Actively Recruiting

Phase 1
Age: 18Years - 60Years
All Genders
NCT06975787

Dose Escalation Study With Bispecific Antibodies in Adult Patients With Lupus Nephritis

Led by Regeneron Pharmaceuticals · Updated on 2026-04-13

90

Participants Needed

11

Research Sites

134 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

This study is researching a particular group of experimental drugs administered for a short period in the treatment of patients 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. This is a main study, called an umbrella study, which includes several independent smaller sub-studies. Each of these smaller main sub-studies tests different drugs at the same time, all aimed at treating LN. The study is looking at several other research questions, including: * What side effects may happen from taking the study drug * How much study drug is in the blood at different times * Whether the body makes antibodies against the study drug (which could make the drug less effective or could lead to side effects)

CONDITIONS

Official Title

Dose Escalation Study With Bispecific Antibodies in Adult Patients With Lupus Nephritis

Who Can Participate

Age: 18Years - 60Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Diagnosis of Systemic Lupus Erythematosus (SLE) and Lupus Nephritis (LN) as described in the protocol
  • Participant has refractory or relapsed disease as described in the protocol
  • Age between 18 and 60 years
Not Eligible

You will not qualify if you...

  • History of or active severe or unstable lupus-associated neuropsychiatric disease likely requiring acute or emergent medical treatment or hospitalization
  • Active overlap syndrome with mixed connective tissue disease or systemic sclerosis within 12 months prior to or during screening
  • Catastrophic or severe antiphospholipid syndrome within 12 months prior to or during screening

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 11 locations

1

Mayo Clinic

Rochester, Minnesota, United States, 55905

Actively Recruiting

2

Baylor College of Medicine

Houston, Texas, United States, 77030

Actively Recruiting

3

University Medical Center of the Johannes Gutenberg-University Mainz

Mainz, Germany, 55131

Actively Recruiting

4

Hallym University Sacred Heart Hospital

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

Actively Recruiting

5

Seoul National University Hospital

Seoul, South Korea, 03080

Actively Recruiting

6

Samsung Medical Center

Seoul, South Korea, 06351

Actively Recruiting

7

Hospital Regional Universitario de Malaga

Málaga, Spain, 290090

Actively Recruiting

8

Changhua Christian Hospital

Changhua, Taiwan, 500

Actively Recruiting

9

Taichung General Veterans Hospital

Taichung, Taiwan, 40705

Actively Recruiting

10

National Taiwan University Hospital

Taipei, Taiwan, 106

Actively Recruiting

11

Taipei Veterans General Hospital

Taipei, Taiwan, 112

Actively Recruiting

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Research Team

C

Clinical Trials Administrator

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

SEQUENTIAL

Primary Purpose

TREATMENT

Number of Arms

2

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Dose Escalation Study With Bispecific Antibodies in Adult Patients With Lupus Nephritis | DecenTrialz