Clinical trial • Phase I|Phase III • Immunology|Rare Disease
VIS171 for Systemic lupus erythematosus | Immune-mediated focal segmental glomerulosclerosis | Alopecia areata
Phase I|Phase III trial of VIS171 for Systemic lupus erythematosus | Immune-mediated focal segmental glomerulosclerosis | Alopecia areata.
Overview
- Trial Therapeutic Area
- Immunology|Rare Disease
- Trial Disease
- Systemic lupus erythematosus | Immune-mediated focal segmental glomerulosclerosis | Alopecia areata
- Trial Stage
- Phase I|Phase III
Key dates
- Initial CTIS Submission Date
- 31-01-2025
- First CTIS Authorization Date
- 15-05-2025
Trial design
None/Not specified-controlled Phase I|Phase III trial across 12 sites in Bulgaria, Poland, Romania and others.
- Comparator
- None/Not specified
- Target Sample Size
- 21
Eligibility
Recruits 21 Vulnerable population not selected; no specific consent or assent handling described in the record..
- Vulnerable Population
- Vulnerable population not selected; no specific consent or assent handling described in the record.
Recruitment
- Planned Sample Size
- 21
- Recruitment Window Months
- 20
Geography
- Total Number Of Sites
- 12
- Total Number Of Participants
- 21
Bulgaria
- Earliest CTIS Part Ii Submission Date
- 18-04-2025
- Latest Decision Or Authorization Date
- 31-03-2026
- Processing Time Days
- 347
- Number Of Sites
- 2
- Number Of Participants
- 4
Sites
- Site Name
- University Multiprofile Hospital For Active Treatment St. Ivan Rilski EAD
- Department Name
- Department of Rheumatology
- Contact Person Name
- Vladimira Boyadzhieva
- Contact Person Email
- admin@rilski.com
- Site Name
- Multispecialty hospital for active treatment Sveta Sofia EOOD
- Department Name
- Department of Dermatology and Venereology
- Contact Person Name
- Emil Bardarov
- Contact Person Email
- arensia.bg@arensia-em.com
Poland
- Earliest CTIS Part Ii Submission Date
- 22-04-2025
- Latest Decision Or Authorization Date
- 31-03-2026
- Processing Time Days
- 343
- Number Of Sites
- 4
- Number Of Participants
- 6
Sites
- Site Name
- Wojskowy Instytut Medyczny Panstwowy Instytut Badawczy
- Department Name
- Centrum Wsparcia Badań Klinicznych
- Contact Person Name
- Stanislaw Niemczyk
- Contact Person Email
- badaniakliniczne@wim.mil.pl
- Site Name
- Narodowy Instytut Geriatrii Reumatologii I Rehabilitacji Im Prof. Dr Hab. Med. Eleonory Reicher
- Department Name
- Centrum Wsparcia Badań Klinicznych
- Contact Person Name
- Maria Maślińska
- Contact Person Email
- cwbk@spartanska.pl
- Site Name
- Uniwersytecki Szpital Kliniczny W Poznaniu
- Department Name
- Uniwersytecki Ośrodek Wczesnych Faz
- Contact Person Name
- Aleksandra Dańczak-Pazdrowska
- Contact Person Email
- owf@ump.edu.pl
- Site Name
- Uniwersytecki Szpital Kliniczny Im. Jana Mikulicza-Radeckiego We Wroclawiu
- Department Name
- Oddział Kliniczny Dermatologii Ogólnej i Onkologicznej
- Contact Person Name
- Alina Jankowska-Konsur
- Contact Person Email
- kdw@usk.wroc.pl
Romania
- Earliest CTIS Part Ii Submission Date
- 14-02-2025
- Latest Decision Or Authorization Date
- 31-03-2026
- Processing Time Days
- 410
- Number Of Sites
- 2
- Number Of Participants
- 4
Sites
- Site Name
- Arensia Clinics S.R.L.
- Department Name
- Arensia Clinics S.R.L.
- Contact Person Name
- Mihai Abobului
- Contact Person Email
- mihai.aboului.ext@arensia-em.com
- Site Name
- Spitalul Clinic Judetean De Urgenta Cluj
- Department Name
- Arensia Exploratory Medicine at Spitalul Clinic Județean de Urgență Cluj
- Contact Person Name
- Daniela Fodor
- Contact Person Email
- daniela.fodor.ext@arensia-em.com
Spain
- Earliest CTIS Part Ii Submission Date
- 19-04-2025
- Latest Decision Or Authorization Date
- 31-03-2026
- Processing Time Days
- 346
- Number Of Sites
- 4
- Number Of Participants
- 7
Sites
- Site Name
- Hospital Universitario La Paz
- Department Name
- Servicio de Medicina Interna
- Contact Person Name
- Juan Ríos Blanco
- Contact Person Email
- UCICEC.hulp@salud.madrid.org
- Site Name
- Complexo Hospitalario Universitario De Santiago
- Department Name
- Servicio de Nefrologia
- Contact Person Name
- Cándido Díaz Rodríguez
- Contact Person Email
- nef.chus.santiago@sergas.es
- Site Name
- Hospital Universitario Virgen De Las Nieves
- Department Name
- Servicio de Medicina Interna
- Contact Person Name
- Nuria Navarrete
- Contact Person Email
- unidadensayosclinicos@gmail.com
- Site Name
- Hospital Universitari Vall D Hebron
- Department Name
- Servicio de Nefrologia
- Contact Person Name
- Laia Sans Atxer
- Contact Person Email
- assajos.nefrologia@vhir.org
Sponsor
Primary sponsor
- Full Name
- Otsuka Pharmaceutical Development & Commercialization Inc.
- Organisation Type
- Pharmaceutical company
- Country Of Registered Address
- United States
Investigational products
- Investigational Product Name
- VIS171
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