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

Recruiting now · Phase 1/Phase 2

Conditions studied: Immune Thrombocytopenia (ITP), ITP, Biologics, Monoclonal, Anti-CD19

In brief

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.

Key facts

Study ID

NCT07043946

Run by

Climb Bio, Inc.

People needed

24

Starts

2025-06-30

Expected to finish

2028-08-01

Last updated by the study team

2026-03-27

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.
• Diagnosis of paroxysmal nocturnal hemoglobinuria, Evan's Syndrome, or other bleeding disorders affecting safety or data integrity.
• 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.
• Active, chronic, or latent infections including hepatitis B/C or HIV.
• Active TB or high TB risk.

Where it is running

• Climb Bio Investigative Site #359202 — Plovdiv, Bulgaria (enrolling)
• Climb Bio Investigative Site #359203 — Plovdiv, Bulgaria (enrolling)
• Climb Bio Investigative Site #359201 — Sofia, Bulgaria (enrolling)
• Climb Bio Investigative Site #300204 — Athens, Attica, Greece (enrolling)
• Climb Bio Investigative Site #300203 — Chaïdári, Attica, Greece (enrolling)
• Climb Bio Investigative Site #300202 — Ioannina, Greece (enrolling)
• Climb Bio Investigative Site #300201 — Thessaloniki, Greece (enrolling)
• Climb Bio Investigative Site #381201 — Belgrade, Serbia (enrolling)
• Climb Bio Investigative Site #381202 — Belgrade, Serbia (enrolling)
• Climb Bio Investigative Site #381203 — Novi Sad, Serbia (enrolling)
• Climb Investigative Site #380206 — Kyiv, Ukraine (enrolling)
• Climb Investigative Site #380201 — Lviv, Ukraine (enrolling)
• Climb Bio Investigative Site #340204 — Madrid, Spain (enrolling)
• Climb Bio Investigative Site #340202 — San Pedro, Spain (enrolling)
• Climb Bio Investigative Site #340203 — Valencia, Spain (enrolling)
• Climb Investigative Site #380204 — Ivano-Frankivsk, Ukraine (enrolling)
• Climb Investigative Site #2380203 — Kyiv, Ukraine (enrolling)
• Climb Investigative Site #380202 — Kyiv, Ukraine (enrolling)
• Climb Bio Investigative Site #340206 — Burgos, Spain
• Climb Bio Investigative Site #380208 — Cherkasy, Ukraine

Full record on ClinicalTrials.gov

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