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    Summary
    EudraCT Number:2018-003987-29
    Sponsor's Protocol Code Number:APD334-303
    National Competent Authority:Germany - BfArM
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2019-09-30
    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 ConcernedGermany - BfArM
    A.2EudraCT number2018-003987-29
    A.3Full title of the trial
    An Open-Label Extension Study 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
    An Open-Label Extension Study for Treatment of Moderately to Severely Active Ulcerative Colitis
    A.3.2Name or abbreviated title of the trial where available
    ELEVATE UC OLE
    A.4.1Sponsor's protocol code numberAPD334-303
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT03950232
    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 number0018582103647
    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
    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 safety of long-term administration of etrasimod in subjects with moderately to severely active ulcerative colitis (UC)
    E.2.2Secondary objectives of the trial
    To assess the long-term efficacy of etrasimod in subjects with moderately to severely active UC
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Must have met the eligibility criteria and have been enrolled in one of
    the two Phase 3 studies (APD334-301 or APD334-302) or other qualified
    region-specific studies and also meet the following additional criteria:
    a. Subjects previously enrolled in Study APD334-301 must have either:
    I. Completed the Week 12 visit whose UC condition in the opinion of the
    Investigator has not improved or has worsened, compared with baseline
    (Week 0/Day 1), may be eligible to enroll provided their ES is ≥ 2 and
    they meet one of the following entry criteria:
    • Rectal bleeding (RB) subscore ≥ 2 at 2 timepoints at least 7 days and
    no more than 14 days apart
    • RB + stool frequency (SF) subscore ≥ 4 at 2 timepoints at least 7 days
    and no more than 14 days apart
    • RB subscore ≥ 2 or RB + SF subscores ≥ 4 (in any order) at 2
    timepoints at least 7 days and no more than 14 days apart
    or
    II. Completed the Week 52 visit
    Note: For subjects discontinuing prior to Week 52, an endoscopic
    evaluation is required to confirm eligibility for the OLE. An endoscopy
    should be scheduled upon the appearance of UC symptoms but no more
    than 14 days after the second timepoint for entry criteria above. A
    proctosigmoidoscopy does not need to be repeated if performed within
    the last 4 weeks
    b. Subjects previously enrolled in APD334-302 must have completed the
    Week 12 visit
    2. Eligible women of childbearing potential must fulfill the following on
    Day 1:
    a. Have a negative urine beta-human chorionic gonadotropin (β-hCG)
    pregnancy test
    b. Not breastfeeding
    3. 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. A female of childbearing potential must agree to using a highly
    effective contraception method during treatment and for 30 days
    following treatment that can achieve a failure rate of less than 1% per
    year when used consistently and correctly.
    The following are considered highly effective birth control methods:
    - 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 participant 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). The reliability of sexual abstinence needs to be
    evaluated in relation to the duration of the clinical study and the
    preferred and usual lifestyle of the subject.
    Periodic abstinence (calendar, symptothermal, post-ovulation methods)
    is not acceptable.
    c. A male must agree to using condoms during treatment and for 4
    weeks following treatment.
    4. Ability to provide written informed consent or assent (parent or legal
    guardian must provide consent for a subject < 18 years of age or as
    required per local regulations who has assented to participate in the
    study) and to be compliant with the schedule of protocol assessments.
    Enrollment of subjects < 18 years should be conducted only if acceptable
    according to local laws and regulations.
    E.4Principal exclusion criteria
    Subjects who meet ANY of the following exclusion criteria will NOT be
    eligible for enrollment into the study:
    1. If the Investigator considers the subject to be unsuitable for any
    reason to participate in the OLE study
    Exclusions related to general health:
    2. Experienced an adverse event that led to discontinuation (except
    when such an event is related to UC flare) from parent study
    3. Day 1 pre-dose sitting vital sign assessment: heart rate (HR) < 50
    bpm OR systolic blood pressure (BP) < 90 mm Hg OR diastolic BP < 55
    mm Hg
    4. Day 1 pre-dose 12-lead ECG in the supine position showing a second
    or third-degree AV block, periods of asystole > 3 seconds, PR interval >
    200 ms, or Fridericia's corrected QT interval (QTcF) ≥ 450 ms (men) or
    QTcF ≥ 470 ms (women)
    5. Subjects requiring partial or tonal colectomy during the parent study
    6. Subjects requiring treatment with prohibited concomitant medications
    as defined in the parent study
    E.5 End points
    E.5.1Primary end point(s)
    • Incidence of treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs)
    • Incidence and severity of laboratory abnormalities, and change from baseline in laboratory values (hematology, serum chemistry, coagulation, and urinalysis)
    • Incidence of vital sign abnormalities and changes from baseline
    E.5.1.1Timepoint(s) of evaluation of this end point
    Week 2, 4, 8, 12, 24, 36, 52, 64, 76, 88, 104, 116, 128, 140, 156, 168, 180, 192, 2018, 220, 232, 244, 260, 2-week and 4-week Follow-up visit
    E.5.2Secondary end point(s)
    • The proportion of subjects achieving clinical remission at each of the
    following weeks: Week 52, 104, 156, 208, and 260, among subjects
    achieving clinical remission at study entry
    • The proportion of subjects achieving clinical response at each of the
    following weeks: Weeks 52, 104, 156, 208, and 260
    • The proportion of subjects achieving symptomatic remission at Weeks
    52, 104, 156, 208, and 260
    • The proportion of subjects achieving non-invasive clinical response at
    each of the following weeks: Weeks 12, 24, 36, 52, 104, 156, 208, and
    260
    • The proportion of subjects achieving clinical remission at the following
    weeks: Weeks 12, 52, 104, 156, 208, and 260, among subjects achieving
    clinical remission at study entry
    • The proportion of subjects achieving symptomatic response at Weeks
    12, 24, 36, 52, 104, 156, 208, and 260
    • Longitudinal change from both OLE and parent study baseline in SF,
    RB, and SF + RB at each of the following weeks: Weeks 12, 24, 36, 52,
    104, 156, 208, and 260
    • The proportion of subjects achieving endoscopic improvement at each
    of the following weeks: Weeks 52, 104, 156, 208, and 260
    E.5.2.1Timepoint(s) of evaluation of this end point
    Weeks 12, 24, 36, 52, 104, 156, 208, and 260
    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 No
    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 No
    E.8.1.1Randomised No
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    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 No
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial1
    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 concerned9
    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
    Argentina
    Australia
    Austria
    Belarus
    Belgium
    Brazil
    Bulgaria
    Canada
    Chile
    China
    Colombia
    Croatia
    Czech Republic
    Denmark
    Egypt
    Estonia
    France
    Georgia
    Germany
    Hungary
    India
    Israel
    Italy
    Japan
    Korea, Republic of
    Latvia
    Lebanon
    Lithuania
    Mexico
    Moldova, Republic of
    Netherlands
    Poland
    Portugal
    Romania
    Russian Federation
    Serbia
    Slovakia
    South Africa
    Spain
    Switzerland
    Taiwan
    Thailand
    Turkey
    Ukraine
    United Kingdom
    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
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years5
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years5
    E.8.9.2In all countries concerned by the trial months0
    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 Yes
    F.1.1Number of subjects for this age range: 25
    F.1.1.1In Utero No
    F.1.1.1.1Number of subjects for this age range: 0
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.2.1Number of subjects for this age range: 0
    F.1.1.3Newborns (0-27 days) No
    F.1.1.3.1Number of subjects for this age range: 0
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.4.1Number of subjects for this age range: 0
    F.1.1.5Children (2-11years) No
    F.1.1.5.1Number of subjects for this age range: 0
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.1.6.1Number of subjects for this age range: 25
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 607
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 70
    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 state54
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 290
    F.4.2.2In the whole clinical trial 702
    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 Decision2019-10-08
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-01-23
    P. End of Trial
    P.End of Trial StatusOngoing
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