Clinical trial • Phase IV • Immunology|Musculoskeletal
SECUKINUMAB for Non-radiographic axial spondyloarthritis
Phase IV trial of SECUKINUMAB for Non-radiographic axial spondyloarthritis.
Overview
- Trial Therapeutic Area
- Immunology|Musculoskeletal
- Trial Disease
- Non-radiographic axial spondyloarthritis
- Trial Stage
- Phase IV
- Drug Modality
- Monoclonal antibody
Key dates
- Initial CTIS Submission Date
- 29-03-2024
- First CTIS Authorization Date
- 17-05-2024
Trial design
Randomised, placebo to ain457 (matching placebo) and secukinumab 150 mg subcutaneous (pre-filled syringe); dosing schedule not specified in the ctis json.-controlled Phase IV trial in Belgium, Czechia, France and others.
- Randomised
- Yes
- Comparator
- Placebo to AIN457 (matching placebo) and SECUKINUMAB 150 mg subcutaneous (pre-filled syringe); dosing schedule not specified in the CTIS JSON.
- Target Sample Size
- 103
- Trial Duration For Participant
- 840
Eligibility
Recruits 103 The trial record indicates 'isVulnerablePopulationSelected': true. Informed consent documents provided are adult main ICFs (multiple languages) and there are specific follow-up ICFs for pregnant participants and parent/legal guardian pregnancy follow-up documents in some countries. Consent is obtained via the adult main ICF (documents available in multiple languages for the participating countries). Minors are excluded by the inclusion criteria (minimum age 18), so assent for minors is not applicable..
- Pregnancy Exclusion
- Male or non-pregnant, non-lactating female participants at least 18 years of age.
- Vulnerable Population
- The trial record indicates 'isVulnerablePopulationSelected': true. Informed consent documents provided are adult main ICFs (multiple languages) and there are specific follow-up ICFs for pregnant participants and parent/legal guardian pregnancy follow-up documents in some countries. Consent is obtained via the adult main ICF (documents available in multiple languages for the participating countries). Minors are excluded by the inclusion criteria (minimum age 18), so assent for minors is not applicable.
Inclusion criteria
- {"criterion_text":"- Male or non-pregnant, non-lactating female participants at least 18 years of age."}
- {"criterion_text":"- Clinical diagnosis of axSpA AND according to ASAS axSpA criteria: a. Inflammatory back pain for at least 6 months b. Onset before 45 years of age c. Sacroiliitis on MRI (as assessed by central reader) with ≥ 1 SpA feature OR HLA-B-27 positive with ≥2 SpA features"}
- {"criterion_text":"- Objective signs of inflammation at screening, evident by either •\tMRI with Sacroiliac Joint inflammation (as assessed by central reader) AND / OR •\thsCRP > ULN (as defined by the central lab)"}
- {"criterion_text":"- Active axSpA as assessed by total BASDAI ≥ 4 cm (0-10 cm) at baseline."}
- {"criterion_text":"- Spinal pain as measured by BASDAI question #2 ≥ 4 cm (0-10 cm) at baseline."}
- {"criterion_text":"- Total back pain as measured by VAS ≥ 40 mm (0-100 mm) at baseline."}
- {"criterion_text":"- Participants should have been on at least 2 different NSAIDs (non-steroidal anti-inflammatory drugs) at the highest recommended dose for at least 4 weeks in total prior to baseline with an inadequate response or failure to respond, or less if therapy had to be withdrawn due to intolerance, toxicity or contraindications."}
Exclusion criteria
- {"criterion_text":"- Participants with radiographic evidence for sacroiliitis, grade ≥ 2 bilaterally or grade ≥ 3 unilaterally (radiological criterion according to the modified New York diagnostic criteria for AS) as assessed by central reader."}
- {"criterion_text":"- Participants taking high potency opioid analgesics (e.g., methadone, hydromorphone, morphine)."}
- {"criterion_text":"- Previous exposure to secukinumab or any other biologic drug directly targeting IL-17 or IL-17 receptor or previous treatment with immunomodulatory biologic agents including those targeting TNFα (tumor necrosis factor α) (unless participants discontinued the treatment with TNFα inhibitor due to a reason other than efficacy [primary or secondary lack of efficacy, inadequate response] and only after appropriate wash-out period prior to baseline was observed)."}
- {"criterion_text":"- History of hypersensitivity to the study drug or its excipients or to drugs of similar chemical classes."}
- {"criterion_text":"- Active ongoing inflammatory diseases other than nr-axSpA that might confound the evaluation of the benefit of secukinumab therapy, including uveitis."}
- {"criterion_text":"- Active inflammatory bowel disease"}
- {"criterion_text":"- History of ongoing, chronic or recurrent infectious disease or evidence of tuberculosis infection."}
Endpoints
Primary endpoints
- {"endpoint_text":"- The proportion of participants remaining flare-free at Week 120","definition_or_measurement_approach":"Proportion of participants who remain free of flare at Week 120 (assessed as the proportion of randomized participants without a flare at Week 120)."}
Secondary endpoints
- {"endpoint_text":"- Time to flare during Treatment Period 2","definition_or_measurement_approach":"Time-to-event measure: time from randomization (start of Treatment Period 2) to occurrence of flare during Treatment Period 2."}
- {"endpoint_text":"- Safety and tolerability demonstrated by assessing: •\tAdverse events (AEs) and serious adverse events (SAEs) (incidence, severity, and relationship with study drug) •\tClinically significant changes in laboratory parameters and vital signs","definition_or_measurement_approach":"Safety endpoints assessed by incidence, severity and relationship of AEs and SAEs; and clinically significant changes in laboratory parameters and vital signs as measured throughout the study up to follow-up visit."}
Recruitment
- Planned Sample Size
- 103
- Recruitment Window Months
- 87
- Consent Approach
- Informed consent is obtained using Main ICF adult documents; country-specific ICFs are provided in multiple languages (English, Dutch, French, German, Hungarian, Czech, Italian, Polish, Romanian). Separate data protection consent and optional assessment consents are available in some countries. There are specific follow-up forms for pregnant participants and, in at least one country, a Pregnancy Follow up Parent Legal Guardian document.
Geography
- Total Number Of Sites
- 56
- Total Number Of Participants
- 244
Belgium
- Earliest CTIS Part Ii Submission Date
- 16-04-2024
- Latest Decision Or Authorization Date
- 21-05-2024
- Processing Time Days
- 35
- Number Of Sites
- 4
- Number Of Participants
- 15
Sites
- Site Name
- CHU Helora
- Department Name
- 6044: Rheumatology
- Principal Investigator Name
- Marc Leon
- Principal Investigator Email
- Marc.leon@hap.be
- Contact Person Name
- Marc Leon
- Contact Person Email
- Marc.leon@hap.be
- Site Name
- Reumaclinic
- Department Name
- 6042: Rheumatology
- Principal Investigator Name
- Johan Vanhoof
- Principal Investigator Email
- Johan@johanvanhoof.be
- Contact Person Name
- Johan Vanhoof
- Contact Person Email
- Johan@johanvanhoof.be
- Site Name
- Az St-Jan Brugge-Oostende A.V.
- Department Name
- 6043: Rheumatology
- Principal Investigator Name
- Sam Beeckman
- Principal Investigator Email
- Sam.beeckman@azsintjan.be
- Contact Person Name
- Sam Beeckman
- Contact Person Email
- Sam.beeckman@azsintjan.be
- Site Name
- Universitair Ziekenhuis Gent
- Department Name
- 6041: Rheumatology
- Principal Investigator Name
- Filip Van den Bosch
- Principal Investigator Email
- Filip.vandenbosch@ugent.be
- Contact Person Name
- Filip Van den Bosch
- Contact Person Email
- Filip.vandenbosch@ugent.be
Czechia
- Earliest CTIS Part Ii Submission Date
- 16-04-2024
- Latest Decision Or Authorization Date
- 21-05-2024
- Processing Time Days
- 35
- Number Of Sites
- 4
- Number Of Participants
- 28
Sites
- Site Name
- Medical Plus s.r.o.
- Department Name
- 2041: Revmatologie
- Principal Investigator Name
- Eva Dokoupilová
- Principal Investigator Email
- evadokoupil@gmail.com
- Contact Person Name
- Eva Dokoupilová
- Contact Person Email
- evadokoupil@gmail.com
- Site Name
- Affidea Praha s.r.o.
- Department Name
- 2045: Revmatologie
- Principal Investigator Name
- Jan Rosa
- Principal Investigator Email
- rosaj@affidea-praha.cz
- Contact Person Name
- Jan Rosa
- Contact Person Email
- rosaj@affidea-praha.cz
- Site Name
- Revmatologicky Ustav
- Department Name
- 2043: Revmatologie
- Principal Investigator Name
- Karel Pavelka
- Principal Investigator Email
- pavelka@revma.cz
- Contact Person Name
- Karel Pavelka
- Contact Person Email
- pavelka@revma.cz
- Site Name
- Fakultni Nemocnice V Motole
- Department Name
- 2044: Oddělení revmatologie dětí a dospělých
- Principal Investigator Name
- Rudolf Horváth
- Principal Investigator Email
- rudolf.horvath@fnmotol.cz
- Contact Person Name
- Rudolf Horváth
- Contact Person Email
- rudolf.horvath@fnmotol.cz
France
- Earliest CTIS Part Ii Submission Date
- 16-04-2024
- Latest Decision Or Authorization Date
- 22-05-2024
- Processing Time Days
- 36
- Number Of Sites
- 6
- Number Of Participants
- 35
Sites
- Site Name
- Centre Hospitalier Le Mans
- Department Name
- 3003: Service de Rhumatologie
- Principal Investigator Name
- Guillaume DIRIEZ
- Principal Investigator Email
- gdiriez@ch-lemans.fr
- Contact Person Name
- Guillaume DIRIEZ
- Contact Person Email
- gdiriez@ch-lemans.fr
- Site Name
- Centre Hospitalier Universitaire D Orleans
- Department Name
- 3004: Service de Rhumatologie
- Principal Investigator Name
- Eric LESPESSAILLES
- Principal Investigator Email
- eric.lespessailles@chr-orleans.fr
- Contact Person Name
- Eric LESPESSAILLES
- Contact Person Email
- eric.lespessailles@chr-orleans.fr
- Site Name
- Hopital Saint Antoine
- Department Name
- 3005: Service de Rhumatologie
- Principal Investigator Name
- Francis BERENBAUM
- Principal Investigator Email
- francis.berenbaum@aphp.fr
- Contact Person Name
- Francis BERENBAUM
- Contact Person Email
- francis.berenbaum@aphp.fr
- Site Name
- Centre Hospitalier Universitaire De Nice
- Department Name
- 3006: Pasteur 2 Service de Rhumatologie
- Principal Investigator Name
- Christian ROUX
- Principal Investigator Email
- roux.c2@chu-nice.fr
- Contact Person Name
- Christian ROUX
- Contact Person Email
- roux.c2@chu-nice.fr
- Site Name
- Centre Hospitalier Regional Universitaire De Tours
- Department Name
- 3001: Service de Rhumatologie
- Principal Investigator Name
- Philippe GOUPILLE
- Principal Investigator Email
- philippe.goupille@univ-tours.fr
- Contact Person Name
- Philippe GOUPILLE
- Contact Person Email
- philippe.goupille@univ-tours.fr
- Site Name
- Centre Hospitalier Universitaire De Toulouse
- Department Name
- 3002: Hôpital Pierre Paul Riquet Service de Rhumatologie
- Principal Investigator Name
- Arnaud CONSTANTIN
- Principal Investigator Email
- constantin.a@chu-toulouse.fr
- Contact Person Name
- Arnaud CONSTANTIN
- Contact Person Email
- constantin.a@chu-toulouse.fr
Germany
- Earliest CTIS Part Ii Submission Date
- 16-04-2024
- Latest Decision Or Authorization Date
- 21-05-2024
- Processing Time Days
- 35
- Number Of Sites
- 10
- Number Of Participants
- 42
Sites
- Site Name
- Rheumatologische Schwerpunktpraxis Rendsburg
- Department Name
- 1014: Rheumatologische Schwerpunktpraxis Rendsburg
- Principal Investigator Name
- Jochen Walter
- Principal Investigator Email
- j.walter@rheuma.sh
- Contact Person Name
- Jochen Walter
- Contact Person Email
- j.walter@rheuma.sh
- Site Name
- Institut Fuer Praeventive Medizin & Klinische Forschung GbR
- Department Name
- 1006: Praeventive Medizin & Klinische Forschung
- Principal Investigator Name
- Ruediger Moericke
- Principal Investigator Email
- prof.moericke@praxismoericke.de
- Contact Person Name
- Ruediger Moericke
- Contact Person Email
- prof.moericke@praxismoericke.de
- Site Name
- BIOMEDRO Biomedizinische Forschung und Entwicklung GmbH
- Department Name
- 1015: Rheumazentrum
- Principal Investigator Name
- Gunther Neeck
- Principal Investigator Email
- Gunther.neeck@biomedro.de
- Contact Person Name
- Gunther Neeck
- Contact Person Email
- Gunther.neeck@biomedro.de
- Site Name
- Klinikum der Stadt Ludwigshafen am Rhein gGmbH
- Department Name
- #1018: Med A Klinik, Rheumatologie
- Principal Investigator Name
- Raoul Bergner
- Principal Investigator Email
- bergnerr@klilu.de
- Contact Person Name
- Raoul Bergner
- Contact Person Email
- bergnerr@klilu.de
- Site Name
- Praxis für klinische Studien
- Department Name
- 1003: Praxis für klinische Studien
- Principal Investigator Name
- Georg Dahmen
- Principal Investigator Email
- gpdahmen@googlemail.com
- Contact Person Name
- Georg Dahmen
- Contact Person Email
- gpdahmen@googlemail.com
- Site Name
- St. Elisabeth Gruppe GmbH Katholische Kliniken Rhein-Ruhr
- Department Name
- 1001: Rheumazentrum
- Principal Investigator Name
- Uta Kiltz
- Principal Investigator Email
- Uta.Kiltz@elisabethgruppe.de
- Contact Person Name
- Uta Kiltz
- Contact Person Email
- Uta.Kiltz@elisabethgruppe.de
- Site Name
- Charite Universitaetsmedizin Berlin KöR
- Department Name
- 1004: Klinik für Rheumatologie
- Principal Investigator Name
- Hildrun Haibel
- Principal Investigator Email
- Hildrun.haibel@charite.de
- Contact Person Name
- Hildrun Haibel
- Contact Person Email
- Hildrun.haibel@charite.de
- Site Name
- Immanuel-Krankenhaus GmbH
- Department Name
- 1005: Rheumatologie und klinische Immunologie
- Principal Investigator Name
- Udo Schneider
- Principal Investigator Email
- udo.schneider@immanuelalbertinen.de
- Contact Person Name
- Udo Schneider
- Contact Person Email
- udo.schneider@immanuelalbertinen.de
- Site Name
- Rheumazentrum Ratingen
- Department Name
- 1017: Studienambulanz
- Principal Investigator Name
- Siegfried Wassenberg
- Principal Investigator Email
- wassenberg@rhzr.de
- Contact Person Name
- Siegfried Wassenberg
- Contact Person Email
- wassenberg@rhzr.de
- Site Name
- Rheumatologische Schwerpunktpraxis
- Department Name
- 1002: Rheumatologische Schwerpunktpraxis
- Principal Investigator Name
- Jan Brandt-Juergens
- Principal Investigator Email
- Jan.brandtjuergens@charite.de
- Contact Person Name
- Jan Brandt-Juergens
- Contact Person Email
- Jan.brandtjuergens@charite.de
Hungary
- Earliest CTIS Part Ii Submission Date
- 16-04-2024
- Latest Decision Or Authorization Date
- 21-05-2024
- Processing Time Days
- 35
- Number Of Sites
- 8
- Number Of Participants
- 22
Sites
- Site Name
- University Of Debrecen
- Department Name
- 6006: Általános Orvostudományi Kar, Belgyógyászati Intézet, Reumatológiai Tanszék
- Principal Investigator Name
- Nóra Bodnár
- Principal Investigator Email
- drbodnarnora@gmail.com
- Contact Person Name
- Nóra Bodnár
- Contact Person Email
- drbodnarnora@gmail.com
- Site Name
- Complex Rendelo Med Zrt.
- Department Name
- 6004
- Principal Investigator Name
- Tünde Varga
- Principal Investigator Email
- vargatundedr1@gmail.com
- Contact Person Name
- Tünde Varga
- Contact Person Email
- vargatundedr1@gmail.com
- Site Name
- Kistarcsai Flor Ferenc Korhaz
- Department Name
- 6009: Reumatológia és Fizioterápiás osztály
- Principal Investigator Name
- Edit Tóth
- Principal Investigator Email
- toth.edit@florhosp.hu
- Contact Person Name
- Edit Tóth
- Contact Person Email
- toth.edit@florhosp.hu
- Site Name
- University Of Szeged
- Department Name
- 6008: Reumatologiai es Immunologiai Klinika
- Principal Investigator Name
- Attila Balog
- Principal Investigator Email
- balog.attila@med.u-szeged.hu
- Contact Person Name
- Attila Balog
- Contact Person Email
- balog.attila@med.u-szeged.hu
- Site Name
- Heves Varmegyei Markhot Ferenc Oktatokorhaz Es Rendelointezet
- Department Name
- 6005
- Principal Investigator Name
- Csaba Kovács
- Principal Investigator Email
- drcsab8@yahoo.com
- Contact Person Name
- Csaba Kovács
- Contact Person Email
- drcsab8@yahoo.com
- Site Name
- Borsod-Abauj-Zemplen Varmegyei Koezponti Korhaz Es Egyetemi Oktatokorhaz
- Department Name
- 6001: Reumatológiai Osztály
- Principal Investigator Name
- Zsófia Kardos
- Principal Investigator Email
- dr.kardos.zsofia@gmail.com
- Contact Person Name
- Zsófia Kardos
- Contact Person Email
- dr.kardos.zsofia@gmail.com
- Site Name
- Vital-Medicina Kft.
- Department Name
- 6002: Reumatológia
- Principal Investigator Name
- Edit Drescher
- Principal Investigator Email
- drescher@invitel.hu
- Contact Person Name
- Edit Drescher
- Contact Person Email
- drescher@invitel.hu
- Site Name
- Betegapolo Irgalmasrend Budai Irgalmasrendi Korhaz
- Department Name
- 6003
- Principal Investigator Name
- Éva Lányi
- Principal Investigator Email
- eva.lanyi@gmail.com
- Contact Person Name
- Éva Lányi
- Contact Person Email
- eva.lanyi@gmail.com
Italy
- Earliest CTIS Part Ii Submission Date
- 16-04-2024
- Latest Decision Or Authorization Date
- 22-05-2024
- Processing Time Days
- 36
- Number Of Sites
- 8
- Number Of Participants
- 34
Sites
- Site Name
- Azienda Ospedaliera Universitaria Senese
- Department Name
- 4048: U.O.C. Reumatologia
- Principal Investigator Name
- Bruno Frediani
- Principal Investigator Email
- fredianibruno60@gmail.com
- Contact Person Name
- Bruno Frediani
- Contact Person Email
- fredianibruno60@gmail.com
- Site Name
- Careggi University Hospital
- Department Name
- 4046: S.O.D. Reumatologia Università degli Studi di Firenze
- Principal Investigator Name
- Serena Guiducci
- Principal Investigator Email
- serena.guiducci@unifi.it
- Contact Person Name
- Serena Guiducci
- Contact Person Email
- serena.guiducci@unifi.it
- Site Name
- IRCCS Ospedale Sacro Cuore Don Calabria
- Department Name
- 4044: UOS Reumatologia
- Principal Investigator Name
- Antonio Marchetta
- Principal Investigator Email
- antonio.marchetta@sacrocuore.it
- Contact Person Name
- Antonio Marchetta
- Contact Person Email
- antonio.marchetta@sacrocuore.it
- Site Name
- Azienda Ospedaliera Universitaria Integrata Verona
- Department Name
- 4041: U.O.C. Reumatologia VI Piano Padiglione Geriatrico Università degli Studi di Verona
- Principal Investigator Name
- Angelo Fassio
- Principal Investigator Email
- angelo.fassio@yahoo.it
- Contact Person Name
- Angelo Fassio
- Contact Person Email
- angelo.fassio@yahoo.it
- Site Name
- Asst Centro Specialistico Ortopedico Traumatologico Gaetano Pini Cto
- Department Name
- 4049: U.O.C. Reumatologia Clinica
- Principal Investigator Name
- Maria Elena Manara
- Principal Investigator Email
- maria.manara@asst-pini-cto.it
- Contact Person Name
- Maria Elena Manara
- Contact Person Email
- maria.manara@asst-pini-cto.it
- Site Name
- Azienda Ospedaliero Universitaria Delle Marche
- Department Name
- 4043: S.O.D. Clinica Medica Università degli Studi
- Principal Investigator Name
- Michele Maria Luchetti Gentiloni
- Principal Investigator Email
- m.luchetti@staff.univpm.it
- Contact Person Name
- Michele Maria Luchetti Gentiloni
- Contact Person Email
- m.luchetti@staff.univpm.it
- Site Name
- Istituto Ortopedico Rizzoli
- Department Name
- 4047: S.S.D. Medicina e Reumatologia
- Principal Investigator Name
- Francesco Ursini
- Principal Investigator Email
- francesco.ursini@ior.it
- Contact Person Name
- Francesco Ursini
- Contact Person Email
- francesco.ursini@ior.it
- Site Name
- Azienda Ospedaliero-Universitaria Policlinico Umberto I
- Department Name
- 4042: U.O.C. Reumatologia D.A.I. Medicina Interna e Specialità Mediche Università La Sapienza
- Principal Investigator Name
- Rossana Scrivo
- Principal Investigator Email
- rossana.scrivo@uniroma1.it
- Contact Person Name
- Rossana Scrivo
- Contact Person Email
- rossana.scrivo@uniroma1.it
Romania
- Earliest CTIS Part Ii Submission Date
- 16-04-2024
- Latest Decision Or Authorization Date
- 20-05-2024
- Processing Time Days
- 34
- Number Of Sites
- 6
- Number Of Participants
- 24
Sites
- Site Name
- Memormed S.R.L.
- Department Name
- 9008: Rheumatology
- Principal Investigator Name
- Iulia Andreea Apostol
- Principal Investigator Email
- andreea.apostol@memormed.ro
- Contact Person Name
- Iulia Andreea Apostol
- Contact Person Email
- andreea.apostol@memormed.ro
- Site Name
- Explora Group S.R.L.
- Department Name
- 9005: Rheumatology
- Principal Investigator Name
- Iulia Codruta Bran
- Principal Investigator Email
- codrutabeli@yahoo.com
- Contact Person Name
- Iulia Codruta Bran
- Contact Person Email
- codrutabeli@yahoo.com
- Site Name
- Spitalul Clinic Judetean De Urgenta Cluj
- Department Name
- 9007: Rheumatology
- Principal Investigator Name
- Laura Muntean
- Principal Investigator Email
- lmuntean13@yahoo.com
- Contact Person Name
- Laura Muntean
- Contact Person Email
- lmuntean13@yahoo.com
- Site Name
- Spitalul Clinic Judetean De Urgenta Sibiu
- Department Name
- 9006: Rheumatology
- Principal Investigator Name
- Liana Chicea
- Principal Investigator Email
- liana.chicea@gmail.com
- Contact Person Name
- Liana Chicea
- Contact Person Email
- liana.chicea@gmail.com
- Site Name
- Saint Maria Hospital
- Department Name
- 9002: 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
- Centrul Medical De Diagnostic Si Tratament Ambulator Neomed S.R.L.
- Department Name
- 9004: Rheumatology
- Principal Investigator Name
- Liliana Duca
- Principal Investigator Email
- liliduca@neomed.org
- Contact Person Name
- Liliana Duca
- Contact Person Email
- liliduca@neomed.org
Netherlands
- Earliest CTIS Part Ii Submission Date
- 16-04-2024
- Latest Decision Or Authorization Date
- 21-05-2024
- Processing Time Days
- 35
- Number Of Sites
- 3
- Number Of Participants
- 9
Sites
- Site Name
- University Hospital Maastricht
- Department Name
- 7004: Rheumatology
- Principal Investigator Name
- Astrid Van Tubergen
- Principal Investigator Email
- a.van.tubergen@mumc.nl
- Contact Person Name
- Astrid Van Tubergen
- Contact Person Email
- a.van.tubergen@mumc.nl
- Site Name
- Amsterdam UMC Stichting
- Department Name
- 7001: Rheumatology
- Principal Investigator Name
- Marleen Van de Sande
- Principal Investigator Email
- m.g.vandesande@amsterdamumc.nl
- Contact Person Name
- Marleen Van de Sande
- Contact Person Email
- m.g.vandesande@amsterdamumc.nl
- Site Name
- Zuyderland Medisch Centrum Stichting
- Department Name
- 7003: Rheumatology
- Principal Investigator Name
- Sofia Ramiro
- Principal Investigator Email
- s.ramiro@zuyderland.nl
- Contact Person Name
- Sofia Ramiro
- Contact Person Email
- s.ramiro@zuyderland.nl
Poland
- Earliest CTIS Part Ii Submission Date
- 16-04-2024
- Latest Decision Or Authorization Date
- 17-05-2024
- Processing Time Days
- 31
- Number Of Sites
- 7
- Number Of Participants
- 35
Sites
- Site Name
- Szpital Uniwersytecki Nr 2 Im Dr Jana Biziela W Bydgoszczy
- Department Name
- 3046: Klinika Reumatologii i Układowych Chorób Tkanki Łącznej
- Principal Investigator Name
- Rafał Wojciechowski
- Principal Investigator Email
- r.wojciechowski@wp.eu
- Contact Person Name
- Rafał Wojciechowski
- Contact Person Email
- r.wojciechowski@wp.eu
- Site Name
- NZOZ "OSTEO-MEDIC" s.c. Artur Racewicz, Jerzy Supronik
- Department Name
- 3042
- Principal Investigator Name
- Jerzy Supronik
- Principal Investigator Email
- Jerzy_supronik@op.pl
- Contact Person Name
- Jerzy Supronik
- Contact Person Email
- Jerzy_supronik@op.pl
- Site Name
- Malopolskie Badania Kliniczne Sp. z o.o.
- Department Name
- 3047
- Principal Investigator Name
- Bogdan Batko
- Principal Investigator Email
- bpbatko@gmail.com
- Contact Person Name
- Bogdan Batko
- Contact Person Email
- bpbatko@gmail.com
- Site Name
- Narodowy Instytut Geriatrii Reumatologii I Rehabilitacji Im Prof. Dr Hab. Med. Eleonory Reicher
- Department Name
- 3048: Centrum Wsparcia Badań Klinicznych
- Principal Investigator Name
- Brygida Kwiatkowska
- Principal Investigator Email
- brygida.kwiatkowska@spartanska.pl
- Contact Person Name
- Brygida Kwiatkowska
- Contact Person Email
- brygida.kwiatkowska@spartanska.pl
- Site Name
- Rcmed Oddzial Sochaczew
- Department Name
- 3043
- Principal Investigator Name
- Monika Wronisz
- Principal Investigator Email
- monika.wronisz@rcmed.com.pl
- Contact Person Name
- Monika Wronisz
- Contact Person Email
- monika.wronisz@rcmed.com.pl
- Site Name
- Pratia S.A.
- Department Name
- 3045
- Principal Investigator Name
- Mariusz Korkosz
- Principal Investigator Email
- mariusz.korkosz@pratia.com
- Contact Person Name
- Mariusz Korkosz
- Contact Person Email
- mariusz.korkosz@pratia.com
- Site Name
- Medicover Integrated Clinical Services Sp. z o.o.
- Department Name
- 3041
- Principal Investigator Name
- Sławomir Jeka
- Principal Investigator Email
- s.jeka@wp.pl
- Contact Person Name
- Sławomir Jeka
- Contact Person Email
- s.jeka@wp.pl
Sponsor
Primary sponsor
- Full Name
- Novartis Pharma AG
- Organisation Type
- Pharmaceutical company
- Country Of Registered Address
- Switzerland
Contract research organisations
- Name
- Parexel International (IRL) Limited
- Name
- Syneos Health Inc.
- Name
- IQVIA Limited
- Responsibilities
- Enrollment/Randomization of patient and Management of drug supply logistics/dispensing/unblinding
- Name
- Icon Clinical Research Limited
Third parties
- {"country":"France","full_name":"SGS France","duties_or_roles":"PK and IG analysis","organisation_type":"Pharmaceutical company"}
- {"country":"France","full_name":"Kayentis","duties_or_roles":"Providing and Programming of PROs and score calculations (ASQOL, ASDAS-CRP and Flare Assessment)","organisation_type":"Non-Pharmaceutical company"}
- {"country":"Hungary","full_name":"ADR Logistics Kft.","duties_or_roles":"drug destruction","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"RWS Life Sciences Inc.","duties_or_roles":"Obtain licenses, translations, and validation of PROs","organisation_type":"Pharmaceutical company"}
- {"country":"Italy","full_name":"Phardis S.r.l.","duties_or_roles":"Local equipment storage","organisation_type":"Pharmaceutical company"}
- {"country":"United Kingdom","full_name":"Q Squared Solutions Limited","duties_or_roles":"","organisation_type":"Non-Pharmaceutical company"}
- {"country":"Ireland","full_name":"Parexel International (IRL) Limited","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
- {"country":"Romania","full_name":"Alliance Healthcare Romania S.R.L.","duties_or_roles":"Supply and delivery of Non-IMP Destruction of IMP and non-IMP","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":"Opt-X-Pense Kft.","duties_or_roles":"patient reimbursement","organisation_type":"Non-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":"United States","full_name":"Perceptive Informatics Inc.","duties_or_roles":"Medical image analysis/review (MRI and X-ray)","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Syneos Health Inc.","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
- {"country":"Ireland","full_name":"Icon Clinical Research Limited","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
- {"country":"Italy","full_name":"Opis S.r.l.","duties_or_roles":"TMF archive","organisation_type":"Pharmaceutical company"}
- {"country":"United Kingdom","full_name":"IQVIA Limited","duties_or_roles":"Enrollment/Randomization of patient and Management of drug supply logistics/dispensing/unblinding","organisation_type":"Pharmaceutical company"}
Investigational products
- Investigational Product Name
- SECUKINUMAB
- Active Substance
- SECUKINUMAB
- Modality
- Monoclonal antibody
- Routes Of Administration
- Subcutaneous use
- Route
- Subcutaneous
- Authorisation Status
- Authorized (prodAuthStatus 2 / SUB33242)
- Starting Dose
- 150 mg
- Dose Levels
- 150 mg
- Maximum Dose
- 150 mg
- Investigational Product Name
- Placebo to AIN457 150 mg/1 mL Solution for injection in pre-filled syringe
- Modality
- Other
- Authorisation Status
- Not applicable
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