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
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

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

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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