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NCT Number: NCT07773727

A Study to Evaluate the Effect of ARGX-121 on the Change in Proteinuria in Adult Participants With IgAN

The study will assess how ARGX-121 affects immunoglobulin A nephropathy (IgAN) disease outcomes, such as renal function, how it is distributed and eliminated from the body, and how the immune system responds in adults with IgAN.

While in the study, participants will continue to receive their usual medical care and medications for IgA nephropathy, unless the study doctor confirms otherwise.

The study will include a double blinded period, followed by an active drug period, and conclude with a follow up period. The total study duration for participants will be approximately 72 weeks, with a maximum of 52 weeks on ARGX-121.

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Key information

Conditions

Immunoglobulin A Nephropathy (IgAN) Autoimmune Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Glomerulonephritis Glomerulonephritis, IGA Immune System Diseases Kidney Diseases Male Urogenital Diseases Nephritis Urogenital Diseases Urologic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Males and females (not pregnant)
  • At least 18 years old
  • Clinically diagnosed with IgAN with biopsy confirmation

Exclusion criteria

  • Diagnosis of another autoimmune disease or known medical condition that would interfere with accurate assessment of clinical systems of IgAN
  • Has secondary form of IgAN leading to IgA deposits
  • History of Malignancy
  • Active infection of concern
  • Recent Major surgery or organ transplant

Treatment and study plan

ARGX-121

Biological

Subcutaneous Injection of ARGX-121

Placebo

Biological

Subcutaneous Injection of Placebo

Primary outcomes

  1. Change in proteinuria from baseline to week 24 as measured by the log-transformed urine protein-to-creatinine ratio (UPCR) derived from 24-h urine collection.

    Time frame: Up to 24 weeks

    UPCR is urine protein-to-creatinine ratio

Secondary outcomes

  1. Total annualized rate of change (slope) in the estimated glomerular filtration rate (eGFR) at week 52

    Time frame: 52 weeks

  2. Incidence of Adverse Events (AEs) and Serious Adverse Events (SAEs)

    Time frame: Up to 68 weeks

  3. Cmax (ARGX-121 maximum observed concentration) in serum

    Time frame: Up to 68 weeks

  4. Percentage change in total IgA from baseline over time in serum

    Time frame: Up to 68 weeks

  5. Percentage change in Gd-IgA1 from baseline over time in serum

    Time frame: Up to 68 weeks

    Gd-IgA1 means galactose-deficient immunoglobulin A1

  6. Percentage change in total IgG from baseline over time in serum

    Time frame: Up to 68 weeks

  7. Incidence of antidrug antibodies (ADA) against ARGX-121 in serum

    Time frame: Up to 68 weeks

Study contacts

Contact information is provided by the study sponsor or research team.

Sabine Coppieters, MD

CONTACT

[email protected]

857-350-4834

Sponsors and collaborators

Lead sponsor

argenx

Industry

Registry information

Official study title

A Phase 2, Multicenter, Randomized, Placebo-Controlled Study to Evaluate the Efficacy, Safety, and Tolerability of ARGX-121 SC in Adult Participants With Primary IgA Nephropathy

Acronym: Verdant

Important dates

Study start
2026
Primary completion
2029
Study completion
2030
First posted
Aug 19, 2026
Registry last updated
Aug 19, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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