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

Launched by CLIMB BIO, INC. · Jun 20, 2025

Keywords

ClinConnect Summary

This clinical trial is testing a new medicine called budoprutug to see if it is safe and well-tolerated in adults who have a condition called Immune Thrombocytopenia (ITP). ITP is a disorder where the body’s immune system attacks platelets, which are cells that help blood clot. People with ITP can have very low platelet counts, which increases the risk of bleeding. This study will also look at how the medicine works in the body and whether it helps improve platelet counts.

Adults aged 18 and older with ITP who have low platelet counts (below 30,000) despite trying at least one treatment before may be eligible to join. To participate, people must meet certain health requirements, like having normal blood clotting test results and no active infections or other serious health conditions. Participants can expect careful monitoring throughout the study to check their safety and how their body responds to the medicine. This trial is currently recruiting volunteers, and both men and women can take part. If you or a family member have ITP and are interested, talking to a doctor about this study might be a good step.

Gender

ALL

Eligibility criteria

• 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.