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

NCT07807995 | Not Yet Recruiting Phase 3 FDA Drug

• 3 other identifiers: VX25-AIS-1022025-525064-14-002025
• Study Type: interventional
• Target: 605
• Locations: 0 countries
• Sites: N/A

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).

Conditions

Immunoglobulin A Nephropathy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• 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

Study Arms (1)

Povetacicept

EXPERIMENTAL

Participants will receive Povetacicept every 4 weeks (Q4W) for 104 weeks.

Drug: Povetacicept

Interventions

Povetacicept DRUG

Subcutaneous injection administration.

Also known as: ALPN-303

Povetacicept

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• \- Planned participation in another interventional, therapeutic clinical trial (other than the parent study).

Sponsors & Collaborators

• Vertex Pharmaceuticals Incorporated: lead

MeSH Terms

Conditions

Glomerulonephritis, IGA

Condition Hierarchy (Ancestors)

Glomerulonephritis; Nephritis; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Autoimmune Diseases; Immune System Diseases

Central Study Contacts

Medical Information

CONTACT

617-341-6777; medicalinfo@vrtx.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 20, 2026
• First Posted: September 8, 2026
• Study Start: September 18, 2026
• Primary Completion (Estimated): December 28, 2029
• Study Completion (Estimated): December 28, 2029
• Last Updated: September 8, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share