ARGX-121 for Berger's Disease

(Verdant Trial)

Not yet recruiting at 2 trial locations
SC
Overseen BySabine Coppieters, MD
Age: 18+
Sex: Any
Trial Phase: Phase 2
Sponsor: argenx
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Are You a Good Fit for This Trial?

This trial is for adults (18+) diagnosed with IgA nephropathy (Berger's Disease) confirmed by a kidney biopsy. Participants must not be pregnant and will continue their usual treatments unless told otherwise by the study doctor.

Inclusion Criteria

I am male or I am female and not pregnant.
I am at least 18 years old.
I have been diagnosed with IgA nephropathy confirmed by a kidney biopsy.

Exclusion Criteria

I have a secondary form of IgA nephropathy with IgA deposits.
I have another autoimmune disease or a condition that affects IgAN assessment.
I have had cancer in the past.
See 2 more

What Are the Treatments Tested in This Trial?

Interventions

  • ARGX-121

Trial Overview

The study compares ARGX-121, a new drug, to a placebo in people with IgA nephropathy. It uses a double-blind design at first, meaning neither patients nor doctors know who gets which treatment, followed by an open-label period where all get ARGX-121.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Placebo Group

Group I: ARGX-121Experimental Treatment1 Intervention
Group II: Placebo followed by ARGX-121Placebo Group2 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

argenx

Lead Sponsor

Trials
76
Recruited
11,500+

Tim Van Hauwermeiren

argenx

Chief Executive Officer since 2008

B.Sc. and M.Sc. in Bioengineering from Ghent University, Executive MBA from The Vlerick School of Management

Dr. Peter Ulrichts

argenx

Chief Medical Officer since 2023

MD from Maastricht University, PhD in Molecular Immunology from Maastricht University