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

ConditionsImmune Thrombocytopenia (ITP)ITPBiologicsMonoclonalAnti-CD19
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorClimb Bio, Inc.

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Sequential

Treatments tested in this trial

  • Budoprutug

    Drug

    Single IV dose of study product on Day 1 and Day 15

Treatment groups

24 Participants
are divided into 4 treatment groups
Group A: Cohort 1: Dose Level AExperimental treatment 1 intervention
Group B: Cohort 2: Dose Level BExperimental treatment 1 intervention
Group C: Cohort 3: Dose Level CExperimental treatment 1 intervention
Group D: Dose Expansion CohortExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Incidence of Treatment-Emergent Adverse Events (TEAEs)

Number of participants experiencing TEAEs, graded per NCI CTCAE v5.0.

Time frame
Up to week 48

Secondary outcomes

1

Area Under the Curve (AUC)

Measurement of the area under the drug concentration-time curve.

Time frame
Up to week 48
2

Maximum Observed Plasma Concentration (Cmax)

Measurement of the maximum observed plasma concentration.

Time frame
Up to week 48
3

Time to Maximum Observed Concentration (Tmax)

Measurement of the time to maximum observed concentration.

Time frame
Up to week 48
4

Terminal Half-Life (T1/2)

Measurement of the terminal half-life in days.

Time frame
Up to week 48

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Climb Bio, Inc.

Lead sponsor

Source ClinicalTrials.gov
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