Nail Psoriasis Severity Index) from baseline at Weeks 4, 8, 12, and 16

  17. Mean absolute change in mNAPSI [ Time Frame: 16 weeks ]
    The efficacy of EDP1815 will be measured using the mean absolute change in mNAPSI total score (modified Nail Psoriasis Severity Index) from baseline at Weeks 4, 8, 12, and 16

  18. Cumulative incidence of partial relapse [ Time Frame: 40 weeks ]
    The efficacy of EDP1815 will be measured by calculating the cumulative incidence of partial relapse at Weeks 20, 24, 28, and 40

  19. Cumulative incidence of complete relapse [ Time Frame: 40 weeks ]
    The efficacy of EDP1815 will be measured by calculating the cumulative incidence of complete relapse at Weeks 20, 24, 28, and 40

  20. Cumulative incidence of rebound [ Time Frame: 40 weeks ]
    The efficacy of EDP1815 will be measured by calculating the cumulative incidence of rebound at Weeks 20, 24, 28, and 40


Eligibility Criteria
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Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Key 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.

Key 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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04603027


Locations
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Sponsors and Collaborators
Evelo Biosciences, Inc.
Investigators
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Principal Investigator: Benjamin Ehst, MD PhD Oregon Medical Research Center
Study Director: Douglas Maslin, MPhil MBBS Evelo Biosciences
More Information
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Responsible Party: Evelo Biosciences, Inc.
ClinicalTrials.gov Identifier: NCT04603027    
Other Study ID Numbers: EDP1815-201
First Posted: October 26, 2020    Key Record Dates
Last Update Posted: January 10, 2022
Last Verified: January 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Evelo Biosciences, Inc.:
PSO
mild psoriasis
moderate psoriasis
 plaque psoriasis
psoriasis
EDP1815
Additional relevant MeSH terms:
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Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases