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

Sponsor
Climb Bio, Inc.
Study ID
NCT07043946
Phase
PHASE1/PHASE2
Status
Recruiting
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Conditions

  • Anti-CD19
  • Biologics
  • ITP
  • Immune Thrombocytopenia (ITP)
  • Monoclonal

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Budoprutug — DRUG
    Single IV dose of study product on Day 1 and Day 15

Study Details

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.

Key Dates

Start date
Jun 30, 2025
Status verified
Mar 2026
Primary completion
Aug 31, 2027
Completion
Aug 31, 2028

Study Design

Enrollment
24 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Cohort 1: Dose Level A
    Single IV dose of study product on Day 1 and on Day 15
  • Experimental: Cohort 2: Dose Level B
    Single IV dose of study product on Day 1 and on Day 15
  • Experimental: Cohort 3: Dose Level C
    Single IV dose of study product on Day 1 and on Day 15
  • Experimental: Dose Expansion Cohort
    Single IV dose of study product on Day 1 and Day 15

Primary Outcome Measure

Incidence of Treatment-Emergent Adverse Events (TEAEs) [ Time Frame: Up to week 48 ]

Central Contacts

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