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

RecruitingPhase 1, Phase 2Ages 18 Years - anyAllClimb Bio, Inc.
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In plain words

What the trial is, and whether it could suit you

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.

Sign in to get the eligibility rules as simple questions to take to your doctor.

📋 Eligibility rules (as published)
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.
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What it tests

  • Budoprutug
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Where

20 sites
Climb Bio Investigative Site #359202
Plovdiv, Bulgaria
Climb Bio Investigative Site #359203
Plovdiv, Bulgaria
Climb Bio Investigative Site #359201
Sofia, Bulgaria
Climb Bio Investigative Site #300204
Athens, Greece
Climb Bio Investigative Site #300203
Chaïdári, Greece
Climb Bio Investigative Site #300202
Ioannina, Greece
Climb Bio Investigative Site #300201
Thessaloniki, Greece
Climb Bio Investigative Site #381201
Belgrade, Serbia

…and 12 more on ClinicalTrials.gov.

🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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