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Clinical Trials in Spain / NCT07043946
Recruiting Phase 1/2

A Phase 1b/2a Study of Budoprutug in Subjects With Immune Thrombocytopenia (ITP)

NCT07043946 · tracked via the Priya Life Science Spain tracker
Phase
Phase 1/2
Started
2025-06-30
Last updated
2026-03-27

Condition(s) studied

Immune Thrombocytopenia (ITP)ITPBiologicsMonoclonalAnti-CD19

Investigational drug(s) / intervention(s)

Budoprutug →

Budoprutug: Single IV dose of study product on Day 1 and Day 15

Study summary

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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: 1. Aged 18 years at the time of consent. 2. 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. 3. 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 Criteria: 1. 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. 2. Diagnosis of paroxysmal nocturnal hemoglobinuria, Evan's Syndrome, or other bleeding disorders affecting safety or data integrity. 3. Prior B-cell depleting therapy (e.g., rituximab) within 24 weeks before first dose or planned during the study. 4. 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. 5. Immunosuppressants (excluding corticosteroids) within 30 days or 5× half-life before Screening; alkylating agents within 180 days. 6. IVIg treatment within 90 days prior to Screening. 7. Active ITP treatment (other than steroids or TPO agonists) within 30 days or 5× half-life before first dose, unless approved by Medical Monitor. 8. Active, chronic, or latent infections including hepatitis B/C or HIV. 9. Active TB or high TB risk.

Primary outcome measure(s)

Trial sites (20)

FacilityCityRegionStatus
Climb Bio Investigative Site #359202 Plovdiv Bulgaria Recruiting
Climb Bio Investigative Site #359203 Plovdiv Bulgaria Recruiting
Climb Bio Investigative Site #359201 Sofia Bulgaria Recruiting
Climb Bio Investigative Site #300204 Athens Attica Recruiting
Climb Bio Investigative Site #300203 Chaïdári Attica Recruiting
Climb Bio Investigative Site #300202 Ioannina Greece Recruiting
Climb Bio Investigative Site #300201 Thessaloniki Greece Recruiting
Climb Bio Investigative Site #381201 Belgrade Serbia Recruiting
Climb Bio Investigative Site #381202 Belgrade Serbia Recruiting
Climb Bio Investigative Site #381203 Novi Sad Serbia Recruiting
Climb Bio Investigative Site #340206 Burgos Spain Not Yet Recruiting
Climb Bio Investigative Site #340204 Madrid Spain Recruiting
Climb Bio Investigative Site #340202 San Pedro Spain Recruiting
Climb Bio Investigative Site #340203 Valencia Spain Recruiting
Climb Bio Investigative Site #380208 Cherkasy Ukraine Not Yet Recruiting
Climb Investigative Site #380204 Ivano-Frankivsk Ukraine Recruiting
Climb Investigative Site #2380203 Kyiv Ukraine Recruiting
Climb Investigative Site #380202 Kyiv Ukraine Recruiting
Climb Investigative Site #380206 Kyiv Ukraine Recruiting
Climb Investigative Site #380201 Lviv Ukraine Recruiting

More Climb Bio, Inc. trials in Spain

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07043946 on ClinicalTrials.gov ↗ ← All trials in Spain