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    Summary
    EudraCT Number:2021-005206-10
    Sponsor's Protocol Code Number:PR200-104
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2022-02-02
    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 ConcernedSpain - AEMPS
    A.2EudraCT number2021-005206-10
    A.3Full title of the trial
    A Double Blind, Randomized, Placebo-Controlled Study to Evaluate the Efficacy and Safety of PRA023 in Subjects with Systemic Sclerosis Associated with Interstitial Lung Disease (SSc-ILD).
    Estudio doble ciego, aleatorizado y controlado con placebo para evaluar la eficacia y la seguridad de PRA023 en sujetos con esclerosis sistémica asociada a enfermedad pulmonar intersticial (ES-EPI).
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study of PRA023 in patients with Systemic Sclerosis Associated with Interstitial Lung Disease.
    Un estudio de PRA023 en pacientes con esclerosis sistémica asociada a enfermedad pulmonar intersticial (ES-EPI).
    A.3.2Name or abbreviated title of the trial where available
    The ATHENA-SSc-ILD Study.
    Estudio ATHENA-SSc-ILD.
    A.4.1Sponsor's protocol code numberPR200-104
    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 SponsorPrometheus Biosciences, 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 supportPrometheus Biosciences, Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationPrometheus Biosciences, Inc.
    B.5.2Functional name of contact pointClinical Operations
    B.5.3 Address:
    B.5.3.1Street Address9410 Carroll Park Drive
    B.5.3.2Town/ citySan Diego
    B.5.3.3Post codeCA 92121
    B.5.3.4CountryUnited States
    B.5.4Telephone number+34900834223
    B.5.6E-mailRegistroEspanolDeEstudiosClinicos@druginfo.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.3.2Product code PRA023
    D.3.4Pharmaceutical form Concentrate for solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNNot yet assigned
    D.3.9.2Current sponsor codePRA023
    D.3.9.3Other descriptive namePRA023
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number60
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    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 placeboSolution for infusion
    D.8.4Route of administration of the placeboIntravenous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Systemic sclerosis associated with interstitial lung disease.
    Esclerosis sistémica asociada a enfermedad pulmonar intersticial.
    E.1.1.1Medical condition in easily understood language
    Systemic sclerosis is a disease characterized by abnormal and excess fibrosis, a hardening of tissues and organs.
    La esclerosis sistémica es una enfermedad caracterizada por alteraciones y exceso de fibrosis, un endurecimiento de los tejidos y órganos.
    E.1.1.2Therapeutic area Diseases [C] - Immune System Diseases [C20]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.0
    E.1.2Level LLT
    E.1.2Classification code 10025109
    E.1.2Term Lung involvement in systemic sclerosis
    E.1.2System Organ Class 100000004855
    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 safety and tolerability of PRA023 in SSc-ILD.
    • To compare the annual rate of change from Baseline in forced vital capacity (FVC), of PRA023 vs. placebo over 50 weeks.
    • Evaluar la seguridad y la tolerabilidad de PRA023 en sujetos con ES-EPI.
    • Comparar la tasa anual de variación con respecto al momento basal de la capacidad vital forzada (FVC), entre PRA023 y placebo durante 50 semanas.
    E.2.2Secondary objectives of the trial
    • To compare the change from Baseline in FVC at Week 50.
    • To compare the change from Baseline in high-resolution computer tomography (HRCT) at Week 50.
    • To compare the annual rate of change in percent predicted FVC.
    • To compare proportion of subjects with an improvement in the American College of Rheumatology Combined Response Index in Systemic Sclerosis (ACR CRISS) score at Week 50.
    • Comparar la variación con respecto al momento basal de la FVC en la semana 50.
    • Comparar la variación con respecto al momento basal en tomografía computarizada de alta resolución (TCAR) en la semana 50.
    • Comparar la tasa anual de variación en porcentaje de valor teórico de la FVC.
    • Comparar la proporción de sujetos con mejoría en la puntuación ACR CRISS (Índice de respuesta combinada en la esclerosis sistémica del American College of Rheumatology) en la semana 50.
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    Skin Biopsy Substudy: to assess change in histology and protein expression.
    Pharmacokinetic Substudy: fully characterize PK of PRA023 in subjects with SSc-ILD.
    Subestudio de biopsia cutánea: para evaluar el cambio en la histología y la expresión de proteínas.
    Subestudio farmacocinético: caracterizar completamente la farmacocinética de PRA023 en sujetos con SSc-ILD.
    E.3Principal inclusion criteria
    1. Confirmed diagnosis of systemic sclerosis with onset of disease < or = 5 years ago.
    2. Diffuse cutaneous scleroderma.
    3. Systemic sclerosis related to interstitial lung disease confirmed by HRCT.
    4. FVC > or = 45% of predicted normal.
    5. Diffusing capacity of lung for carbon monoxide (DLCO) > or = 45% of predicted normal.
    6. Stable dosing of myocphenolate mofetil (MMF), methotrexate (MTX) or azathioprine, as well as corticosteroids.
    7. Able to provide written informed consent and understand and comply with the requirements of the study.
    1. Diagnóstico confirmado de esclerosis sistémica con aparición de la enfermedad < o = hace 5 años.
    2. Esclerodermia cutánea difusa.
    3. Esclerosis sistémica relacionada con enfermedad pulmonar intersticial confirmada mediante TCAR.
    4. FVC > o = 45% de lo normal previsto.
    5. Capacidad de difusión pulmonar del monóxido de carbono (DLCO) > o = 45% del valor teórico normal.
    6. Dosis estable de micofenolato mofetilo (MMF), metotrexato (MTX) o azatioprina, así como corticoides.
    7. Capacidad de otorgar el consentimiento informado por escrito y de comprender y cumplir con los requisitos del estudio.
    E.4Principal exclusion criteria
    1. WOCBP and men with female partners of childbearing potential who are unwilling or unable to use tow highly effective methods of contraception to avoid pregnancy for the entire study period and for up to 12 weeks after the last dose of study drug.
    2. Airway obstruction per pulmonary function test (PFT) or clinically significant pulmonary arterial hypertension.
    3. Current clinical diagnosis of another inflammatory connective tissue disease.
    4. Any active infections, a serious infection within the past 3 months, or chronic bacterial infection.
    5. Current smoker or smoking within 6 months of screening.
    6. Subjects in the opinion of the investigator that are at an unacceptable risk for participation in the study.
    7. Subjects who meet the protocol criteria for important laboratory exclusion criteria.
    1. MEF y varones con parejas en edad fértil que no se muestren dispuestos o no puedan utilizar dos métodos anticonceptivos muy eficaces para evitar el embarazo durante todo el período del estudio y hasta 12 semanas después de la última dosis del fármaco del estudio.
    2. Obstrucción de las vías respiratorias por prueba de función pulmonar (PFT) o hipertensión arterial pulmonar clínicamente significativa.
    3. Diagnóstico clínico actual de otra enfermedad inflamatoria del tejido conjuntivo.
    4. Cualquier infección activa, una infección grave en los últimos 3 meses o una infección bacteriana crónica.
    5. Fumador actual o fumador en los 6 meses previos a la selección.
    6. Sujetos para los que, en opinión del investigador, suponga un riesgo inaceptable la participación en el estudio.
    7. Sujetos que cumplan con los criterios del protocolo para criterios importantes de exclusión de laboratorio.
    E.5 End points
    E.5.1Primary end point(s)
    _ The proportion of subjects reporting adverse events (AEs), serious adverse events (SAEs), AEs leading to discontinuation, and markedly abnormal laboratory values.
    _ To compare the annual rate of change from Baseline in FVC.
    _ Proporción de sujetos que informaron eventos adversos (AE), eventos adversos graves (SAE), AEs que llevaron a la interrupción y valores de laboratorio marcadamente anormales.
    _ Comparar la tasa anual de variación desde el momento basal de la FVC.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Week 50.
    Semana 50.
    E.5.2Secondary end point(s)
    _To compare the change from Baseline in FVC.
    _To compare the annual rate of change in percent predicted FVC.
    _To compare the change from Baseline in HRCT.
    _To compare proportion of subjects with an improvement of the ACR CRISS score.
    _Comparar la variación con respecto al momento basal de la FVC.
    _Comparar la tasa anual de variación en porcentaje de valor teórico de la FVC.
    _Comparar la variación con respecto al momento basal en tomografía computarizada de alta resolución (TCAR).
    _Comparar la proporción de sujetos con mejoría en la puntuación ACR CRISS.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Week 50.
    Semana 50.
    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 Yes
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic Yes
    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 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 concerned9
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA39
    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
    Australia
    Belgium
    Canada
    France
    Germany
    Hungary
    Israel
    Italy
    Netherlands
    Norway
    Poland
    Spain
    Switzerland
    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
    UVUP
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    E.8.9.1In the Member State concerned months3
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years3
    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: 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 state16
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 61
    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)
    Subjects who complete the 50-week Treatment Period, irrespective of treatment assignment, will have the option to enter OLE starting at Week 54 visit, contingent upon the analysis of emerging safety and efficacy data in this patient population.
    Los sujetos que completen el periodo de tratamiento de 50 semanas, con independencia del tratamiento asignado, tendrán la opción de incorporarse a la ERA a partir de la visita de la semana 54 dependiendo del análisis de los datos de seguridad y eficacia que vayan surgiendo en esta población de pacientes.
    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 Decision2022-04-12
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2022-03-09
    P. End of Trial
    P.End of Trial StatusOngoing
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