Clinical trial • Phase III • Immunology

IANALUMAB for Systemic lupus erythematosus

Phase III trial of IANALUMAB for Systemic lupus erythematosus.

Overview

Trial Therapeutic Area
Immunology
Trial Disease
Systemic lupus erythematosus
Trial Stage
Phase III
Drug Modality
Monoclonal antibody | Small molecule
Paediatric Trial
Yes

Key dates

Initial CTIS Submission Date
12-01-2024
First CTIS Authorization Date
07-05-2024

Trial design

Randomised, placebo to vay736 300 mg/2 ml solution for injection in pre-filled syringe; placebo to vay736 300 mg/2 ml solution for injection in pre-filled pen (placebo comparator for vay736). vay736 (ianalumab) is administered subcutaneously 300 mg monthly or every 3 months (as described in objectives).-controlled Phase III trial in Italy, Romania, Hungary and others.

Randomised
Yes
Comparator
Placebo to VAY736 300 mg/2 mL Solution for injection in pre-filled syringe; Placebo to VAY736 300 mg/2 mL Solution for injection in pre-filled pen (placebo comparator for VAY736). VAY736 (ianalumab) is administered subcutaneously 300 mg monthly or every 3 months (as described in objectives).
Target Sample Size
389
Trial Duration For Participant
1512

Eligibility

Recruits 389 paediatric patients.

Pregnancy Exclusion
Pregnant or nursing (breastfeeding) women.
Vulnerable Population
Participants < 18 years: Parent or legal guardian's signed informed consent and child's assent, if appropriate, are required before any assessment is performed. If a participant reaches the local age of consent during the study, they must sign the study ICF at the next visit.

Inclusion criteria

  • {"criterion_text":"- Signed informed consent prior to participation in the extension study. Parent or legal guardian's signed informed consent and child's assent, if appropriate, are required before any assessment is performed for participants below18 years of age. Of note, if the participant reaches age of consent (age as per local law) during the study, they will also need to sign the corresponding study Informed Consent Form (ICF) at the next study visit."}
  • {"criterion_text":"- Participants must have participated in either one of the two SIRIUS-SLE core studies, CVAY736F12301 or CVAY736F12302, and have completed the treatment period through Week 60 without treatment discontinuation."}
  • {"criterion_text":"- In the judgement of the investigator, participants must be expected to clinically benefit from continued study treatment."}

Exclusion criteria

  • {"criterion_text":"- Use of prohibited therapies"}
  • {"criterion_text":"- Active viral, bacterial or other infections requiring intravenous or intramuscular treatment for clinically significant infection which in the opinion of the investigator will place the participant at risk for participation."}
  • {"criterion_text":"- Plans for administration of live vaccines during the study period."}
  • {"criterion_text":"- Pregnant or nursing (breastfeeding) women."}
  • {"criterion_text":"- Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, refusing or unable to use highly effective methods of contraception while on study treatment and for 6 months after stopping of study drug (or longer if required by concomitant medications)."}
  • {"criterion_text":"- United States (and other countries, where male contraception is locally required): sexually active males, unless they agree to use barrier protection during intercourse with women of child-bearing potential while taking study treatment."}

Endpoints

Primary endpoints

  • {"endpoint_text":"- Incidence of treatment-emergent AEs (TEAEs)/SAEs","definition_or_measurement_approach":"Incidence (occurrence) of treatment-emergent adverse events and serious adverse events as reported during the study period."}

Secondary endpoints

  • {"endpoint_text":"- Proportion of participants who achieved SRI-4 response up to Week 216","definition_or_measurement_approach":""}
  • {"endpoint_text":"- Change from baseline in SLICC/ACR Damage Index up to Week 216","definition_or_measurement_approach":""}
  • {"endpoint_text":"- Average daily dose of oral corticosteroids administered up to Week 216","definition_or_measurement_approach":""}
  • {"endpoint_text":"- Annualized BILAG moderate or severe flare rate up to Week 216","definition_or_measurement_approach":""}
  • {"endpoint_text":"- Ianalumab serum concentrations during treatment and follow-up after last dose","definition_or_measurement_approach":""}
  • {"endpoint_text":"- Incidence and titer of anti-ianalumab antibodies in serum (ADA assay) over time","definition_or_measurement_approach":""}

Recruitment

Planned Sample Size
389
Recruitment Window Months
91
Consent Approach
Signed informed consent is required prior to participation. For participants under 18, a parent or legal guardian must sign informed consent and the child must provide assent when appropriate. If a participant reaches the local age of consent during the study, they must sign the appropriate ICF at the next study visit.

Geography

Total Number Of Sites
68
Total Number Of Participants
161

Italy

Earliest CTIS Part Ii Submission Date
01-04-2024
Latest Decision Or Authorization Date
09-05-2024
Processing Time Days
38
Number Of Sites
10
Number Of Participants
14

Sites

Site Name
Azienda Sanitaria Locale Napoli 1 Centro
Department Name
#3612: U.O.S.D. Reumatologia
Principal Investigator Name
Enrico Tirri
Principal Investigator Email
enrico.tirri@aslnapoli1centro.it
Contact Person Name
Enrico Tirri
Site Name
Azienda Ospedaliero Universitaria Delle Marche
Department Name
#3608:SOD Clinica Medica
Principal Investigator Name
Gianluca Moroncini
Principal Investigator Email
g.moroncini@staff.univpm.it
Contact Person Name
Gianluca Moroncini
Contact Person Email
g.moroncini@staff.univpm.it
Site Name
Azienda Ospedaliera Ordine Mauriziano Di Torino
Department Name
#3607:S.C.D.U. Allergologia e Immunologia Clinica
Principal Investigator Name
Luisa Brussino
Principal Investigator Email
luisa.brussino@unito.it
Contact Person Name
Luisa Brussino
Contact Person Email
luisa.brussino@unito.it
Site Name
Asst Centro Specialistico Ortopedico Traumatologico Gaetano Pini Cto
Department Name
#3606:U.O.C. Reumatologia Clinica
Principal Investigator Name
Maria Gerosa
Principal Investigator Email
maria.gerosa@unimi.it
Contact Person Name
Maria Gerosa
Contact Person Email
maria.gerosa@unimi.it
Site Name
Azienda Ospedaliera di Padova
Department Name
#3603: U.O.C. di Reumatologia DIDAS Medicina dei Sistemi
Principal Investigator Name
Luca Iaccarino
Principal Investigator Email
luca.iaccarino@unipd.it
Contact Person Name
Luca Iaccarino
Contact Person Email
luca.iaccarino@unipd.it
Site Name
University Hospital Of Ferrara
Department Name
#3604:U.O.C. Reumatologia
Principal Investigator Name
Marcello Govoni
Principal Investigator Email
gvl@unife.it
Contact Person Name
Marcello Govoni
Contact Person Email
gvl@unife.it
Site Name
Azienda Ospedaliero Universitaria Pisana
Department Name
#3602:U O Reumatologia
Principal Investigator Name
Marta Mosca
Principal Investigator Email
marta.mosca@med.unipi.it
Contact Person Name
Marta Mosca
Contact Person Email
marta.mosca@med.unipi.it
Site Name
San Camillo Forlanini Hospital
Department Name
#3609: U.O.C. Reumatologia
Principal Investigator Name
Gian Domenico Sebastiani
Principal Investigator Email
gsebastiani@scamilloforlanini.rm.it
Contact Person Name
Gian Domenico Sebastiani
Site Name
Azienda Ospedaliera Sant Anna E San Sebastiano Di Caserta
Department Name
#3610:US Reumatologia_Medina Interna
Principal Investigator Name
Giovanni Italiano
Principal Investigator Email
reumagio@gmail.com
Contact Person Name
Giovanni Italiano
Contact Person Email
reumagio@gmail.com
Site Name
Azienda Ospedaliera Sant Anna E San Sebastiano Di Caserta (duplicate entry in list)
Department Name
#3610:US Reumatologia_Medina Interna
Principal Investigator Name
Giovanni Italiano
Principal Investigator Email
reumagio@gmail.com
Contact Person Name
Giovanni Italiano
Contact Person Email
reumagio@gmail.com

Romania

Earliest CTIS Part Ii Submission Date
30-01-2024
Latest Decision Or Authorization Date
13-05-2024
Processing Time Days
104
Number Of Sites
3
Number Of Participants
11

Sites

Site Name
Centrul Medical De Diagnostic Si Tratament Ambulator Neomed S.R.L.
Department Name
#3301:Rheumatology
Principal Investigator Name
Liliana Duca
Principal Investigator Email
office@neomed.org
Contact Person Name
Liliana Duca
Contact Person Email
office@neomed.org
Site Name
Saint Maria Hospital
Department Name
#3304:Rheumatology
Principal Investigator Name
Andra Rodica Balanescu
Principal Investigator Email
balanescu.andra@gmail.com
Contact Person Name
Andra Rodica Balanescu
Contact Person Email
balanescu.andra@gmail.com
Site Name
Spitalul Clinic Judetean De Urgenta Cluj
Department Name
#3302:Rheumatology
Principal Investigator Name
Simona Rednic
Principal Investigator Email
srednic@umfcluj.ro
Contact Person Name
Simona Rednic
Contact Person Email
srednic@umfcluj.ro

Hungary

Earliest CTIS Part Ii Submission Date
11-03-2024
Latest Decision Or Authorization Date
08-05-2024
Processing Time Days
58
Number Of Sites
5
Number Of Participants
8

Sites

Site Name
Belvarosi Egeszseghaz Kft.
Department Name
#3105
Principal Investigator Name
Monika Kovacs
Principal Investigator Email
monikakovacsdr75@gmail.com
Contact Person Name
Monika Kovacs
Contact Person Email
monikakovacsdr75@gmail.com
Site Name
Bekes Varmegyei Koezponti Korhaz
Department Name
#3101:Infektologia hepatologia Oszt
Principal Investigator Name
Tibor Martyin
Principal Investigator Email
martyintibor@freemail.hu
Contact Person Name
Tibor Martyin
Contact Person Email
martyintibor@freemail.hu
Site Name
Vita Verum Medical Bt.
Department Name
#3102
Principal Investigator Name
Tunde Varga
Principal Investigator Email
vargatundedr1@gmail.com
Contact Person Name
Tunde Varga
Contact Person Email
vargatundedr1@gmail.com
Site Name
Semmelweis University
Department Name
#3104: Reumatologiai es Immunologiai Klinika
Principal Investigator Name
Zsofia Kiss
Principal Investigator Email
drkisszsofia@gmail.com
Contact Person Name
Zsofia Kiss
Contact Person Email
drkisszsofia@gmail.com
Site Name
Qualiclinic Kft.
Department Name
#3103
Principal Investigator Name
Istvan Szombati
Principal Investigator Email
i.szombati@qclinic.hu
Contact Person Name
Istvan Szombati
Contact Person Email
i.szombati@qclinic.hu

Poland

Earliest CTIS Part Ii Submission Date
17-04-2024
Latest Decision Or Authorization Date
07-05-2024
Processing Time Days
20
Number Of Sites
6
Number Of Participants
38

Sites

Site Name
Szpital Specjalistyczny Nr I W Bytomiu SPZOZ
Department Name
#3204:Oddział Reumatologii i Rehabilitacji
Principal Investigator Name
Aleksandra Zon-Giebel
Principal Investigator Email
azongiebel@gmail.com
Contact Person Name
Aleksandra Zon-Giebel
Contact Person Email
azongiebel@gmail.com
Site Name
Wojskowy Instytut Medyczny Panstwowy Instytut Badawczy
Department Name
#3203:Centrum Wsparcia Badań Klinicznych
Principal Investigator Name
Joanna Kur-Zalewska
Principal Investigator Email
jkur-zalewska@wim.mil.pl
Contact Person Name
Joanna Kur-Zalewska
Contact Person Email
jkur-zalewska@wim.mil.pl
Site Name
Szpital Uniwersytecki Nr 2 Im Dr Jana Biziela W Bydgoszczy
Department Name
#3201:Klinika Reumatologii i Ukladowych Chorb Tkanki Lacznej
Principal Investigator Name
Rafal Wojciechowski
Principal Investigator Email
r.wojciechowski@wp.eu
Contact Person Name
Rafal Wojciechowski
Contact Person Email
r.wojciechowski@wp.eu
Site Name
Reumatop Grzegorz Rozumek Karin Pistorius Sp. j.
Department Name
#3202
Principal Investigator Name
Grzegorz Rozumek
Principal Investigator Email
grozumek@wp.pl
Contact Person Name
Grzegorz Rozumek
Contact Person Email
grozumek@wp.pl
Site Name
Medicover Integrated Clinical Services Sp. z o.o. (Warsaw)
Department Name
#3206:Centrum Medyczne Warszawa
Principal Investigator Name
Katarzyna Romanowska-Prochnicka
Contact Person Name
Katarzyna Romanowska-Prochnicka
Site Name
Medicover Integrated Clinical Services Sp. z o.o. (Bydgoszcz)
Department Name
#3205:Centrum Medyczne Bydgoszcz
Principal Investigator Name
Katarzyna Kolossa
Principal Investigator Email
k.kolossa@naszlekarz.pl
Contact Person Name
Katarzyna Kolossa
Contact Person Email
k.kolossa@naszlekarz.pl

France

Earliest CTIS Part Ii Submission Date
30-01-2024
Latest Decision Or Authorization Date
13-05-2024
Processing Time Days
104
Number Of Sites
9
Number Of Participants
11

Sites

Site Name
Centre Hospitalier Universitaire De Montpellier
Department Name
#3505: Rhumatologie
Principal Investigator Name
Jacques MOREL
Principal Investigator Email
j-morel@chu-montpellier.fr
Contact Person Name
Jacques MOREL
Contact Person Email
j-morel@chu-montpellier.fr
Site Name
Assistance Publique Hopitaux De Paris (47 Boulevard De L Hopital)
Department Name
#3501: Médecine Interne
Principal Investigator Name
Zahir AMOURA
Principal Investigator Email
zahir.amoura@aphp.fr
Contact Person Name
Zahir AMOURA
Contact Person Email
zahir.amoura@aphp.fr
Site Name
Assistance Publique Hopitaux De Paris (46 Rue Henri Huchard)
Department Name
#3509: Médecine Interne
Principal Investigator Name
Karim SACRE
Principal Investigator Email
karim.sacre@aphp.fr
Contact Person Name
Karim SACRE
Contact Person Email
karim.sacre@aphp.fr
Site Name
Assistance Publique Hopitaux De Paris (27 Rue Du Faubourg Saint Jacques)
Department Name
#3502: Médecine Interne
Principal Investigator Name
Véronique LE GUERN
Principal Investigator Email
veronique.le-guern@aphp.fr
Contact Person Name
Véronique LE GUERN
Contact Person Email
veronique.le-guern@aphp.fr
Site Name
Centre Hospitalier Universitaire De Toulouse
Department Name
#3512: Médecine Interne
Principal Investigator Name
Gregory PUGNET
Principal Investigator Email
pugnet.g@chu-toulouse.fr
Contact Person Name
Gregory PUGNET
Contact Person Email
pugnet.g@chu-toulouse.fr
Site Name
Centre Hospitalier Universitaire De Toulouse (Place Du Docteur Joseph Baylac)
Department Name
#3510: Medecine Interne
Principal Investigator Name
Laurent SAILLER
Principal Investigator Email
sailler.l@chu-toulouse.fr
Contact Person Name
Laurent SAILLER
Contact Person Email
sailler.l@chu-toulouse.fr
Site Name
Centre Hospitalier Universitaire D'Angers
Department Name
#3504: Médecine Interne -Immunologie Clinique
Principal Investigator Name
Christian LAVIGNE
Principal Investigator Email
chlavigne@chu-angers.fr
Contact Person Name
Christian LAVIGNE
Contact Person Email
chlavigne@chu-angers.fr
Site Name
Centre Hospitalier Universitaire Grenoble Alpes
Department Name
#3507: Médecine Interne
Principal Investigator Name
Laurence BOUILLET
Principal Investigator Email
lbouilet@chu-grenoble.fr
Contact Person Name
Laurence BOUILLET
Contact Person Email
lbouilet@chu-grenoble.fr
Site Name
Centre Hospitalier Regional Universitaire De Tours
Department Name
#3508: Médecine Interne & Immunologie Clinique
Principal Investigator Name
Nicole FERREIRA-MALDENT
Principal Investigator Email
n.ferreira-maldent@chu-tours.fr
Contact Person Name
Nicole FERREIRA-MALDENT

Czechia

Earliest CTIS Part Ii Submission Date
08-04-2024
Latest Decision Or Authorization Date
10-05-2024
Processing Time Days
32
Number Of Sites
3
Number Of Participants
9

Sites

Site Name
Medical Plus s.r.o.
Department Name
#3053
Principal Investigator Name
Eva Dokoupilova
Principal Investigator Email
evadokoupil@gmail.com
Contact Person Name
Eva Dokoupilova
Contact Person Email
evadokoupil@gmail.com
Site Name
Revmatologicky Ustav
Department Name
#3051
Principal Investigator Name
Hana Ciferska
Principal Investigator Email
ciferska@revma.cz
Contact Person Name
Hana Ciferska
Contact Person Email
ciferska@revma.cz
Site Name
Revmatologie s.r.o.
Department Name
#3052
Principal Investigator Name
Leona Prochazkova
Principal Investigator Email
revmatologie.prochazkova@seznam.cz
Contact Person Name
Leona Prochazkova

Germany

Earliest CTIS Part Ii Submission Date
01-04-2024
Latest Decision Or Authorization Date
08-05-2024
Processing Time Days
37
Number Of Sites
6
Number Of Participants
17

Sites

Site Name
Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz KöR
Department Name
#3558: I. Medizinische Klinik und Poliklinik
Principal Investigator Name
Julia Weinmann-Menke
Principal Investigator Email
Julia.weinmann-menke@unimedizin-mainz.de
Contact Person Name
Julia Weinmann-Menke
Site Name
Universitaet Leipzig
Department Name
#3556: Klinik und Poliklinik für Endokrinologie, Nephrologie, Rheumatologie
Principal Investigator Name
Ulf Wagner
Principal Investigator Email
ulf.wagner@medizin.uni-leipzig.de
Contact Person Name
Ulf Wagner
Site Name
University Hospital Cologne AöR
Department Name
#3557: Klinik I für Innere Medizin
Principal Investigator Name
Philipp Koehler
Principal Investigator Email
philipp.koehler@uk-koeln.de
Contact Person Name
Philipp Koehler
Contact Person Email
philipp.koehler@uk-koeln.de
Site Name
Medical Center - University Of Freiburg
Department Name
#3555: Klinik für Rheumatologie und Klinische Immunologie
Principal Investigator Name
Stephanie Finzel
Principal Investigator Email
Stephanie.finzel@uniklinik-freiburg.de
Contact Person Name
Stephanie Finzel
Site Name
Charite Universitaetsmedizin Berlin KöR
Department Name
#3553: Medizinische Klinik mit Schwerpunkt Rheumatologie und klinische Immunologie
Principal Investigator Name
Thomas Doerner
Principal Investigator Email
Thomas.doerner@charite.de
Contact Person Name
Thomas Doerner
Contact Person Email
Thomas.doerner@charite.de
Site Name
St. Elisabeth Gruppe GmbH Katholische Kliniken Rhein-Ruhr
Department Name
#3552: Rheumazentrum Ruhrgebiet
Principal Investigator Name
Ioana Andreica
Principal Investigator Email
Ioana.andreica@elisabethgruppe.de
Contact Person Name
Ioana Andreica

Spain

Earliest CTIS Part Ii Submission Date
04-03-2024
Latest Decision Or Authorization Date
09-05-2024
Processing Time Days
66
Number Of Sites
14
Number Of Participants
29

Sites

Site Name
Complexo Hospitalario Universitario De Vigo
Department Name
3405: Reumatología
Principal Investigator Name
Jose María Pego Reigosa
Principal Investigator Email
jose.maria.pego.reigosa@sergas.es
Contact Person Name
Jose María Pego Reigosa
Site Name
Hospital General Universitario De Elche
Department Name
3415: Reumatología
Principal Investigator Name
Fernando Lidon Perez
Principal Investigator Email
lidon_fer@gva.es
Contact Person Name
Fernando Lidon Perez
Contact Person Email
lidon_fer@gva.es
Site Name
Hospital Universitario Infanta Sofía
Department Name
3409: Reumatología
Principal Investigator Name
Maria Tatiana Cobo Ibanez
Principal Investigator Email
mtatiana.cobo@salud.madrid.org
Contact Person Name
Maria Tatiana Cobo Ibanez
Contact Person Email
mtatiana.cobo@salud.madrid.org
Site Name
Hospital Universitario Ramon Y Cajal
Department Name
3413: Reumatología
Principal Investigator Name
Andres Gonzalez Garcia
Principal Investigator Email
andres.gonzalez@salud.madrid.org
Contact Person Name
Andres Gonzalez Garcia
Site Name
Hospital Del Mar
Department Name
3411: Reumatología
Principal Investigator Name
Tarek Carlos Salman Monte
Principal Investigator Email
tsalman@psmar.cat
Contact Person Name
Tarek Carlos Salman Monte
Contact Person Email
tsalman@psmar.cat
Site Name
Hospital General Universitario De Valencia
Department Name
3417: Reumatología
Principal Investigator Name
Jorge Juan Fragio Gil
Principal Investigator Email
fragio_jor@gva.es
Contact Person Name
Jorge Juan Fragio Gil
Contact Person Email
fragio_jor@gva.es
Site Name
Hospital Germans Trias I Pujol
Department Name
3404: Reumatología
Principal Investigator Name
Anne Margaret Riveros Frutos
Principal Investigator Email
amriveros.germanstrias@gencat.cat
Contact Person Name
Anne Margaret Riveros Frutos
Site Name
Hospital Universitario Marques De Valdecilla
Department Name
3406: Reumatología
Principal Investigator Name
Ricardo Blanco Alonso
Principal Investigator Email
ricardo.blanco@scsalud.es
Contact Person Name
Ricardo Blanco Alonso
Contact Person Email
ricardo.blanco@scsalud.es
Site Name
Hospital Universitario Rio Hortega
Department Name
3412: Reumatología
Principal Investigator Name
Julia Barbado Ajo
Principal Investigator Email
jbarbadoa@saludcastillayleon.es
Contact Person Name
Julia Barbado Ajo
Site Name
Hospital Universitario Araba
Department Name
3414: Reumatología
Principal Investigator Name
Jaime Calvo Alen
Principal Investigator Email
jcalvo@ser.es
Contact Person Name
Jaime Calvo Alen
Contact Person Email
jcalvo@ser.es
Site Name
Complexo Hospitalario Universitario De Santiago
Department Name
3402: Reumatología
Principal Investigator Name
Eva María Pérez Pampín
Principal Investigator Email
eva.perez.pampin@sergas.es
Contact Person Name
Eva María Pérez Pampín
Contact Person Email
eva.perez.pampin@sergas.es
Site Name
Hospital Universitario De Navarra
Department Name
3408: Reumatología
Principal Investigator Name
Maria Concepcion Fito Manteca
Principal Investigator Email
mc.fito.manteca@navarra.es
Contact Person Name
Maria Concepcion Fito Manteca
Contact Person Email
mc.fito.manteca@navarra.es
Site Name
Hospital Universitario De Canarias
Department Name
3403: Reumatología
Principal Investigator Name
Jose Federico Diaz Gonzalez
Principal Investigator Email
jdiagonc@gobiernodecanarias.org
Contact Person Name
Jose Federico Diaz Gonzalez
Site Name
Hospital Universitari Vall D Hebron
Department Name
3401: 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

Bulgaria

Earliest CTIS Part Ii Submission Date
15-11-2024
Latest Decision Or Authorization Date
07-11-2024
Processing Time Days
-8
Number Of Sites
2
Number Of Participants
5

Sites

Site Name
University Multiprofile Hospital For Active Treatment Kaspela EOOD
Department Name
3001:Rheumatology clinic
Principal Investigator Name
Anastas Batalov
Principal Investigator Email
abatalov@hotmail.com
Contact Person Name
Anastas Batalov
Contact Person Email
abatalov@hotmail.com
Site Name
University Multiprofile Hospital For Active Treatment St. Ivan Rilski EAD
Department Name
3004: Clinic of Rheumatology
Principal Investigator Name
Vladimira Boyadzhieva
Principal Investigator Email
Vladimira.boyadzhieva@gmail.com
Contact Person Name
Vladimira Boyadzhieva

Slovakia

Earliest CTIS Part Ii Submission Date
01-04-2024
Latest Decision Or Authorization Date
07-05-2024
Processing Time Days
36
Number Of Sites
3
Number Of Participants
11

Sites

Site Name
Univerzitna nemocnica Nemocnica svaeteho Michala a.s.
Department Name
#3358: Reumatologická ambulancia
Principal Investigator Name
Lenka Tarabčáková
Principal Investigator Email
lenka.tarabcakova@gmail.com
Contact Person Name
Lenka Tarabčáková
Contact Person Email
lenka.tarabcakova@gmail.com
Site Name
Zazabie s.r.o.
Department Name
#3357: Reumatologická ambulancia
Principal Investigator Name
Juraj Semančík
Principal Investigator Email
zazabie.sro@gmail.com
Contact Person Name
Juraj Semančík
Contact Person Email
zazabie.sro@gmail.com
Site Name
Narodny Ustav Reumatickych Chorob
Department Name
#3351:Reumatologická ambulancia a Zariadenie biomedicínskeho výskumu
Principal Investigator Name
Alena Tuchyňová
Principal Investigator Email
alena.tuchynova@nurch.sk
Contact Person Name
Alena Tuchyňová
Contact Person Email
alena.tuchynova@nurch.sk

Portugal

Earliest CTIS Part Ii Submission Date
15-04-2024
Latest Decision Or Authorization Date
08-05-2024
Processing Time Days
23
Number Of Sites
7
Number Of Participants
8

Sites

Site Name
Unidade Local De Saude De Lisboa Ocidental E.P.E.
Department Name
#3253: Serviço de Reumatologia
Principal Investigator Name
Maria Goncalves
Principal Investigator Email
mjggoncalves@ulslo.min-saude.pt
Contact Person Name
Maria Goncalves
Site Name
Unidade Local De Saude De Gaia/Espinho E.P.E.
Department Name
#3256: Serviço de Reumatologia
Principal Investigator Name
Ana Sofia Rocha Pinto
Principal Investigator Email
ana.rocha.pinto@ulsge.min-saude.pt
Contact Person Name
Ana Sofia Rocha Pinto
Site Name
Centro Hospitalar Universitario De Lisboa Norte E.P.E.
Department Name
#3252: Serviço de Reumatologia
Principal Investigator Name
Nikita Khmelinski
Principal Investigator Email
nikita.khmelinskii@chln.min-saude.pt
Contact Person Name
Nikita Khmelinski
Site Name
CCAB Centro Clinico Academico Braga Associacao
Department Name
#3254: Serviço de Reumatologia
Principal Investigator Name
Joana Silva
Principal Investigator Email
joana.leite.silva@ulsb.min-saude.pt
Contact Person Name
Joana Silva
Site Name
Instituto Portugues De Reumatologia
Department Name
#3251
Principal Investigator Name
Helena Santos
Principal Investigator Email
ipr-ensaiosclinicos@hotmail.com
Contact Person Name
Helena Santos
Site Name
Unidade Local De Saude Da Regiao De Leiria E.P.E.
Department Name
#3255: Serviço de Reumatologia
Principal Investigator Name
Diogo Jesus
Principal Investigator Email
diogo.jesus@chleiria.min-saude.pt
Contact Person Name
Diogo Jesus
Site Name
Centro Hospitalar Universitario De Lisboa Norte E.P.E. (duplicate entry)
Department Name
#3252: Serviço de Reumatologia
Principal Investigator Name
Nikita Khmelinski
Principal Investigator Email
nikita.khmelinskii@chln.min-saude.pt
Contact Person Name
Nikita Khmelinski

Sponsor

Primary sponsor

Full Name
Novartis Pharma AG
Organisation Type
Pharmaceutical company
Country Of Registered Address
Switzerland

Contract research organisations

Name
Syneos Health Inc.
Responsibilities
sponsorDuties codes: [1]
Name
Parexel International (IRL) Limited
Responsibilities
sponsorDuties codes: [12]
Name
Icon Clinical Research Limited
Responsibilities
sponsorDuties codes: [1,10]
Name
IQVIA Limited
Responsibilities
Data Montioring; sponsorDuties codes: [1,15,3]

Third parties

  • {"country":"United States","full_name":"Medidata Solutions Inc.","duties_or_roles":"sponsorDuties codes: [6]","organisation_type":"Non-Pharmaceutical company"}
  • {"country":"United States","full_name":"RWS Life Sciences Inc.","duties_or_roles":"Patient reported outcomes formatting, Licensing and translations","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Syneos Health Inc.","duties_or_roles":"sponsorDuties codes: [1]","organisation_type":"Pharmaceutical company"}
  • {"country":"Ireland","full_name":"Parexel International (IRL) Limited","duties_or_roles":"sponsorDuties codes: [12]","organisation_type":"Pharmaceutical company"}
  • {"country":"United Kingdom","full_name":"IQVIA Limited","duties_or_roles":"Data Montioring (and sponsorDuties codes: [1,15,3])","organisation_type":"Pharmaceutical company"}
  • {"country":"United Kingdom","full_name":"Q Squared Solutions Limited","duties_or_roles":"sponsorDuties codes: [4]","organisation_type":"Non-Pharmaceutical company"}
  • {"country":"Ireland","full_name":"Icon Clinical Research Limited","duties_or_roles":"sponsorDuties codes: [1,10]","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Clinical Ink Inc.","duties_or_roles":"PROs/CROs management, Trial Feedback questionnaires, data collection via tablet","organisation_type":"Pharmaceutical company"}
  • {"country":"Romania","full_name":"Alliance Healthcare Romania S.R.L.","duties_or_roles":"Destruction of IMP and non-IMP","organisation_type":"Pharmaceutical company"}
  • {"country":"Poland","full_name":"Eco-Abc Sp. z o. o.","duties_or_roles":"Destruction of the investigational medicinal products","organisation_type":"Pharmaceutical company"}
  • {"country":"Poland","full_name":"Statmed Sp. z o.o.","duties_or_roles":"Compensation for patients travel to the clinical site","organisation_type":"Pharmaceutical company"}
  • {"country":"Hungary","full_name":"ADR Logistics Kft.","duties_or_roles":"Drug storage, distribution, and destruction","organisation_type":"Pharmaceutical company"}
  • {"country":"United Kingdom","full_name":"Labcorp Early Development Laboratories Limited","duties_or_roles":"sponsorDuties codes: [4]","organisation_type":"Pharmaceutical company"}

Investigational products

Investigational Product Name
VAY736
Active Substance
IANALUMAB
Modality
Monoclonal antibody
Routes Of Administration
SUBCUTANEOUS | SUBCUTANEOUS USE
Route
Subcutaneous
Starting Dose
300 mg
Dose Levels
300 mg administered subcutaneously monthly or every 3 months
Frequency
Monthly or every 3 months
Maximum Dose
300 mg (per dosing event; maxDailyDoseAmount: 300 mg listed)
Investigational Product Name
Placebo to VAY736 300 mg/2 mL Solution for injection in pre-filled syringe
Modality
Other
Investigational Product Name
Placebo to VAY736 300 mg/2 mL Solution for injection in pre-filled pen
Modality
Other
Investigational Product Name
ENTECAVIR
Active Substance
ENTECAVIR
Modality
Small molecule
Routes Of Administration
ORAL
Route
Oral
Maximum Dose
0.5 mg (maxDailyDoseAmount listed)
Investigational Product Name
TENOFOVIR ALAFENAMIDE
Active Substance
TENOFOVIR ALAFENAMIDE
Modality
Small molecule
Routes Of Administration
ORAL
Route
Oral
Maximum Dose
25 mg (maxDailyDoseAmount listed)
Investigational Product Name
TENOFOVIR DISOPROXIL / EMTRICITABINE
Active Substance
EMTRICITABINE, TENOFOVIR DISOPROXIL
Modality
Small molecule
Routes Of Administration
ORAL
Route
Oral
Maximum Dose
300 mg (maxDailyDoseAmount listed)
Investigational Product Name
GLUCOCORTICOIDS
Active Substance
-
Modality
Small molecule
Routes Of Administration
UNKNOWN USE
Maximum Dose
DF dosage form (maxDailyDoseAmount listed as 0)

Related trials

Other published trials that may interest you.