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    Summary
    EudraCT Number:2020-000622-26
    Sponsor's Protocol Code Number:CNTO1959GCA2001
    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:2021-05-24
    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 number2020-000622-26
    A.3Full title of the trial
    A Phase 2, Multicenter, Randomized, Placebo-Controlled, Double-Blind, Proof-of-Concept Study to Evaluate Guselkumab for the Treatment of Participants with New-Onset or Relapsing Giant Cell Arteritis
    Studio di fattibilità di Fase 2, multicentrico, randomizzato, controllato con placebo, in doppio cieco, volto a valutare guselkumab per il trattamento dei partecipanti con arterite a cellule giganti di nuova insorgenza o recidivante
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Proof-of-Concept Study of Guselkumab in the Treatment of Subjects with New-Onset or Relapsing Giant Cell Arteritis
    Uno studio proof-of-concept volto a valutare guselkumab per il trattamento dei partecipanti con arterite a cellule giganti di nuova insorgenza o recidivante
    A.3.2Name or abbreviated title of the trial where available
    THEIA
    THEIA
    A.4.1Sponsor's protocol code numberCNTO1959GCA2001
    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 SponsorJANSSEN CILAG INTERNATIONAL NV
    B.1.3.4CountryBelgium
    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 supportJanssen Pharmaceutica N.V.
    B.4.2CountryNetherlands
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationJanssen Biologics B.V.
    B.5.2Functional name of contact pointClinical Registry group
    B.5.3 Address:
    B.5.3.1Street AddressArchimedesweg 29
    B.5.3.2Town/ cityLeiden
    B.5.3.3Post code2333 CM
    B.5.3.4CountryNetherlands
    B.5.4Telephone number0031715242166
    B.5.5Fax number0031715242110
    B.5.6E-mailClinicalTrialsEU@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 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 nameGuselkumab
    D.3.2Product code [CNTO1959]
    D.3.4Pharmaceutical form 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 INNGUSELKUMAB
    D.3.9.1CAS number 1350289-85-8
    D.3.9.2Current sponsor codeCNTO1959
    D.3.9.3Other descriptive name* D.3.6.2.1 - valore :Every 4 weeks dosing of 400 mg
    D.3.9.4EV Substance CodeSUB179789
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    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 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 Yes
    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 Yes
    D.3.11.13.1Other medicinal product typeANTICORPO MONOCLONALE
    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.2.1.2Country 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 nameGuselkumab
    D.3.2Product code [CNTO1959]
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSubcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNGUSELKUMAB
    D.3.9.1CAS number 1350289-85-8
    D.3.9.2Current sponsor codeCNTO1959
    D.3.9.3Other descriptive name* D.3.6.2.1 - valore : Every 4 weeks dosing of 200 mg * D.3.6.2.1 - valore:Every 4 week dosing from week 12 to week 48
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    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 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 Yes
    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 Yes
    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 Yes
    D.3.11.13.1Other medicinal product typeMonoclonal antibody
    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
    D.8 Placebo: 2
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboSolution for injection
    D.8.4Route of administration of the placeboSubcutaneous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Giant Cell Arteritis
    Artrite a cellule giganti
    E.1.1.1Medical condition in easily understood language
    Giant Cell Arteritis
    Artrite a cellule giganti
    E.1.1.2Therapeutic area Diseases [C] - Virus Diseases [C02]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 23.1
    E.1.2Level PT
    E.1.2Classification code 10018250
    E.1.2Term Giant cell arteritis
    E.1.2System Organ Class 10047065 - Vascular 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 efficacy of guselkumab compared to placebo, in combination with a 26-week glucocorticoid (GC) taper regimen, in adult participants with new-onset or relapsing giant cell arteritis (GCA)
    Valutare l’efficacia di guselkumab rispetto al placebo, in combinazione con un regime di riduzione graduale di glucocorticoidi (GC) della durata di 26 settimane, in partecipanti adulti con arterite a cellule giganti (Giant Cell Arteritis, GCA) di nuova insorgenza o recidivante
    E.2.2Secondary objectives of the trial
    - To evaluate the efficacy of guselkumab compared to placebo, in combination with a 26-week GC taper regimen, in adult participants with new-onset or relapsing GCA as measured by alternative definitions of GC free remission, GC-sparing effects, and prevention of disease flares.
    - To evaluate the safety of guselkumab, in combination with a 26-week GC taper regimen, in adult participants with new-onset or relapsing GCA.
    - To evaluate the PK and immunogenicity of guselkumab, in combination with a 26-week GC taper regimen, in adult participants with new-onset or relapsing GCA.
    • Valutare l’efficacia di guselkumab rispetto al placebo, in combinazione con un regime di riduzione graduale di GC della durata di 26 settimane, in partecipanti adulti con GCA di nuova insorgenza o recidivante, misurata mediante definizioni alternative di remissione libera da GC, effetti di risparmio di GC e prevenzione delle riacutizzazioni della malattia.
    • Valutare la sicurezza di guselkumab, in combinazione con un regime di riduzione graduale di GC della durata di 26 settimane, in partecipanti adulti con GCA di nuova insorgenza o recidivante.
    • Valutare la farmacocinetica (Pharmacokinetics, PK) e l’immunogenicità di guselkumab, in combinazione con un con un regime di riduzione graduale di GC della durata di 26 settimane, in partecipanti adulti con GCA di nuova insorgenza o recidivante.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Male or female (according to their reproductive organs and functions assigned by chromosomal complement)
    2. At least 50 years of age, inclusive
    3. Diagnosis of GCA according to the revised American College of Rheumatology criteria
    4. Temporal artery biopsy revealing features of GCA OR, Evidence of cranial GCA by doppler-ultrasound, cranial Magnetic Resonance Imaging or Magnetic Resonance Angiography
    5. Have new onset or relapsing GCA
    6. Have active GCA within 6 weeks of first study intervention

    Please see section 5.1 in the protocol for all inclusion criteria.
    1. sesso maschile o femminile (in base agli organi riproduttivi e alle funzioni assegnate dal complemento cromosomico)
    2. età pari o superiore a 50 anni
    3. diagnosi di GCA in base ai criteri revisionati dell’American College of Rheumatology
    4. Biopsia dell’arteria temporale che rivela le caratteristiche della GCA OPPURE, evidenza di GCA cranica rilevata mediante eco-doppler, risonanza magnetica per immagini o angiografia a risonanza magnetica del cranio o altra modalità di diagnostica per immagini in accordo con lo sponsor.
    5. Presentano GCA di nuova insorgenza o recidivante
    6.Nuova insorgenza: diagnosi di GCA entro 6 settimane dal primo trattamento dello studio

    si prega di far riferimento alla sezione 5.1 del protocollo per tutti i criteri di inclusione
    E.4Principal exclusion criteria
    1. Has any known severe or uncontrolled GCA complications
    2. Has any rheumatic disease other than GCA such as Takayasu's Arteritis, granulomatosis with polyangiitis (Wegener's), RA, PMR, systemic lupus erythematosus that could interfere with assessment of GCA
    3. Has a current diagnosis or signs or symptoms of severe, progressive, or uncontrolled renal, cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic, hematologic, rheumatologic, psychiatric, or metabolic disturbances
    4. Has or has had any major ischemic event, within 12 weeks of first study intervention
    5. Has a history of lymphoproliferative disease, including lymphoma; a history of monoclonal gammopathy of indetermined significance; or signs and symptoms suggestive of possible lymphoproliferative disease, such as lymphadenopathy or splenomegaly

    Please see section 5.2 in the protocol for all exclusion criteria.
    1. Presenta complicanze gravi o non controllate della GCA
    2. È affetto/a da una malattia reumatica diversa da GCA come l’arterite di Takayasu, la granulomatosi con poliangioite (di Wegener), l’artrite reumatoide (AR), la polimialgia reumatica (PMR), il lupus eritematoso sistemico che potrebbe interferire con la valutazione della GCA
    3. Presenta diagnosi o segni o sintomi attuali di gravi disturbi progressivi o non controllati cardiaci, renali, vascolari, polmonari, gastrointestinali, endocrini, neurologici, ematologici, reumatologici, psichiatrici o metabolici
    4. Ha o ha avuto un evento ischemico maggiore, entro 12 settimane dal primo trattamento dello studio
    5. Presenta un’anamnesi di malattia linfoproliferativa, incluso il linfoma; un’anamnesi di gammopatia monoclonale di significatività indeterminata; o segni e sintomi suggestivi di possibile malattia linfoproliferativa, come linfoadenopatia o splenomegalia

    si prega di far riferimento alla sezione 5.2 del protocollo per tutti i criteri di inclusione
    E.5 End points
    E.5.1Primary end point(s)
    The proportion of participants achieving GC-free remission
    percentuale di partecipanti che raggiungono la remissione libera da GC
    E.5.1.1Timepoint(s) of evaluation of this end point
    48 weeks
    48 settimane
    E.5.2Secondary end point(s)
    The proportion of participants achieving GC-free remission from Week 28 by visit through Week 52; The proportion of participants achieving GC-free remission and normalization of ESR and/or CRP at Week 28 and by visit through Week 52; Number/proportion of participants with treatment emergent adverse events (TEAEs) through Week 60; Mean (standard deviation [SD]) serum concentrations of guselkumab through Week 52 in participants receiving active study intervention.; Number/proportion of participants with antibodies to guselkumab in participants receiving active study intervention.
    La percentuale di partecipanti che raggiungono la remissione libera da GC dalla settimana 28 tramite visita fino alla settimana 52; La percentuale di partecipanti che hanno raggiunto la remissione libera da GC e la normalizzazione della ESR e / o della CRP alla settimana 28 e per visita fino alla settimana 52; Numero / proporzione di partecipanti con eventi avversi emergenti dal trattamento (TEAE) fino alla settimana 60; Concentrazioni sieriche medie (deviazione standard [SD]) di guselkumab fino alla settimana 52 nei partecipanti che hanno ricevuto l'intervento attivo dello studio.; Numero / proporzione di partecipanti con anticorpi anti-guselkumabb nei partecipanti che hanno ricevuto un intervento attivo nello studio.
    E.5.2.1Timepoint(s) of evaluation of this end point
    through Week 52; through Week 52; through Week 60; through Week 52; through Week 52
    fino alla settimana 52; fino alla settimana 52; fino alla settimana 60; fino alla settimana 52; fino 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 Yes
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic Yes
    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 concerned6
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA27
    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
    Belgium
    Canada
    France
    Germany
    Italy
    Poland
    Spain
    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
    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 months5
    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 months5
    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: 12
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 48
    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 state16
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 52
    F.4.2.2In the whole clinical trial 60
    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)
    Participants should return to their primary physician to determine standard of care. Participants who complete the study and are in glucocorticoid (GC)-free remission may have the option to participate in a long-term extension (LTE) study.
    I partecipanti dovrebbero tornare dal proprio medico di base per determinare lo standard di cura. I partecipanti che completano lo studio e sono in remissione senza glucocorticoidi (GC) possono avere la possibilità di partecipare a uno studio di estensione a lungo termine (LTE).
    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 Decision2020-12-18
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-11-11
    P. End of Trial
    P.End of Trial StatusOngoing
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