Health TrialsbyHealthPanel

A Phase 2 Study of Budoprutug in Subjects With Primary Membranous Nephropathy

ConditionPrimary Membranous Nephropathy
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorClimb Bio, Inc.

About this trial

To evaluate the safety and tolerability of three dose regimens of budoprutug in subjects with PMN

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Confirmed diagnosis of PMN with positive anti-PLA2R antibodies

CD19+ B cell count ≥40 cells/μL

UPCR ≥2.0 g/g

eGFR ≥35 mL/min/1.73 m²

Disqualifiers

Secondary Membranous Nephropathy

Rapidly progressive glomerulonephritis or other glomerulopathies

Prior B cell-depleting therapy within 24 weeks

Recent use of immunosuppressants

Trial design

Design model

Sequential

Treatments tested in this trial

  • budoprutug

    Drug

    Single IV dose of study product on Day 1, Day 15, Day 169 and Day 183

Treatment groups

45 Participants
are divided into 3 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

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

Change in total B Cell Count

Absolute and % change in total number of peripheral B cells over time.

Time frame
Up to Week 48
2

Change in Anti-PLA2R Antibodies

Change from Baseline in anti-PLA2R antibody titers over time.

Time frame
Up to Week 48
3

Complete Remission Rate

Proportion of subjects who achieve complete remission at Week 48.

Time frame
Week 48
4

Complete or Partial Remission Rate

Proportion of subjects who achieve complete or partial remission at Week 48.

Time frame
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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