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    Summary
    EudraCT Number:2017-000216-42
    Sponsor's Protocol Code Number:AC-065A404
    National Competent Authority:Germany - BfArM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2017-05-26
    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 ConcernedGermany - BfArM
    A.2EudraCT number2017-000216-42
    A.3Full title of the trial
    A multi-center, double-blind, placebo-controlled, Phase 4 study in patients with pulmonary arterial hypertension to assess the effect of selexipag on daily life physical activity and patient’s self-reported symptoms and their impacts
    Eine multizentrische, doppelblinde, placebokontrollierte Phase-4-Studie an Patienten mit pulmonal-arterieller Hypertonie zur Beurteilung der Wirkung von Selexipag auf die körperliche Aktivität im Alltagsleben sowie die vom Patienten selbst berichteten Symptome und deren Auswirkungen
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Daily life physical activity and disease symptoms assessed in patients with
    pulmonary arterial hypertension (PAH) treated with selexipag
    A.3.2Name or abbreviated title of the trial where available
    TRACE
    A.4.1Sponsor's protocol code numberAC-065A404
    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 SponsorActelion Pharmaceuticals Ltd
    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 supportActelion Pharmaceuticals Ltd.
    B.4.2CountrySwitzerland
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationActelion Pharmaceuticals Ltd
    B.5.2Functional name of contact pointGlobal Medical Affairs
    B.5.3 Address:
    B.5.3.1Street AddressGewerbestrasse 16
    B.5.3.2Town/ cityAllschwil
    B.5.3.3Post code4123
    B.5.3.4CountrySwitzerland
    B.5.6E-maillperchen@its.jnj.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 Yes
    D.2.1.1.1Trade name Uptravi
    D.2.1.1.2Name of the Marketing Authorisation holderJanssen-Cilag International NV
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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 nameSelexipag
    D.3.2Product code ACT-293987
    D.3.4Pharmaceutical form Film-coated 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 INNSelexipag
    D.3.9.2Current sponsor codeACT-293987
    D.3.9.3Other descriptive nameSELEXIPAG
    D.3.9.4EV Substance CodeSUB130805
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number200
    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 placeboFilm-coated tablet
    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
    Pulmonary arterial hypertension
    E.1.1.1Medical condition in easily understood language
    Pulmonary Arterial Hypertension is an increase in blood pressure in the
    pulmonary arteries leading to shortness of breath, dizziness, fainting
    and other symptoms.
    E.1.1.2Therapeutic area Diseases [C] - Cardiovascular Diseases [C14]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level PT
    E.1.2Classification code 10064911
    E.1.2Term Pulmonary arterial hypertension
    E.1.2System Organ Class 10038738 - Respiratory, thoracic and mediastinal disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To evaluate the effect of selexipag on daily life physical activity (DLPA)
    of patients with pulmonary arterial hypertension (PAH) as assessed by a
    wearable actigraphy device.
    E.2.2Secondary objectives of the trial
    • To evaluate the effect of selexipag on PAH symptoms and their impacts in patients’ daily life.
    • To evaluate the effect of selexipag on exercise capacity, and disease severity in patients with PAH.
    • To evaluate the safety and tolerability of selexipag in patients with PAH.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Male or female between 18 and 75 years old inclusive.
    - Women of childbearing potential must have a negative serum
    pregnancy test at planned visits and use an acceptable method of birth control from screening up to 30 days after study treatment
    discontinuation.
    - Symptomatic PAH belonging to one of the following subgroups only:
    . Idiopathic
    . Heritable
    . Drug or toxin induced
    . Associated with one of the following: connective tissue disease; HIV
    infection; corrected simple congenital heart disease.
    - With the following hemodynamic characteristics assessed by right
    heart catheterization (RHC) prior to randomization:
    . Mean pulmonary artery pressure (mPAP) ≥ 25 mmHg
    . Pulmonary vascular resistance (PVR) ≥ 240 dyn•sec/cm5 (or 3 Wood Units)
    . Pulmonary artery wedge pressure (PCWP) or left ventricular end-diastolic pressure (LVEDP) ≤ 15 mmHg.
    - Treatment with an endothelin receptor antagonist (ERA) for at least
    90 days and on a stable dose for 30 days prior to randomization.
    - Possible treatment with a Phosphodiesterase-5 inhibitor or sGC
    stimulator must be ongoing for at least 90 days and on a stable dose for 30 days prior to randomization.
    - WHO functional class (FC) II or III at randomization.
    - 6-minute walk distance (6MWD) ≥ 100 m at screening.
    - Ability to walk without a walking aid.
    - Valid baseline data for daily life physical activity (DLPA) and PAH-SYMPACT®.
    E.4Principal exclusion criteria
    - Patients on a PAH-specific monotherapy targeting the nitric oxide
    pathway (i.e. PDE-5 inhibitor or sGC stimulator).
    - Patients treated with prostacyclin, prostacyclin analog or selexipag at any time prior to Day 1.
    - Any hospitalization during the last 30 days prior to screening (Visit 1).
    - Severe coronary heart disease or unstable angina.
    - Documented severe hepatic impairment or severe renal insufficiency at screening (Visit 1).
    - Participation in a cardio-pulmonary rehabilitation program based on
    exercise training within 8 weeks prior to screening.
    - Any factor or condition likely to affect full participation in the study or compliance with the protocol (such as adherence to protocol mandated procedures), as judged by the investigator.
    E.5 End points
    E.5.1Primary end point(s)
    - Change from baseline to Week 24 / EOT in actigraphy-assessed daily life physical activity (DLPA) as measured by:
    . Daily time spent (minutes) in non-sedentary activity
    (> 100 activity counts per minute)
    . Percentage of daily time spent in non-sedentary activity (> 100 activity counts per minute)
    . Total DLPA in counts/min
    . Sleep variables: Total sleep time (minutes); wake after sleep onset (minutes); number of awakenings, sleep efficiency (percentage)
    E.5.1.1Timepoint(s) of evaluation of this end point
    Up to Week 24
    E.5.2Secondary end point(s)
    - Change from baseline to Week 24 / EOT for following PAH SYMPACT® domain scores:
    . Cardiovascular symptom domain score
    . Cardiopulmonary symptom domain score
    . Physical impact domain score
    . Cognitive/emotional impact domain score

    - Change from baseline to Week 24 / EOT for following variables:
    . WHO FC
    . 6MWD
    . Borg dyspnea index at 6MWT
    . N-terminal pro b-type natriuretic peptide (NT-proBNP)
    E.5.2.1Timepoint(s) of evaluation of this end point
    Up to Week 24
    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 No
    E.6.5Efficacy No
    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 Yes
    E.6.13.1Other scope of the trial description
    effect of selexipag on daily life physical activity of patients with pulmonary arterial hypertension
    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) No
    E.7.4Therapeutic use (Phase IV) Yes
    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 concerned6
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA16
    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
    Austria
    France
    Germany
    Ireland
    Netherlands
    Norway
    Portugal
    Sweden
    Switzerland
    United Kingdom
    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
    end of study telephone call 30 days after end of treatment of the last patient
    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 months8
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months8
    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 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: 80
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 20
    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 state15
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 40
    F.4.2.2In the whole clinical trial 100
    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 the patient’s study completion or premature withdrawal from the study, whichever applies, the investigator/delegate will explain to patients what treatment(s) / medical care is necessary and available according to local regulations.
    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 Decision2017-10-17
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2017-11-30
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2020-02-10
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