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New antibody cocktail takes on tough lupus kidney disease

NCT ID NCT06975787

Disease control Sponsor: Regeneron Pharmaceuticals Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Sep 15, 2026 · Updated 6 times

Summary

This early-stage trial is testing two experimental drugs, vonsetamig and odronextamab, in people with lupus nephritis that has not responded to standard treatments. The main goal is to check safety and side effects over the long term. Researchers will also see if the drugs can help reduce steroid use and improve kidney function.

What this could mean

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

Active substance
bispecific antibodies (vonsetamig and odronextamab)
What this could lead to
If successful, this could point toward a new treatment option for people with hard-to-treat lupus nephritis, potentially reducing the need for steroids.
What could go wrong
This is an early Phase 1 trial with only 90 participants, so safety and effectiveness are not yet proven. The drugs may cause side effects or fail to control the disease.

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 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

About 90 people

The number the study aims to enrol. It can still change while the study runs.

Started

Dec 2025

Expected to finish

Sep 2029

An estimate. End dates often move.

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 to 60 years

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.

Key General Inclusion Criteria: 1. Diagnosis of Systemic Lupus Erythematosus (SLE) and LN, as described in the protocol 2. Participant must have refractory or relapsed disease, as described in the protocol Key General Exclusion Criteria: 1. History of or active severe or unstable lupus-associated neuropsychiatric disease that is likely to require acute or emergent medical treatment or hospitalization 2. Active overlap syndrome with mixed connective tissue disease or systemic sclerosis within 12 months prior to screening or during screening 3. Catastrophic or severe antiphospholipid syndrome within 12 months prior to screening or during screening NOTE: Other protocol defined inclusion/exclusion criteria apply

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Conditions

The condition(s) this trial relates to.

lupus nephritis systemic lupus erythematosus

As listed by the trial registrant

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

Lupus nephritis (LN)

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    19 sites in 6 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Baylor College of Medicine

    RECRUITING

    Houston, Texas, 77030, United States

  • Centre Hospitalier Universitaire (CHU) Bordeaux

    RECRUITING

    Bordeaux, New Aquitaine, 33076, France

  • Changhua Christian Hospital

    RECRUITING

    Changhua, 500, Taiwan

  • Clinica Universidad de Navarra

    RECRUITING

    Pamplona, Navarre, 31008, Spain

  • Hallym University Sacred Heart Hospital

    RECRUITING

    Anyang-si, Gyeonggi-do, 14068, South Korea

  • Hospital Gregorio Maranon

    RECRUITING

    Madrid, 28007, Spain

  • Hospital Regional Universitario de Malaga

    RECRUITING

    Málaga, 290090, Spain

  • Hospital Universitario 12 de Octubre

    RECRUITING

    Madrid, 28041, Spain

  • Hospital Universitario Virgen del Rocio

    RECRUITING

    Seville, Andalusia, 41013, Spain

  • Mayo Clinic

    RECRUITING

    Rochester, Minnesota, 55905, United States

  • National Taiwan University Hospital

    RECRUITING

    Taipei, 106, Taiwan

  • Samsung Medical Center

    RECRUITING

    Seoul, 06351, South Korea

  • Seoul National University Hospital

    RECRUITING

    Seoul, 03080, South Korea

  • Taichung General Veterans Hospital

    RECRUITING

    Taichung, 40705, Taiwan

  • Taipei Veterans General Hospital

    RECRUITING

    Taipei, 112, Taiwan

  • University Hospital Regensburg

    RECRUITING

    Regensburg, Bavaria, D-93053, Germany

  • University Medical Center of the Johannes Gutenberg-University Mainz

    RECRUITING

    Mainz, 55131, Germany

  • University of California San Francisco - Zuckerberg San Francisco General

    RECRUITING

    San Francisco, California, 94110, United States

  • Yonsei University College of Medicine, Severance Hospital

    RECRUITING

    Seoul, 3722, South Korea

More trials for these conditions

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