Clinical trial • Phase I • Immunology
RAY121 for Bullous pemphigoid|Behcet's syndrome|Dermatomyositis|Antiphospholipid syndrome|Immune-mediated necrotizing myopathy|Immune thrombocytopenia
Phase I trial of RAY121 for Bullous pemphigoid|Behcet's syndrome|Dermatomyositis|Antiphospholipid syndrome|Immune-mediated necrotizing myopathy|Immune thr…
Overview
- Trial Therapeutic Area
- Immunology
- Trial Disease
- Bullous pemphigoid|Behcet's syndrome|Dermatomyositis|Antiphospholipid syndrome|Immune-mediated necrotizing myopathy|Immune thrombocytopenia
- Trial Stage
- Phase I
Key dates
- Initial CTIS Submission Date
- 18-03-2024
- First CTIS Authorization Date
- 09-07-2024
Trial design
open-label Phase I trial across 42 sites in Italy, Bulgaria, Poland and others.
- Open Label
- Yes
- Target Sample Size
- 57
Eligibility
Recruits 57 Vulnerable population not selected; no specific consent/assent handling described..
- Vulnerable Population
- Vulnerable population not selected; no specific consent/assent handling described.
Recruitment
- Planned Sample Size
- 57
- Recruitment Window Months
- 22
Geography
- Total Number Of Sites
- 42
- Total Number Of Participants
- 87
Italy
- Earliest CTIS Part Ii Submission Date
- 11-06-2024
- Latest Decision Or Authorization Date
- 23-12-2025
- Processing Time Days
- 560
- Number Of Sites
- 3
- Number Of Participants
- 4
Sites
- Site Name
- Istituto Romagnolo Per Lo Studio Dei Tumori Dino Amadori IRST S.r.l.
- Department Name
- Oncologia ed Ematologia Clinica e Sperimentale
- Contact Person Name
- Alessandro Lucchesi
- Contact Person Email
- alessandro.lucchesi@irst.emr.it
- Site Name
- Humanitas Mirasole S.p.A.
- Department Name
- Dermatology
- Contact Person Name
- Antonio Costanzo
- Contact Person Email
- antonio.costanzo@hunimed.eu
- Site Name
- Ospedale San Giovanni Bosco
- Department Name
- SCdU Nefrologia e Dialisi
- Contact Person Name
- Savino Sciascia
- Contact Person Email
- savino.sciascia@unito.it
Bulgaria
- Earliest CTIS Part Ii Submission Date
- 13-06-2024
- Latest Decision Or Authorization Date
- 05-01-2026
- Processing Time Days
- 571
- Number Of Sites
- 3
- Number Of Participants
- 6
Sites
- Site Name
- Umbal - Prof. D-R Stoyan Kirkovich AD
- Department Name
- Department of Clinical Hematology
- 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
- Contact Person Name
- Vladimira Boyazhieva
- Contact Person Email
- vladimira.boyazhieva@gmail.com
- Site Name
- Specialized Hospital For Active Treatment Of Hematological Diseases EAD
- Department Name
- Clinic of Clinical Hematology
- Contact Person Name
- Tanya Yankova
- Contact Person Email
- t.yankova@hematology.bg
Poland
- Earliest CTIS Part Ii Submission Date
- 03-06-2024
- Latest Decision Or Authorization Date
- 04-01-2026
- Processing Time Days
- 580
- Number Of Sites
- 1
- Number Of Participants
- 10
Sites
- Site Name
- Narodowy Instytut Geriatrii Reumatologii I Rehabilitacji Im Prof. Dr Hab. Med. Eleonory Reicher
- Department Name
- Centrum Wsparcia Badań Klinicznych
- Contact Person Name
- Małgorzata Wisłowska
- Contact Person Email
- malgorzata.wislowska@spartanska.pl
Germany
- Earliest CTIS Part Ii Submission Date
- 14-06-2024
- Latest Decision Or Authorization Date
- 06-01-2026
- Processing Time Days
- 571
- Number Of Sites
- 5
- Number Of Participants
- 7
Sites
- Site Name
- Immanuel Klinik Ruedersdorf
- Department Name
- Neurologie
- Contact Person Name
- Jens Schmidt
- Contact Person Email
- jens.schmidt@mhb-fontane.de
- Site Name
- Universitaetsmedizin Goettingen
- Department Name
- Klinik für Neurologie
- Contact Person Name
- Jana Zschuentzsch
- Contact Person Email
- j.zschuentzsch@med.uni-goettingen.de
- Site Name
- Technische Universitaet Dresden
- Department Name
- Klinik und Poliklinik f. Dermatologie
- Contact Person Name
- Susanne Abraham
- Contact Person Email
- susanne.abraham@ukdd.de
- Site Name
- Universitaetsklinikum Tuebingen AöR
- Department Name
- Hautklinik
- Contact Person Name
- Matthias Hahn
- Contact Person Email
- Matthias.hahn@med.uni-tuebingen.de
- Site Name
- Universitaetsklinikum Erlangen AöR
- Department Name
- Hautklinik
- Contact Person Name
- Michael Sticherling
- Contact Person Email
- michael.sticherling@uk-erlangen.de
France
- Earliest CTIS Part Ii Submission Date
- 14-06-2024
- Latest Decision Or Authorization Date
- 23-12-2025
- Processing Time Days
- 557
- Number Of Sites
- 2
- Number Of Participants
- 6
Sites
- Site Name
- Hopital Universitaire Pitie Salpetriere
- Department Name
- Internal Medicine
- Contact Person Name
- David SAADOUN
- Contact Person Email
- david.saadoun@aphp.fr
- Site Name
- Centre Hospitalier Universitaire De Montpellier
- Department Name
- Rheumatology
- Contact Person Name
- Christian JORGENSEN
- Contact Person Email
- c-jorgensen@chu-montpellier.fr
Romania
- Earliest CTIS Part Ii Submission Date
- 03-04-2024
- Latest Decision Or Authorization Date
- 12-01-2026
- Processing Time Days
- 649
- Number Of Sites
- 2
- Number Of Participants
- 10
Sites
- Site Name
- Arensia Clinics S.R.L.
- Department Name
- Internal Medcine
- 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
- Hematology
- Contact Person Name
- Ionut-Ciprian Tomuleasa
- Contact Person Email
- ciprian.tomuleasa@gmail.com
Portugal
- Earliest CTIS Part Ii Submission Date
- 05-08-2024
- Latest Decision Or Authorization Date
- 30-12-2025
- Processing Time Days
- 512
- Number Of Sites
- 2
- Number Of Participants
- 6
Sites
- Site Name
- Unidade Local De Saude De Gaia/Espinho E.P.E.
- Department Name
- Rheumatology
- 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
- Contact Person Name
- Joana Neves
- Contact Person Email
- joana.neves@hb.min-saude.pt
Croatia
- Earliest CTIS Part Ii Submission Date
- 15-11-2024
- Latest Decision Or Authorization Date
- 05-01-2026
- Processing Time Days
- 416
- Number Of Sites
- 6
- Number Of Participants
- 6
Sites
- Site Name
- Specijalna Bolnica Medico
- Department Name
- Rheumatology
- Contact Person Name
- Marija Rogoznica Pavlović
- Contact Person Email
- marija.rogoznica@tto.hr
- Site Name
- Klinicki bolnicki centar Sestre milosrdnice
- Department Name
- Clinic for skin and venereal diseases
- Contact Person Name
- Iva Blajić
- Contact Person Email
- ivablajic@hotmail.com
- Site Name
- KBC Zagreb
- Department Name
- Immunodermatology
- Contact Person Name
- Branka Marinović
- Contact Person Email
- branka.marinovic@kbc-zagreb-hr
- Site Name
- Specijalna Bolnica Medico
- Department Name
- Hematology
- Contact Person Name
- Toni Valković
- Contact Person Email
- toni.valkovic@medico.hr
- Site Name
- Specijalna Bolnica Medico
- Department Name
- Dermatology and Venerology
- Contact Person Name
- Sandra Peternel
- Contact Person Email
- sandra.peternel@medico.hr
- Site Name
- Specijalna Bolnica Medico
- Department Name
- Clinical pharmacology
- Contact Person Name
- Andrej Belančić
- Contact Person Email
- a.belancic93@gmail.com
Czechia
- Earliest CTIS Part Ii Submission Date
- 21-10-2024
- Latest Decision Or Authorization Date
- 08-01-2026
- Processing Time Days
- 444
- Number Of Sites
- 1
- Number Of Participants
- 6
Sites
- Site Name
- Fakultní nemocnice Královské Vinohrady
- Contact Person Name
- Petr Arenberger
- Contact Person Email
- avemedica@email.cz
Netherlands
- Earliest CTIS Part Ii Submission Date
- 04-07-2024
- Latest Decision Or Authorization Date
- 30-12-2025
- Processing Time Days
- 544
- Number Of Sites
- 2
- Number Of Participants
- 6
Sites
- Site Name
- Universitair Medisch Centrum Groningen
- Department Name
- Hematology
- Contact Person Name
- Joost Meijer
- Contact Person Email
- j.m.meijer@umcg.nl
- Site Name
- Universitair Medisch Centrum Utrecht
- Department Name
- Hematology
- Contact Person Name
- Ward van Beers
- Contact Person Email
- e.j.vanbeers-3@umcutrecht.nl
Austria
- Earliest CTIS Part Ii Submission Date
- 14-06-2024
- Latest Decision Or Authorization Date
- 29-12-2025
- Processing Time Days
- 563
- Number Of Sites
- 1
- Number Of Participants
- 4
Sites
- Site Name
- Medical University Of Vienna
- Department Name
- Department of Clinical Pharmacology
- Contact Person Name
- Bernd Jilma
- Contact Person Email
- bernd.jilma@meduniwien.ac.at
Hungary
- Earliest CTIS Part Ii Submission Date
- 13-06-2024
- Latest Decision Or Authorization Date
- 08-01-2026
- Processing Time Days
- 574
- Number Of Sites
- 2
- Number Of Participants
- 5
Sites
- Site Name
- Semmelweis University
- Department Name
- Belgyógyászati és Onkológiai Klinika
- Contact Person Name
- István Takács
- Contact Person Email
- takacs.istvan@med.semmelweis-univ.hu
- Site Name
- University Of Szeged
- Department Name
- Szent-Györgyi Albert Klinikai Központ, Klinikai Farmakológiai Központ Fázis I. vizsgálóhely
- Contact Person Name
- Róbert Takács
- Contact Person Email
- takacs.robert@med.u-szeged.hu
Spain
- Earliest CTIS Part Ii Submission Date
- 11-06-2024
- Latest Decision Or Authorization Date
- 02-01-2026
- Processing Time Days
- 570
- Number Of Sites
- 9
- Number Of Participants
- 7
Sites
- Site Name
- Hospital Universitario Y Politecnico La Fe
- Department Name
- Hematology
- Contact Person Name
- Santiago Bonanad
- Contact Person Email
- bonanad_san@gva.es
- Site Name
- Hospital Universitari Vall D Hebron
- Department Name
- Internal Medicine
- Contact Person Name
- Jose Pardos Gea
- Contact Person Email
- jose.pardos@vallhebron.cat
- Site Name
- Hospital Universitari Vall D Hebron
- Department Name
- Hematology
- Contact Person Name
- David Valcarcel Ferreiras
- Contact Person Email
- dvalcarcelct@vhio.net
- Site Name
- Hospital Universitario Ramon Y Cajal
- Department Name
- Rheumatology
- Contact Person Name
- Francisco Javier Bachiller Corral
- Contact Person Email
- fbachiller@salud.madrid.org
- Site Name
- Hospital General Universitario Reina Sofia
- Department Name
- Rheumatology
- Contact Person Name
- Alejandro Escudero Contreras
- Contact Person Email
- alexcudero@hotmail.com
- Site Name
- Clinica Universidad De Navarra (Pamplona)
- Department Name
- Hematology
- Contact Person Name
- Carlos Grande Garcia
- Contact Person Email
- cgrandeg@unav.es
- Site Name
- Hospital Universitario 12 De Octubre
- Department Name
- Rheumatology
- Contact Person Name
- Patricia Carreira Delgado
- Contact Person Email
- carreira@h12o.es
- Site Name
- University Hospital Virgen Del Rocio S.L.
- Department Name
- Hematology
- Contact Person Name
- Maria Eva Mingot Castellano
- Contact Person Email
- mariae.mingot.sspa@juntadeandalucia.es
- Site Name
- Clinica Universidad De Navarra (Madrid)
- Department Name
- Hematology
- Contact Person Name
- Carlos Grande Garcia
- Contact Person Email
- cgrandeg@unav.es
Norway
- Earliest CTIS Part Ii Submission Date
- 18-10-2024
- Latest Decision Or Authorization Date
- 23-12-2025
- Processing Time Days
- 431
- Number Of Sites
- 3
- Number Of Participants
- 4
Sites
- Site Name
- Sorlandet Sykehus HF
- Department Name
- Rheumatology
- Contact Person Name
- Katarzyna Weronika Losinska
- Contact Person Email
- klosinks@elgur.pl
- Site Name
- Helse Stavanger HF
- Department Name
- Department of Rheumatology
- Contact Person Name
- Jens Vikse
- Contact Person Email
- jensvikse@gmail.com
- Site Name
- Sykehuset Ostfold HF
- Department Name
- Hematology
- Contact Person Name
- Eirik Tjønnfjord
- Contact Person Email
- Eirik.tjonnfjord@so-hf.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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