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    The EU Clinical Trials Register currently displays   42883   clinical trials with a EudraCT protocol, of which   7063   are clinical trials conducted with subjects less than 18 years old.
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    EudraCT Number:2019-002414-40
    Sponsor's Protocol Code Number:CXA-10-2302
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2019-10-24
    Trial results
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    A. Protocol Information
    A.1Member State ConcernedUK - MHRA
    A.2EudraCT number2019-002414-40
    A.3Full title of the trial
    A Phase 2, Multi-Center, Open-Label Study to Evaluate Long-term Safety and Efficacy of CXA-10 in Subjects with Pulmonary Arterial Hypertension on Stable Background Therapy: Extension to Study CXA-10-301.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    An extension study, at multiple study sites, for patients with Pulmonary Arterial Hypertension who took part in study CXA-10-301, to look at the continuing safety of CXA-10 and how well it works long term: all patients will receive CXA-10 treatment.
    A.3.2Name or abbreviated title of the trial where available
    Open label extension of CXA-10 in Pulmonary Arterial Hypertension
    A.4.1Sponsor's protocol code numberCXA-10-2302
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT04053543
    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 SponsorComplexa 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 support
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationComplexa Inc.
    B.5.2Functional name of contact pointCraig Pfister
    B.5.3 Address:
    B.5.3.1Street Address1055 Westlakes Drive, Suite 200
    B.5.3.2Town/ cityBerwyn, Pennsylvania
    B.5.3.3Post code19312
    B.5.3.4CountryUnited States
    B.5.4Telephone number0014843298432
    B.5.5Fax number0018552756340
    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 nameCXA-10
    D.3.2Product code CXA-10
    D.3.4Pharmaceutical form Capsule, hard
    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 INN10-nitro-9(E)-octadec-9-enoic acid
    D.3.9.1CAS number 88127-53-1
    D.3.9.2Current sponsor codeCXA-10
    D.3.9.4EV Substance CodeAS1
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number150 to mg
    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. cell therapy medicinal product No
    D. therapy medical product No
    D. Engineered Product No
    D. ATIMP (i.e. one involving a medical device) No
    D. 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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Pulmonary Arterial Hypertension (PAH).
    E.1.1.1Medical condition in easily understood language
    Patients with PAH have high pressure in the blood vessels between their heart and lungs. These have become narrow, so the heart works harder, leading to a weakened heart.
    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.1.2 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 Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The primary objective of this study is see if CXA-10, a new study drug, when taken long term by patients with pulmonary arterial hypertension (PAH), is safe, when patients are also taking regular doses of standard PAH therapy.

    The safety of CXA-10 on stable background therapy, and how well patients tolerate taking it, will be assessed by adverse event reporting (recording any unwanted symptom in a patient), including if patients experience a serious adverse or withdraw from the study due to an adverse event, and by performing and evaluating safety assessments throughout the study═ż vital signs (blood pressure, heart rate, breathing rate, and body temperature at baseline), Electrocardiograms (ECGs - that measure the electrical activity of the heart to show if it is working normally), laboratory safety tests on blood and urine samples, and physical examinations. The number of patients with changes in PAH therapies will also be considered.

    All patients on the study will receive the same
    E.2.2Secondary objectives of the trial
    The secondary objectives of this study look at safety and how well CXA-10 works.

    Safety will be asssessed by how many subjects have changes in PAH-specific medications, including any dose changes over the course of the study.

    To assess how well CXA-10 works, when taken long term by patients with pulmonary arterial hypertension (PAH), when patients are also taking regular doses of standard PAH therapy, the study will look at clinical measures used to assess PAH patients and if they improve.

    How well CXA-10 works will be assessed by changes in: measurements of the structure and function of the right ventricle (the chamber of the heart that pumps blood to the lungs) using MRI, how far a patient can walk in 6 minutes, PAH disease biomarker level (the biomarker naturally occurs in the blood and the amount of it shows changes in PAH), WHO functional classification (a study doctor will assess how PAH is effecting a patient's physical activity), patient questionnaires, and any clinical wors
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Evidence of a personally signed and dated informed consent document indicating subject has been informed of all pertinent aspects of the study prior to initiation of any study-required procedures.
    2. Is willing and able to comply with scheduled visits, treatment plan, laboratory tests and other study procedures.
    3. Has completed the CXA-10-301 study and demonstrated compliance with study medication administration and all study requirements.
    4. If receiving simvastatin-containing products: simvastatin (Zocor), Vytorin, or any other combination therapy containing simvastatin, simvastatin dose does not exceed 20 mg/day.
    5. Currently receiving no more than three of the following previously approved PAH therapies: phosphodiesterase type 5 (PDE-5) inhibitors, endothelin receptor antagonists (ERA), soluble guanylate cyclase (sGC) stimulator, prostanoids, prostacyclin receptor agonists.
    6. Women of childbearing potential and males with partners of childbearing potential must agree to use a reliable method of contraception while taking study medication. Acceptable methods of birth control are defined in the protocol.
    E.4Principal exclusion criteria
    1. Severe hypotension: systolic blood pressure <90 mmHg (sitting) at Baseline (Visit 1).
    2. Hypertensive: >160 mmHg systolic or >110 mmHg diastolic (sitting) at Baseline (V1).
    3. QTcF on supine ECGs at Baseline (V1) of >500 msec.
    4. Acute myocardial infarction or acute coronary syndrome (ST-Elevation Myocardial Infarction [STEMI], Non STEMI [NSTEMI] and or unstable angina) within the last 90 days prior to Baseline (V1).
    5. Recent cerebrovascular accident/transient ischemic attack (CVA/TIA) within the last 90 days prior to Baseline (V1).
    6. Recent hospitalization for left heart failure within the last 90 days prior to Baseline (V1).
    7. Clinically significant aortic or mitral valve disease defined as greater than mild regurgitation or mild stenosis; pericardial constriction; restrictive or constrictive cardiomyopathy; left ventricular dysfunction (LVEF < 50%); left ventricular outflow obstruction; symptomatic coronary artery disease; autonomic hypotension; or fluid depletion, in the opinion of the investigator.
    8. Chronic atrial fibrillation and life-threatening cardiac arrhythmias.
    9. Personal or family history of congenital prolonged QTc syndrome or sudden unexpected death due to a cardiac reason.
    10. Clinically significant anemia in the opinion of the investigator that precludes enrollment into this study, or Hb <9 gm/dl.
    11. Severe hepatic impairment (Child-Pugh class C with or without cirrhosis) at Baseline (V1) or active chronic hepatitis.
    12. Received intravenous inotropes within 2 weeks prior to Baseline (V1) (e.g. dopamine, dobutamine).
    13. History of angina pectoris or other condition that was treated with long or short acting nitrates <12 weeks of Baseline (V1).
    14. History of herbal or natural medication use (including fish oil) within 2 weeks or 5 half-lives, whichever is longer, prior to Baseline (V1).
    15. Received prednisone at doses >15 mg/ day or changes in immunosuppressive medications <12 weeks prior to Baseline (V1).
    16. Currently taking a drug that may affect the assay measurement of serum creatinine (e.g. cimetidine, Bactrim, Pyridium).
    17. Newly prescribed drug or increased dose of an existing drug that is known to prolong the QTc interval and has been associated with Torsades de Pointes (TdP) identified in the CredibleMeds.org website list as known risk (KR) of TdP.
    Note: Stable doses of drugs classified as conditional risk (CR) of TdP or possible risk (PR) of TdP are permitted (i.e., subject has received the same dose and regimen for at least 30 days prior to Baseline (V1) with no anticipated changes to the dose or regimen during the course of the study).
    18. Currently taking dimethyl fumarate (Tecfidera™).
    19. Any of the following laboratories abnormal and unresolved in CXA-10-301:
    a. Absolute lymphocyte counts < 0.5 x 10^9 cells/L.
    b. Aspartate aminotransferase and/or alanine aminotransferase > 3.0X upper limit of normal (ULN), alkaline phosphatase > 2X ULN of liver origin, and total bilirubin >2X ULN. If all liver function tests (LFTs) are within normal limits and total bilirubin is elevated, examination of direct and indirect bilirubin may be conducted to evaluate for Rotor’s/Gilbert’s Syndrome. Subjects with Rotor’s/Gilbert’s Syndrome may be enrolled.
    c. eGFR < 30 mL/min/1.73 m2 (estimated by Chronic Kidney Disease Epidemiology Collaboration [CKD-EPI] Creatinine/Cystatin C 2012 algorithm) at Baseline (Visit 1).
    20. Females who are pregnant or breastfeeding, or who are trying to conceive.
    21. Recent (within 1 year) history of abusing alcohol or illicit drugs.
    22. History of any primary malignancy, including a history of melanoma or suspicious undiagnosed skin lesions, or other malignancies (such as thyroid or testicular) that have been curatively treated and with no evidence of disease for at least 3 years or prostate cancer who is not currently or expected, during the study, to undergo radiation therapy, chemotherapy, and/or surgical intervention, or to initiate hormonal treatment.
    Exception: subjects with history of basal cell or squamous cell carcinomas of the skin or cervical carcinoma in situ are eligible for enrollment.
    23. Cardiovascular, liver, renal, hematologic, gastrointestinal, immunologic, endocrine, metabolic, central nervous system or psychiatric disease that, in the opinion of the investigator, may adversely affect the safety of the subject and/or efficacy of the investigational product or severely limit the lifespan of the subject other than the condition being studied.
    24. Clinically significant hyperthyroidism or hypothyroidism not adequately treated.
    25. Any other condition and/or situation that causes the Investigator to deem a subject unsuitable for the study
    26. Known hypersensitivity to CXA-10, the metabolites, or formulation excipients.
    27. Treatment with any investigational drug (other than CXA-10) or device within 30 days or 5 half-lives (whichever is longer) of baseline, or plan to do so during the study.
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoints will look at safety. These are:
    • Incidence of Adverse Events (AEs), Serious Adverse Events, and withdrawal due to AEs;
    • Changes in vital signs, 12-lead ECG, clinical laboratory tests, and physical
    examination findings over the course of the study.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Adverse Events, Serious Adverse Events, and withdrawal due to AEs will be collected throughout the study.

    Vital signs, 12-lead ECG, clinical laboratory tests, and physical examinations will be assessed at each clinic visit during the study.
    E.5.2Secondary end point(s)
    Secondary endpoints include measures of safety, efficacy, and exploratory endpoints.

    Safety will be asssessed by how many subjects have changes in PAH-specific medications, including any dose changes over the course of the study.

    Efficacy endpoints:
    • Change from baseline in the following structural and functional parameters as measured by CMRI: Right Ventricular Ejection Fraction (RVEF), Right and Left Ventricular End Diastolic and End Systolic Volume Index (RVEDVI, RVESVI, LVEDVI and LVESVI), Right and Left Stroke Volume Index (RVSVI & LVSVI), Right and Left Ventricular Mass Index (RVMI and LVMI), Left Ejection fraction (LVEF) and Ventricular-vascular coupling estimate (RV SVI/RV ESVI) at 6 months;
    • Change from baseline in 6-minute walk distance (6MWD) over the course of the study;
    • Change from baseline in serum N-Terminal Pro-B-Type Natriuretic Peptide (NT proBNP) over the course of the study;
    • Change from baseline in WHO Classification of Functional Status of Patients with PH over the course of the study;
    • Change from baseline in Patient Reported Outcome (PRO) instrument Pulmonary Arterial Hypertension – Symptoms and Impact (PAH-SYMPACT®) Questionnaire over the course of the study;
    • Change from baseline in Borg Dyspnea Index (BDI) immediately following exercise over the course of the study; and
    • Clinical worsening.

    Exploratory endpoints are pharmacodynamic measures:
    • Additional cardiac parameters as measured by CMRI as appropriate; and
    • Lipids (triglycerides, total cholesterol, low-density lipoprotein [LDL], high-density lipoprotein [HDL]), Fasting blood glucose (FBG), insulin, FBG/insulin ratios, hemoglobin A1c (where appropriate), serum leptin and serum uric acid.
    E.5.2.1Timepoint(s) of evaluation of this end point
    How many subjects have changes in PAH-specific medications, including any dose changes, will be assessed throughout the study.

    The Cardiac MRI is performed at 6 months.
    The 6-minute walk test, WHO Classification of Functional Status, PAH-SYMPACT® Questionnaire, BDI Questionnaire and Clinical worsening are performed each clinic visit.
    The test for NT proBNP is performed on each clinic visit that the patients are receiving study medication.
    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 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 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. 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 No
    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.8.3 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 No
    E.8.5.1Number of sites anticipated in the EEA0
    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
    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
    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 months7
    E.8.9.1In the Member State concerned days15
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months2
    E.8.9.2In all countries concerned by the trial days6
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1Number of subjects for this age range: 0
    F.1.1.1In Utero No
    F. of subjects for this age range: 0
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F. of subjects for this age range: 0
    F.1.1.3Newborns (0-27 days) No
    F. of subjects for this age range: 0
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F. of subjects for this age range: 0
    F.1.1.5Children (2-11years) No
    F. of subjects for this age range: 0
    F.1.1.6Adolescents (12-17 years) No
    F. of subjects for this age range: 0
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 85
    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 No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    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 state25
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 25
    F.4.2.2In the whole clinical trial 115
    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)
    There is no intention to provide additional treatment beyond 6-months at this time.
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2019-12-16
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-12-17
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2020-08-12
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