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    Summary
    EudraCT Number:2016-001586-87
    Sponsor's Protocol Code Number:RSLV-132-04
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2016-07-06
    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 ConcernedUK - MHRA
    A.2EudraCT number2016-001586-87
    A.3Full title of the trial
    A Phase 2, Double Blind, Placebo Controlled Study of RSLV-132 in Subjects with Primary Sjogren’s Syndrome
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Phase 2 Study of RSLV-132 in Subjects with Sjogren’s Syndrome
    A.3.2Name or abbreviated title of the trial where available
    RSLV-132 in Primary Sjogren’s Syndrome
    A.4.1Sponsor's protocol code numberRSLV-132-04
    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 SponsorResolve Therapeutics, LLC
    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 supportResolve Therapeutics, LLC
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationResolve Therapeutics, LLC
    B.5.2Functional name of contact pointChief Executive Officer
    B.5.3 Address:
    B.5.3.1Street Address721 1st Ave. N.
    B.5.3.2Town/ citySt Petersburg, Florida
    B.5.3.3Post codeFL 33701
    B.5.3.4CountryUnited States
    B.5.4Telephone number001208727 7010
    B.5.6E-mailjp@resolvebio.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 nameRSLV-132
    D.3.4Pharmaceutical form Concentrate for solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    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 Yes
    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 placeboSolution for infusion
    D.8.4Route of administration of the placeboIntravenous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Primary Sjogrens Syndrome
    E.1.1.1Medical condition in easily understood language
    Sjogrens Syndrome
    E.1.1.2Therapeutic area Body processes [G] - Immune system processes [G12]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The primary endpoint of the study is to assess changes in blood cell gene expression or serum protein levels indicative of reduced inflammation in the active versus control groups.


    E.2.2Secondary objectives of the trial
    The secondary endpoints of the study are to assess the following parameters in the active versus control groups:

    •safety and tolerability;
    •Ro autoantibody levels;
    •total immunoglobulins;
    •complement levels (C3 & C4)
    •Erythrocyte Sedimentation Rate (ESR)
    •minor salivary gland histopathology
    •minor salivary gland interferon-stimulated gene expression;
    •disease activity (ESSDAI or PGA, Schirmer’s test, stimulated and unstimulated salivary flow);
    •patient-reported outcomes
    Additional exploratory evaluations may be considered as driven by the evolving understanding of the mechanism of action, technical feasibility, and any other clinical or immunological information that may become available during the course of the clinical study.
    Note: Additional exploratory endpoints will be specified in a separate laboratory manual and will be reported separately to the main safety, tolerability and efficacy endpoints of the study.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Subjects who meet all of the following criteria at Screening may be included in the study:
    1. Meet 4 of the 6 criteria (must include histopathology or autoantibodies) of the 2002 American-European Consensus Group (AECG) criteria for Primary Sjogren’s Syndrome

    2. Elevated levels of anti Ro-52 or anti Ro-60 antibodies (within laboratory positive range);

    3. Positive interferon signature (whole blood cell interferon signature metric >1);

    4. Stable medications used to treat Sjogren’s syndrome for the 30 days prior to the Baseline visit;

    5. Able to communicate and able to provide valid, written informed consent;

    6. Ages 18 to 85 inclusive;

    7. Minimum weight of 45 kg;

    8. Female participants shall be either of non-child-bearing potential (permanently sterilized by bilateral tubal occlusion, hysterectomy, or bilateral salpingectomy), or menopausal (more than one year since last menstrual cycle and confirmed by blood FSH levels > 22 mIU/mL) OR practicing highly effective contraception (e.g., oral (but not including progestogen-only oral contraceptives), injectable, implantable or transdermal contraceptives, a non-hormonal intrauterine device [IUD], an intrauterine hormone releasing system [IUS] a male sexual partner who agrees to use a male condom with spermicide; a sterile or vasectomized sexual partner) for at least 2 months prior to dosing and until 90 days following the End of Study. Female participants of child-bearing potential will also be required to have a negative serum pregnancy test [ß-hCG] at Screening and negative pregnancy urine test at Baseline. Female participants must agree not to donate eggs from the first dose until 90 days after the last dose.

    9. Male participants, who are not sterile or vasectomized, must agree to use a male condom with spermicide from the first dose until 90 days after the last dose. Male participants must also agree not to donate sperm from the first dose until 90 days after the last dose.
    E.4Principal exclusion criteria
    Any of the following will exclude potential subjects from the study:
    1. Previously diagnosed with systemic lupus, systemic sclerosis, or inflammatory myopathy

    2. Use of hydroxychloroquine within 30 days of Baseline;

    3. Use of cyclophosphamide within 180 days of Baseline;

    4. use of belimumab, abatacept, or TNF inhibitors wit Uin 90 days of Baseline;

    5. Use of rituximab within 6 months of Baseline (documentation of B-cell counts within the normal range for the reference laboratory is required for subjects within 1 year of rituximab usage)

    6. Use of oral corticosteroids equivalent to prednisone dose of >10 mg/day within 30 days of Baseline;

    7. Past head and neck radiation;

    8. Current untreated lymphoma at Baseline;

    9. Known IgG4-related disease

    10. Graft versus host disease

    11. The presence of a clinically significant infection in the judgement of the Investigator within seven days prior to the receipt of the first dose of study drug;

    12. Positive test for hepatitis B, C, or HIV at Screening;

    13. Participation in another clinical study with receipt of an investigational product within 3 months or 5 half- lives, of last administration (whichever is longer) from Baseline;

    14. Positive pregnancy test at Screening or Baseline;

    15. Female subjects currently breast feeding at Baseline;

    16. Inability or unwillingness to comply with protocol-specified procedures which, in the opinion of the Investigator, would make the subject unsuitable for study participation.
    E.5 End points
    E.5.1Primary end point(s)
    Changes in blood cell gene expression or serum protein levels indicative of reduced inflammation in the active versus control groups comparing Baseline with Day 99
    E.5.1.1Timepoint(s) of evaluation of this end point
    Day 99
    E.5.2Secondary end point(s)
    Changes in the following parameters in the active versus control groups between baseline and day 99:

    • Safety and tolerability;
    • Ro autoantibody levels;
    • Total immunoglobulins;
    • Complement levels (C3 & C4)
    • Erythrocyte sedimentation rate (ESR)
    • Minor salivary gland histopathology
    • Minor salivary gland interferon-stimulated gene expression;
    • Disease activity (ESSDAI or PGA, Schirmer’s test, stimulated and unstimulated salivary flow);
    • Patient-reported outcomes as measured by the following: ESSPRI, FACIT, Profile of fatigue, EQ-5D-L, Fatigue VAS, and Neuropsychological analysis scales;
    E.5.2.1Timepoint(s) of evaluation of this end point
    Day 99
    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 Yes
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    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 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 concerned2
    E.8.5The trial involves multiple Member States No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    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 years1
    E.8.9.1In the Member State concerned months6
    E.8.9.1In the Member State concerned 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: 22
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 6
    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 state28
    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 Decision2016-08-23
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-09-29
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2018-08-28
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