Clinical trial • Phase III • Immunology
budoprutug (TNT119) for Systemic lupus erythematosus
Phase III trial of budoprutug (TNT119) for Systemic lupus erythematosus. 13 participants.
Overview
- Trial Therapeutic Area
- Immunology
- Trial Disease
- Systemic lupus erythematosus
- Trial Stage
- Phase III
Key dates
- Initial CTIS Submission Date
- 28-07-2025
- First CTIS Authorization Date
- 31-10-2025
Trial design
Phase III trial across 8 sites in Bulgaria, Spain, Romania and others.
- Target Sample Size
- 13
Recruitment
- Planned Sample Size
- 13
- Recruitment Window Months
- 20
Geography
- Total Number Of Sites
- 8
- Total Number Of Participants
- 11
Bulgaria
- Earliest CTIS Part Ii Submission Date
- 22-10-2025
- Latest Decision Or Authorization Date
- 03-11-2025
- Processing Time Days
- 12
- Number Of Sites
- 2
- Number Of Participants
- 3
Sites
- Site Name
- Multispecialty hospital for active treatment Sveta Sofia EOOD
- Department Name
- Department of Internal Diseases
- Contact Person Name
- Silviya Naydenova
- Contact Person Email
- silviya.naydenova.ext@arensiaem.com
- Site Name
- University Multiprofile Hospital For Active Treatment Saint Georgi EAD
- Department Name
- Clinic of Rheumatology,
- Contact Person Name
- Krasimir Kraev
- Contact Person Email
- dr.krasimir.kraev@gmail.com
Spain
- Earliest CTIS Part Ii Submission Date
- 14-08-2025
- Latest Decision Or Authorization Date
- 31-10-2025
- Processing Time Days
- 78
- Number Of Sites
- 2
- Number Of Participants
- 3
Sites
- Site Name
- Parc Tauli Hospital Universitari
- Department Name
- Rheumatology Service
- Contact Person Name
- Joan Calvet Fontova
- Contact Person Email
- calvet.parctauli@gmail.com
- Site Name
- Complexo Hospitalario Universitario A Coruna
- Department Name
- Rheumatology Service
- Contact Person Name
- Mercedes Freire Gonzalez
- Contact Person Email
- mercedes.freire.gonzalez@sergas.es
Romania
- Earliest CTIS Part Ii Submission Date
- 14-08-2025
- Latest Decision Or Authorization Date
- 03-11-2025
- Processing Time Days
- 81
- Number Of Sites
- 1
- Number Of Participants
- 2
Sites
- Site Name
- Spitalul Clinic Judetean De Urgenta Cluj
- Department Name
- Medical II
- Contact Person Name
- Daniela FODOR
- Contact Person Email
- daniela.fodor.ext@arensia-em.com
Greece
- Earliest CTIS Part Ii Submission Date
- 03-09-2025
- Latest Decision Or Authorization Date
- 31-10-2025
- Processing Time Days
- 58
- Number Of Sites
- 3
- Number Of Participants
- 3
Sites
- Site Name
- Laiko General Hospital Of Athens
- Department Name
- A’ Department of Propaeudeutic Internal Medicine
- Contact Person Name
- Maria Tektonidou
- Contact Person Email
- mtektonidou@gmail.com
- Site Name
- Ippokratio General Hospital Of Thessaloniki
- Department Name
- Nephrology Department
- Contact Person Name
- Maria Stangou
- Contact Person Email
- mstangou@auth.gr
- Site Name
- Geniko Nosokomeio Thessalonikis George Papanikolaou
- Department Name
- Nephrology Department
- Contact Person Name
- Gerasimos Bamichas
- Contact Person Email
- gbamihas@gmail.com
Sponsor
Primary sponsor
- Full Name
- Climb Bio Inc.
- Organisation Type
- Pharmaceutical company
- Country Of Registered Address
- United States
Investigational products
- Investigational Product Name
- budoprutug (TNT119)
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