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    Summary
    EudraCT Number:2021-006271-42
    Sponsor's Protocol Code Number:HZNP-HZN-825-302
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2022-11-21
    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 ConcernedItaly - Italian Medicines Agency
    A.2EudraCT number2021-006271-42
    A.3Full title of the trial
    A Multicenter, Open-label Extension Trial to Evaluate the Efficacy, Safety and Tolerability of HZN-825 in Patients with Diffuse Cutaneous Systemic Sclerosis.
    Studio multicentrico, di estensione in aperto per valutare l'efficacia, la sicurezza e la tollerabilità di HZN-825 in pazienti con sclerosi sistemica cutanea diffusa.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Open-label Study to Evaluate the Efficacy, Safety, Tolerability of HZN-825 in Patients with Diffuse Cutaneous Systemic Sclerosis.
    Studio in aperto per valutare l'efficacia, la sicurezza e la tollerabilità di HZN-825 in pazienti con sclerosi sistemica cutanea diffusa.
    A.3.2Name or abbreviated title of the trial where available
    HZNP-HZN-825-302
    HZNP-HZN-825-302
    A.4.1Sponsor's protocol code numberHZNP-HZN-825-302
    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 SponsorHORIZON THERAPEUTICS IRELAND DAC
    B.1.3.4CountryIreland
    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 supportHorizon Therapeuthics USA, Inc
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationHorizon Therapeutics U.S.A, Inc
    B.5.2Functional name of contact pointFarah Ali
    B.5.3 Address:
    B.5.3.1Street Address1 Horizon Way
    B.5.3.2Town/ cityDeerfield, IL
    B.5.3.3Post code60015
    B.5.3.4CountryUnited States
    B.5.4Telephone number0012243833050
    B.5.5Fax number000000000000000000000000
    B.5.6E-mailfali@horizontherapeutics.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 Yes
    D.2.5.1Orphan drug designation numberEU/3/13/1108
    D.3 Description of the IMP
    D.3.1Product nameHZN-825
    D.3.2Product code [HZN-825]
    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.3.9.2Current sponsor codeHZN-825
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number150
    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 Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    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
    Diffuse Cutaneous Systemic Sclerosis
    Sclerosi sistemica cutanea diffusa
    E.1.1.1Medical condition in easily understood language
    Disease characterized by skin hardening (fibrosis) and problems in many organs of the body.
    Malattia caratterizzata da indurimento cutaneo (fibrosi) e problemi in molti organi del corpo.
    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 10042953
    E.1.2Term Systemic sclerosis
    E.1.2System Organ Class 100000004859
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The overall objective is to investigate the efficacy, safety and tolerability of HZN-825, a selective antagonist of LPAR1, administered BID to subjects with diffuse cutaneous SSc in a 52-week open-label extension following completion of the randomized, double-blind, 52-week clinical trial (HZNP-HZN-825-301). The primary efficacy objective is to assess the efficacy of 52 weeks of open-label treatment with HZN-825 in subjects with diffuse cutaneous SSc, as measured by change from both Baselines in FVC % predicted. The primary safety objective is to examine the safety and tolerability of 52 weeks of open-label treatment with HZN-825 as assessed by AEs and SAEs from Day 1 to 4 weeks after last dose.
    L'obiettivo generale è studiare l'efficacia, la sicurezza e la tollerabilità di HZN-825, un antagonista selettivo di LPAR1, somministrato due volte al giorno (BID) a soggetti con SSc cutanea diffusa in un'estensione in aperto di 52 settimane dopo il completamento dello studio clinico randomizzato, in doppio cieco, di 52 settimane (HZNP-HZN-825-301).
    L'obiettivo primario di efficacia è valutare l'efficacia di 52 settimane di trattamento in aperto con HZN-825 in soggetti con SSc cutanea diffusa, misurata dalla variazione rispetto a entrambe le baseline nella percentuale di CVF prevista. L'obiettivo primario di sicurezza è esaminare la sicurezza e la tollerabilità di 52 settimane di trattamento in aperto con HZN-825 secondo la valutazione di eventi avversi (AE) ed eventi avversi gravi (SAE) dal Giorno 1 a 4 settimane dopo l'ultima dose.
    E.2.2Secondary objectives of the trial
    The exploratory objectives are to evaluate the following after 52 weeks of open-label treatment with HZN-825:
    • Change from both Baselines in HAQ-DI; Physician Global Assessment
    (MDGA); Patient Global Assessment (PTGA); the Physical Effects and
    Physical Limitations subscales of the scleroderma skin patient-reported outcome (SSPRO-18); the mRSS; American College of Rheumatology-Composite Response Index in Systemic
    Sclerosis (ACR-CRISS), among others as indicated in protocol section 8.2.
    • The PK of HZN-825 and metabolite(s)
    Gli obiettivi esplorativi sono valutare quanto segue dopo 52 settimane di trattamento in aperto con HZN-825:
    • Variazione rispetto a entrambe le baseline in HAQ-DI; valutazione globale del medico (MDGA); valutazione globale del paziente (PTGA); le sottoscale relative agli effetti fisici e alle limitazioni fisiche dell'esito riferito dal paziente affetto da sclerodermia cutanea (SSPRO-18); l'mRSS; Indice di risposta combinato dell'American
    College of Rheumatology nella sclerosi sistematica (ACR-CRISS), tra gli altri come indicato nella sezione 8.2 del protocollo.
    • La farmacocinetica (PK) di HZN-825 e uno o più metaboliti
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Written informed consent.
    2. Completed the double-blind Treatment Period (Week 52) in Trial HZNP-HZN-825-301; subjects prematurely discontinued from trial drug in Trial HZNP-HZN-825-301 for reasons other than safety or toxicity can
    be included at the discretion of the Investigator after completing Trial HZNP-HZN-825-301 scheduled visits, including Week 52 assessments.
    3. Willing and able to comply with the prescribed treatment protocol and evaluations for the duration of the trial.
    1. Consenso informato scritto.
    2. Completamento del periodo di trattamento in doppio cieco (Settimana 52) nello studio HZNP-HZN-825-301; i soggetti a cui è stata sospesa prematuramente la somministrazione del farmaco sperimentale nello studio HZNP-HZN-825-301 per motivi diversi dalla sicurezza o dalla tossicità possono essere inclusi a discrezione dello sperimentatore dopo aver completato le visite programmate dello studio HZNP-HZN-825-301, comprese le valutazioni
    3. Disponibilità e capacità di attenersi al protocollo di trattamento prescritto e alle valutazioni per tutta la durata della sperimentazione.
    E.4Principal exclusion criteria
    1. Anticipated use of another investigational agent for any condition during the course of the trial.
    2. New diagnosis of malignant condition after enrolling in Trial HZNPHZN- 825-301 (except successfully treated basal/squamous cell carcinoma of the skin or cervical cancer in situ).
    3. Women of childbearing potential (WOCBP) or male subjects not agreeing to use highly effective method(s) of birth control throughout the trial and for 1 month after last dose of trial drug. Male subjects must refrain from sperm donation and females from egg/ova donation for this same time period. Women are considered of childbearing potential if they are not postmenopausal and not surgically sterile (documented bilateral salpingectomy, bilateral oophorectomy or hysterectomy). A postmenopausal state is defined as no menses for 12 months without an alternative medical cause. A high follicle-stimulating hormone (FSH) level in the postmenopausal range may be used to confirm a postmenopausal state in women not using hormonal contraception or hormonal replacement therapy. However, in the absence of 12 months of
    amenorrhea, a single FSH measurement is insufficient. A man is considered fertile after puberty unless permanently sterile by bilateral orchidectomy.
    4. Pregnant or lactating women.
    5. Any new development with the subject's disease or condition or any significant laboratory test abnormality during the course of Trial HZNPHZN- 825-301 that, in the opinion of the Investigator, would potentially
    put the subject at unacceptable risk.
    6. Subjects will be ineligible if, in the opinion of the Investigator, they are unlikely to comply with the trial protocol or have a concomitant disease or condition that could interfere with the conduct of the trial.
    1. Uso previsto di un altro agente sperimentale per qualsiasi patologia
    nel corso della sperimentazione.
    2. Nuova diagnosi di patologia maligna dopo l'arruolamento nello studio HZNP-HZN-825-301 (tranne il carcinoma basale/squamoso della pelle o il cancro della cervice in situ trattati con successo).
    3. Donne in età fertile (WOCBP) o soggetti di sesso maschile che non accettano di utilizzare metodi altamente efficaci di controllo delle nascite durante lo studio e per 1 mese dopo l'ultima dose di farmaco sperimentale. I soggetti di sesso maschile devono astenersi dalla donazione di sperma e quelli di sesso femminile dalla donazione di ovuli per lo stesso periodo di tempo. Le donne sono considerate in età fertile se non sono in post-menopausa e non chirurgicamente sterili (salpingectomia bilaterale, ovariectomia bilaterale o isterectomia documentate). Si definisce stato post-menopausale lo stato in cui vi è l'assenza di mestruazioni per 12 mesi senza una causa medica alternativa. Un alto livello di ormone follicolo-stimolante (FSH) nell'intervallo post-menopausale può essere utilizzato per confermare uno stato post-menopausale nelle donne che non usano la contraccezione ormonale o la terapia ormonale sostitutiva. Tuttavia, in assenza di 12 mesi di amenorrea, una singola misurazione dell'FSH è insufficiente. Un uomo è considerato fertile dopo la pubertà a meno che non sia permanentemente sterile mediante orchidectomia bilaterale.
    4. Donne in gravidanza o in allattamento.
    5. Qualsiasi nuovo sviluppo della malattia o della patologia del soggetto o qualsiasi anomalia significativa dei test di laboratorio durante il corso dello studio HZNP-HZN-825-301 che, a parere dello sperimentatore, comporterebbero potenzialmente un rischio inaccettabile per il soggetto.
    6. I soggetti non saranno idonei se, a giudizio dello sperimentatore, è improbabile che rispettino il protocollo di sperimentazione o abbiano una malattia o patologia concomitante che potrebbe interferire con lo svolgimento dello studio.
    E.5 End points
    E.5.1Primary end point(s)
    Change from both Baselines in FVC % predicted at Week 52
    Variazione rispetto a entrambe le baseline nella percentuale di CVF prevista alla Settimana 52
    E.5.1.1Timepoint(s) of evaluation of this end point
    From Baseline to Week 52
    Dalla baseline alla Settimana 52
    E.5.2Secondary end point(s)
    Exploratory Efficacy Endpoints
    1. Change from both Baselines in HAQ-DI at Week 52.
    2. Change from both Baselines in MDGA at Week 52.
    3. Change from both Baselines in PTGA at Week 52.
    4. Change from both Baselines in the Physical Effects subscale of the SSPRO-18 at Week 52.
    5. Change from both Baselines in the Physical Limitations subscale of the SSPRO-18 at Week 52.
    6. Proportion of subjects with an mRSS decrease of =5 points and 25% from both Baselines at Week 52.
    7. Responder rate (defined as ACR-CRISS [predicted probability] of at least 0.6) at Week 52.
    8. Proportion of subjects with an improvement in =3 of 5 core measures from both Baselines: =20% in mRSS, =20% in HAQ-DI, =20% in PTGA, =20% in MDGA and =5% in FVC % predicted at Week 52 (ACR-CRISS- 20).
    9. Change from both Baselines in the SSPRO-18 at Week 52.
    10. Change from both Baselines in each scale of the UCLA SCTC GIT 2.0 and the total GIT score at Week 52.
    11. Change from both Baselines in Raynaud's phenomenon using the Raynaud's Assessment at Week 52.
    12. Change from both Baselines in the SHAQ at Week 52.
    13. Change from both Baselines in SScQoL scores at Week 52.
    14. Change from both Baselines in SF-12 scores at Week 52.
    15. Change from both Baselines in pain and pain component scale scores at Week 52.
    16. Change from both Baselines in the FACIT-F score at Week 52.
    17. Change from both Baselines in the mRSS at Week 52.
    18. Change from both Baselines in lung fibrosis based on HRCT at Week 52.
    19. Change from both Baselines in DLCO at Week 52.
    20. Change from both Baselines in serum and plasma biomarkers associated with LPAR1 pathway, inflammation and/or fibrosis at Week 52.
    Endpoint esplorativi di efficacia
    1.Variazione rispetto a entrambe le baseline nell'HAQ-DI alla Settimana 52.
    2.Variazione rispetto a entrambe le baseline nella MDGA alla Settimana 52.
    3.Variazione rispetto a entrambe le baseline nella PTGA alla Settimana 52.
    4.Variazione rispetto a entrambe le baseline nella sottoscala degli effetti fisici di SSPRO-18 alla Settimana 52.
    5.Variazione rispetto a entrambe le baseline nella sottoscala delle limitazioni fisiche di SSPRO-18 alla Settimana 52.
    6.Percentuale di soggetti con una diminuzione di mRSS di =5 punti e il 25% rispetto a entrambe le baseline alla Settimana 52.
    7.Tasso di risposta (definito come ACR-CRISS [probabilità prevista] di almeno 0,6) alla Settimana 52.
    8.Percentuale di soggetti con un miglioramento >3 su 5 misure fondamentali rispetto a entrambe le baseline: >20% in mRSS, >20% in
    9. Variazione rispetto a entrambe le baseline nell'SSPRO-18 alla Settimana 52.
    10.Variazione rispetto a entrambe le baseline in ciascuna scala dell'UCLA SCTC GIT 2.0 e il punteggio GIT totale alla Settimana 52.
    11.Variazione rispetto a entrambe le baseline nel fenomeno di Raynaud usando la valutazione di Raynaud alla Settimana 52.
    12.Variazione rispetto a entrambe le baseline nello SHAQ alla Settimana 52.
    13.Variazione rispetto a entrambe le baseline nei punteggi SScQoL alla Settimana 52.
    14.Variazione rispetto a entrambe le baseline nei punteggi SF-12 alla Settimana 52.
    15.Variazione rispetto a entrambe le baseline nei punteggi della scala del dolore e della componente del dolore alla Settimana 52.
    16.Variazione rispetto a entrambe le baseline nel punteggio FACIT-F alla Settimana 52.
    17.Variazione rispetto a entrambe le baseline nell'mRSS alla Settimana 52.
    18.Variazione rispetto a entrambe le baseline nella fibrosi polmonare in base all'HRCT alla Settimana 52.
    19.Variazione rispetto a entrambe le baseline nella DLCO alla Settimana 52.
    20.Variazione rispetto a entrambe le baseline nei biomarcatori sierici e plasmatici associati al percorso del LPAR1, all'infiammazione e/o alla fibrosi alla Settimana 52.
    E.5.2.1Timepoint(s) of evaluation of this end point
    From Baseline to Week 52
    Dalla baseline alla Settimana 52
    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 Yes
    E.6.13.1Other scope of the trial description
    Tolerability
    Tollerabilità
    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 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 Yes
    E.8.1.7.1Other trial design description
    in aperto
    open
    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 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 concerned8
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA61
    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 Information not present in EudraCT
    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
    Israel
    Japan
    Korea, Republic of
    Mexico
    United States
    Austria
    France
    Poland
    Netherlands
    Romania
    Spain
    Switzerland
    Germany
    Greece
    Italy
    Belgium
    Portugal
    United Kingdom
    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
    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 months7
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months7
    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: 144
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 96
    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 state17
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 157
    F.4.2.2In the whole clinical trial 240
    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 will return to the clinic 4 weeks after the last dose of HZN-825 for a Safety Follow-up Visit.
    I soggetti torneranno in clinica 4 settimane dopo l'ultima dose di HZN-825 per una visita di follow-up di sicurezza.
    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 Decision2023-02-07
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2023-05-31
    P. End of Trial
    P.End of Trial StatusOngoing
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
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