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NCT07890909Not yet recruitingPhase 3

A Phase 3b Study of Participant Experience on Povetacicept Administered Via Autoinjector as Compared to Sibeprenlimab Administered Via Prefilled Syringe

A Phase 3b, Open-label, Single-arm, Patient Experience Study of Povetacicept Injection (Via Autoinjector) as Compared to Sibeprenlimab Injection (Via Prefilled Syringe) in Adults With Immunoglobulin A Nephropathy

Source: ClinicalTrials.gov · Last updated 22 Oct 2026

Brief summary (registry, in English)

The purpose of this study is to evaluate participant treatment experience with Povetacicept injection administered via autoinjector relative to Sibeprenlimab injection administered via prefilled syringe (PFS), and to assess the safety and tolerability of Povetacicept in participants with Immunoglobulin A nephropathy (IgAN).

Status (registry)
Not yet recruiting
Phase (registry)
Phase 3
Study type
Interventional
Enrollment
40 (estimated)
First submitted
15 Oct 2026
Start date
23 Oct 2026
Primary completion date
12 Dec 2027
Lead sponsor
Vertex Pharmaceuticals Incorporated
NCT number
NCT07890909

What you commit to

  • Study type: Interventional · Phase 3
  • Planned participants: 40
  • From 23 Oct 2026 to the primary completion date, 12 Dec 2027
  • No sites listed in no country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Use of immunosuppressive or immunomodulatory therapies (except for sibeprenlimab)

Lab values

  • Rapidly progressive glomerulonephritis with eGFR reduction \>50% within 12 weeks of the start of screening
    • Other protocol defined Inclusion/Exclusion criteria may apply.

Who the study is looking for

  • Receiving commercial sibeprenlimab 400 mg subcutaneous via PFS for up to (but not exceeding) a maximum of 4 doses of which at least 1 dose is self-injected prior to signing informed consent form
  • Willing and able to comply with scheduled visits, treatment plan including transitioning to povetacicept
  • Biopsy-confirmed primary IgAN
  • 24-hr urine protein/creatinine ratio (UPCR) greater than \>0.5 gram (g)/g
  • Estimated glomerular filtration rate (eGFR) greater than or equal to (≥) 30 millilitres per minute (mL/min)/1.73 square meter (m\^2)
  • Able to understand and complete the domains of the Self-Injection Administration Questionnaire (SIAQ)

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

This page is information, not medical advice. Discuss any trial with your doctor.