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    Summary
    EudraCT Number:2016-000196-24
    Sponsor's Protocol Code Number:402-C-1504
    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:2016-07-11
    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 number2016-000196-24
    A.3Full title of the trial
    A STUDY OF THE EFFICACY AND SAFETY OF BARDOXOLONE METHYL IN PATIENTS WITH CONNECTIVE TISSUE DISEASE-ASSOCIATED PULMONARY ARTERIAL HYPERTENSION
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A STUDY OF THE EFFICACY AND SAFETY OF BARDOXOLONE METHYL IN PATIENTS WITH CONNECTIVE TISSUE DISEASE-ASSOCIATED PULMONARY ARTERIAL HYPERTENSION
    A.3.2Name or abbreviated title of the trial where available
    CATALYST
    A.4.1Sponsor's protocol code number402-C-1504
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT02657356
    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 SponsorReata 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 supportReata Pharmaceuticals, Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationReata Pharmaceuticals, Inc.
    B.5.2Functional name of contact pointClinical Study Manager
    B.5.3 Address:
    B.5.3.1Street Address2801 Gateway Drive, Suite 150
    B.5.3.2Town/ cityIrving
    B.5.3.3Post codeTX 75063
    B.5.3.4CountryUnited States
    B.5.4Telephone number1972865-2202
    B.5.6E-mailErin.Collins@reatapharma.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 nameBardoxolone Methyl
    D.3.2Product code RTA 402
    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 INNbardoxolone methyl
    D.3.9.1CAS number 218600-53-4
    D.3.9.2Current sponsor codeRTA 402
    D.3.9.3Other descriptive nameBARDOXOLONE METHYL, CDDO-Me, CDDO-Methyl Ester, NSC 713200, Chemical Name: Oleana-1,9(11)-dien-28-oic acid, 2-cyano-3,12-dioxo-, methyl ester
    D.3.9.4EV Substance CodeSUB33044
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number2.5
    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.IMP: 2
    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 nameBardoxolone Methyl
    D.3.2Product code RTA 402
    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 INNbardoxolone methyl
    D.3.9.1CAS number 218600-53-4
    D.3.9.2Current sponsor codeRTA 402
    D.3.9.3Other descriptive nameBARDOXOLONE METHYL, CDDO-Me, CDDO-Methyl Ester, NSC 713200, Chemical Name: Oleana-1,9(11)-dien-28-oic acid, 2-cyano-3,12-dioxo-, methyl ester
    D.3.9.4EV Substance CodeSUB33044
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number5
    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 placeboCapsule
    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
    Connective Tissue Disease-Associated Pulmonary Arterial Hypertension (WHO Group I CTD-PAH)
    E.1.1.1Medical condition in easily understood language
    Connective tissue disease-associated pulmonary arterial hypertension (CTD-PAH)
    E.1.1.2Therapeutic area Diseases [C] - Cardiovascular Diseases [C14]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To assess the efficacy of bardoxolone methyl relative to placebo.
    E.2.2Secondary objectives of the trial
    To assess the safety of bardoxolone methyl relative to placebo
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    a) Pulmonary Function Testing and Diffusion Capacity (DLco) assessments.
    b) Additional PK testing.

    The diffusion capacity (DLco) assessment will be performed on a subset of sites.
    Similarly, although systemic exposure to bardoxolone methyl will be assessed in all patients, there will be a subgroup of patients that will participate on a more extensive PK testing.

    Although the protocol refers to these as "substudies" separate sub-study protocols were not created to describe the procedures.
    Please refer to study protocol section 9.10.12. for details of the Pulmonary Function Testing and Diffusion Capacity (DLco) testing and section 9.10.31. for details regarding the optional PK sub-study.

    DLCO Substudy Objective: Evaluate the diffusion capacity for carbon monoxide in patients enrolled at sites that have the capability to perform this assessment and agree to participate in the substudy.

    PK Substudy Objective: Collect additional serial blood samples to obtain more robust pharmacokinetic parameter estimates in patients that agree to participate in the substudy.
    E.3Principal inclusion criteria
    1. Adult male and female patients ≥ 18 to ≤ 75 years of age upon study consent;
    2. BMI > 18.5 kg/m2;
    3. Symptomatic pulmonary hypertension WHO/NYHA FC class II and III;
    4. WHO Group I PAH associated with connective tissue disease;
    5. Had a diagnostic right heart catheterization performed and documented within 36 months prior to Day 1 that confirmed a diagnosis of PAH according to all the following criteria:
    a. Mean pulmonary artery pressure ≥ 25 mm Hg (at rest);
    b. Pulmonary capillary wedge pressure (PCWP) ≤ 15 mm Hg;
    c. Pulmonary vascular resistance > 240 dyn•sec/cm5 or > 3 mm Hg/liter (L)/minute;
    6. Has BNP level ≤ 400 pg/mL;
    7. Had an average 6MWD ≥ 150 meters on two consecutive tests performed on different days prior to randomization, with both tests measuring within 15% of one another;
    8. Has been receiving no more than two (2) approved disease-specific PAH therapies. PAH therapy must have been at a stable dose for at least 90 days prior to Day 1. No additions or changes should be made to PAH therapies and doses should remain stable for the duration of the study;
    9. Has maintained a stable dose for 30 days prior to Day 1 if receiving any of the following therapies that may affect PAH: vasodilators (including calcium channel blockers), digoxin, L-arginine supplementation, or oxygen supplementation. No additions or changes should be made to therapies and doses should remain stable for the duration of the study;
    10. If receiving treatment for CTD with prednisone or any other drugs, doses must remain stablefor at least 30 days prior to Day 1 and for the duration of the study;
    11. Had pulmonary function tests (PFTs) within 90 days prior to Day 1 with total lung capacity ≥ 65% (predicted);
    12. Had a ventilation-perfusion (V/Q) lung scan, spiral/helical/electron beam computed tomography (CT), or pulmonary angiogram prior to Day 1 that shows no evidence of thromboembolic disease (i.e., should note normal or low probability for pulmonary embolism). If V/Q scan was abnormal (i.e., results other than normal or low probability), then a confirmatory CT or selective pulmonary angiography must exclude chronic thromboembolic pulmonary hypertension;
    13. Has adequate kidney function defined as an estimated glomerular filtration rate (eGFR) ≥ 45 mL/min/1.73 m2 as measured by the central lab;
    14. Willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures;
    15. Evidence of a personally signed and dated informed consent document indicating that the patient (or a legally acceptable representative) has been informed of all pertinent aspects of the study prior to initiation of any patient-mandated procedures.
    E.4Principal exclusion criteria
    1. Participation in other investigational clinical studies involving interventional products being tested or used in a way different from the approved form or when used for an unapproved indication within 30 days prior to Day 1;
    2. Initiation of an exercise program for cardio-pulmonary rehabilitation within 90 days prior to Day 1 or planned initiation during the study;
    3. Stopped receiving any PAH chronic therapy within 60 days prior to Day 1;
    4. Received a dose of prednisone > 20 mg/day (or equivalent dose if other corticosteroid) within 30 days prior to Day 1;
    5. Received intravenous (iv) or subcutaneous (sc) prostacyclin/prostacyclin analogues within 90 days prior to Day 1;
    6. Received intravenous inotropes within 30 days prior to Day 1;
    7. Has uncontrolled systemic hypertension as evidenced by sitting systolic blood pressure (BP) > 160 mm Hg or sitting diastolic BP > 100 mm Hg during Screening after a period of rest;
    8. Has systolic BP < 90 mm Hg during Screening after a period of rest;
    9. Has a history of clinically significant left-sided heart disease and/or clinically significant cardiac disease, including but not limited to any of the following: a. Congenital or acquired valvular disease if clinically significant apart from tricuspid valvular insufficiency due to pulmonary hypertension; b. Pericardial constriction; c. Restrictive or congestive cardiomyopathy; d. Left ventricular ejection fraction < 40% per echocardiogram (ECHO) within 90 days of Day 1; e. Symptomatic coronary artery disease within the last 3 years;
    10. Acutely decompensated heart failure within 30 days prior to Day 1, per investigator assessment;
    11. Has more than two of the following clinical risk factors for left ventricular diastolic dysfunction: a. Age > 65 years; b. BMI ≥ 30 kg/m2; c. History of systemic hypertension; d. History of type 2 diabetes; e. History of atrial fibrillation;
    12. History of atrial septostomy within 180 days prior to Day 1;
    13. History of uncontrolled obstructive sleep apnea;
    14. Has a history of portal hypertension or chronic liver disease, including hepatitis B and/or hepatitis C (with evidence of recent infection and/or active virus replication) defined as mild to severe hepatic impairment (Child-Pugh Class A-C);
    15. Serum aminotransferase (ALT or AST) levels > 1.5X the upper limit of normal (ULN) at Screening;
    16. Hemoglobin (Hgb) concentration < 8.5 g/dL at Screening;
    17. Diagnosis of Down syndrome;
    18. History of malignancy within 5 years prior to Screening, with the exception of localized skin or cervical carcinomas;
    19. Untreated or uncontrolled active bacterial, fungal, or viral infection;
    20. Known or suspected active drug or alcohol abuse, per investigator judgment;
    21. Use of Herbalife supplements within 14 days prior to Day 1;
    22. Use of inhaled nitric oxide within 7 days prior to Screening and Day 1 visits, excluding acute vasodilator testing during diagnostic cardiac catheterization;
    23. Major surgery within 30 days prior to Day 1 or planned to occur during the course of the study;
    24. Unwilling to practice acceptable methods of birth control (both males who have partners of childbearing potential and females of childbearing potential) during Screening, while taking study drug, and for at least 30 days after the last dose of study drug is ingested;
    25. Women who are pregnant or breastfeeding;
    26. Any disability or impairment that would prohibit performance of the 6MWT;
    27. Any abnormal laboratory level that, in the opinion of the investigator, would put the patient at risk by trial enrollment;
    28. Patient is, in the opinion of the investigator, unable to comply with the requirements of the study protocol or is unsuitable for the study for any reason;
    29. Known hypersensitivity to any component of the study drug;
    30. Unable to communicate or cooperate with the investigator because of language problems, poor mental development, or impaired cerebral function.
    E.5 End points
    E.5.1Primary end point(s)
    Change from baseline in six-minute-walk distance (6MWD) relative to placebo at week 24.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Six minute walk test will be performed at screening, baseline, weeks 4, 8, 16, 24, End of treatment (if applicable) and Follow-up visit (week 28). Change from baseline will be calculated by comparing results at Day 1 and Week 24.
    E.5.2Secondary end point(s)
    SECONDARY ENDPOINTS
    Time-to-first clinical improvement event consisting of a persistent change for any of the following:
    • Improvement by at least one WHO functional class.
    • Increase from baseline in 6 minute walk distance (6MWD) by at least 10%.
    • Decrease from baseline in creatine kinase (as a surrogate biomarker for muscle injury and inflammation) by at least 10%.

    OTHER
    Exploratory Efficacy Endpoints:
    Time-to-first clinical worsening event consisting of any of the following:
    • Persistent worsening of WHO functional class due to worsening pulmonary hypertension
    • Initiation of parenteral prostacyclin therapy due to worsening pulmonary hypertension
    • Heart/lung transplantation or atrial septostomy
    • All cause death

    Safety Endpoints:
    Frequency, intensity, and relationship to study drug of adverse events and serious adverse events, and change from baseline in the following assessments: physical examinations, vital sign measurements, 12-lead electrocardiograms (ECGs), clinical laboratory measurements, and weight.

    Additional Exploratory Endpoints
    Change from baseline in the following assessments: parameters assessed with an optional wearable activity monitor; Borg dyspnea index at termination of 6MWT; WHO/NYHA functional class (FC); quality of life (SF-36); autoantibody levels; number of digital ulcers in scleroderma patients; and proportion of scleroderma patients with no new digital ulcers.

    Pharmacokinetic Endpoints:
    Systemic exposure to bardoxolone methyl will be assessed in all patients. Additional blood sampling will be performed in a subset of patients for the purpose of obtaining more robust pharmacokinetic (PK) parameter estimates (e.g., AUC, Cmax, Tmax) for bardoxolone methyl in the CTD-PAH population.
    E.5.2.1Timepoint(s) of evaluation of this end point
    SECONDARY:
    Whenever clinical improvement is observed (time to improvement constitute the endpoint).
    Clinical exam and blood chemistry (including creatine kinase testing) will be performed at screening, baseline, weeks 1, 2, 4, 8, 16, 24, End of treatment (if applicable) and Follow-up visit (week 28).

    6 minute walk and assesment of dyspnea and fatigue will be performed at screening, baseline, weeks 4, 8, 16, 24, End of treatment (if applicable) and Follow-up visit (week 28).

    Other:
    Exploratory and Ancillary Study Measures and Time Points for Exploratory Efficacy, Safety, additional exploratory and Pharmacokinetics are detailed in the study protocol.
    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 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 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) 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 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 Information not present in EudraCT
    E.8.4 The trial involves multiple sites in the Member State concerned Information not present in EudraCT
    E.8.4.1Number of sites anticipated in Member State concerned2
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA24
    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
    Belgium
    Brazil
    Canada
    Chile
    Czech Republic
    Germany
    Ireland
    Israel
    Japan
    Mexico
    Netherlands
    Spain
    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 years2
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months3
    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: 117
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 13
    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 state5
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 44
    F.4.2.2In the whole clinical trial 130
    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)
    The Sponsor plans to execute an open-label extension study of patients that complete the base trial, are treatment-compliant and provide informed consent for this study. The protocol is not yet available; however, current expected design consider continuation of treatment until all patients are withdrawn from the trial (subject decision or medical reasons), lost to follow-up, die, or bardoxolone methyl becomes commercially available (whichever occurs first).
    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 Decision2016-08-18
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-10-17
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2020-05-07
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