Phase 1b/2a study to evaluate Budoprutug in Subjects with Immune Thrombocytopenia (ITP)
Research type
Research Study
Full title
A Phase 1b/2a, Open-Label, Sequential-Cohort, Dose Escalation and Expansion Study to Evaluate Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Preliminary ClinicalEffectiveness of Budoprutug (TNT119) in Subjects with Immune Thrombocytopenia (ITP)
IRAS ID
1012091
Contact name
Janaki Subramanyam
Contact email
Sponsor organisation
Climb Bio Inc.
Clinicaltrials.gov Identifier
Research summary
This is a Phase 1b/2a, sequential-cohort, dose escalation and expansion study to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of Budoprutug in adult participants with immune thrombocytopenia (ITP). Budoprutug is a biologic compound (monoclonal antibody) administered intravenously and designed to decrease overactive B cells also known as B lymphocytes.
The maximum duration of study participation may be up to 2 years, including Screening and Qualifying Visits (up to 3 weeks), treatment period (2 weeks), and follow-up visits up to Week 48 in the main part of the study, and 52 weeks of long-term follow-up. There will be 25 study visits of different durations.
Study procedures will involve physical examinations, blood samples, urine samples, study drug dosing, quality of life questionnaires, electrocardiogram and a chest x-ray at screening.
Climb Bio, Inc. is the sponsor of this study.REC name
London - Central Research Ethics Committee
REC reference
25/LO/0618
Date of REC Opinion
9 Oct 2025
REC opinion
Further Information Favourable Opinion