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    Summary
    EudraCT Number:2017-000574-11
    Sponsor's Protocol Code Number:SHP647-304
    National Competent Authority:Lithuania - SMCA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2017-10-31
    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 ConcernedLithuania - SMCA
    A.2EudraCT number2017-000574-11
    A.3Full title of the trial
    A Phase 3 Long-term Safety Extension Study of SHP647 in Subjects with Moderate to Severe Ulcerative Colitis or Crohn’s Disease (AIDA)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Research study to determine whether an investigational drug, SHP647, is safe and effective long term in the treatment of moderate to severe Ulcerative Colitis or Crohn’s Disease (AIDA)
    A.3.2Name or abbreviated title of the trial where available
    AIDA
    A.4.1Sponsor's protocol code numberSHP647-304
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT03283085
    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 SponsorShire Human Genetic Therapies, 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 supportShire Human Genetic Therapies, Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationShire Human Genetic Therapies, Inc.
    B.5.2Functional name of contact pointHolly Oakley
    B.5.3 Address:
    B.5.3.1Street Address300 Shire Way
    B.5.3.2Town/ cityLexington
    B.5.3.3Post codeMA 02421
    B.5.3.4CountryUnited States
    B.5.4Telephone number0017818967560
    B.5.6E-mailholly.oakley@takeda.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.3.2Product code SHP647
    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 INNontamalimab
    D.3.9.2Current sponsor codeSHP647
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number75
    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.IMP: 2
    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.3.2Product code SHP647
    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 INNontamalimab
    D.3.9.2Current sponsor codeSHP647
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number25
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Ulcerative colitis or Crohn’s Disease
    E.1.1.1Medical condition in easily understood language
    Long-term condition that results in inflammation and ulcers of the colon and rectum or long-term condition that results in inflammation of the the gastrointestinal tract.
    E.1.1.2Therapeutic area Diseases [C] - Digestive System Diseases [C06]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.1
    E.1.2Level LLT
    E.1.2Classification code 10045365
    E.1.2Term Ulcerative colitis
    E.1.2System Organ Class 10017947 - Gastrointestinal disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10011401
    E.1.2Term Crohn's disease
    E.1.2System Organ Class 10017947 - Gastrointestinal disorders
    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 objective of the study is to evaluate the safety and tolerability of long-term treatment with ontamalimab in subjects with moderate to severe ulcerative colitis (UC) or Crohn's disease (CD).
    E.2.2Secondary objectives of the trial
    Secondary - Subjects with Ulcerative Colitis:
     To evaluate the maintenance of response to long-term treatment with
    ontamalimab as measured by clinical composite score and biomarkers,
    with or without endoscopy.
    Secondary - Subjects with Crohn's Disease:
     To evaluate the maintenance of response to long-term treatment with
    ontamalimab as measured by Crohn's Disease Activity Index (CDAI)
    score and biomarkers, with or without endoscopy.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Subjects with UC:
    1. Subjects and/or their parent or legally authorized representative must
    have an understanding, ability, and willingness to fully comply with
    study procedures and restrictions.
    2. Subjects must be able to voluntarily provide written, signed, and
    dated (personally or via a legally authorized representative) informed
    consent and/or assent, as applicable, to participate in the study.
    3. Subjects must have been enrolled previously in Study SHP647-301 or
    SHP647-302 and are in the treatment period of Study SHP647-303,
    completed the ET or Week 52 visit in the maintenance study SHP647-303, had responded to ontamalimab treatment (in the induction and/or
    maintenance studies), and meet one of the following criteria:
    o Subjects are on placebo at the maintenance study ET or Week 52 visit:
    they received ontamalimab in the induction studies and fulfilled the
    maintenance study response entry criteria, OR
    o Subjects have received ontamalimab at the maintenance study ET or
    Week 52 visit:
     Clinical composite score that has decreased by ≥2 points and ≥30%,
    with an accompanying decrease in the subscore for RB ≥1 point or a
    subscore for RB ≤1, compared to the baseline value for induction
    studies, AND/OR
     Composite score that has decreased by ≥30% and ≥3 points compared
    to the baseline value for induction studies.
    4. Subjects receiving any treatment(s) for UC described in Section 5.2.1
    are eligible provided they have been on a
    stable dose for the designated period of time.
    Subjects with Crohn's Disease
    1. Subjects and/or their parent or legally authorized representative must
    have an understanding, ability, and willingness to fully comply with
    study procedures and restrictions.
    2. Subjects must be able to voluntarily provide written, signed, and
    dated (personally or via a legally authorized representative) informed
    consent and/or assent, as applicable, to participate in the study.
    3. Subjects must have been enrolled previously in Study SHP647-305 or
    SHP647-306 and are in the treatment period of Study SHP647-307,
    completed the ET or Week 52 visit in maintenance study SHP647-307,
    had responded to ontamalimab treatment (in the induction and/or
    maintenance studies), and meet one of the following criteria:
    o Subjects are on placebo at the maintenance study ET or Week 52 visit:
    they received ontamalimab in the induction study and fulfilled the
    maintenance study response criteria, OR
    o Subjects have received ontamalimab at the maintenance study ET or
    Week 52 visit:
    • CDAI score that has decreased by ≥100 points at the end of treatment
    visit compared to the baseline value for induction studies, AND/OR
    • SES-CD that has decreased by ≥25% compared to the baseline value
    for induction studies.
    4. Subjects receiving any treatment(s) for CD described in Section 5.3.1
    are eligible provided they have been on a
    stable dose for the designated period of time.
    E.4Principal exclusion criteria
    Subjects with UC:
    1. Subjects who had major protocol deviation(s) (as determined by the
    sponsor) in Study SHP647-301, SHP647-302, or SHP647-303.
    2. Subjects who permanently discontinued investigational product
    because of an adverse event (AE), regardless of relatedness to
    investigational product, in Study SHP647-301, SHP647-302, or SHP647-
    303.
    3. Subjects who are likely to require major surgery for UC.
    4. Subjects are females who became pregnant during Study SHP647-301,
    SHP647-302, or SHP647-303, females who are lactating, females who
    are planning to become pregnant during the study period, or males or
    females of childbearing potential not agreeing to continue using
    appropriate contraception methods (ie, highly effective methods for
    female and medically appropriate methods for male study subjects)
    through the conclusion of study participation.
    5. Subjects who do not agree to postpone donation of any organ or
    tissue, including male subjects who are planning to bank or donate
    sperm and female subjects who are planning to harvest or donate eggs,
    for the duration of the study and through 16 weeks after last dose of
    investigational product.
    6. Subjects who, in the opinion of the investigator or the sponsor, will be
    uncooperative or unable to comply with study procedures.
    7. Subjects who have a newly-diagnosed malignancy or recurrence of
    malignancy (other than resected cutaneous basal cell carcinoma,
    squamous cell carcinoma, or carcinoma in situ of the uterine cervix that
    has been treated with no evidence of recurrence).
    8. Subjects who have developed any major illness/condition or evidence
    of an unstable clinical condition (eg, renal, hepatic, hematologic,
    gastrointestinal [GI] [except disease under study], endocrine,
    cardiovascular, pulmonary, immunologic [eg, Felty's syndrome], or local
    active infection/infectious illness) that, in the investigator's judgment,
    will substantially increase the risk to the subject if he or she participates
    in the study.
    9. Subjects with any other severe acute or chronic medical or psychiatric
    condition or laboratory or electrocardiogram (ECG) abnormality 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, would make the subject
    inappropriate for entry into this study.
    10. Subjects with known exposure to Mycobacterium tuberculosis (TB)
    since testing at screening in Study SHP647-301 or SHP647-302 and who
    have been advised to require treatment for latent or active disease, but
    who are without a generally accepted course of treatment.
    11. Subjects who are investigational site staff members or relatives of
    those site staff members or subjects who are sponsor employees directly
    involved in the conduct of the study.
    12. Subjects who are participating in other investigational studies (other
    than SHP647-301, SHP647-302, or SHP647-303) or plan to participate in
    other investigational studies during long-term extension study SHP647-
    304.
    Subjects with CD:
    1. Subjects who had major protocol deviation(s) (as determined by the
    sponsor) in Study SHP647-305, SHP647-306, or SHP647-307.
    2. Subjects who permanently discontinued investigational product
    because of an AE, regardless of relatedness to investigational product, in
    Study SHP647-305, SHP647-306, or SHP647-307.
    3. Subjects who are likely to require major surgery for CD or developed
    acute severe complications of CD (with or without fulfilling the
    treatment failure criteria in the maintenance study) that required
    immediate intervention (eg, need for immediate biologic treatment with
    proven effect) and/or CDAI score >450.
    4. Subjects are females who became pregnant during Study SHP647-305,
    SHP647-306, or SHP647-307, females who are lactating, females who
    are planning to become pregnant during the study period, or males or
    females of childbearing potential not agreeing to continue using
    appropriate contraception methods (ie, highly effective methods for
    female and medically appropriate methods for male study subjects)
    through the conclusion of study participation.
    5.,6.,7.,8.,9. - The same as for the subjects with UC
    10. Subjects with known exposure to TB since testing at screening in
    Study SHP647-305 or SHP647-306, and who have been advised to
    require treatment for latent or active disease, but who are without a
    generally accepted course of treatment.
    11. Subjects who are investigational site staff members or relatives of
    those site staff members or subjects who are sponsor employees directly involved in the conduct of the study.
    12. Subjects who are participating in other investigational studies (other
    than SHP647-305, SHP647-306, or SHP647-307) or plan to participate in
    other investigational studies during long-term extension study
    SHP647-304.
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint is assessment of safety as measured by: incidence and severity of AEs; incidence and nature of serious infections; actual values and change from baseline, as well as the incidence of abnormalities in laboratory tests, ECGs, and vital signs; and antidrug antibodies.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Please refer to section “Study Schedules” of the Protocol
    E.5.2Secondary end point(s)
    Secondary Endpoints – Subjects with Ulcerative Colitis:
    The secondary endpoint is as follows:
    • Treatment response over time, with response defined as clinical
    composite score that has decreased by ≥2 points and ≥30%, with an
    accompanying decrease in the subscore for RB ≥1 point or a subscore for
    RB ≥1 , and/or composite score that has decreased by ≥30% and ≥3
    points compared to the baseline value for induction studies.
    Secondary Endpoints – Subjects with Crohn's Disease:
    The secondary endpoint is as follows:
    • Treatment response over time, with response defined as CDAI score
    that has decreased by ≥100 points compared to the baseline value for
    induction studies and/or SES-CD that has decreased by ≥25% compared
    to the baseline value for induction studies.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Secondary endpoints will be summarized by treatment group using
    descriptive statistics at each assessment visit.
    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 No
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    Quality of Life
    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) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    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 No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    25 mg or 75 mg SHP647
    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 EEA364
    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
    Australia
    Bosnia and Herzegovina
    Colombia
    Lebanon
    Mexico
    Serbia
    South Africa
    Turkey
    Estonia
    Argentina
    Austria
    Belgium
    Brazil
    Bulgaria
    Canada
    Croatia
    Czechia
    Germany
    Greece
    Hungary
    Ireland
    Israel
    Italy
    Japan
    Korea, Republic of
    Lithuania
    Netherlands
    New Zealand
    Poland
    Portugal
    Romania
    Russian Federation
    Slovakia
    Spain
    Switzerland
    Ukraine
    United Kingdom
    United States
    France
    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
    The Study Completion Date is defined as the date the final subject, across all sites, completes their final protocol-defined assessment. Please note that this includes the follow-up visit or contact, whichever is later.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years4
    E.8.9.1In the Member State concerned months10
    E.8.9.1In the Member State concerned days25
    E.8.9.2In all countries concerned by the trial years4
    E.8.9.2In all countries concerned by the trial months10
    E.8.9.2In all countries concerned by the trial days25
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 Yes
    F.1.1Number of subjects for this age range: 247
    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) Yes
    F.1.1.6.1Number of subjects for this age range: 247
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 2158
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 48
    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 Yes
    F.3.3.7.1Details of other specific vulnerable populations
    Adolescents (16-17 years)
    F.4 Planned number of subjects to be included
    F.4.1In the member state39
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 967
    F.4.2.2In the whole clinical trial 2453
    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)
    Subjects will enter a 12-week safety follow-up period following the last
    dose of investigational product.
    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 Decision2018-01-30
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-01-23
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2023-12-13
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