Clinical trial • Phase III • Immunology
Clinical trial in Lupus nephritis
Phase III trial for Lupus nephritis. adaptive. 41 participants.
Overview
- Trial Therapeutic Area
- Immunology
- Trial Disease
- Lupus nephritis
- Trial Stage
- Phase III
- Drug Modality
- Bispecific antibody
Key dates
- Initial CTIS Submission Date
- 19-06-2025
- First CTIS Authorization Date
- 07-10-2025
Trial design
adaptive Phase III trial across 8 sites in Germany, France, Spain.
- Adaptive
- Yes
- Single Multiple Or Escalation Dose Combined
- Yes
- Target Sample Size
- 41
Eligibility
Recruits 41 Vulnerable populations not selected; trial enrols adult patients only (public title: "...in Adult Patients..."); implied standard informed consent by participant (no assent procedures described)..
- Vulnerable Population
- Vulnerable populations not selected; trial enrols adult patients only (public title: "...in Adult Patients..."); implied standard informed consent by participant (no assent procedures described).
Recruitment
- Planned Sample Size
- 41
- Recruitment Window Months
- 30
- Consent Approach
- Informed consent to be provided by adult participants; no vulnerable population/assent procedures selected or described; languages and age-specific documents not specified.
Geography
- Total Number Of Sites
- 8
- Total Number Of Participants
- 19
Germany
- Earliest CTIS Part Ii Submission Date
- 10-09-2025
- Latest Decision Or Authorization Date
- 08-10-2025
- Processing Time Days
- 28
- Number Of Sites
- 2
- Number Of Participants
- 4
Sites
- Site Name
- Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz KöR
- Department Name
- 276002: I.Medizinische Klinik und Poliklinik, Nephrologie
- Contact Person Name
- Julia Weinmann-Menke
- Contact Person Email
- julia.weinmann-menke@unimedizin-mainz.de
- Site Name
- Universitaetsklinikum Regensburg AöR
- Department Name
- 276001: Abteilung für Nephrologie
- Contact Person Name
- Bernhard Banas
- Contact Person Email
- bernhard.banas@ukr.de
France
- Earliest CTIS Part Ii Submission Date
- 19-09-2025
- Latest Decision Or Authorization Date
- 07-10-2025
- Processing Time Days
- 18
- Number Of Sites
- 1
- Number Of Participants
- 6
Sites
- Site Name
- Centre Hospitalier Universitaire De Bordeaux
- Department Name
- 250001: Nephrology
- Contact Person Name
- Marine Novion
- Contact Person Email
- marine.novion@chu-bordeaux.fr
Spain
- Earliest CTIS Part Ii Submission Date
- 03-10-2025
- Latest Decision Or Authorization Date
- 08-10-2025
- Processing Time Days
- 5
- Number Of Sites
- 5
- Number Of Participants
- 9
Sites
- Site Name
- University Hospital Virgen Del Rocio S.L.
- Department Name
- 724002;Nefrología
- Contact Person Name
- Manuel Lopez Mendoza
- Contact Person Email
- lolopezmen@gmail.com
- Site Name
- Hospital General Universitario Gregorio Maranon
- Department Name
- 724001;Nefrología
- Contact Person Name
- Maria Goicoechea Diezhandino
- Contact Person Email
- marian.goicoechea@salud.madrid.org
- Site Name
- Hospital Universitario 12 De Octubre
- Department Name
- 724005: Nefrología
- Contact Person Name
- Enrique Morales
- Contact Person Email
- emorales@salud.madrid.org
- Site Name
- Hospital Universitario Regional De Malaga
- Department Name
- 724004;Reumatología
- Contact Person Name
- Antonio Fernández Nebro
- Contact Person Email
- antonio.fernandez.nebro.sspa@juntadeandalucia.es
- Site Name
- Clinica Universidad De Navarra
- Department Name
- 724003;Nefrología
- Contact Person Name
- José María Mora-Gutiérrez
- Contact Person Email
- jmora@unav.es
Sponsor
Primary sponsor
- Full Name
- Regeneron Pharmaceuticals Inc.
- Organisation Type
- Pharmaceutical company
- Country Of Registered Address
- United States
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