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    Summary
    EudraCT Number:2016-003797-40
    Sponsor's Protocol Code Number:APD334-006
    National Competent Authority:Belgium - FPS Health-DGM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2016-10-28
    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 ConcernedBelgium - FPS Health-DGM
    A.2EudraCT number2016-003797-40
    A.3Full title of the trial
    A Phase 2a, Proof of Concept, Open-label Study Evaluating the Efficacy and Safety of Etrasimod (APD334) in Inflammatory Bowel Disease Patients with active Skin Extra-intestinal Manifestations
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A clinical study to investigate the effectiveness and safety of treatment with the drug APD334 in ulcerative colitis and crohn's disease patients with skin conditions
    A.4.1Sponsor's protocol code numberAPD334-006
    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.1.3.4CountrySwitzerland
    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 pointMagdalena Pirozek-Lawniczek
    B.5.3 Address:
    B.5.3.1Street AddressGotthardstrasse 3
    B.5.3.2Town/ cityZug
    B.5.3.3Post code6300
    B.5.3.4CountrySwitzerland
    B.5.4Telephone number+41415522682
    B.5.6E-mailmpirozek@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 nameAPD334
    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 INNNot yet available
    D.3.9.1CAS number 1206123 97 8
    D.3.9.2Current sponsor codeAPD334
    D.3.9.3Other descriptive nameAPD334
    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
    Active Skin Extra-Intestinal Manifestations in Inflammatory Bowel Disease.
    E.1.1.1Medical condition in easily understood language
    Skin Conditions associated with Inflammatory Bowel Disease.
    E.1.1.2Therapeutic area Diseases [C] - Digestive System Diseases [C06]
    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 objectives will be to determine the:

    a) Effect of Etrasimod (APD334) in Inflammatory Bowel Disease patients on the clinical improvement of active skin extraintestinal manifestation.

    b) Safety and tolerability profile of Etrasimod (APD334).
    E.2.2Secondary objectives of the trial
    Not applicable.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Men or women of age 18 to 80 years, inclusive.

    2. Able to give signed informed consent and willing and able to comply with the study requirements.

    3. Considered to be in stable health in the opinion of the investigator as determined by:
    a.) A pre-study physical examination with no clinically significant abnormalities unrelated to IBD.
    b.) Vital signs (VS) at screening: pulse rate ≥ 55 bpm, systolic blood pressure (SBP) ≥ 90, and diastolic blood pressure (DBP) ≥ 55 mmHg.
    c.) Liver function tests (ALT/AST, bilirubin and alkaline phosphatase) < 2x the upper limit of normal [ULN].
    d.) All other pre-study clinical laboratory findings within normal range, or if outside of the normal range are not deemed clinically significant in the opinion of the investigator.
    e.) 12-lead electrocardiogram (ECG) showing no clinically significant abnormalities in the opinion of the investigator (for confirmation please refer to exclusion criteria # 22).
    f.) A chest x- ray showing no evidence of active pulmonary disease (a chest x-ray taken within the previous 12 months from the screening visit may also be used).
    g.) Ophthalmology evaluation (by an ophthalmologist) without evidence of macular edema, supported with OCT where available (dependent on site capability) no later than 3 months prior to screening.

    4. Patients receiving stable treatment for IBD and EIM as defined in section 6.12 of protocol.

    5. Diagnosis of active psoriasis, erythema nodosum or pyoderma gangrenosum by Investigator assessments. After the enrollment of 10 patients with active EIM, patients with active psoriasis due to anti TNF-alpha therapy can also be included.

    6. Diagnosis of ulcerative colitis (UC) or Crohn’s disease (CD) established prior to screening by clinical and endoscopic evidence.

    7. Eligible female patients must be:
    a.) non-pregnant, evidenced by a negative serum human chorionic gonadotropin (hCG) pregnancy test at screening and a urine dipstick pregnancy test at Day 1.
    b.) non-lactating.
    c.) sexually abstinent (if this is the preferred and usual lifestyle of the individual). Periodic abstinence (calendar, symptothermal, post-ovulation methods), withdrawal (coitus interruptus), and lactational amenorrhoea method are not acceptable methods of contraception.
    d.) surgically sterile or postmenopausal or agree to continue to use an accepted method of birth control during and for at least 30 days after last study medication administration. Acceptable methods of birth control are:
    - combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation)
    o oral
    o intravaginal
    o transdermal
    - progestogen-only hormonal contraception associated with inhibition of ovulation
    o oral
    o injectable
    o implantable
    - intrauterine device (IUD)
    - intrauterine hormone-releasing system (IUS) patients should be consistently taking the hormonal contraceptive for at least 3 months [90 days] prior to screening);
    - surgical sterility for at least 6 months prior to screening for tubal ligation performed laparoscopically, hysterectomy and/or bilateral oophorectomy; and/or postmenopausal (defined as at least 2 years without menses).

    Contraceptive measures, such as Plan B (used after unprotected sex), are not acceptable methods of contraception for this study.

    8. Eligible male patients will either be:
    - surgically sterile (i.e., vasectomy), for at least 3 months (90 days) prior to screening
    or
    - when sexually active with a female partner, the partner must be either surgically sterile, postmenopausal, or agree to continue to use an
    accepted method of birth control during and for at least 30 days after last study medication administration as defined in 7 above. Please note that
    the use of condoms is an acceptable method of contraception for this study.

    9. Eligible male and female patients must agree not to participate in a conception process (i.e. active attempt to become pregnant or to impregnate, sperm donation, in vitro fertilization) for 30 days after the last dose of study drug.
    E.4Principal exclusion criteria
    1. Evidence of abdominal abscess or toxic megacolon at the screening visit.

    2. Patients with history of extensive colitis or pancolitis of > 8 years duration or left-sided colitis of > 12 years duration must have documented evidence that a surveillance colonoscopy was performed within 12 months of the initial screening visit (if not, the patient should undergo a colonoscopy in lieu of a flexible proctosigmoidoscopy during screening).

    3. Previous extensive colonic resection (subtotal or total colectomy).

    4. Current evidence of adenomatous colonic polyps that have not been removed.

    5. Current evidence of colonic mucosal dysplasia.

    6. Ileostomy, colostomy, or known fixed symptomatic stenosis of the intestine or stoma.

    7. Clinical significant infection as judged by the investigator in the previous 6 weeks before enrollment.

    8. Evidence of or treatment for C. difficile infection within 60 days or other intestinal pathogen within 30 days prior to
    randomization.

    9. Within 5 half-lives prior to randomization exposure to natalizumab or rituximab.

    10. Within 30 days prior to randomization, treatment of underlying disease other than those specifically listed in Section 6.12.

    11. Within 30 days or 5 half-lives (whichever is longer) prior to randomization receipt of any investigational agent.

    12. Currently require or are anticipated to require surgical intervention for IBD during the study.

    13. FEV1 or FVC < 80% of predicted values (i.e., abnormal).

    14. Infection with the Hepatitis B or C virus.

    15. Active or latent tuberculosis, regardless of treatment history, as evidenced by any of the following:
    a. History of tuberculosis (that has not been successfully treated)
    b. A positive diagnostic tuberculosis (TB) test within one month of randomization defined as a positive
    QuantiFERON® test or 2 successive indeterminate
    QuantiFERON tests
    c. Chest X-ray within 12 months of randomization in which active or latent pulmonary tuberculosis cannot be excluded.

    16. Any known history of congenital or acquired immunodeficiency (e.g., common variable immunodeficiency, human
    immunodeficiency virus [HIV] infection [ELISA and Western blot] test result, organ transplantation).

    17. Clinically significant extra-intestinal infection (e.g., pneumonia, pyelonephritis) within 30 days prior to randomization.

    18. Recent history (within 6 months of screening visit) of cardio or cerebrovascular disease, ACS, MI, unstable angina, CVA, TIA
    at screening.

    19. Any surgical procedure requiring general anesthesia within 30 days prior to randomization or plans to undergo major surgery
    during the study period.

    20. History of retinal macular edema.

    21. History of or signs and symptoms of progressive multifocal leukoencephalopathy (PML) as assessed by the PML checklist.

    22. History of cardiac arrhythmia, conduction system disease (including AV node dysfunction, 2nd or 3rd degree heart block,
    and sick sinus syndrome), or use of Class Ia and Class III antiarrhythmic agents, or baseline QTc ≥ 500 msec.

    23. Infection requiring hospitalization or intravenous antimicrobial therapy, or opportunistic infection within 4 weeks of screening.

    24. History of more than one episode of herpes zoster or any episode of disseminated zoster.

    25. Without documented positive varicella zoster virus (VZV) IgG antibody status or who have completed VZV vaccination within
    30 days prior to randomization.

    26. Receipt of live vaccine within 4 weeks prior to screening.

    27. History of lymphoproliferative disorder, lymphoma, leukemia, myeloproliferative disorder, or multiple myeloma.

    28. History of malignancy except for adequately treated basal cell skin cancer.

    29. History of severe allergic or anaphylactic reactions requiring medical attention.

    30. Current or recent history (within one year prior to randomization) of alcohol dependence or illicit drug use.

    31. History of clinically significant leukopenia or lymphopenia at screening.

    32. Active psychiatric problems that, in the investigator’s opinion, may interfere with compliance with the study procedures.

    33. History of any clinically significant medical condition that, in the investigator's opinion, would preclude participation in the
    study.

    34. Use of moderate to strong inhibitors of CYP2C9.

    35. History of severe renal or hepatic impairment.

    36. Inability to attend all the study visits or comply with study procedures.

    37. Prior exposure of etrasimod.
    E.5 End points
    E.5.1Primary end point(s)
    As this is a proof-of-concept study, all endpoints are exploratory.

    - UC endpoint: Change from baseline in stool frequency, rectal bleeding, PGA (Physicians Global Assessments) at weeks 1, 2, 4, 8 and 12.

    - CD endpoint: Change from baseline in disease activity score at week 1, 2, 4, 8 and 12.

    - Change from baseline in endoscopic improvement/histologic healing using endoscopy or flexible proctosigmoidoscopy (only if there are signs of inflammation at screening another
    evaluation will be performed at week 12).

    - Change from baseline in level of fecal calprotectin at week 4, 8 and 12.

    - Change from baseline in Physician Global Assessments for active skin extra-intestinal manifestations (PG, EN and psoriasis) at week 1, 2, 4, 8 and 12.

    - Change from baseline in Patients Global Assessments for active skin extra-intestinal manifestations (PG, EN and psoriasis) at week 1, 2, 4, 8 and 12.

    - Change from baseline in the Dermatology Life Quality Index (DLQI) score at week 1, 2, 4, 8 and 12.

    - Psoriasis endpoint only (all other endpoints are for all skin manifestations): Change from baseline in Psoriasis Area and Severity Index (PASI) score at week 1, 2, 4, 8 and 12.

    - Change from baseline in Inflammatory Bowel Disease Questionnaire (IBDQ) score at week 2, 4, 8 and 12.

    - Skin punch biopsies (from healthy skin and from target lesion) will be collected before treatment and at week 8 or 12. Immunohistochemistry and other analyzing methods such as RT-PCR will be performed to evaluate immune cell infiltration, cytokine expression in the skin and other inflammatory parameters.

    - Change from baseline in C - reactive protein (CRP) at Weeks 1, 2, 4, 8 and 12.

    - Chang from baseline in leucocyte characterization.

    - Change from baseline in lymphocyte counts at Weeks 1, 2, 4, 8 and 12.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Endpoints will be evaluated during visits at weeks 1, 2, 4, 8 and 12
    E.5.2Secondary end point(s)
    NA
    E.5.2.1Timepoint(s) of evaluation of this end point
    NA
    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 No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    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 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 Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA2
    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
    Belgium
    Germany
    United States
    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 years
    E.8.9.1In the Member State concerned months11
    E.8.9.1In the Member State concerned days
    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: 15
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 5
    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 state7
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 14
    F.4.2.2In the whole clinical trial 20
    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)
    After subjects have ended the participation in the trial, the subjects should be returned to the care of a physician and standard of care therapies, as required.
    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 Decision2016-11-21
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2017-02-23
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2017-10-02
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