Clinical trial • Phase III • Immunology|Nephrology
IANALUMAB for Lupus nephritis
Phase III trial of IANALUMAB for Lupus nephritis.
Overview
- Trial Therapeutic Area
- Immunology|Nephrology
- Trial Disease
- Lupus nephritis
- Trial Stage
- Phase III
- Drug Modality
- Monoclonal antibody
Key dates
- Initial CTIS Submission Date
- 14-06-2024
- First CTIS Authorization Date
- 19-07-2024
Trial design
Randomised, placebo to vay736 (matching placebo pre-filled syringe for vay736 150 mg/1 ml and 300 mg/2 ml) (placebo comparator arm)-controlled Phase III trial in Spain, Estonia, Hungary and others.
- Randomised
- Yes
- Comparator
- Placebo to VAY736 (matching placebo pre-filled syringe for VAY736 150 mg/1 mL and 300 mg/2 mL) (placebo comparator arm)
- Target Sample Size
- 315
- Trial Duration For Participant
- 504
Eligibility
Recruits 315 Vulnerable population selected. Eligibility restricts to adults (inclusion: "Adult male and female participants aged 18 years or older at the time of screening") and participants must be "Able to provide signed informed consent". Multiple subject information and informed consent form (ICF) documents are provided (main ICFs, optional ICFs, partner/ pregnancy follow-up ICFs) in country-specific languages. No assent process for minors or under‑18 enrolment is described..
- Pregnancy Exclusion
- Pregnant or nursing (lactating) women
- Vulnerable Population
- Vulnerable population selected. Eligibility restricts to adults (inclusion: "Adult male and female participants aged 18 years or older at the time of screening") and participants must be "Able to provide signed informed consent". Multiple subject information and informed consent form (ICF) documents are provided (main ICFs, optional ICFs, partner/ pregnancy follow-up ICFs) in country-specific languages. No assent process for minors or under‑18 enrolment is described.
Inclusion criteria
- {"criterion_text":"-Adult male and female participants aged 18 years or older at the time of screening\n-Weigh at least 35 kg at screening\n-Have a confirmed clinical diagnosis of SLE according to EULAR/ACR SLE classification criteria\n-Have a positive anti-nuclear antibody (ANA) test result defined as an ANA titer ≥1:80 (based on an indirect HEp-2 immunofluorescence assay or solid-phase ANA immunoassay with at least equivalent performance) at screening based on central laboratory results or a documented, positive historical result (ANA titer ≥1:80)\n-Presence of active LN at screening requiring induction therapy, as defined by meeting the 3 following criteria: •\tRenal biopsy within 6 months prior to screening period indicating ISN/RPS class III or IV active glomerulonephritis with or without co-existing class V features, or pure class V membranous LN. If no biopsy was performed within 6 months prior to screening period, a biopsy will need to be performed during the screening period after having met all other inclusion/exclusion criteria. •\tUPCR ≥1.0 g/g on 24-hour urine collection at Screening •\teGFR ≥25mL/min/1.73 m2\n-Newly diagnosed participants, as well as pre-treated LN participants (including refractory cases) can be included, as long as they are currently on, or willing to initiate SoC induction therapy for LN using MPA. •\tInduction therapy, as defined by treatment including both high dose corticosteroids and MPA, should be initiated prior to or on day of randomization. •\tAnti-malarial treatment at stable dosing prior to randomization is strongly recommended, in the absence of contraindications. •\tParticipants on azathioprine treatment at Screening must be switched to MPA prior to randomization.\n-Receipt of at least one dose of pulse methylprednisolone i.v. (250-1000 mg per day up to 3000 mg cumulative dose) or equivalent for treatment of current episode of active LN within 60 days prior to randomization. Participants who cannot take the pulse i.v. corticosteroid therapy should directly start on 0.8-1.0 mg/kg/day (max 80 mg/day) oral predniso(lo)ne\n-Able to provide signed informed consent"}
Exclusion criteria
- {"criterion_text":"-Severe renal impairment as defined by i) presence of oliguria (defined as a documented urine volume <400 mL/24 hrs), or ii) End-Stage Renal Disease (ESRD) requiring dialysis or transplantation\n-United States (and other countries, if locally required): sexually active male participants who do not agree to use barrier protection during intercourse with women of child-bearing potential while taking study treatment. As condom use alone has a reported failure rate exceeding 1% per year, it is recommended female partners of male study participants use a second method of birth control.\n-History of known intolerance/hypersensitivity to MPA, oral corticosteroids, or any component of the study drug(s) or its excipients or to drugs of similar chemical classes (e.g., mAb of IgG1 class) or to any of the constituents of the study drug\n-Receipt of live/attenuated vaccine within a 4-week period prior to randomization\n-History of primary or secondary immunodeficiency, including a positive HIV test result\n-History of malignancy of any organ system (other than localized basal cell carcinoma or squamous cell carcinoma of the skin or\n-Any surgical, medical, psychiatric or additional physical condition that may jeopardize participation in this study\n-Sclerosis in >50% of glomeruli on renal biopsy\n-Use of other investigational drugs within 5 half-lives of enrollment, or within 30 days or until the expected pharmacodynamic effect has returned to baseline. Use of the following Traditional Chinese Medicines: Total glucoside of peony (TGP) or Tripterygium glycosides (TG) administered within 30 days prior to randomization.\n-Prior treatment with any of the following •\tWithin 12 weeks prior to randomization o\tbelimumab, telitacicept, abatacept, TNF-α mAb, immunoglobulins (i.v./s.c.) plasmapheresis o\tany other immuno-suppressants (e.g., i.v. or oral cyclophosphamide, calcineurin inhibitors, JAK inhibitors or other kinase inhibitors) o\tthalidomide treatment and/or methotrexate •\tImidazole derivative (e.g., azathioprine, mizoribine) must be discontinued prior to starting treatment with MPA\n-Receipt of more than 3000 mg i.v. pulse methylprednisolone (cumulative dose) within 12 weeks prior to randomization\n-History of major organ transplant or hematopoietic stem cell/bone marrow transplant or are due to receive transplantation\n-Any one of the following laboratory values at screening: •\tHemoglobin (Hgb) <8.0 g/dL (<5 mmol/L), or <7.0 g/dL (<4.3 mmol/L) if related to participant's SLE such as in active hemolytic anaemia •\tPlatelet count <25 x 103/µL •\tAbsolute neutrophil count (ANC) <0.8 x 103/µL\n-Active viral, bacterial or other infections requiring intravenous or intramuscular treatment for clinically significant infection or history of recurrent clinically significant infection which in the opinion of the investigator will place the participant at risk for participation.\n-Chronic infection with hepatitis B (HBV) or hepatitis C (HCV). xxx\n-Evidence of active tuberculosis (TB) infection xxx.\n-Pregnant or nursing (lactating) women"}
Endpoints
Primary endpoints
- {"endpoint_text":"-Achieving stable CRR at Week 72; participants who discontinue treatment before Week 72 or use corticosteroids at a dose >7.5 mg/day after Week 60 will be considered non-responders","definition_or_measurement_approach":"Proportion of participants achieving a stable complete renal response (CRR) at Week 72. Participants who discontinue treatment before Week 72 or who use corticosteroids at a dose >7.5 mg/day after Week 60 are counted as non-responders."}
Secondary endpoints
- {"endpoint_text":"-Time to first occurrence of XX from baseline up to Week 72","definition_or_measurement_approach":"Time-to-event analysis from baseline up to Week 72 for the first occurrence of the specified event (XX)."}
- {"endpoint_text":"-Achieving stable CRR at Week 72 while maintaining daily corticosteroid dose ≤5mg/day between Week 24 and Week 72. Participants who discontinue treatment before Week 72 will be considered non-responders","definition_or_measurement_approach":"Proportion achieving stable CRR at Week 72 with maintenance of daily corticosteroid dose ≤5 mg/day between Week 24 and Week 72; discontinuations before Week 72 considered non-responders."}
- {"endpoint_text":"-Experiencing renal flares related event or death through Week 72","definition_or_measurement_approach":"Proportion of participants experiencing renal-related events (flares) or death through Week 72."}
- {"endpoint_text":"-Achieving of stable ORR at Week 48; participants who discontinue treatment before Week 48 or use corticosteroids at a dose >7.5 mg/day after Week 36 will be considered non-responders","definition_or_measurement_approach":"Proportion achieving stable overall renal response (ORR) at Week 48; discontinuation before Week 48 or corticosteroid use >7.5 mg/day after Week 36 considered non-response."}
- {"endpoint_text":"-Change from baseline in BILAG-2004 at Week 72","definition_or_measurement_approach":"Change from baseline in BILAG-2004 disease activity score measured at Week 72."}
- {"endpoint_text":"-Change from baseline in FACIT-Fatigue at Week 72","definition_or_measurement_approach":"Change from baseline in FACIT‑Fatigue patient-reported outcome score at Week 72."}
- {"endpoint_text":"-Treatment-emergent Adverse Events (TEAEs)","definition_or_measurement_approach":"Incidence and description of treatment‑emergent adverse events during treatment and follow-up."}
- {"endpoint_text":"-Serious Adverse Events (SAEs)","definition_or_measurement_approach":"Incidence of serious adverse events during treatment and follow-up."}
- {"endpoint_text":"-Vital signs","definition_or_measurement_approach":"Clinical vital sign measurements assessed over time."}
- {"endpoint_text":"-Clinical laboratory measurements","definition_or_measurement_approach":"Standard clinical laboratory parameters monitored over time."}
- {"endpoint_text":"-Ianalumab concentration in serum and calculated PK parameters","definition_or_measurement_approach":"Measured serum concentrations of ianalumab and derived pharmacokinetic parameters."}
- {"endpoint_text":"-Incidence and titer of anti-ianalumab antibodies in serum (ADA assay) over time","definition_or_measurement_approach":"Incidence and titers of anti-ianalumab antibodies measured by ADA assay longitudinally."}
Recruitment
- Planned Sample Size
- 315
- Recruitment Window Months
- 96
- Consent Approach
- Participants must be able to provide signed informed consent (inclusion: "Able to provide signed informed consent"). Country-specific main ICFs and related ICF documents are provided (examples: Main ICFs and optional ICFs in Spanish, Estonian, Russian, English, Hungarian, Czech, Lithuanian, French, German, Italian, Romanian). Additional information sheets (e.g. Info Sheet Female Partner) and follow-up ICFs for pregnant participants/partners are provided. No assent process for minors is described.
Methods
- K1_Recruitment Arrangements documents submitted for multiple countries (country-specific recruitment arrangements documents present)
- K2_Advertisements documents (country-specific advertisement materials) — advertisements in national/local languages listed in documents
Geography
- Total Number Of Sites
- 44
- Total Number Of Participants
- 57
Spain
- Earliest CTIS Part Ii Submission Date
- 11-07-2024
- Latest Decision Or Authorization Date
- 01-04-2026
- Processing Time Days
- 629
- Number Of Sites
- 10
- Number Of Participants
- 9
Sites
- Site Name
- Hospital Universitario 12 De Octubre
- Department Name
- #2244; Reumatología
- Principal Investigator Name
- Maria Galindo Izquierdo
- Principal Investigator Email
- mgalindo@h12o.es
- Contact Person Name
- Maria Galindo Izquierdo
- Contact Person Email
- mgalindo@h12o.es
- Site Name
- Hospital Universitario Dr Peset Aleixandre
- Department Name
- #2240; Reumatología
- Principal Investigator Name
- Juan Jose Alegre Sancho
- Principal Investigator Email
- alegre_juasan@gva.es
- Contact Person Name
- Juan Jose Alegre Sancho
- Contact Person Email
- alegre_juasan@gva.es
- Site Name
- Complexo Hospitalario Universitario De Santiago
- Department Name
- #2248; Reumatología
- Principal Investigator Name
- Eva Perez Pampin
- Principal Investigator Email
- eva.perez.pampin@sergas.es
- Contact Person Name
- Eva Perez Pampin
- Contact Person Email
- eva.perez.pampin@sergas.es
- Site Name
- Hospital Universitari Vall D Hebron
- Department Name
- #2247; Reumatología
- Principal Investigator Name
- Josefina Cortes Hernandez
- Principal Investigator Email
- fina.cortes@vhir.org
- Contact Person Name
- Josefina Cortes Hernandez
- Contact Person Email
- fina.cortes@vhir.org
- Site Name
- Hospital Universitario Fundacion Jimenez Diaz
- Department Name
- #2243; Nefrología
- Principal Investigator Name
- Maria Vanessa Perez Gomez
- Principal Investigator Email
- mvanessa@fjd.es
- Contact Person Name
- Maria Vanessa Perez Gomez
- Contact Person Email
- mvanessa@fjd.es
- Site Name
- Clinica Universidad De Navarra
- Department Name
- #2250; Nefrología
- Principal Investigator Name
- Jose Maria Mora Gutierrez
- Principal Investigator Email
- jmora@unav.es
- Contact Person Name
- Jose Maria Mora Gutierrez
- Contact Person Email
- jmora@unav.es
- Site Name
- Complexo Hospitalario Universitario De Vigo
- Department Name
- #2249; Reumatología
- Principal Investigator Name
- Jose Maria Pego Reigosa
- Principal Investigator Email
- jose.maria.pego.reigosa@sergas.es
- Contact Person Name
- Jose Maria Pego Reigosa
- Contact Person Email
- jose.maria.pego.reigosa@sergas.es
- Site Name
- Hospital Del Mar
- Department Name
- #2245; Nefrología
- Principal Investigator Name
- Eva Rodriguez Garcia
- Principal Investigator Email
- erodriguezg@psmar.cat
- Contact Person Name
- Eva Rodriguez Garcia
- Contact Person Email
- erodriguezg@psmar.cat
- Site Name
- Clinica Universidad De Navarra
- Department Name
- #2250; Nefrología
- Principal Investigator Name
- Jose Maria Mora Gutierrez
- Principal Investigator Email
- jmora@unav.es
- Contact Person Name
- Jose Maria Mora Gutierrez
- Contact Person Email
- jmora@unav.es
- Site Name
- Hospital Universitario De Canarias
- Department Name
- #2242; Reumatología
- Principal Investigator Name
- Jose Federico Diaz Gonzalez
- Principal Investigator Email
- federico.diaz.gonzalez@gmail.com
- Contact Person Name
- Jose Federico Diaz Gonzalez
- Contact Person Email
- federico.diaz.gonzalez@gmail.com
Estonia
- Earliest CTIS Part Ii Submission Date
- 11-07-2024
- Latest Decision Or Authorization Date
- 02-04-2026
- Processing Time Days
- 630
- Number Of Sites
- 2
- Number Of Participants
- 1
Sites
- Site Name
- East Tallinn Central Hospital
- Department Name
- 2022: Clinic of Internal Medicine, Department of Rheumatology
- Principal Investigator Name
- Tiina Veldi
- Principal Investigator Email
- tiina.veldi@itk.ee
- Contact Person Name
- Tiina Veldi
- Contact Person Email
- tiina.veldi@itk.ee
- Site Name
- Innomedica OÜ
- Department Name
- 2020
- Principal Investigator Name
- Sandra Meisalu
- Principal Investigator Email
- sandra.meisalu@innomedica.ee
- Contact Person Name
- Sandra Meisalu
- Contact Person Email
- sandra.meisalu@innomedica.ee
Hungary
- Earliest CTIS Part Ii Submission Date
- 11-07-2024
- Latest Decision Or Authorization Date
- 31-03-2026
- Processing Time Days
- 628
- Number Of Sites
- 4
- Number Of Participants
- 8
Sites
- Site Name
- Szent Margit Korhaz
- Department Name
- 2103: Nephrologiai Osztaly
- Principal Investigator Name
- Szabina Czirok
- Principal Investigator Email
- szabina.czirok@gmail.com
- Contact Person Name
- Szabina Czirok
- Contact Person Email
- szabina.czirok@gmail.com
- Site Name
- Del-Pesti Centrumkorhaz Orszagos Hematologiai Es Infektologiai Intezet
- Department Name
- 2102
- Principal Investigator Name
- Janos Kadar
- Principal Investigator Email
- drkadarj@t-online.hu
- Contact Person Name
- Janos Kadar
- Contact Person Email
- drkadarj@t-online.hu
- Site Name
- University Of Debrecen
- Department Name
- 2101
- Principal Investigator Name
- Gabriella Szucs
- Principal Investigator Email
- szucs.gabriella@med.unideb.hu
- Contact Person Name
- Gabriella Szucs
- Contact Person Email
- szucs.gabriella@med.unideb.hu
- Site Name
- Somogy Varmegyei Kaposi Mor Oktato Korhaz
- Department Name
- 2105: Nephrológiai Osztály
- Principal Investigator Name
- Tamas Szelestei
- Principal Investigator Email
- szelestei.tamas@kmmk.hu
- Contact Person Name
- Tamas Szelestei
- Contact Person Email
- szelestei.tamas@kmmk.hu
Germany
- Earliest CTIS Part Ii Submission Date
- 11-07-2024
- Latest Decision Or Authorization Date
- 02-04-2026
- Processing Time Days
- 630
- Number Of Sites
- 3
- Number Of Participants
- 2
Sites
- Site Name
- St. Elisabeth Gruppe GmbH Katholische Kliniken Rhein-Ruhr
- Department Name
- 2072: Medizinische Klinik I
- Principal Investigator Name
- Timm Westhoff
- Principal Investigator Email
- Timm.Westhoff@elisabethgruppe.de
- Contact Person Name
- Timm Westhoff
- Contact Person Email
- Timm.Westhoff@elisabethgruppe.de
- Site Name
- Universitaetsklinikum Muenster AöR
- Department Name
- 2073: Sektion für Rheumatologie und klinische Immunologie, Medizinische Klinik D
- Principal Investigator Name
- Gert Gabriels
- Principal Investigator Email
- Gert.Gabriels@ukmuenster.de
- Contact Person Name
- Gert Gabriels
- Contact Person Email
- Gert.Gabriels@ukmuenster.de
- Site Name
- Universitaetsklinikum Aachen AöR
- Department Name
- 2070: Medizinische Klinik II
- Principal Investigator Name
- Thomas Rauen
- Principal Investigator Email
- trauen@ukaachen.de
- Contact Person Name
- Thomas Rauen
- Contact Person Email
- trauen@ukaachen.de
France
- Earliest CTIS Part Ii Submission Date
- 11-07-2024
- Latest Decision Or Authorization Date
- 03-04-2026
- Processing Time Days
- 631
- Number Of Sites
- 9
- Number Of Participants
- 10
Sites
- Site Name
- CHRU De Nancy
- Department Name
- 2048: Service de Néphrologie
- Principal Investigator Name
- Adrien Flahault
- Principal Investigator Email
- a.flahault@chru-nancy.fr
- Contact Person Name
- Adrien Flahault
- Contact Person Email
- a.flahault@chru-nancy.fr
- Site Name
- Centre Hospitalier Regional De Marseille
- Department Name
- 2046; Service de Néphrologie
- Principal Investigator Name
- Noemie Jourde-Chiche
- Principal Investigator Email
- noemie.jourde@ap-hm.fr
- Contact Person Name
- Noemie Jourde-Chiche
- Contact Person Email
- noemie.jourde@ap-hm.fr
- Site Name
- Centre Hospitalier Universitaire De Poitiers
- Department Name
- 2042; Service de Néphrologie et Transplantation rénale
- Principal Investigator Name
- Vincent Javaugue
- Principal Investigator Email
- Vincent.javaugue@chu-poitiers.fr
- Contact Person Name
- Vincent Javaugue
- Contact Person Email
- Vincent.javaugue@chu-poitiers.fr
- Site Name
- Centre Hospitalier Universitaire De Toulouse
- Department Name
- 2047: Service de Néphrologie
- Principal Investigator Name
- Stanislas Faguer
- Principal Investigator Email
- Faguer.s@chu-toulouse.fr
- Contact Person Name
- Stanislas Faguer
- Contact Person Email
- Faguer.s@chu-toulouse.fr
- Site Name
- Centre Hospitalier Universitaire De Bordeaux
- Department Name
- 2040; Service de Néphrologie, Transplantation, Dialyse
- Principal Investigator Name
- Lionel Couzi
- Principal Investigator Email
- lionel.couzi@chu-bordeaux.fr
- Contact Person Name
- Lionel Couzi
- Contact Person Email
- lionel.couzi@chu-bordeaux.fr
- Site Name
- Besancon University Hospital Center
- Department Name
- 2043; Service de Néphrologie
- Principal Investigator Name
- Didier Ducloux
- Principal Investigator Email
- dducloux@chu-besancon.fr
- Contact Person Name
- Didier Ducloux
- Contact Person Email
- dducloux@chu-besancon.fr
- Site Name
- Centre Hospitalier Universitaire Grenoble Alpes
- Department Name
- 2041; Département de Néphrologie
- Principal Investigator Name
- Thomas Jouve
- Principal Investigator Email
- TJouve@chu-grenoble.fr
- Contact Person Name
- Thomas Jouve
- Contact Person Email
- TJouve@chu-grenoble.fr
- Site Name
- Hospital Edouard Herriot
- Department Name
- 2044; Service de Néphrologie
- Principal Investigator Name
- Emilie Kalbacher
- Principal Investigator Email
- emilie.kalbacher@chu-lyon.fr
- Contact Person Name
- Emilie Kalbacher
- Contact Person Email
- emilie.kalbacher@chu-lyon.fr
- Site Name
- Centre Hospitalier Universitaire De Toulouse
- Department Name
- 2047: Service de Néphrologie
- Principal Investigator Name
- Stanislas Faguer
- Principal Investigator Email
- Faguer.s@chu-toulouse.fr
- Contact Person Name
- Stanislas Faguer
- Contact Person Email
- Faguer.s@chu-toulouse.fr
Italy
- Earliest CTIS Part Ii Submission Date
- 11-07-2024
- Latest Decision Or Authorization Date
- 31-03-2026
- Processing Time Days
- 628
- Number Of Sites
- 7
- Number Of Participants
- 4
Sites
- Site Name
- Universita Cattolica Del Sacro Cuore
- Department Name
- #2124: Dipartimento di scienze ortopediche e reumatologiche
- Principal Investigator Name
- Maria Antonietta D’Agostino
- Principal Investigator Email
- mariaantonietta.dagostino@policlinicogemelli.it
- Contact Person Name
- Maria Antonietta D’Agostino
- Contact Person Email
- mariaantonietta.dagostino@policlinicogemelli.it
- Site Name
- Ospedale San Raffaele S.r.l.
- Department Name
- #2121: U.O. di Immunologia, Reumatologia, Allergologia e Malattie Rare
- Principal Investigator Name
- Lorenzo Dagna
- Principal Investigator Email
- lorenzo.dagna@hsr.it
- Contact Person Name
- Lorenzo Dagna
- Contact Person Email
- lorenzo.dagna@hsr.it
- Site Name
- Ospedale San Giovanni Bosco
- Department Name
- #2126: S.C. Nefrologia e Dialisi - CMID
- Principal Investigator Name
- Savino Sciascia
- Principal Investigator Email
- savino.sciascia@unito.it
- Contact Person Name
- Savino Sciascia
- Contact Person Email
- savino.sciascia@unito.it
- Site Name
- Azienda Ospedaliero Universitaria Ospedali Riuniti
- Department Name
- #2128: S.C. Reumatologia Universitaria
- Principal Investigator Name
- Addolorata Corrado
- Principal Investigator Email
- ada.corrado@unifg.it
- Contact Person Name
- Addolorata Corrado
- Contact Person Email
- ada.corrado@unifg.it
- Site Name
- Fondazione IRCCS Policlinico San Matteo
- Department Name
- #2127: U.O.C. Reumatologia Day Hospital
- Principal Investigator Name
- Lorenzo Cavagna
- Principal Investigator Email
- lorenzo.cavagna@unipv.it
- Contact Person Name
- Lorenzo Cavagna
- Contact Person Email
- lorenzo.cavagna@unipv.it
- Site Name
- Azienda Sanitaria Universitaria Friuli Centrale
- Department Name
- #2123: S.O.C. Clinica di Reumatologia
- Principal Investigator Name
- Luca Quartuccio
- Principal Investigator Email
- luca.quartuccio@asufc.sanita.fvg.it
- Contact Person Name
- Luca Quartuccio
- Contact Person Email
- luca.quartuccio@asufc.sanita.fvg.it
- Site Name
- Careggi University Hospital
- Department Name
- #2122: S.O.D. Medicina Interna Interdisciplinare
- Principal Investigator Name
- Elena Silvestri
- Principal Investigator Email
- elena.silvestri@unifi.it
- Contact Person Name
- Elena Silvestri
- Contact Person Email
- elena.silvestri@unifi.it
Romania
- Earliest CTIS Part Ii Submission Date
- 11-07-2024
- Latest Decision Or Authorization Date
- 06-04-2026
- Processing Time Days
- 634
- Number Of Sites
- 5
- Number Of Participants
- 10
Sites
- Site Name
- Institutul Clinic Fundeni
- Department Name
- #2171: Nephrology
- Principal Investigator Name
- Gener Ismail
- Principal Investigator Email
- gener732000@yahoo.com
- Contact Person Name
- Gener Ismail
- Contact Person Email
- gener732000@yahoo.com
- Site Name
- Saint Maria Hospital
- Department Name
- #2176: Rheumatology
- Principal Investigator Name
- Daniela Opriș-Belinski
- Principal Investigator Email
- danaopris0103@yahoo.com
- Contact Person Name
- Daniela Opriș-Belinski
- Contact Person Email
- danaopris0103@yahoo.com
- Site Name
- Spitalul Clinic Judetean De Urgenta Bihor
- Department Name
- #2172: Nephrology
- Principal Investigator Name
- Cristian Gavril Toma
- Principal Investigator Email
- crtoma2003@yahoo.com
- Contact Person Name
- Cristian Gavril Toma
- Contact Person Email
- crtoma2003@yahoo.com
- Site Name
- Spitalul Clinic Judetean De Urgenta Pius Brinzeu Timisoara
- Department Name
- #2174: Nephrology
- Principal Investigator Name
- Flaviu Raul Bob
- Principal Investigator Email
- flaviu_bob@yahoo.com
- Contact Person Name
- Flaviu Raul Bob
- Contact Person Email
- flaviu_bob@yahoo.com
- Site Name
- Spitalul Clinic Judetean De Urgenta Cluj
- Department Name
- #2173: Rheumatology
- Principal Investigator Name
- Simona Rednic
- Principal Investigator Email
- srednic@umfcluj.ro
- Contact Person Name
- Simona Rednic
- Contact Person Email
- srednic@umfcluj.ro
Czechia
- Earliest CTIS Part Ii Submission Date
- 11-07-2024
- Latest Decision Or Authorization Date
- 31-03-2026
- Processing Time Days
- 628
- Number Of Sites
- 2
- Number Of Participants
- 7
Sites
- Site Name
- University Hospital Olomouc
- Department Name
- 2002: Interni klinika
- Principal Investigator Name
- Pavel Horak
- Principal Investigator Email
- pavel.horak@fnol.cz
- Contact Person Name
- Pavel Horak
- Contact Person Email
- pavel.horak@fnol.cz
- Site Name
- Revmatologicky Ustav
- Department Name
- 2001: Revmatologie
- Principal Investigator Name
- Jakub Zavada
- Principal Investigator Email
- zavada@revma.cz
- Contact Person Name
- Jakub Zavada
- Contact Person Email
- zavada@revma.cz
Lithuania
- Earliest CTIS Part Ii Submission Date
- 11-07-2024
- Latest Decision Or Authorization Date
- 30-03-2026
- Processing Time Days
- 627
- Number Of Sites
- 2
- Number Of Participants
- 6
Sites
- Site Name
- Lietuvos sveikatos mokslu universiteto ligonine Kauno klinikos
- Department Name
- 2150: neurology
- Principal Investigator Name
- Asta Baranauskaite
- Principal Investigator Email
- Asta.Baranauskaite@lsmuni.lt
- Contact Person Name
- Asta Baranauskaite
- Contact Person Email
- Asta.Baranauskaite@lsmuni.lt
- Site Name
- Vilniaus Universiteto Ligonine Santaros Klinikos Vsi
- Department Name
- 2151: neurology
- Principal Investigator Name
- Marius Miglinas
- Principal Investigator Email
- Marius.Miglinas@santa.lt
- Contact Person Name
- Marius Miglinas
- Contact Person Email
- Marius.Miglinas@santa.lt
Sponsor
Primary sponsor
- Full Name
- Novartis Pharma AG
- Organisation Type
- Pharmaceutical company
- Country Of Registered Address
- Switzerland
Contract research organisations
- Name
- Iqvia Laboratories Limited
- Responsibilities
- Storage of blood biomarkers analysis and PK samples, Biological scanned slides repository; contact q2_eu_clinical_trials_information@iqvia.com
- Name
- IQVIA Limited
- Responsibilities
- Operational responsibilities (codes listed: 1,13,3); contact eu_clinical_trials_information@iqvia.com
- Name
- Icon Clinical Research Limited
- Responsibilities
- Operational responsibilities (codes listed: 1,10); contact Triona.PriceSmith1@docsglobal.com
- Name
- Syneos Health Inc.
- Responsibilities
- Operational responsibility (code:1); contact sm_ctis@syneoshealth.com
- Name
- Parexel International (IRL) Limited
- Responsibilities
- Responsibility code:12; contact Clinicaltrial.Enquiries@parexel.com
Third parties
- {"country":"France","full_name":"SGS France","duties_or_roles":"code:4","organisation_type":"Pharmaceutical company"}
- {"country":"United Kingdom","full_name":"Iqvia Laboratories Limited","duties_or_roles":"Storage of blood biomarkers analysis and PK samples, Biological scanned slides repository; code:15; code:4","organisation_type":"Non-Pharmaceutical company"}
- {"country":"Estonia","full_name":"East Tallinn Central Hospital","duties_or_roles":"Provide service: core needle renal biopsy under ultrasound or x-ray control","organisation_type":"Hospital/Clinic/Other health care facility"}
- {"country":"United States","full_name":"Jumo Health USA Inc.","duties_or_roles":"Infographics for urine collection and IMP self-administration","organisation_type":"Hospital/Clinic/Other health care facility"}
- {"country":"United States","full_name":"RWS Life Sciences Inc.","duties_or_roles":"ePRO translators","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Clinical Ink Inc.","duties_or_roles":"code:7","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"EPL Pathology Archives LLC","duties_or_roles":"Long term lab sample storage","organisation_type":"Laboratory/Research/Testing facility"}
- {"country":"United States","full_name":"Syneos Health Inc.","duties_or_roles":"code:1","organisation_type":"Pharmaceutical company"}
- {"country":"United Kingdom","full_name":"Medical Equipment Supplies And Management Limited","duties_or_roles":"ancillary supplies","organisation_type":"Pharmaceutical company"}
- {"country":"Romania","full_name":"Alloga Logistics Romania S.R.L.","duties_or_roles":"re-labeling for A X MP drug","organisation_type":"Pharmaceutical company"}
- {"country":"United Kingdom","full_name":"IQVIA Limited","duties_or_roles":"code:1; code:13; code:3","organisation_type":"Pharmaceutical company"}
- {"country":"Estonia","full_name":"Tartu University Hospital","duties_or_roles":"Assessment of renal biopsy","organisation_type":"Hospital/Clinic/Other health care facility"}
- {"country":"Ireland","full_name":"Icon Clinical Research Limited","duties_or_roles":"code:1; code:10","organisation_type":"Pharmaceutical company"}
- {"country":"France","full_name":"Kayentis","duties_or_roles":"code:7","organisation_type":"Non-Pharmaceutical company"}
- {"country":"Ireland","full_name":"Parexel International (IRL) Limited","duties_or_roles":"code:12","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Labcorp Central Laboratory Services LP","duties_or_roles":"code:4","organisation_type":"Pharmaceutical company"}
Investigational products
- Investigational Product Name
- VAY736
- Active Substance
- IANALUMAB
- Modality
- Monoclonal antibody
- Routes Of Administration
- SUBCUTANEOUS INJECTION
- Route
- SUBCUTANEOUS INJECTION
- Authorisation Status
- Authorised
- Investigational Product Name
- Placebo to VAY736 150 mg/1 mL Solution for injection in pre-filled syringe , Placebo to VAY736 300 mg/2 mL Solution for injection in pre-filled syringe
- Modality
- Other
- Combination Treatment
- Yes
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