Actively Recruiting
A Phase 1b/2a Study of Budoprutug in Subjects With Immune Thrombocytopenia (ITP)
Led by Climb Bio, Inc. · Updated on 2026-03-27
24
Participants Needed
20
Research Sites
161 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
A Phase 1b/2a Study of Budoprutug in Subjects With Immune Thrombocytopenia (ITP)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Aged 18 years or older at the time of consent
- Platelet count below 30,000/µL confirmed twice between 5 and 14 days apart despite at least one prior treatment attempt
- Partial thromboplastin time less than 1.5 times upper limit of normal
- Prothrombin time less than 1.5 times upper limit of normal
- Total bilirubin less than 1.5 times upper limit of normal unless due to Gilbert's syndrome
- International normalized ratio less than 1.5 at screening
You will not qualify if you...
- CD19+ B cell count less than 80 cells/µL at screening or less than 40 cells/µL if B-cell depletion 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 within 24 weeks before first dose or planned during the study
- Chronic use of anticoagulants or antiplatelet agents within 14 days before dosing through follow-up (intermittent NSAID use allowed)
- Use of immunosuppressants (excluding corticosteroids) within 30 days or 5 half-lives 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-lives before first dose unless approved
- Active, chronic, or latent infections including hepatitis B, hepatitis C, or HIV
- Active tuberculosis or high tuberculosis risk
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 20 locations
1
Climb Bio Investigative Site #359202
Plovdiv, Bulgaria, 4002
Actively Recruiting
2
Climb Bio Investigative Site #359203
Plovdiv, Bulgaria, 4003
Actively Recruiting
3
Climb Bio Investigative Site #359201
Sofia, Bulgaria, 1797
Actively Recruiting
4
Climb Bio Investigative Site #300204
Athens, Attica, Greece, 11527
Actively Recruiting
5
Climb Bio Investigative Site #300203
Chaïdári, Attica, Greece, 12462
Actively Recruiting
6
Climb Bio Investigative Site #300202
Ioannina, Greece, 45500
Actively Recruiting
7
Climb Bio Investigative Site #300201
Thessaloniki, Greece, 57010
Actively Recruiting
8
Climb Bio Investigative Site #381201
Belgrade, Serbia
Actively Recruiting
9
Climb Bio Investigative Site #381202
Belgrade, Serbia
Actively Recruiting
10
Climb Bio Investigative Site #381203
Novi Sad, Serbia
Actively Recruiting
11
Climb Bio Investigative Site #340206
Burgos, Spain, 9006
Not Yet Recruiting
12
Climb Bio Investigative Site #340204
Madrid, Spain, 28041
Actively Recruiting
13
Climb Bio Investigative Site #340202
San Pedro, Spain
Actively Recruiting
14
Climb Bio Investigative Site #340203
Valencia, Spain, 46010
Actively Recruiting
15
Climb Bio Investigative Site #380208
Cherkasy, Ukraine
Not Yet Recruiting
16
Climb Investigative Site #380204
Ivano-Frankivsk, Ukraine
Actively Recruiting
17
Climb Investigative Site #2380203
Kyiv, Ukraine
Actively Recruiting
18
Climb Investigative Site #380202
Kyiv, Ukraine
Actively Recruiting
19
Climb Investigative Site #380206
Kyiv, Ukraine
Actively Recruiting
20
Climb Investigative Site #380201
Lviv, Ukraine
Actively Recruiting
Research Team
C
Climb Bio Study Director
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
4
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