A Phase 1b/2a Study of Budoprutug in Subjects With Immune Thrombocytopenia (ITP)
Key facts
- Where
- Cherkasy, Ivano-Frankivsk, Kyiv, and Lviv, UkraineSee the 6 sites
- Phase
- Phase 1/2
Where in Ukraine
- CherkasyHospital not named in the registryContact: Climb Bio Study DirectorNot yet recruiting
- Ivano-FrankivskHospital not named in the registryContact: Climb Bio Study DirectorTaking people
- KyivHospital not named in the registryContact: Climb Bio Study DirectorTaking people
- KyivHospital not named in the registryContact: Climb Bio Study DirectorTaking people
- KyivHospital not named in the registryContact: Climb Bio Study DirectorTaking people
- LvivHospital not named in the registryContact: Climb Bio Study DirectorTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial details
- Who runs it
- Climb Bio, Inc.
- Trial code
- NCT07043946
- Record updated
- 27 March 2026
- Original description
The main objective is to assess the safety and tolerability of budoprutug in adults with ITP. Pharmacokinetics, pharmacodynamics, and preliminary clinical efficacy will also be assessed.Read full original descriptionShow less
A Phase 1b/2a, Open-Label, Sequential-Cohort, Dose Escalation and Expansion Study to Evaluate Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Preliminary Clinical Effectiveness of Budoprutug (TNT119) in Subjects With Immune Thrombocytopenia (ITP)
The main objective is to assess the safety and tolerability of budoprutug in adults with ITP. Pharmacokinetics, pharmacodynamics, and preliminary clinical efficacy will also be assessed.
Inclusion: Aged 18 years at the time of consent; Platelet count < 30,000/µL despite an adequate trial of at least one prior therapeutic attempt. Platelet counts of < 30,000/µL must be confirmed on 2 occasions at least 5 days apart, but no more than 14 days apart; Partial thromboplastin time < 1.5 x upper limit of normal (ULN), prothrombin time < 1.5 x ULN, total bilirubin < 1.5 x ULN unless due to Gilbert's syndrome, or an international normalized ratio < 1.5 at screening.
Exclusion: Prior B-cell depleting therapy (e.g., rituximab) within 24 weeks before first dose or planned during the study; Chronic use of anticoagulants or antiplatelet agents (e.g., aspirin, NSAIDs, thienopyridines) within 14 days before dosing through follow-up. Intermittent NSAID use is allowed; Immunosuppressants (excluding corticosteroids) within 30 days or 5× half-life before Screening; alkylating agents within 180 days; IVIg treatment within 90 days prior to Screening; Active ITP treatment (other than steroids or TPO agonists) within 30 days or 5× half-life before first dose, unless approved by Medical Monitor; Diagnosis of paroxysmal nocturnal hemoglobinuria, Evan's Syndrome, or other bleeding disorders affecting safety or data integrity; Active, chronic, or latent infections including hepatitis B/C or HIV; CD19+ B cell count < 80 cells/µL at Screening, or < 40 cells/µL if B-cell depleting therapy was received within 24 weeks to 2 years prior; Active TB or high TB risk.