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    Summary
    EudraCT Number:2018-000305-23
    Sponsor's Protocol Code Number:BOS161721-02
    National Competent Authority:Bulgarian Drug Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2018-11-12
    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 ConcernedBulgarian Drug Agency
    A.2EudraCT number2018-000305-23
    A.3Full title of the trial
    A Randomized Double-Blind Phase 1b/2 Combined Staggered Multiple Dose Escalation Study of BOS161721 in Systemic Lupus Erythematosus (SLE) Patients on a Background of Limited Standard of Care
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Phase 1b/2 Study of BOS161721 in Systemic Lupus Erythematosus (SLE) Patients
    A.4.1Sponsor's protocol code numberBOS161721-02
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT03371251
    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 SponsorBoston Pharmaceuticals, 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 supportBoston Pharmaceuticals, Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationBoston Pharmaceuticals, Inc.
    B.5.2Functional name of contact pointKathleen V. Murphy
    B.5.3 Address:
    B.5.3.1Street Address55 Cambridge Parkway, Suite 400
    B.5.3.2Town/ cityCambridge, MA
    B.5.3.3Post code02142
    B.5.3.4CountryUnited States
    B.5.4Telephone number+16178260287
    B.5.6E-mailkat@bostonpharmaceuticals.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 nameBOS161721
    D.3.2Product code BOS161721
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSubcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNNot known
    D.3.9.1CAS number 2229685-51-0
    D.3.9.2Current sponsor codeBOS161721
    D.3.9.3Other descriptive nameIMMUNOGLOBULIN G
    D.3.9.4EV Substance CodeSUB20618
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number50
    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 injection
    D.8.4Route of administration of the placeboSubcutaneous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Systemic lupus erythematosus
    E.1.1.1Medical condition in easily understood language
    NA
    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 21.1
    E.1.2Level PT
    E.1.2Classification code 10042945
    E.1.2Term Systemic lupus erythematosus
    E.1.2System Organ Class 10028395 - Musculoskeletal and connective tissue disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Proof of Concept (POC) Phase 2 Primary Objective:

    To demonstrate a superior effect of BOS161721 at the chosen dose compared with placebo for response on the SRI-4.
    E.2.2Secondary objectives of the trial
    POC Phase 2 Secondary Objectives:

    To demonstrate a superior effect of BOS161721 at the chosen dose compared with placebo for response on clinical indicators of SLE activity, in adult patients with moderately to severely active SLE on limited background standard of care treatment.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Men and women, ages 18 to 70 years, inclusive
    2. Patients must be mentally capable of giving consent and there must
    be evidence of a personally signed and dated informed consent
    document indicating that the patient has been informed of all pertinent
    aspects of the study
    3. Patients must have SLE as defined by meeting 4 of the Systemic Lupus
    International Collaborating Clinics (SLICC) classification criteria for SLE
    (with at least 1 clinical and 1 immunologic criterion OR Lupus nephritis
    as the sole clinical criterion in the presence of antinuclear antibodies
    [ANA] or anti- double-stranded deoxyribonucleic acid [dsDNA]
    antibodies), either sequentially or simultaneously
    4. At screening, patients must have at least 1 of the following:
    a. Elevated ANA ≥ 1:80 via immunofluorescent assay at the central
    laboratory
    b. Positive anti-dsDNA or anti-Smith (Sm) above the normal level asdetermined by the central laboratory
    5. At screening, the total SLEDAI-2K score must be ≥ 8, including points
    from at least 1 of the following clinical components:
    a. Arthritis, rash, myositis, mucosal ulcers, pleurisy, pericarditis, and
    vasculitis
    Note: Points from lupus headache and organic brain syndrome will also
    be excluded from qualifying total and clinical SLEDAI-2K scores at
    screening and Day 0.
    6. A clinical SLEDAI-2K score of ≥ 6 at screening at Day 0. Clinical
    SLEDAI-2K score is defined as follows:
    a. Contains points from arthritis, rash, myositis, mucosal ulcers, pleurisy,
    pericarditis, or vasculitis
    b. Excludes parameters which require central laboratory results:
    hematuria, pyuria, urinary casts, proteinuria, positive anti-dsDNA,
    decreased complement, thrombocytopenia, and leukopenia
    Note: Points from lupus headache and organic brain syndrome will also
    be excluded from qualifying total and clinical SLEDAI-2K scores at
    screening and Day 0.
    7. Patients must have at least 1 qualifying A or 2Bs from the following
    manifestations of SLE, as defined by the BILAG criteria as modified for
    use in this study, which must be confirmed by the central data reviewer:
    a. BILAG A or B score in the mucocutaneous body system. If a BILAG B
    score is due to BILAG number 6, mild skin eruption, the CLASI activity
    score including erythema and scale/hypertrophy must be ≥ 3 excluding
    points from mucosal ulcers and alopecia.
    b. BILAG A or B score in the musculoskeletal body system due to active
    polyarthritis as defined in the protocol Section 4.4
    Note: Hips, shoulders, back, neck, and temporomandibular joints do not
    count towards the total number of joints with active synovitis.
    If only one "B" and no "A" score is present in the mucocutaneous body
    system or in the musculoskeletal body system due to arthritis, then at
    least 1 "B" must be present in at least 1 other body system for a total of
    2 "B" BILAG body system scores.
    8. Patients must be currently receiving at least 1 of the following:
    a. Administration for a minimum of 12 weeks, and a stable dose for at
    least 56 days (8 weeks prior to Day 0) of the following permitted
    steroid-sparing agents:
    i. Azathioprine (AZA), mycophenolate mofetil or mycophenolic acid,
    chloroquine, hydroxychloroquine, or methotrexate (MTX)
    b. If AZA, myocophenolate mofetil, mycophenolic acid,
    hydroxychloroquine, or MTX were discontinued prior to screening, the
    washout period must be ≥ 12 weeks.
    c. Corticosteroids (prednisone or prednisone-equivalent) at a stable dose
    of up to 30 mg/day for at least 6 weeks prior to Day 0 (see APPENDIX 3)
    i. For patients whose only SLE treatment is CSs, the stable CS dose must
    be ≥ 10 mg/day for at least 6 weeks prior to Day 0 and no more than 30
    mg/day at the time of randomization.
    ii. Topical steroids may be used, but the dose must be stable for at least
    6 weeks prior to Day 0. PRN topical steroids are not permitted.
    9. Women of childbearing potential (WOCBP; see Section 4.7 for full
    information regarding WOCBP, definition of menopause, and
    contraception):
    a. Must have a negative serum pregnancy test at screening. Urine
    pregnancy test must be negative prior to first dose
    b. Must not be breastfeeding
    c. Must agree to follow instructions for method(s) of contraception for
    the duration of treatment with study drug plus 52 weeks
    10. Men who are sexually active with WOCBP must agree to follow
    instructions for method(s) of contraception for the duration of treatment
    with study drug plus 52 weeks
    11. Patients must demonstrate willingness and ability to comply with the scheduled study visits, treatment plans, laboratory tests, and other
    procedures
    E.4Principal exclusion criteria
    1. Drug-induced SLE, rather than "idiopathic" SLE
    2. Other systemic autoimmune disease (eg, erosive arthritis, rheumatoid
    arthritis [RA], multiple sclerosis [MS], systemic sclerosis, or vasculitis
    not related to SLE)
    a. RA-Lupus overlap (Rupus), and secondary Sjögren syndrome are
    allowed
    3. Any major surgery within 6 weeks of study drug administration, (Day
    0), or any elective surgery planned during the course of the study
    4. Any history or risk for tuberculosis (TB) -please see the details in the
    protocol
    5. Active or unstable lupus neuropsychiatric manifestations, including
    but not limited to any condition defined by BILAG A criteria, with the
    exception of mononeuritis multiplex and polyneuropathy, which are
    allowed
    6. Severe proliferative lupus nephritis, (WHO Class III, IV), which
    requires or may require induction treatment with cytotoxic agents or
    high dose CS
    7. Concomitant illness that, in the opinion of the investigator or the
    sponsor or their designee, is likely to require additional systemic
    glucocorticosteroid therapy during the study, (eg, asthma), is
    exclusionary
    a. However, treatment for asthma with inhalational CS therapy is
    allowed
    8. Use or planned use of concomitant medication outside of standard of
    baseline treatment for SLE from Day -1 or for any time during the study
    9. Active and clinically significant infection (bacterial, fungal, viral, or
    other) within 60 days prior to first dose of study drug. Clinically
    significant is defined as requiring systemic parenteral antibiotics or
    hospitalization
    10. A history of opportunistic infection, or a history of recurrent or
    severe disseminated herpes zoster or disseminated herpes simplex
    within the last 3 years
    11. Chronic viral hepatitis including hepatitis B (HBV) and hepatitis C
    (HCV) unless patient received curative treatment for HCV and has a
    documented negative viral load, known human immunodeficiency virus
    (HIV), or acquired immunodeficiency syndrome (AIDS)-related illness
    12. Cryptosporidium in the stool sample at screening
    13. White blood cells (WBC) < 1,200/mm3 (1.2 × 109/L) at screening
    14. Absolute neutrophil count (ANC) < 500/mm3 at screening
    15. CD4+ count < 150/μL at screening
    16. Platelets < 50,000/mm3 (50 × 109/L) or < 35,000/ mm3 (35 ×
    109/L) if related to SLE, at screening
    17. Hemoglobin < 8 g/dL or < 7 g/dL at screening if related to SLE
    18. Proteinuria > 3.0 g/day (3000 mg/day) at screening or equivalent
    level of proteinuria as assessed by protein/creatinine ratio (3 mg/mg or
    339 mg/mmol)
    19. Serum creatinine > 2.0 mg/dL at screening or creatinine clearance
    (CrCL) < 40 ml/minute based on Cockcroft-Gault calculation
    20. Serum alanine aminotransferase (ALT) and/or serum aspartate
    aminotransferase (AST) > 2 × the upper limit of normal (ULN) at
    screening, unless explicitly related to lupus based on the investigator's
    judgment
    21. Creatinine kinase (CK) > 3.0 × ULN at screening unless related to
    lupus myositis
    22. Total bilirubin > 1.5 × ULN at screening (unless related to Gilbert's
    syndrome)
    23. Any other laboratory test results that, in the opinion of the
    Investigator or the sponsor or sponsor's designee, might place a patient
    at unacceptable risk for participating in this study
    24. History of allergic or anaphylactic reaction to any therapeutic or
    diagnostic mAb (eg, IgG protein) or molecules made of components of
    mAbs
    25. History substance and/or alcohol abuse, or dependence within the
    past 1 year, at the investigator's judgment
    26. History of cancer within the last 5 years (see protocol)
    27. Any other severe acute or chronic medical or psychiatric condition,
    including recent (within the past year) medical conditions (eg,
    cardiovascular conditions, respiratory illnesses) that may increase the
    risk associated with study participation or investigational product
    administration or may interfere with the interpretation of study results
    and, in the judgment of the investigator, sponsor or sponsor's designee,
    would make the patient inappropriate for entry into this study
    28. Investigational site staff members directly involved in the conduct of
    the trial and their family members, site staff members otherwise
    supervised by the investigator, or patients who are employees of the
    sponsor or directly involved in the conduct of the trial
    29. Currently participating in, or who have participated in other
    interventional (drug or device) clinical study within 30 days or 5 halflives
    of baseline, whichever is longer
    30. Recent (within the past 12 months) or active suicidal ideation or
    behavior based on patient responding "yes" to question 3, 4, or 5 on the
    C-SSRS
    31. Current or pending incarceration
    32. Current or pending compulsory detainment for treatment of either a
    psychiatric or physical (eg, infectious disease) illness
    33. Currently taking a total daily dose of > 30 mg morphine or morphine
    equivalent (see APPENDIX 7)
    34. Body mass index (BMI) ≥ 40.0
    E.5 End points
    E.5.1Primary end point(s)
    POC Phase 2 Primary (Efficacy) Endpoints:

    The proportion of patients with a SRI-4 response at Day 210.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Timepoints for evaluation of POC primary endpoints are listed in the endpoint description above.
    E.5.2Secondary end point(s)
    POC Phase 2 Secondary (Efficacy) Endpoints:
    • The proportion of patients with:
    - SRI-4 response at each visit
    - SRI-5 and SRI-6 response at each visit (Section 6.3.4.2)
    - a sustained reduction from baseline of oral corticosteroid (CS) (≤ 7.5
    mg/day and < Day 0 dose) between Day 150 and Day 210
    - new or recurrent BILAG flares (≥ 1 qualifying BILAG A or > 1 qualifying
    BILAG B) through Day 210
    - PGA worsening
    - a BICLA response
    - a CLASI response
    - medication failures
    • Results and changes from baseline in:
    - CLASI
    - Total number of swollen joints, tender joints, and active joints
    (swelling and tenderness in the same joint) in the ACR-28 joint count
    - SLEDAI-2K
    - SLICC/ACR damage index
    • Time to medication failure
    • Group mean percent reduction in corticosteroid administration from
    baseline Day 0 dose through Day 210 in patients receiving ≥ 7.5 mg/day
    prednisone equivalent at Day 0
    • Duration of longest SRI-4 response
    • Time to first SRI-4 response
    • Time to first BILAG flare (≥ 1 new or recurrent BILAG A or > 1 new or
    recurrent BILAG B) relative to baseline through Day 210
    E.5.2.1Timepoint(s) of evaluation of this end point
    Timepoints for evaluation of POC secondary endpoints are listed in the endpoint description above.
    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 Yes
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    Immunogenicity
    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 concerned4
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA20
    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
    Argentina
    Bulgaria
    Colombia
    Georgia
    Hungary
    Mexico
    Peru
    Philippines
    Poland
    Romania
    Ukraine
    United States
    E.8.7Trial has a data monitoring committee Yes
    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
    End of trial will be when last patient completes the safety follow-up visit at Day 270.
    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 months3
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months11
    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: 156
    F.1.3Elderly (>=65 years) No
    F.1.3.1Number of subjects for this age range: 0
    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 state16
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 37
    F.4.2.2In the whole clinical trial 156
    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 Decision2018-12-14
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-03-20
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2020-11-16
    The status of studies in GB is no longer updated from 1.1.2021
    For the UK, as from 1.1.2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI
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