Recruiting PHASE1 Lupus Nephritis (LN)

New treatment option for Lupus Nephritis (LN)

Official title Dose Escalation Study With Bispecific Antibodies in Adult Participants With Lupus Nephritis

ClinicalTrials.gov ID: NCT06975787

What this study is testing

What is Vonsetamig?

Vonsetamig is an investigational medicine, being studied as a potential treatment for lupus nephritis (ln).

Also referred to as REGN5459.

Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.

What it's testing
This study is researching a particular group of experimental drugs administered for a short period in the treatment of participants with Lupus Nephritis (LN). The main aim of the current study is to see how safe and tolerable the study drugs are in a long-term follow-up.
  • Phase 1: an early, usually small safety study

A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.

Who can take part

Ages 18 to 60

You may be able to join if

  • Key General
  • Diagnosis of Systemic Lupus Erythematosus (SLE) and LN, as described in the protocol
  • Participant must have refractory or relapsed disease, as described in the protocol Key General

You likely can't join if

  • History of or active severe or unstable lupus-associated neuropsychiatric disease that is likely to require acute or emergent medical treatment or...
  • Active overlap syndrome with mixed connective tissue disease or systemic sclerosis within 12 months prior to screening or during screening
  • Catastrophic or severe antiphospholipid syndrome within 12 months prior to screening or during screening NOTE: Other protocol defined...

The study team makes the final eligibility decision.

Where it's taking place

  • Rochester, Minnesota, United States
  • Houston, Texas, United States
  • Bordeaux, New Aquitaine, France
  • Regensburg, Bavaria, Germany
  • Mainz, Germany
  • Anyang-si, Gyeonggi-do, South Korea
  • Seoul, South Korea
  • Seville, Andalusia, Spain
  • Pamplona, Navarre, Spain
  • Madrid, Spain
  • Málaga, Spain
  • Changhua, Taiwan
  • Taichung, Taiwan
  • Taipei, Taiwan

Questions & answers

Do participants get paid in this trial?

This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.

Is it free to join, and do I need insurance?

Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.

How long does this study last?

The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.

Who can join this trial?

This study is enrolling all sexes, 18 years to 60 years. The study team makes the final eligibility decision.

Where is this trial taking place?

Study sites include Rochester, Minnesota, United States; Houston, Texas, United States; Bordeaux, New Aquitaine, France; Regensburg, Bavaria, Germany; Mainz, Germany; Anyang-si, Gyeonggi-do, South Korea and 8 more location(s). Enter your location above to see the nearest site and check your eligibility.

Explore other conditions

BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.