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    Summary
    EudraCT Number:2018-003986-33
    Sponsor's Protocol Code Number:APD334-302
    National Competent Authority:Netherlands - Competent Authority
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2019-08-22
    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 ConcernedNetherlands - Competent Authority
    A.2EudraCT number2018-003986-33
    A.3Full title of the trial
    A Phase 3, Randomized, Double Blind, Placebo Controlled, 12 Week Study to Assess the Efficacy and Safety of Etrasimod in Subjects with Moderately to Severely Active Ulcerative Colitis
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study evaluating the efficacy and safety of Etrasimod in the treatment of patients with moderately to severely active Ulcerative Colitis
    A.3.2Name or abbreviated title of the trial where available
    ELEVATE UC 12
    A.4.1Sponsor's protocol code numberAPD334-302
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT03996369
    A.5.4Other Identifiers
    Name:IND numberNumber:125154
    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 SponsorArena 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 supportArena Pharmaceuticals Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationArena Pharmaceuticals, Inc.
    B.5.2Functional name of contact pointSnehal Naik
    B.5.3 Address:
    B.5.3.1Street Address6154 Nancy Ridge Drive
    B.5.3.2Town/ citySan Diego - CA
    B.5.3.3Post code92121
    B.5.3.4CountryUnited States
    B.5.4Telephone number001858210 3647
    B.5.6E-mailsnaik@arenapharm.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 nameEtrasimod
    D.3.2Product code APD334
    D.3.4Pharmaceutical form Tablet
    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 INNetrasimod L-arginine
    D.3.9.1CAS number 1206123-97-8
    D.3.9.2Current sponsor codeAPD334 L-arginine
    D.3.9.3Other descriptive nameAR401959 L-arginine
    D.3.9.4EV Substance CodeSUB171412
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number2
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    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 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 placeboTablet
    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
    Ulcerative Colitis
    E.1.1.1Medical condition in easily understood language
    Ulcerative Colitis, a form of inflammatory bowel disease.
    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 100000004856
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.1
    E.1.2Level LLT
    E.1.2Classification code 10045366
    E.1.2Term Ulcerative colitis, unspecified
    E.1.2System Organ Class 100000004856
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To assess the efficacy of etrasimod when administered for 12 weeks on clinical remission in subjects with moderately to severely active ulcerative colitis (UC).
    E.2.2Secondary objectives of the trial
    Secondary:
    The secondary objective is to assess the efficacy of etrasimod when administered for 12 weeks on clinical response, symptomatic response and remission, endoscopic changes, and mucosal healing in subjects with moderately to severely active UC.

    Safety:
    The safety objective is to assess the safety of etrasimod after daily doses of 2 mg for 12 weeks in subjects with moderately to severely active UC.

    Other:
    Other objectives include evaluation of etrasimod pharmacokinetics (PK) and the effect of etrasimod on health related subject reported outcomes and biomarkers.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Men, women and adolescents 16 to 80 years of age, inclusive, at the time of assent/consent. Enrollment of subjects < 18 years should be conducted only if acceptable according to local laws and regulations
    2. Ability to provide written informed consent or assent and to be compliant with the schedule of protocol assessments
    3. Diagnosed with UC ≥ 3 months prior to screening confirmed by endoscopic and histologic evidence
    4. Active UC confirmed by endoscopy with ≥ 10 cm rectal involvement. Subjects with proctitis only at baseline who meet the other eligibility criteria for inclusion, including the endoscopic and rectal bleeding criteria for moderate to severe disease,will be capped at 15% of the total subjects enrolled
    5. Moderately to severely active UC defined as MMS of 4 to 9, including an ES of ≥ 2 and RB score ≥ 1
    6. Received a surveillance colonoscopy within 12 months before baseline to rule out dysplasia in subjects with pancolitis > 8 years duration or subjects with left-sided colitis > 12 years duration. Subjects without a surveillance colonoscopy within the prior 12 months will have a colonoscopy at screening (ie, in place of screening proctosigmoidoscopy). Any adenomatous polyps must be removed prior to their first dose of study treatment
    7. Demonstrated an inadequate response to, loss of response to, or intolerance to at least 1 of the following therapies as defined below:
    Conventional therapy
    a. Corticosteroids
    b. Thiopurines
    Biologic therapy or JAK inhibitor therapy
    a. Antitumor necrosis factor alpha (TNFα) antibodies (eg, infliximab, adalimumab, golimumab, or biosimilars)
    b. Anti-integrin antibodies (eg, vedolizumab)
    c. Anti-Interleukin 12/23 antibodies (eg, ustekinumab)
    d. JAK inhibitors (eg, tofacitinib)
    8. Subjects are permitted to be receiving a therapeutic dose of the following drugs:
    • Oral 5 ASA compounds provided the dose has been stable for ≥ 2 weeks immediately prior to randomization
    • Oral corticosteroid therapy (prednisone at a stable dose ≤ 20 mg/day, budesonide at a stable dose ≤ 9 mg/day, or equivalent steroid) provided the dose has been stable for the 4 weeks immediately prior to the screening endoscopy assessment
    • Immunosuppressive agents such as oral azathioprine or 6 mercaptopurine must be discontinued ≥ 2 weeks prior to randomization
    • Probiotics (eg, Culturelle®, Saccharomyces boulardii) provided the dose has been stable for the 2 weeks immediately prior to randomization
    If oral 5-ASA or corticosteroids have been recently discontinued, they must have been stopped for at least 2 weeks prior to the endoscopy used for the baseline MMS.
    9. Adequate hematological function defined by white blood cell count ≥ 3.5 × 109/L with absolute neutrophil count (ANC) ≥ 1.5 × 109/L, lymphocyte count ≥ 0.8 × 109/L, platelet count ≥ 100 × 109/L, and hemoglobin ≥ 8 g/dL
    10. Adequate hepatic function defined by a total bilirubin level ≤ 1.5 × the upper limit of normal (ULN) range and aspartate aminotransferase (AST) and alanine aminotransferase (ALT) levels ≤2.0 × ULN. Subjects with an isolated total bilirubin and normal AST and ALT diagnosed with Gilbert's syndrome may participate
    11. Adequate renal function defined by an estimated glomerular filtration rate ≥ 30 mL/min/1.73 m2 by the Chronic Kidney Disease Epidemiology Collaboration equation at screening
    12. Females must meet either a or b of the following criteria and males must meet criterion c to qualify for the study:
    a. A female who is not of childbearing potential must meet 1 of the following:
    Postmenopausal, defined as no menses for 12 months without an alternative medical cause;
     Permanent sterilization procedure, such as hysterectomy, bilateral salpingectomy, or bilateral oophorectomy.
    b. Nonpregnant female of childbearing potential must agree to using a highly effective contraception method during treatment, and for 30 days following treatment. The following are considered highly effective birth control methods include:
    - Combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation, which may be oral, intravaginal, or transdermal
    - Progestogen only hormonal contraception associated with inhibition of ovulation, which may be oral, injected, or implanted
    - Intrauterine device (IUD)
    - Intrauterine hormone-releasing system
    - Bilateral tubal occlusion
    - Vasectomized partner, provided that partner is the sole sexual partner of the WOCBP trial subject and that the vasectomized partner has received medical assessment of the surgical success
    - Sexual abstinence (complete sexual abstinence defined as refraining from heterosexual intercourse for the entire period of risk associated with study treatments).
    c. A male subject with a pregnant or nonpregnant female of childbearing
    potential partner must agree to using condoms during treatment and for 4 weeks following treatment.
    E.4Principal exclusion criteria
    1.Severe extensive colitis evidenced by: Physician judgement that the subject is likely to require hospitalization for medical care or surgical intervention of any kind for UC (eg, colectomy) within 12w following randomization
    Current evidence of fulminant colitis, toxic megacolon or recent history (within last 6m) of toxic megacolon, or bowel perforation
    Previous total or partial colectomy
    2.Diagnosis of Crohn's disease (CD)/indeterminate colitis/the presence or history of a fistula consistent with CD
    3.Diagnosis of microscopic colitis, ischemic colitis, or infectious colitis
    4.Hospitalization for exacerbation of UC requiring IV steroids within 12w of screening
    5.Positive assay or stool culture for pathogens or positive test for Clostridioides difficile toxin at screening
    6.Pregnancy, lactation, or a positive serum β hCG measured during screening
    7.Clinically relevant neurological, endocrine, metabolic, psychiatric, cognitive impairment, alcohol/drug abuse/dependence, or other major systemic disease making implementation of the protocol or interpretation of the study difficult or would put the subject at risk
    8.Have any of following conditions or receiving treatments that may affect cardiovascular function:
    Myocardial infarction, unstable angina, stroke/transient ischemic attack, decompensated heart failure requiring hospitalization or Class III/IV heart failure ≤6 m prior to and during of the Screening Period
    History or presence of second-degree or third-degree atrioventricular block, sick sinus syndrome, or periods of asystole for >3 seconds without a functional pacemaker
    History or presence of recurrent symptomatic bradycardia or recurrent cardiogenic syncope
    Screening and W0/D1 prerandomization vital signs with a heart rate <50 bpm OR systolic blood pressure <90 mm Hg OR diastolic BP <55 mm Hg & Screening and W0/D1 prerandomization ECG with PR interval >200 ms or Fridericia's corrected QT interval QTcF ≥450 ms in men or ≥470 ms in women
    Start, stop, change or planned in dosage of any anti-arrhythmic drugs (Class I- IV) ≤1w before screening or 1w b4 or after randomization
    9.Forced expiratory volume at 1 second (FEV1) or forced vital capacity (FVC) < 70% of predicted values and FEV1/FVC ratio <0.70 at screening
    10.Uncontrolled diabetes as determined by hemoglobin A1c (HbA1c) > 9% at screening, or subjects with diabetes with significant comorbid conditions such as retinopathy
    11.History of macular edema/retinopathy
    12.History of TB, history of untreated or inadequately treated latent TB infection, active or latent TB infection at screening
    13.A clinically significant active infection ≤28d prior to randomization
    14.Have HIV/acquired immune deficiency syndrome or test positive for HIV antibodies
    15.Have acute or chronic hep B infection or test positive for hep B virus at screening (detectable HBV DNA/positive for hep B surface antigen/negative for HBsAg and positive for antihepatitis B core antibody in conjunction with detectable HBV DNA)
    16.Have current hepatitis C infection or test positive for hepatitis C virus
    17.History of an opportunistic infection or a history of disseminated herpes simplex or disseminated herpes zoster
    18.History of or currently active primary or secondary immunodeficiency
    19.History of cancer within the last 5y, including solid tumors and hematological malignancies (except basal cell and in situ squamous cell carcinomas of the skin that have been excised and resolved) or colonic mucosal dysplasia
    20.History of lymphoproliferative disorder, lymphoma, leukemia, myeloproliferative disorder, or multiple myeloma
    21.Hypersensitivity to etrasimod or any of the excipients or placebo compounds
    22.Prior treatment with sphingosine 1 phosphate receptor modulators
    23.Treatment with a biologic agent ≤8 w or a small molecule agent ≤5
    elimination half lives and detectable drug level prior to randomization
    24.Treatment with an investigational therapy ≤3 m prior to randomization
    25.Treatment with ≥3 biologic agents or ≥2 biologics plus a JAK inhibitor
    26.Treatment with topical rectal 5 ASA, short chain fatty acid enemas, or
    steroids ≤2w prior to &during screening
    27.Treatment with topical rectal traditional medicine (eg, Chinese
    medicine), herb enemas,or suppositories ≤2w prior to randomization
    28.Treatment with methotrexate within 8w of screening or cyclosporine, tacrolimus, sirolimus, or mycophenolate mofetil within 16 weeks of screening
    29. Receipt of a live vaccine within 4w prior to randomization
    30. Previous treatment with natalizumab
    31. Previous treatment with lymphocyte-depleting therapies
    32. Previous treatment with D penicillamine, or thalidomide, dimethyl fumarate, or pyrimidine synthesis inhibitors
    33. Treatment with IV immune globulin or plasmapheresis ≤3m prior to randomization
    34. Chronic use of therapies that moderately/strongly inhibit/induce cytochrome P450 (CYP) 2C8 and 2C9 metabolism and inhibitors of UGT1A7 ≤4w prior to randomization.
    E.5 End points
    E.5.1Primary end point(s)
    The primary efficacy endpoints will evaluate etrasimod versus placebo in:
    • The proportion of subjects achieving clinical remission at Week 12
    E.5.1.1Timepoint(s) of evaluation of this end point
    Week 12
    E.5.2Secondary end point(s)
    The key secondary efficacy endpoints are:
    • The proportion of subjects achieving endoscopic improvement at Week 12
    • The proportion of subjects achieving symptomatic remission at Week 12
    • The proportion of subjects with mucosal healing at Week 12

    The other secondary endpoints are:
    • The proportion of subjects achieving clinical response at Week 12
    • The proportion of subjects achieving endoscopic normalization at Week 12
    • The proportion of subjects achieving symptomatic remission at Weeks 2, 4, 8
    • The proportion of subjects achieving complete symptomatic remission at each study visit (Weeks 2, 4, 8, 12)
    • The proportion of subjects achieving noninvasive clinical response at each study visit (Weeks 2, 4, 8, 12)
    • The proportion of subjects achieving symptomatic response at each study visit (Weeks 2, 4, 8, 12)
    E.5.2.1Timepoint(s) of evaluation of this end point
    Weeks 2, 4, 8, and 12, and 2 & 4 weeks follow-up
    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 No
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic Yes
    E.6.12Pharmacoeconomic Yes
    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) 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 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 concerned3
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA253
    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
    Belarus
    Canada
    Chile
    Colombia
    Egypt
    Georgia
    India
    Israel
    Japan
    Korea, Republic of
    Lebanon
    Mexico
    Moldova, Republic of
    Russian Federation
    Serbia
    South Africa
    Thailand
    Turkey
    Ukraine
    United States
    Austria
    Belgium
    Bulgaria
    Croatia
    Denmark
    Estonia
    France
    Germany
    Hungary
    Italy
    Latvia
    Lithuania
    Netherlands
    Poland
    Portugal
    Romania
    Slovakia
    Spain
    Switzerland
    United Kingdom
    Czechia
    Argentina
    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
    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 months0
    E.8.9.1In the Member State concerned days15
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months6
    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: 10
    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: 10
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 290
    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 state8
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 126
    F.4.2.2In the whole clinical trial 330
    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. However eligible participants will be given the opportunity to enter an open label extension study (OLE) with etrasimod
    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 Decision2019-08-22
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-10-03
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2021-12-07
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