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    Summary
    EudraCT Number:2022-001631-82
    Sponsor's Protocol Code Number:EDP2939-101
    National Competent Authority:Poland - Office for Medicinal Products
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2022-10-26
    Trial results View 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 number2022-001631-82
    A.3Full title of the trial
    A Phase 1/2, randomised, placebo-controlled study of EDP2939 in healthy
    volunteers and participants with moderate plaque psoriasis.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study to investigate EDP2939 in healthy volunteers and participants with moderate psoriasis.
    A.4.1Sponsor's protocol code numberEDP2939-101
    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 organisationPPD - Project Delivery
    B.5.2Functional name of contact pointMonika Deme
    B.5.3 Address:
    B.5.3.1Street AddressBornweg 12c
    B.5.3.2Town/ cityBennekom NL
    B.5.3.3Post code6721
    B.5.3.4CountryNetherlands
    B.5.4Telephone number+316300 37735
    B.5.6E-mailmonika.deme@ppd.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 nameEDP2939
    D.3.2Product code EDP2939
    D.3.4Pharmaceutical form Capsule
    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 INNNot yet assigned
    D.3.9.2Current sponsor codeEDP2939
    D.3.9.3Other descriptive nameEDP2939
    D.3.9.4EV Substance CodeSUB267909
    D.3.10 Strength
    D.3.10.1Concentration unit Other
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number3900000000000
    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 Yes
    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 No
    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
    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
    Moderate plaque psoriasis
    E.1.1.1Medical condition in easily understood language
    Psoriasis
    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
    • To demonstrate the superiority of EDP2939 compared to placebo on the proportion of participants with moderate plaque psoriasis achieving PASI-50
    E.2.2Secondary objectives of the trial
    • To evaluate the safety and tolerability of EDP2939 in participants with moderate plaque psoriasis
    • To evaluate the effect of EDP2939 on other measures of clinical efficacy in moderate plaque psoriasis
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Capable of giving signed informed consent as described in the protocol, which includes compliance with the requirements and restrictions listed in the ICF and in this protocol. Informed consent will be obtained prior to any screening procedures and in accordance with national, local, and institutional guidelines.
    2. Contraception:
    A male participant with a female partner of child-bearing potential must meet the criteria for acceptable contraception as detailed in the protocol during the study and for a period of 90 days after the last dose. All male participants must refrain from donating sperm during this period. A female participant is eligible to participate if she is not pregnant, not breastfeeding, and at least 1 of the following conditions applies:
    I. Not a woman of child-bearing potential, as defined in the protocol.
    OR
    II. A woman of child-bearing potential who agrees to follow the contraceptive guidance in the protocol during participation in this study, 28 days prior to the first dose and for at least 1 complete menstrual cycle (≥30 days) after the last dose
    3. Males or females aged 18 to 75 years, inclusive, at the time of signing the ICF.
    4. Body mass index of 18 to 35 kg/m2 inclusive.
    5. A documented diagnosis of plaque psoriasis, with a patient- or clinician-reported disease duration of at least 6 months prior to screening.
    6. Have plaque psoriasis meeting all of the following criteria at screening and baseline:
    a. PGA score of 3 (moderate), and
    b. BSA ≥5% and ≤20%, and
    c. PASI ≥5 and ≤20.
    E.4Principal exclusion criteria
    1. Participant has GI tract disease that could interfere with the GI delivery and transit time of EDP2939.
    2. Participant has an active infection or has had an infection requiring antibiotic treatment within 6 weeks prior to study intervention administration.
    3. Infection with HIV, HBV, or HCV; or known to be positive for HCV RNA or HbsAg.
    4. Participant has undergone major surgery within 3 months prior to screening or in whom major surgery is planned during study participation.
    5. History of neoplastic disease within 5 years of screening except for basal or squamous cell
    carcinoma of the skin or carcinoma in situ of the cervix that has been successfully treated.
    6. History of hypersensitivity or allergies to Prevotella or Prevotella-containing probiotics or any excipients in the IMP, or has a history of hypersensitivity or allergies to capsule shells.
    7. Participant has received live or live-attenuated vaccination within 6 weeks prior to screening or intends to have such a vaccination during the study. Non-live and non-replicating vaccines are permitted if administered at least 14 days before randomisation.
    8. Participant has received any investigational drug or experimental procedure within 90 days prior to randomisation.
    9. Previous participation in a clinical study of EDP1815.
    10. History of drug abuse or current regular use of illicit drugs or a history of alcohol abuse within 1 year prior to screening.
    11. Female participant who is pregnant, or plans to become pregnant during the study, or breastfeeding.
    12. Male participant who intends to donate sperm during the course of this study and for a period of 90 days after the last dose.
    13. Any other conditions, which, in the opinion of the investigator or sponsor, would make the participant unsuitable for inclusion.
    14. Plaque psoriasis limited to the scalp/ hands / feet.
    15. Psoriasis flare within 8 weeks prior to screening.
    16. Evidence of dermatologic conditions that, would interfere with psoriasis evaluation or the assessment of treatment response.
    17. Use of systemic immunosuppressive therapy, systemic medications that could affect psoriasis or its symptoms, or phototherapy within 28 days of randomisation.
    18. Treatment with topical medications that could affect psoriasis within 14 days of randomisation. Such topical medications would include, but are not limited to: corticosteroids, topical vitamin D derivatives, retinoids, tazarotene, pimecrolimus, and tacrolimus. Unmedicated emollients and moisturisers are not excluded and may be used throughout the study (but should be withheld on the day of study visits at which skin assessments of psoriasis are made by the investigator (e.g. PASI).
    19. Received any of the following:
    - Any cell-depleting agent, including rituximab, within 6 months prior to randomisation, or until lymphocyte cell counts return to normal, whichever is longer.
    - Any other biologic agent, within 6 months prior to randomisation.
    - Any other investigational drug within 3 months to randomisation.
    20. Screening laboratory values showing:
    - ALT or AST >2xULN.
    - Elevated serum creatinine, defined for women as serum creatinine ≥125 μmol/L (1.414 mg/dL) and for men, serum creatinine ≥135 μmol/L (1.527 mg/dL).
    - Other clinically significant abnormalities in screening laboratory values that in the opinion of the investigator would make a participant unsuitable for inclusion in the study.
    21. History of clinically significant acute cardiac or cerebrovascular event within 6 months before screening.
    22. Evidence of clinically important abnormalities at screening or baseline ECG.
    23. Active mental or psychiatric disorder, which, in the opinion of the investigator or sponsor, would make the participant unsuitable for inclusion or could interfere with the participant participating in or completing the study.
    24. Any serious conditions that would be anticipated to require the use of systemic corticosteroids or otherwise interfere with study participation or require active frequent monitoring.
    E.5 End points
    E.5.1Primary end point(s)
    • Efficacy endpoint: proportion of participants achieving PASI-50 at Week 16
    E.5.1.1Timepoint(s) of evaluation of this end point
    The primary endpoints will be evaluated at week 16.
    E.5.2Secondary end point(s)
    • Safety endpoints: AEs, SAEs, vital signs, safety laboratory tests, and ECGs
    Key secondary efficacy endpoints:
    • Proportion of participants achieving PASI-75 at Week 16
    • Proportion of participants achieving PGA 0 or 1 at Week 16
    Other secondary efficacy endpoints:
    • Proportion of participants achieving PASI-90 at Week 16
    • Proportion of participants achieving PASI-100 at Week 16
    • Mean percentage change in PASI from baseline at Week 16
    • Mean absolute change in PASI from baseline at Week 16
    • Mean percentage change in PGA*BSA from baseline at Week 16
    • Proportion of participants achieving a PGA*BSA-50 (at least 50% improvement) at Week 16
    • Proportion of participants achieving a PGA*BSA-75 (at least 75% improvement) at Week 16
    • Mean percentage change in BSA from baseline at Week 16
    • Proportion of participants achieving a BSA-50 at Week 16
    • Proportion of participants achieving a BSA-75 at Week 16
    • Proportion of participants achieving a BSA of 3% or less at Week 16
    • Mean absolute change in DLQI from baseline at Week 16
    • Proportion of participants achieving an improvement in DLQI of ≥4 points at Week 16, in those with a DLQI of ≥4 at baseline
    • Proportion of participants with a DLQI of 0 or 1 at Week 16
    • Mean absolute change in PP-NRS from baseline at Week 16
    • Proportion of participants achieving an improvement in PP-NRS of ≥4 points at Week 16, in those with a PP-NRS of ≥4 at baseline
    • Mean absolute change in EQ-PSO from baseline at Week 16
    • Mean absolute change in fatigue VAS from baseline at Week 16
    • Proportion of participants achieving an improvement in fatigue VAS of ≥3 points at Week 16 from baseline, in those with a score of ≥3 at baseline
    E.5.2.1Timepoint(s) of evaluation of this end point
    Timepoint of evaluation is week 16 for efficacy and week 20 for the safety endpoints.
    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 No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic Yes
    E.6.11Pharmacogenomic No
    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 No
    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 concerned14
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA21
    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
    Bulgaria
    Canada
    Poland
    United Kingdom
    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
    The end of the study is defined as the date of the last visit of the last participant in the study or the last scheduled procedure shown in the SoA
    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 months7
    E.8.9.1In the Member State concerned days23
    E.8.9.2In all countries concerned by the trial years0
    E.8.9.2In all countries concerned by the trial months10
    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: 135
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 11
    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 state75
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 90
    F.4.2.2In the whole clinical trial 146
    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 Decision2022-11-29
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2022-10-25
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2023-09-06
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