A Phase 1b/2a Study of Budoprutug in Subjects With Immune Thrombocytopenia (ITP)
NCT ID: NCT07043946
Last Updated: 2026-01-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1/PHASE2
24 participants
INTERVENTIONAL
2025-06-30
2028-08-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SEQUENTIAL
TREATMENT
NONE
Study Groups
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Cohort 1: Dose Level A
Single IV dose of study product on Day 1 and on Day 15
Budoprutug
Single IV dose of study product on Day 1 and Day 15
Cohort 2: Dose Level B
Single IV dose of study product on Day 1 and on Day 15
Budoprutug
Single IV dose of study product on Day 1 and Day 15
Cohort 3: Dose Level C
Single IV dose of study product on Day 1 and on Day 15
Budoprutug
Single IV dose of study product on Day 1 and Day 15
Dose Expansion Cohort
Single IV dose of study product on Day 1 and Day 15
Budoprutug
Single IV dose of study product on Day 1 and Day 15
Interventions
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Budoprutug
Single IV dose of study product on Day 1 and Day 15
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
ALL
No
Sponsors
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Climb Bio, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Study Director
Role: STUDY_DIRECTOR
Climb Bio, Inc.
Locations
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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, Attica, Greece
Climb Bio Investigative Site #300203
Chaïdári, Attica, Greece
Climb Bio Investigative Site #300202
Ioannina, , Greece
Climb Bio Investigative Site #300201
Thessaloniki, , Greece
Climb Bio Investigative Site #381201
Belgrade, , Serbia
Climb Bio Investigative Site #381202
Belgrade, , Serbia
Climb Bio Investigative Site #381203
Novi Sad, , Serbia
Climb Bio Investigative Site #340206
Burgos, , Spain
Climb Bio Investigative Site #340204
Madrid, , Spain
Climb Bio Investigative Site #340202
San Pedro, , Spain
Climb Bio Investigative Site #340203
Valencia, , Spain
Climb Investigative Site #380204
Ivano-Frankivsk, , Ukraine
Climb Investigative Site #2380203
Kyiv, , Ukraine
Climb Investigative Site #380202
Kyiv, , Ukraine
Climb Investigative Site #380206
Kyiv, , Ukraine
Climb Investigative Site #380201
Lviv, , Ukraine
Countries
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Central Contacts
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Other Identifiers
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TNT119-ITP-201
Identifier Type: -
Identifier Source: org_study_id
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