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

NCT07890909 — Phase 3, Not yet recruiting, 40 participants, Vertex Pharmaceuticals Incorporated

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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

Registry	NCT07890909
Status	Not yet recruiting
Phase	Phase 3
Study type	Interventional; na, single group, masking: none, treatment
Enrollment	40 (Estimated)
Sponsor	Vertex Pharmaceuticals Incorporated (Industry)
Conditions	Immunoglobulin A Nephropathy
Interventions	Povetacicept, Sibeprenlimab (Drug)
Dates	start 2026-10-23 (estimated), primary completion 2027-12-12 (estimated), completion 2028-03-02 (estimated), first posted 2026-10-22, last updated 2026-10-22

-Summary

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).

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+Arms and interventions

Arm	Type	Interventions	Description
Povetacicept	Experimental	Drug: Povetacicept; Drug: Sibeprenlimab	Participants previously receiving Sibeprenlimab will self-administer Povetacicept.

Povetacicept (Drug), also known as ALPN-303: Subcutaneous injection administration.
Sibeprenlimab (Drug): Subcutaneous injection administration.

+Outcome measures

Primary outcomes

Change from Baseline in the Self-Injection Administration Questionnaire (SIAQ) Scores at Week 12 After Transitioning to Povetacicept Injection [Baseline up to Week 12]

Secondary outcomes

Safety and Tolerability as Assessed by Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs) [From Signing of Informed Consent up to Week 24]

+Eligibility

Sex: All, ages: 18 Years to any

Key Inclusion Criteria:

* 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)

Key Exclusion Criteria:

* Use of immunosuppressive or immunomodulatory therapies (except for sibeprenlimab)
* Rapidly progressive glomerulonephritis with eGFR reduction >50% within 12 weeks of the start of screening

Other protocol defined Inclusion/Exclusion criteria may apply.

My Notes

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