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    The EU Clinical Trials Register currently displays   41472   clinical trials with a EudraCT protocol, of which   6816   are clinical trials conducted with subjects less than 18 years old.
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    Summary
    EudraCT Number:2019-004901-28
    Sponsor's Protocol Code Number:EDP1815-201
    National Competent Authority:Poland - Office for Medicinal Products
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2020-05-22
    Trial results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedPoland - Office for Medicinal Products
    A.2EudraCT number2019-004901-28
    A.3Full title of the trial
    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
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Phase 2 Study Investigating the Effect of EDP1815 in the Treatment of Mild to Moderate Plaque Psoriasis
    A.3.2Name or abbreviated title of the trial where available
    A Phase 2 Study Investigating the Effect of EDP1815 in the Treatment of Mild to Moderate Plaque Psor
    A.4.1Sponsor's protocol code numberEDP1815-201
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorEvelo Biosciences Inc.
    B.1.3.4CountryUnited States
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportEvelo Biosciences Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationEvelo Biosciences Inc.
    B.5.2Functional name of contact pointStuart Abel
    B.5.3 Address:
    B.5.3.1Street Address620 Memorial Drive, Suite 500
    B.5.3.2Town/ cityCambridge
    B.5.3.3Post codeMA 02139
    B.5.3.4CountryUnited States
    B.5.4Telephone number+44(0)779 626 8347
    B.5.6E-mailsabel@evelobio.com
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameEDP1815
    D.3.2Product code EDP1815
    D.3.4Pharmaceutical form Capsule, hard
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNPrevotella histicola
    D.3.9.2Current sponsor codeEDP1815
    D.3.9.4EV Substance CodeSUB196483
    D.3.10 Strength
    D.3.10.1Concentration unit Other
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number80000000000
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product Yes
    D.3.11.13.1Other medicinal product typeMonoclonal microbial (specific pure strain of Prevotella histicola)
    D.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboCapsule, hard
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Mild to Moderate Plaque Psoriasis
    E.1.1.1Medical condition in easily understood language
    Plaque psoriasis is a skin condition that causes red, flaky, crusty patches of skin covered with white scales.
    E.1.1.2Therapeutic area Diseases [C] - Skin and Connective Tissue Diseases [C17]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10071117
    E.1.2Term Plaque psoriasis
    E.1.2System Organ Class 100000004858
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Evaluate the efficacy of EDP1815 for the treatment of psoriasis following daily dosing for 16 weeks.
    E.2.2Secondary objectives of the trial
    • To evaluate the efficacy dose response of EDP1815 at Week 16
    • To evaluate the maximal clinical benefit of EDP1815 at Week 16
    • To evaluate the optimal dose of EDP1815 based on efficacy and safety up to Week 16
    • To evaluate the safety and tolerability of EDP1815 (all dose levels) throughout the study
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Give written informed consent (signed and dated) and any authorizations required by local law and be able to comply with all study requirements.
    2. Males or females ≥18 and ≤70 years old at the time of informed consent.
    3. A documented diagnosis of plaque psoriasis for ≥6 months.
    4. Have mild to moderate plaque psoriasis with plaque covering body surface area (BSA) of ≥3% and ≤10% and meet at least 1 of the following additional criteria:
    - a. PASI score of ≥6 and ≤15.
    - b. PGA score of 2 or 3.
    5. Meet the following contraception criteria:
    - a. Male participants:
    - i. A male participant must agree to use contraception as detailed in Appendix 13.1 of the study protocol during their participation in this study and for a period of 90 days after the last dose and refrain from donating sperm during this period.
    - b. Female participants: i. A female participant is eligible to participate if she is not pregnant (Appendix 13.1of the study protocol), not breastfeeding, and at least 1 of the following conditions applies:
    1. Not a WOCBP as defined in Appendix 13.1, OR
    2. A WOCBP who agrees to follow the contraceptive guidance in Appendix 13.1 during their participation in this study, 28 days prior to the first dose and for at least 1 complete menstrual cycle (≥ 28 days) after the last dose.
    6. Agrees to not increase their usual sun exposure during the study.
    E.4Principal exclusion criteria
    1. Have received EDP1815 within the 3 months prior to screening.
    2. Have a diagnosis of non-plaque psoriasis.
    3. Plaque psoriasis restricted to scalp, palms, and soles only.
    4. Evidence of skin conditions that would interfere with psoriasis evaluation or treatment response (eg, atopic dermatitis, fungal or bacterial superinfection).
    5. 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.
    6. 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).
    7. If prior biologic therapy and responsive, participants must have been off therapy for at least 12 months prior to first administration of study drug.
    8. 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, 1,25-dihydroxy vitamin D3 and analogues, psoralens, sulfasalazine, hydroxyurea, or fumaric acid derivatives) within 4 weeks of first administration of study drug.
    9. 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.
    10. Have used topical medications/treatments that could affect psoriasis or PGA evaluation (including [but not limited to] high- and mid-potency corticosteroids [Appendix 13.2], 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.
    11. Gastrointestinal tract disease (eg, short-bowel syndrome, diarrhea-predominant irritable bowel syndrome) that could interfere with GI delivery and transit time.
    12. Active inflammatory bowel disease.
    13. Active infection requiring systemic antiviral or antimicrobial therapy that will not be completed prior to Day 1 (Visit 2).
    14. Have received live or live attenuated vaccination within 6 weeks prior to screening or intend to have such a vaccination during the study.
    15. Clinically significant abnormalities in screening laboratory values that would render a participant unsuitable for inclusion (per investigator judgment).
    16. For women, serum creatinine ≥125 μmol/L (1.414 mg/dL); for men, serum creatinine ≥135 μmol/L (1.527 mg/dL).
    17. ALT and AST >2 × ULN.
    18. Known history of or positive test for HIV, or active infection with hepatitis C or chronic hepatitis B.
    19. 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]).
    20. In the opinion of the investigator, evidence of clinically important cardiac conduction abnormalities at screening as judged by ECG.
    21. Current acute or chronic inflammatory disease other than psoriasis or psoriatic arthritis (eg, inflammatory bowel disease, rheumatoid arthritis, systemic lupus erythematosus).
    22. Hypersensitivity to P histicola or to any of the excipients.
    23. 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.
    24. Any major or minor GI surgery within 6 months of screening.
    25. Any major surgery within 6 months of screening.
    26. 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.
    27. Treatment with another investigational drug, biological agent, or device within 1 month of screening, or 5 half-lives of investigational agent, whichever is longer.
    28. Initiating any OTC or prescription medication including vitamins, herbal supplements and nutraceuticals except acetaminophen/paracetamol and anti-histamines, within 14 days prior to baseline or anticipate 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).
    29. Blood donation of >100 mL within 30 days of screening or >499 mL within 12 weeks of screening.
    30. Unwillingness to comply with study procedures or unwillingness to cooperate fully with the investigator.
    31. Have any other conditions, which would make the participant unsuitable for inclusion or could interfere with the participant participating in or completing the study.
    E.5 End points
    E.5.1Primary end point(s)
    The effect of EDP1815 on the percent change in Psoriasis Area and Severity Index (PASI) score from baseline to Week 16
    E.5.1.1Timepoint(s) of evaluation of this end point
    Week 16
    E.5.2Secondary end point(s)
    • Mean percentage change from baseline in PASI Score at Weeks 4, 8, and 12.
    • Mean absolute change from baseline in PASI Score at Weeks 4, 8, 12, and 16
    • Achievement of PASI-50 at Weeks 4, 8, 12, and 16
    • Time to first achievement of PASI-50
    • Achievement of PASI-75, PASI-90 and PASI-100 at Week 16
    • Achievement of PGA of 0 or 1 with a ≥2-point improvement from baseline at Week 16
    • Achievement of PGA of 0 at Week 16
    • Mean percentage change from baseline in PGA×BSA at Weeks 4, 8, 12, and 16
    • Mean absolute change from baseline in PGA×BSA at Weeks 4, 8, 12, and 16
    • Mean percentage change from baseline in LSS at Weeks 4, 8, 12, and 16
    • Mean absolute change from baseline in LSS at Weeks 4, 8, 12, and 16
    • Mean percentage change from baseline in DLQI score at Weeks 4, 8, 12, and 16
    • Mean absolute change from baseline in DLQI score at Weeks 4, 8, 12, and 16
    • Mean percentage change from baseline in mNAPSI total score at Weeks 4, 8, 12, and 16
    •Mean absolute change from baseline in mNAPSI total score at Weeks 4, 8, 12, and 16
    •All adverse events and serious adverse events throughout the study
    E.5.2.1Timepoint(s) of evaluation of this end point
    Efficacy endpoints -Weeks 4, 8, 12, and 16
    Safety (AE and SAE) - throughout the study
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic Yes
    E.6.11Pharmacogenomic Yes
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial2
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned8
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA14
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Poland
    United Kingdom
    United States
    E.8.7Trial has a data monitoring committee No
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years0
    E.8.9.1In the Member State concerned months8
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years0
    E.8.9.2In all countries concerned by the trial months8
    E.8.9.2In all countries concerned by the trial days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 195
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 30
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state90
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 150
    F.4.2.2In the whole clinical trial 225
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    None
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2021-05-21
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-03-24
    P. End of Trial
    P.End of Trial StatusOngoing
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