A Phase 3 Open-Label Study of Long-term Treatment With Povetacicept in Adults With Immunoglobulin A Nephropathy

A Phase 3, Single-Arm, Open-Label Extension Study Evaluating the Long-Term Safety and Efficacy of Povetacicept in Adults With Immunoglobulin A Nephropathy

Status

Not yet recruiting

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT07807995

Enrollment

605

Registered

2026-09-08

Start date

2026-09-18

Completion date

2029-12-28

Last updated

2026-09-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Immunoglobulin A Nephropathy

Brief summary

The purpose of this study is to evaluate the long-term safety, tolerability and efficacy of povetacicept in participants with immunoglobulin A nephropathy (IgAN).

Interventions

DRUGPovetacicept

Subcutaneous injection administration.

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

Key Inclusion Criteria: * Completed the Week 104 visit in the parent study VX24-AIS-D08 (NCT06564142) and has not permanently discontinued study drug * Estimated glomerular filtration rate (eGFR) greater than or equal to (≥) 15 milliliters per minute (mL/min)/1.73 square meter (m\^2) within 45 days of Day 1 of this study Key

Exclusion criteria

\- Planned participation in another interventional, therapeutic clinical trial (other than the parent study). Other protocol defined Inclusion/

Design outcomes

Primary

Measure	Time frame
Safety and Tolerability as Assessed by Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs)	From Day 1 up to Week 112

Secondary

Measure	Time frame	Description
Percentage Change From Baseline in 24-hour Urine Protein to Creatinine Ratio (uPCR)	From Baseline through Week 104	—
Total Estimated Glomerular Filtration Rate (eGFR) Slope	From Baseline through Week 104	—
Change from Baseline in Galactose-deficient immunoglobulin A1 (Gd-IgA1)	From Baseline through Week 104	—
Percent Change from Baseline in Galactose-deficient immunoglobulin A1 (Gd-IgA1)	From Baseline through Week 104	—
Proportion of Participants Achieving Clinical Remission	From Baseline through Week 104	Clinical remission is defined as UPCR less than (\<)0.5 grams per gram (g/g), absence of hematuria, and eGFR decrease \<25 percentage (%) from baseline.
Proportion of Participants to Achieve Hematuria Resolution	From Baseline through Week 104	—
Time to Kidney Disease Progression	From Baseline through Week 104	Kidney disease progression is defined as greater than or equal to (≥) 30% decline in eGFR, end stage kidney disease, or non-accidental death

Contacts

CONTACTMedical Information

medicalinfo@vrtx.com617-341-6777

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Sep 9, 2026