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Could efgartigimod tame lupus nephritis? early trial hints at hope

NCT ID NCT05810948

Disease control Sponsor: argenx Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This phase 2 study tested the drug efgartigimod in 73 Chinese patients with active lupus nephritis, a serious kidney complication of lupus. Participants received either the drug or a placebo by IV infusion over 24 weeks. The main goal was to see if the drug could reduce protein in the urine, a sign of kidney damage.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
efgartigimod (a drug given by IV infusion that targets the immune system)
What this could lead to
If it works, this could point toward a new treatment option for lupus nephritis, potentially helping control kidney inflammation and reduce protein in urine.
What could go wrong
This is an early proof-of-concept study with only 73 participants, so results may not be conclusive. The drug may not show clear benefit over placebo, and side effects are possible.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

73 people

The number who actually took part.

Started

Feb 2023

Finished

Sep 2025

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Aged ≥18 years when signing the informed consent form (ICF) * Capable of providing signed informed consent, and complying with protocol requirements * Diagnosis of SLE according to the Systemic Lupus Erythematosus International Collaborating Clinic (SLICC) 2012 classification criteria * Active, proliferative LN Class III or IV \[excluding Class III (C), IV-S (C), and IV-G (C)\], either with or without the presence of Class V using the 2003 International Society of Nephrology (ISN)/Renal Pathology Society (RPS) criteria, proven by kidney biopsy within 6 months before randomization and confirmed by the central biopsy reading group * Require LN induction therapy (glucocorticoids and MMF/MPA) based on investigator's clinical judgment. Induction therapy may begin before screening but should be initiated within 60 days before randomization * Agree to use contraceptives consistent with local regulations. Full inclusion criteria can be found in the protocol Exclusion Criteria: * Active or chronic infection requiring treatment * Any evidence of central nervous system lupus (including but not limited to seizures, psychosis, organic brain syndrome, cerebrovascular accident, cerebritis, or CNS vasculitis) * Currently on renal dialysis or expected to require dialysis during study period * Previous kidney transplantation or planned transplantation during study period * History of malignancy unless deemed cured by adequate treatment with no evidence of recurrence for ≥3 years before randomization. The following cancers are not exclusionary: basal cell or squamous cell skin cancer; carcinoma in situ of the cervix; carcinoma in situ of the breast; incidental histological finding of prostate cancer * Heart failure due to Systemic Lupus Erythematodes, or any other severe cardiovascular involvement with safety concerns according to investigator's judgment * Any other known autoimmune disease that would interfere with an accurate assessment of clinical symptoms of SLE/LN or put the participant at undue risk * Previously failed treatment with MMF or any form of mycophenolate-based induction therapy, based on the investigator's opinion * Use of complementary therapies, including Traditional Chinese Medicine, herbs, or procedure (eg, acupuncture) that can potentially interfere with the efficacy and safety of participants as assessed by the investigator * SARS-CoV-2 antigen-based positive test at screening. The test is required regardless of whether the participant has been vaccinated * Known hypersensitivity or contraindication to efgartigimod, any excipient of the IMP, or SoC medication used in the study * In the opinion of the investigator, current or history of (ie, within 12 months of randomization) alcohol, drug, or medication abuse * Pregnant or lactating females and those who intend to become pregnant during study participation * Any conditions or circumstances that in the opinion of the investigator may make the participant unsuitable for the study The full list of criteria can be found in the protocol.

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Conditions

The condition(s) this trial relates to.

glomerulonephritis kidney disorder lupus nephritis nephritis urinary system disorder

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Lupus nephritis

Contacts and locations

Locations

  • Affiliated Hospital of Jining Medical University

    Jining, China

  • First Affiliated Hospital of University of South China

    Hengyang, China

  • Fujian Medical University Union Hospital

    Fujian, China

  • Guangdong Provincial People's Hospital

    Guangzhou, China

  • Henan Provincial People's Hospital

    Zhengzhou, China

  • Huashan Hospital Fudan University

    Shanghai, China

  • Hunan Provincial People's Hospital

    Changsha, China

  • Jiangsu Province Hospital

    Nanjing, China

  • Jiangxi Provincial People's Hospital

    Nanchang, 330006, China

  • Jieyang People's Hospital

    Jieyang, 522091, China

  • Liu Zhou Works Hospital

    Liuzhou, China

  • Peking University People's Hospital

    Beijing, China

  • Peking University Third Hospital

    Beijing, 100191, China

  • Renmin Hospital of Wuhan University

    Wuhan, China

  • Shaanxi Provincial Hospital of Chinese Medicine

    Xi'an, China

  • Shandong Provincial Hospital Affiliated to Shandong First Medical University

    Jinan, China

  • ShengJing Hospital of China Medical University

    Shenyang, China

  • Shenzhen People's Hospital

    Shenzhen, China

  • Sun Yat-sen Memorial Hospital, Sun Yat-sen University

    Guangzhou, China

  • The Affiliated Huaian No.1 People's Hospital of Nanjing Medical University

    Huainan, China

  • The First Affiliated Hospital of Nanchang University

    Nanchang, China

  • The First Affiliated Hospital of Xiamen University

    Xiamen, China

  • The First Affiliated Hospital of Zhengzhou University

    Zhengzhou, 310058, China

  • The First Affiliated Hospital, Zhejiang University

    Hangzhou, China

  • The First Affiliated Hospital,Sun Yat-sen University

    Guanzhou, China

  • The First Hospital of Hebei Medical University

    Shijia Zhuang, China

  • The People's Hospital of Guangxi Zhuang Autonomous Region

    Nanning, China

  • The Second Affiliated Hospital of Chongqing Medical University

    Chongqing, China

  • The Second Hospital of Tianjin Medical University

    Tianjin, China

  • Wuxi People's Hospital

    Wuxi, China

  • Zhongda Hospital Southeast University

    Nanjing, China

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