Evaluation of Efficacy of Povetacicept in Adults With Immunoglobulin A Nephropathy (IgAN)

Alpine Immune Sciences Inc, A Subsidiary of Vertex

Status and phase: Enrolling; Phase 3

Conditions: Immunoglobulin A Nephropathy

Treatments: Drug: Placebo (matched to Povetacicept); Drug: Povetacicept

Study type: Interventional

Funder types: Industry

Identifiers

NCT06564142

VX24-AIS-D08

Details and patient eligibility

About

The purpose of this study is to evaluate the efficacy of povetacicept in adult participants compared with placebo in reducing proteinuria and preserving renal function.

Enrollment: 480 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Key Inclusion Criteria:

• Diagnosed IgAN, with biopsy confirmation within 10 years of screening
• 24-hr proteinuria excretion ≥1.0 g/day or 24-hour uPCR ≥0.75 g/g
• Estimated glomerular filtration rate (eGFR) ≥ 30 mL/min/1.73m^2
• Stable angiotensin converting enzyme inhibitor (ACEi) or angiotensin II receptor blocker (ARBs) as per protocol specification

Key Exclusion Criteria:

• Have received any immunosuppressive treatment or procedures (including corticosteroids, oral immunosuppressive agents, B cell or plasma cell targeted therapies, complement targeted therapies, herbal medicines per protocol, and tonsillectomy) within a wash-out period per protocol
• Rapidly progressive glomerulonephritis with eGFR reduction >50% within 12 weeks of the start of screening

Other protocol defined Inclusion/Exclusion criteria may apply.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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480 participants in 2 patient groups, including a placebo group

Povetacicept

Experimental group

Description:

Participants will be randomized to receive Povetacicept.

Treatment:

Drug: Povetacicept

Placebo

Placebo Comparator group

Description:

Participants will be randomized to receive placebo matched to Povetacicept.

Treatment:

Drug: Placebo (matched to Povetacicept)