Recruiting
Phase 2

ARGX-121

Sponsor:

argenx

Code:

NCT07773727

Conditions

Immunoglobulin A Nephropathy (IgAN)

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

ARGX-121

Placebo

Study Details

Brief summary:

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.

Conditions

Immunoglobulin A Nephropathy (IgAN)

Study ID

NCT07773727

Start date

Nov 5, 2026

Status verified date

Oct, 2026

Completion date

Feb 18, 2030

Anticipated

Primary completion date

Oct 29, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

120 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: ARGX-121

Participants will receive ARGX-121 in subcutaneous injections during the double blinded treatment period and active only treatment periods (Total of 52 weeks)

placebo comparator: Placebo followed by ARGX-121

Participants receive placebo for the double-blinded period of 24 weeks, followed by subcutaneous injections of ARGX-121 during the active only treatment period of 28 weeks.

Interventions

ARGX-121

Subcutaneous Injection of ARGX-121

Placebo

Subcutaneous Injection of Placebo

Primary outcome measure

  • 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 ]

Central Contacts and Locations

Central contacts

Sabine Coppieters, MD

857-350-4834Clinicaltrials@argenx.com

Locations

Amicis Research Center - Valencia

Recruiting

Valencia, California, United States, 91355

Contacts

857-350-4834clinicaltrials@argenx.com

Principal Investigator:

Billy Hour, MD

Bioresearch Partners

Recruiting

Miami, Florida, United States, 33127

Contacts

+1 857-350-4834clinicaltrials@argenx.com

Principal Investigator:

Jose Miguel Cardona-Guzman, MD

Nephrology Associates of South Miami PA

Recruiting

Miami, Florida, United States, 33173-3456

Contacts

+1 857-350-4834clinicaltrials@argenx.com

Principal Investigator:

Fernando Trespalacios, MD

BioResearch Partner - Pembroke Pines

Recruiting

Pembroke Pines, Florida, United States, 33029

Contacts

857-350-4834clinicaltrials@argenx.com

Principal Investigator:

Max Benjamin, MD

Michigan Kidney Consultants

Recruiting

Pontiac, Michigan, United States, 48341

Contacts

+1 857-350-4834clinicaltrials@argenx.com

Principal Investigator:

Fahd Al-Saghir, MD

Prolato Clinical Research Center

Recruiting

Houston, Texas, United States, 77054

Contacts

857-350-4834clinicaltrials@argenx.com

Principal Investigator:

Biruh Workeneh, MD

Utah Kidney Research Institute

Recruiting

Salt Lake City, Utah, United States, 84115

Contacts

857-350-4834clinicaltrials@argenx.com

Principal Investigator:

Sanjiv Anand, MD, MS

Kidney and Hypertension Specialists- Virginia

Recruiting

Manassas, Virginia, United States, 20110

Contacts

+1 857-350-4834clinicaltrials@argenx.com

Principal Investigator:

Rashida Rahman, MD

More Information

Sponsor

argenx

Last update posted

Oct 27, 2026

Last verified

Oct, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-28. This information was provided to ClinicalTrials.gov by argenx on 2026-10-27. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.