Clinical trial • Phase III • Immunology
Cevostamab for Systemic lupus erythematosus | Lupus nephritis
Phase III trial of Cevostamab for Systemic lupus erythematosus | Lupus nephritis. 29 participants.
Overview
- Trial Therapeutic Area
- Immunology
- Trial Disease
- Systemic lupus erythematosus | Lupus nephritis
- Trial Stage
- Phase III
Key dates
- Initial CTIS Submission Date
- 17-12-2025
- First CTIS Authorization Date
- 22-04-2026
Trial design
Phase III trial across 11 sites in France, Germany, Italy and others.
- Target Sample Size
- 29
Eligibility
Recruits 29 Vulnerable population selected; no details on consent or assent handling provided in source..
- Vulnerable Population
- Vulnerable population selected; no details on consent or assent handling provided in source.
Recruitment
- Planned Sample Size
- 29
- Recruitment Window Months
- 41
Geography
- Total Number Of Sites
- 11
- Total Number Of Participants
- 17
France
- Earliest CTIS Part Ii Submission Date
- 17-03-2026
- Latest Decision Or Authorization Date
- 22-04-2026
- Processing Time Days
- 36
- Number Of Sites
- 3
- Number Of Participants
- 4
Sites
- Site Name
- Centre Hospitalier Universitaire De Poitiers
- Department Name
- Néphrologie, hémodialyse et transplantation rénale
- Principal Investigator Name
- Antoine THIERRY
- Principal Investigator Email
- antoine.thierry@chu-poitiers.fr
- Contact Person Name
- Antoine THIERRY
- Contact Person Email
- antoine.thierry@chu-poitiers.fr
- Site Name
- Hospices Civils De Lyon
- Department Name
- Médecine interne
- Principal Investigator Name
- Thomas BARBA
- Principal Investigator Email
- thomas.barba@chu-lyon.fr
- Contact Person Name
- Thomas BARBA
- Contact Person Email
- thomas.barba@chu-lyon.fr
- Site Name
- Centre Hospitalier Universitaire De Toulouse
- Department Name
- Néphrologie et transplantation d'organes
- Principal Investigator Name
- Dominique CHAUVEAU
- Principal Investigator Email
- chauveau.d@chu-toulouse.fr
- Contact Person Name
- Dominique CHAUVEAU
- Contact Person Email
- chauveau.d@chu-toulouse.fr
Germany
- Earliest CTIS Part Ii Submission Date
- 26-03-2026
- Latest Decision Or Authorization Date
- 27-04-2026
- Processing Time Days
- 32
- Number Of Sites
- 2
- Number Of Participants
- 3
Sites
- Site Name
- LMU Klinikum Muenchen AöR
- Principal Investigator Name
- Hendrik Schulze-Koops
- Principal Investigator Email
- hendrik.schulze-koops@med.uni-muenchen.de
- Contact Person Name
- Hendrik Schulze-Koops
- Contact Person Email
- hendrik.schulze-koops@med.uni-muenchen.de
- Site Name
- Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz KöR
- Principal Investigator Name
- Julia Weinmann-Menke
- Principal Investigator Email
- julia.weinmann-menke@unimedizin-mainz.de
- Contact Person Name
- Julia Weinmann-Menke
- Contact Person Email
- julia.weinmann-menke@unimedizin-mainz.de
Italy
- Earliest CTIS Part Ii Submission Date
- 23-03-2026
- Latest Decision Or Authorization Date
- 22-04-2026
- Processing Time Days
- 30
- Number Of Sites
- 3
- Number Of Participants
- 6
Sites
- Site Name
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS
- Department Name
- UOC Rheumatology
- Principal Investigator Name
- Maria Antonietta D' Agostino
- Principal Investigator Email
- mariaantonietta.dagostino@policlinicogemelli.it
- Contact Person Name
- Maria Antonietta D' Agostino
- Contact Person Email
- mariaantonietta.dagostino@policlinicogemelli.it
- Site Name
- Azienda Socio Sanitaria Territoriale Degli Spedali Civili Di Brescia
- Department Name
- UO Nephrology
- Principal Investigator Name
- Federico Alberici
- Principal Investigator Email
- federico.alberici@unibs.it
- Contact Person Name
- Federico Alberici
- Contact Person Email
- federico.alberici@unibs.it
- Site Name
- Humanitas Mirasole S.p.A.
- Department Name
- Rheumatology and Clinical immunology
- Principal Investigator Name
- Elisa Gremese
- Principal Investigator Email
- elisa.gremese@hunimed.eu
- Contact Person Name
- Elisa Gremese
- Contact Person Email
- elisa.gremese@hunimed.eu
Spain
- Earliest CTIS Part Ii Submission Date
- 25-03-2026
- Latest Decision Or Authorization Date
- 27-04-2026
- Processing Time Days
- 33
- Number Of Sites
- 3
- Number Of Participants
- 4
Sites
- Site Name
- Hospital Universitario Araba
- Department Name
- Rheumatology
- Principal Investigator Name
- Carmen Lucia Garcia Gomez
- Principal Investigator Email
- carmengargo5@gmail.com
- Contact Person Name
- Carmen Lucia Garcia Gomez
- Contact Person Email
- carmengargo5@gmail.com
- Site Name
- Hospital Universitario Virgen De La Macarena
- Department Name
- Nephorology
- Principal Investigator Name
- Mercedes Salgueira Lazo
- Principal Investigator Email
- siag.investigacion.hym.sspa@juntadeandalucia.es
- Contact Person Name
- Mercedes Salgueira Lazo
- Contact Person Email
- siag.investigacion.hym.sspa@juntadeandalucia.es
- Site Name
- Clinica Universidad De Navarra
- Department Name
- Nephrology
- Principal Investigator Name
- Jose Maria Mora Gutierrez
- Principal Investigator Email
- jmora@unav.es
- Contact Person Name
- Jose Maria Mora Gutierrez
- Contact Person Email
- jmora@unav.es
Sponsor
Primary sponsor
- Full Name
- Genentech Inc.
- Organisation Type
- Pharmaceutical company
- Country Of Registered Address
- United States
Investigational products
- Investigational Product Name
- Cevostamab
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