Clinical trial • Phase I • Dermatology|Immunology
RAY121 for Immune-mediated necrotizing myopathy | Antiphospholipid syndrome | Behçet’s syndrome | Bullous pemphigoid | Dermatomyositis | Immune thrombocytopenia
Phase I trial of RAY121 for Immune-mediated necrotizing myopathy | Antiphospholipid syndrome | Behçet’s syndrome | Bullous pemphigoid | Dermatomyositis |…
Overview
- Trial Therapeutic Area
- Dermatology|Immunology
- Trial Disease
- Immune-mediated necrotizing myopathy | Antiphospholipid syndrome | Behçet’s syndrome | Bullous pemphigoid | Dermatomyositis | Immune thrombocytopenia
- Trial Stage
- Phase I
Key dates
- Initial CTIS Submission Date
- 07-10-2024
- First CTIS Authorization Date
- 11-02-2025
Trial design
open-label Phase I trial in Austria, Romania, France and others.
- Open Label
- Yes
- Target Sample Size
- 66
Recruitment
- Planned Sample Size
- 66
- Recruitment Window Months
- 21
Geography
- Total Number Of Sites
- 43
- Total Number Of Participants
- 78
Austria
- Earliest CTIS Part Ii Submission Date
- 28-01-2025
- Latest Decision Or Authorization Date
- 17-02-2025
- Processing Time Days
- 20
- Number Of Sites
- 1
- Number Of Participants
- 4
Sites
- Site Name
- Medical University Of Vienna
- Department Name
- Department of Clinical Pharmacology
- Principal Investigator Name
- Bernd Jilma
- Principal Investigator Email
- bernd.jilma@meduniwien.ac.at
- Contact Person Name
- Bernd Jilma
- Contact Person Email
- bernd.jilma@meduniwien.ac.at
Romania
- Earliest CTIS Part Ii Submission Date
- 24-10-2024
- Latest Decision Or Authorization Date
- 14-02-2025
- Processing Time Days
- 113
- Number Of Sites
- 2
- Number Of Participants
- 7
Sites
- Site Name
- Arensia Clinics S.R.L.
- Department Name
- Internal Medicine
- Principal Investigator Name
- Mihai Abobului
- Principal Investigator Email
- mihai.abobului.ext@arensia-em.com
- Contact Person Name
- Mihai Abobului
- Contact Person Email
- mihai.abobului.ext@arensia-em.com
- Site Name
- Institute Of Oncology Prof. Dr. Ion Chiricuta Cluj-Napoca
- Department Name
- Internal Medicine
- Principal Investigator Name
- Ionut-Ciprian Tomuleasa
- Principal Investigator Email
- ciprian.tomuleasa.ext@arensia-em.com
- Contact Person Name
- Ionut-Ciprian Tomuleasa
- Contact Person Email
- ciprian.tomuleasa.ext@arensia-em.com
France
- Earliest CTIS Part Ii Submission Date
- 15-11-2024
- Latest Decision Or Authorization Date
- 12-02-2025
- Processing Time Days
- 89
- Number Of Sites
- 2
- Number Of Participants
- 10
Sites
- Site Name
- Centre Hospitalier Universitaire De Montpellier
- Department Name
- Rheumatology
- Principal Investigator Name
- Christian Jorgensen
- Principal Investigator Email
- c-jorgensen@chu-montpellier.fr
- Contact Person Name
- Christian Jorgensen
- Contact Person Email
- c-jorgensen@chu-montpellier.fr
- Site Name
- Hopitaux Universitaires Pitie Salpetriere
- Department Name
- Internal Medicine and Clinical Immunology
- Principal Investigator Name
- David Saadoun
- Principal Investigator Email
- david.saadoun@aphp.fr
- Contact Person Name
- David Saadoun
- Contact Person Email
- david.saadoun@aphp.fr
Spain
- Earliest CTIS Part Ii Submission Date
- 24-10-2024
- Latest Decision Or Authorization Date
- 27-03-2025
- Processing Time Days
- 154
- Number Of Sites
- 9
- Number Of Participants
- 10
Sites
- Site Name
- Hospital Universitario Y Politecnico La Fe
- Department Name
- Hematology
- Principal Investigator Name
- Santiago Bonanad Boix
- Principal Investigator Email
- bonanad_san@gva.es
- Contact Person Name
- Santiago Bonanad Boix
- Contact Person Email
- bonanad_san@gva.es
- Site Name
- Hospital Universitario Ramon Y Cajal
- Department Name
- Rheumatology
- Principal Investigator Name
- Francisco Javier Bachiller Corral
- Principal Investigator Email
- javierbachiller@gmail.com
- Contact Person Name
- Francisco Javier Bachiller Corral
- Contact Person Email
- javierbachiller@gmail.com
- Site Name
- Hospital Universitario 12 De Octubre
- Department Name
- Rheumatology
- Principal Investigator Name
- Patricia Carreira Delgado
- Principal Investigator Email
- carreira@h12o.es
- Contact Person Name
- Patricia Carreira Delgado
- Contact Person Email
- carreira@h12o.es
- Site Name
- Clinica Universidad De Navarra
- Department Name
- Hematology
- Principal Investigator Name
- Carlos Grande Garcia
- Principal Investigator Email
- cgrandeg@unav.es
- Contact Person Name
- Carlos Grande Garcia
- Contact Person Email
- cgrandeg@unav.es
- Site Name
- Hospital Universitari Vall D Hebron
- Department Name
- Hematology
- Principal Investigator Name
- David Valcarcel Ferreiras
- Principal Investigator Email
- dvalcarcelct@vhio.net
- Contact Person Name
- David Valcarcel Ferreiras
- Contact Person Email
- dvalcarcelct@vhio.net
- Site Name
- Hospital Universitario Reina Sofia
- Department Name
- Rheumatology
- Principal Investigator Name
- Alejandro Escudero Contreras
- Principal Investigator Email
- alexcudero@hotmail.com
- Contact Person Name
- Alejandro Escudero Contreras
- Contact Person Email
- alexcudero@hotmail.com
- Site Name
- University Hospital Virgen Del Rocio S.L.
- Department Name
- Hematology
- Principal Investigator Name
- Maria Eva Mingot Castellano
- Principal Investigator Email
- mariae.mingot.sspa@juntadeandalucia.es
- Contact Person Name
- Maria Eva Mingot Castellano
- Contact Person Email
- mariae.mingot.sspa@juntadeandalucia.es
- Site Name
- Hospital Universitari Vall D Hebron
- Department Name
- Internal Medicine
- Principal Investigator Name
- Jose Pardos Gea
- Principal Investigator Email
- jose.pardos@vallhebron.cat
- Contact Person Name
- Jose Pardos Gea
- Contact Person Email
- jose.pardos@vallhebron.cat
- Site Name
- Clinica Universidad De Navarra
- Department Name
- Hematology
- Principal Investigator Name
- Carlos Grande Garcia
- Principal Investigator Email
- cgrandeg@unav.es
- Contact Person Name
- Carlos Grande Garcia
- Contact Person Email
- cgrandeg@unav.es
Italy
- Earliest CTIS Part Ii Submission Date
- 13-12-2024
- Latest Decision Or Authorization Date
- 12-02-2025
- Processing Time Days
- 61
- Number Of Sites
- 3
- Number Of Participants
- 2
Sites
- Site Name
- Ospedale San Giovanni Bosco
- Department Name
- SCdU Nefrologia e Dialisi
- 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
- Humanitas Mirasole S.p.A.
- Department Name
- Dermatology
- Principal Investigator Name
- Antonio Costanzo
- Principal Investigator Email
- antonio.costanzo@hunimed.eu
- Contact Person Name
- Antonio Costanzo
- Contact Person Email
- antonio.costanzo@hunimed.eu
- Site Name
- Istituto Romagnolo Per Lo Studio Dei Tumori Dino Amadori IRST S.r.l.
- Department Name
- Oncologia ed Ematologia Clinica e Sperimentale
- Principal Investigator Name
- Alessandro Lucchesi
- Principal Investigator Email
- alessandro.lucchesi@irst.emr.it
- Contact Person Name
- Alessandro Lucchesi
- Contact Person Email
- alessandro.lucchesi@irst.emr.it
Poland
- Earliest CTIS Part Ii Submission Date
- 14-01-2025
- Latest Decision Or Authorization Date
- 17-02-2025
- Processing Time Days
- 34
- Number Of Sites
- 1
- Number Of Participants
- 4
Sites
- Site Name
- Narodowy Instytut Geriatrii Reumatologii I Rehabilitacji Im Prof. Dr Hab. Med. Eleonory Reicher
- Department Name
- Centrum Wsparcia Badań Klinicznych
- Principal Investigator Name
- Małgorzata Wisłowska
- Principal Investigator Email
- malgorzata.wislowska@spartanska.pl
- Contact Person Name
- Małgorzata Wisłowska
- Contact Person Email
- malgorzata.wislowska@spartanska.pl
Czechia
- Earliest CTIS Part Ii Submission Date
- 16-01-2025
- Latest Decision Or Authorization Date
- 12-02-2025
- Processing Time Days
- 27
- Number Of Sites
- 1
- Number Of Participants
- 2
Sites
- Site Name
- Fakultni Nemocnice Kralovske Vinohrady
- Department Name
- Dermatovenerologická klinika
- Principal Investigator Name
- Petr Arenberger
- Principal Investigator Email
- avemedica@email.cz
- Contact Person Name
- Petr Arenberger
- Contact Person Email
- avemedica@email.cz
Bulgaria
- Earliest CTIS Part Ii Submission Date
- 24-10-2024
- Latest Decision Or Authorization Date
- 12-02-2025
- Processing Time Days
- 111
- Number Of Sites
- 3
- Number Of Participants
- 6
Sites
- Site Name
- Specialized Hospital For Active Treatment Of Hematological Diseases EAD
- Department Name
- Clinic of Clinical Hematology
- Principal Investigator Name
- Tanya Yankova
- Principal Investigator Email
- t.yankova@hematology.bg
- Contact Person Name
- Tanya Yankova
- Contact Person Email
- t.yankova@hematology.bg
- Site Name
- Umbal - Prof. D-R Stoyan Kirkovich AD
- Department Name
- Department of Clinical Hematology
- Principal Investigator Name
- Mariya Todorova
- Principal Investigator Email
- dr.maria.dtodorova@gmail.com
- Contact Person Name
- Mariya Todorova
- Contact Person Email
- dr.maria.dtodorova@gmail.com
- Site Name
- University Multiprofile Hospital For Active Treatment St. Ivan Rilski EAD
- Department Name
- Clinic of Rheumatology
- Principal Investigator Name
- Vladimira Boyazhieva
- Principal Investigator Email
- vladimira.boyazhieva@gmail.com
- Contact Person Name
- Vladimira Boyazhieva
- Contact Person Email
- vladimira.boyazhieva@gmail.com
Croatia
- Earliest CTIS Part Ii Submission Date
- 13-01-2025
- Latest Decision Or Authorization Date
- 25-02-2025
- Processing Time Days
- 43
- Number Of Sites
- 6
- Number Of Participants
- 6
Sites
- Site Name
- Specijalna Bolnica Medico
- Department Name
- Hematology
- Principal Investigator Name
- Toni Valkovic
- Principal Investigator Email
- medico@medico.hr
- Contact Person Name
- Toni Valkovic
- Contact Person Email
- medico@medico.hr
- Site Name
- Specijalna Bolnica Medico
- Department Name
- Clinical pharmacology
- Principal Investigator Name
- Andrej Belančić
- Principal Investigator Email
- a.belancic93@gmail.com
- Contact Person Name
- Andrej Belančić
- Contact Person Email
- a.belancic93@gmail.com
- Site Name
- Specijalna Bolnica Medico
- Department Name
- Dermatology and Venerology
- Principal Investigator Name
- Sandra Peternel
- Principal Investigator Email
- sandra.peternel@medico.hr
- Contact Person Name
- Sandra Peternel
- Contact Person Email
- sandra.peternel@medico.hr
- Site Name
- Klinicki bolnicki centar Sestre milosrdnice
- Department Name
- Dermatovenerology
- Principal Investigator Name
- Iva Blajić
- Principal Investigator Email
- ivablajic@hotmail.com
- Contact Person Name
- Iva Blajić
- Contact Person Email
- ivablajic@hotmail.com
- Site Name
- KBC Zagreb
- Department Name
- Immunodermatology
- Principal Investigator Name
- Branka Marinović
- Principal Investigator Email
- branka.marinovic@kbc-zagreb.hr
- Contact Person Name
- Branka Marinović
- Contact Person Email
- branka.marinovic@kbc-zagreb.hr
- Site Name
- Specijalna Bolnica Medico
- Department Name
- Rheumatology
- Principal Investigator Name
- Marija Rogoznica Pavlović
- Principal Investigator Email
- marija.rogoznica@gmail.com
- Contact Person Name
- Marija Rogoznica Pavlović
- Contact Person Email
- marija.rogoznica@gmail.com
Hungary
- Earliest CTIS Part Ii Submission Date
- 06-12-2024
- Latest Decision Or Authorization Date
- 13-02-2025
- Processing Time Days
- 69
- Number Of Sites
- 2
- Number Of Participants
- 7
Sites
- Site Name
- University Of Szeged
- Department Name
- Szent-Györgyi Albert Klinikai Központ, Klinikai Farmakológiai Központ Fázis I. Vizsgálóhely
- Principal Investigator Name
- Róbert Takács
- Principal Investigator Email
- takacs.robert@med.u-szeged.hu
- Contact Person Name
- Róbert Takács
- Contact Person Email
- takacs.robert@med.u-szeged.hu
- Site Name
- Semmelweis University
- Department Name
- Belgyógyászati és Onkológiai Klinika
- Principal Investigator Name
- István Takács
- Principal Investigator Email
- takacs.istvan@semmelweis.hu
- Contact Person Name
- István Takács
- Contact Person Email
- takacs.istvan@semmelweis.hu
Netherlands
- Earliest CTIS Part Ii Submission Date
- 30-01-2025
- Latest Decision Or Authorization Date
- 14-02-2025
- Processing Time Days
- 15
- Number Of Sites
- 2
- Number Of Participants
- 6
Sites
- Site Name
- Universitair Medisch Centrum Utrecht
- Department Name
- Haematology
- Principal Investigator Name
- Ward Van Beers
- Principal Investigator Email
- E.J.vanBeers-3@umcutrecht.nl
- Contact Person Name
- Ward Van Beers
- Contact Person Email
- E.J.vanBeers-3@umcutrecht.nl
- Site Name
- Universitair Medisch Centrum Groningen
- Department Name
- Dermatology
- Principal Investigator Name
- Joost Meijer
- Principal Investigator Email
- j.m.meijer@umcg.nl
- Contact Person Name
- Joost Meijer
- Contact Person Email
- j.m.meijer@umcg.nl
Germany
- Earliest CTIS Part Ii Submission Date
- 23-01-2025
- Latest Decision Or Authorization Date
- 19-03-2025
- Processing Time Days
- 55
- Number Of Sites
- 6
- Number Of Participants
- 9
Sites
- Site Name
- Universitaetsmedizin Goettingen
- Department Name
- Klinik für Neurologie
- Principal Investigator Name
- Jana Zschüntzsch
- Principal Investigator Email
- j.zschuentzsch@med.uni-goettingen
- Contact Person Name
- Jana Zschüntzsch
- Contact Person Email
- j.zschuentzsch@med.uni-goettingen
- Site Name
- Universitaetsklinikum Schleswig-Holstein AöR
- Department Name
- Institut für Entzündungsmedizin
- Principal Investigator Name
- Diamant Thaci
- Principal Investigator Email
- diamant.thaci@uksh.de
- Contact Person Name
- Diamant Thaci
- Contact Person Email
- diamant.thaci@uksh.de
- Site Name
- Technische Universitaet Dresden
- Department Name
- Klinik und Poliklinik für Dermatologie
- Principal Investigator Name
- Susanne Abraham
- Principal Investigator Email
- susanne.abraham@ukdd.de
- Contact Person Name
- Susanne Abraham
- Contact Person Email
- susanne.abraham@ukdd.de
- Site Name
- Immanuel Klinik Ruedersdorf
- Department Name
- Neurologie
- Principal Investigator Name
- Jens Schmidt
- Principal Investigator Email
- jens.schmidt@mhb-fontane.de
- Contact Person Name
- Jens Schmidt
- Contact Person Email
- jens.schmidt@mhb-fontane.de
- Site Name
- Universitaetsklinikum Tuebingen AöR
- Department Name
- Hautklinik
- Principal Investigator Name
- Matthias Hahn
- Principal Investigator Email
- matthias.hahn@med.uni-tuebingen.de
- Contact Person Name
- Matthias Hahn
- Contact Person Email
- matthias.hahn@med.uni-tuebingen.de
- Site Name
- Universitaetsklinikum Erlangen AöR
- Department Name
- Hautklinik
- Principal Investigator Name
- Michael Sticherling
- Principal Investigator Email
- michael.sticherling@uk-erlangen.de
- Contact Person Name
- Michael Sticherling
- Contact Person Email
- michael.sticherling@uk-erlangen.de
Portugal
- Earliest CTIS Part Ii Submission Date
- 22-01-2025
- Latest Decision Or Authorization Date
- 11-02-2025
- Processing Time Days
- 20
- Number Of Sites
- 2
- Number Of Participants
- 3
Sites
- Site Name
- Unidade Local De Saude De Gaia/Espinho E.P.E.
- Department Name
- Rheumatology
- Principal Investigator Name
- Taciana Videira
- Principal Investigator Email
- taciana.videira@ulsge.min-saude.pt
- Contact Person Name
- Taciana Videira
- Contact Person Email
- taciana.videira@ulsge.min-saude.pt
- Site Name
- CCAB Centro Clinico Academico Braga Associacao
- Department Name
- Rheumatology
- Principal Investigator Name
- Joana Sousa Neves
- Principal Investigator Email
- joana.neves@hb.min-saude.pt
- Contact Person Name
- Joana Sousa Neves
- Contact Person Email
- joana.neves@hb.min-saude.pt
Norway
- Earliest CTIS Part Ii Submission Date
- 21-01-2025
- Latest Decision Or Authorization Date
- 13-02-2025
- Processing Time Days
- 23
- Number Of Sites
- 3
- Number Of Participants
- 2
Sites
- Site Name
- Helse Stavanger HF
- Department Name
- Rheumatology
- Principal Investigator Name
- Jens Vikse
- Principal Investigator Email
- jens.vikse@sus.no
- Contact Person Name
- Jens Vikse
- Contact Person Email
- jens.vikse@sus.no
- Site Name
- Sykehuset Oestfold HF Kalnes
- Department Name
- Hematology
- Principal Investigator Name
- Eirik Tjønnfjord
- Principal Investigator Email
- eirik.tjonnfjord@so-hf.no
- Contact Person Name
- Eirik Tjønnfjord
- Contact Person Email
- eirik.tjonnfjord@so-hf.no
- Site Name
- Sorlandet Sykehus HF
- Department Name
- Rheumatology
- Principal Investigator Name
- Katarzyna Weronika Losinska
- Principal Investigator Email
- katarzyna.weronika.losinska@sshf.no
- Contact Person Name
- Katarzyna Weronika Losinska
- Contact Person Email
- katarzyna.weronika.losinska@sshf.no
Sponsor
Primary sponsor
- Full Name
- Chugai Pharmaceutical Co. Ltd.
- Organisation Type
- Pharmaceutical company
- Country Of Registered Address
- Japan
Investigational products
- Investigational Product Name
- RAY121
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