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.
Budoprutug is a humanized, immunoglobulin (Ig) G1 monoclonal antibody that selectively binds to CD19 and is projected to deplete targeted cells through antibody-dependent cellular cytotoxicity. This Phase 1b/2a, open-label, sequential-cohort, dose escalation and expansion study will evaluate the safety, tolerability, PK, PD, and preliminary clinical effectiveness of budoprutug in subjects with ITP. Budoprutug will be administered as two (2) IV infusions 14 days apart in ascending dose cohorts of patients aged 18 years and above with a platelet count \< 30,000/µL despite an adequate trial of at least one prior therapeutic attempt.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
24
Single IV dose of study product on Day 1 and Day 15
Climb Bio Investigative Site #359202
Plovdiv, Bulgaria
RECRUITINGIncidence of Treatment-Emergent Adverse Events (TEAEs)
Number of participants experiencing TEAEs, graded per NCI CTCAE v5.0.
Time frame: Up to week 48
Area Under the Curve (AUC)
Measurement of the area under the drug concentration-time curve.
Time frame: Up to week 48
Maximum Observed Plasma Concentration (Cmax)
Measurement of the maximum observed plasma concentration.
Time frame: Up to week 48
Time to Maximum Observed Concentration (Tmax)
Measurement of the time to maximum observed concentration.
Time frame: Up to week 48
Terminal Half-Life (T1/2)
Measurement of the terminal half-life in days.
Time frame: Up to week 48
Apparent Clearance (CL/F)
Measurement of the apparent clearance in L/hour.
Time frame: Up to week 48
Change from Baseline in CD20+ B-cell Count
Change in absolute peripheral CD20+ B-cell count
Time frame: Up to week 48
Change in Platelet Count
Change in platelet count over time
Time frame: Up to week 48
Proportion of Participants with stable, partial or complete platelet response
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Climb Bio Investigative Site #359203
Plovdiv, Bulgaria
RECRUITINGClimb Bio Investigative Site #359201
Sofia, Bulgaria
RECRUITINGClimb Bio Investigative Site #300204
Athens, Attica, Greece
NOT_YET_RECRUITINGClimb Bio Investigative Site #300203
Chaïdári, Attica, Greece
NOT_YET_RECRUITINGClimb Bio Investigative Site #300202
Ioannina, Greece
NOT_YET_RECRUITINGClimb Bio Investigative Site #300201
Thessaloniki, Greece
NOT_YET_RECRUITINGClimb Bio Investigative Site #381201
Belgrade, Serbia
RECRUITINGClimb Bio Investigative Site #381202
Belgrade, Serbia
RECRUITINGClimb Bio Investigative Site #381203
Novi Sad, Serbia
RECRUITING...and 9 more locations
Percentage of participants with stable, partial or complete platelet response.
Time frame: Up to week 48
Incidence of Anti-Drug Antibodies (ADAs)
Number of participants with detectable ADAs.
Time frame: Up to week 48
Steroid Discontinuation Rate
% of baseline steroid users who discontinue steroids.
Time frame: Up to week 48