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Recruiting NCT06975787

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

Phase I Interventional Lupus Nephritis (LN)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Vonsetamig, Odronextamab.
Who it may be relevant to
Registry conditions: Lupus Nephritis (LN). Basic parameters: 18 years — 60 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States, France, Germany, South Korea, Spain +1
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

A Dose Escalation Study Investigating Bispecific Antibody Therapy in Patients With Lupus Nephritis

Overview

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. 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)

Interventions

  • Drug Vonsetamig
    Administered as per the protocol
  • Drug Odronextamab
    Administered as per the protocol

Primary outcome measures

  • Occurrence of Dose Limiting Toxicities (DLT) [Time frame: Up to 56 days]
  • Occurrence of Treatment Emergent Adverse Events (TEAEs) [Time frame: Through week 76]
  • Severity of TEAEs [Time frame: Through week 76]
Secondary outcome measures (12)
  • Proportion of participants no longer receiving a corticosteroid [Time frame: At 6 months]
  • Cumulative total exposure to corticosteroids [Time frame: At 76 weeks]
  • Absolute values of urine Protein-Creatinine Ratio (uPCR) [Time frame: Through week 76]
  • Percent change from baseline of uPCR [Time frame: Through week 76]
  • Absolute values of estimated Glomerular Filtration Rate (eGFR) serum creatinine [Time frame: Through week 76]
  • Percent change from baseline of eGFR serum creatinine [Time frame: Through week 76]
  • Absolute values of blood B-cell counts and other immune cell populations [Time frame: Through week 76]
  • Change from baseline of blood B-cell counts and other immune cell populations [Time frame: Through week 76]
  • Absolute values of double-stranded DNA (dsDNA) antibodies [Time frame: Through week 76]
  • Percent change from baseline of dsDNA antibodies [Time frame: Through week 76]
  • Absolute values of anti-Smith antibodies [Time frame: Through week 76]
  • Percent change from baseline of anti-Smith antibodies [Time frame: Through week 76]

Eligibility criteria

Key General Inclusion Criteria:

  • 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 Exclusion Criteria:

  • History of or active severe or unstable lupus-associated neuropsychiatric disease that is likely to require acute or emergent medical treatment or hospitalization
  • 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 inclusion/exclusion criteria apply

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Non-randomized
Model
Sequential
Masking
Open label
Primary purpose
Treatment

Study locations

Spain · 5 centers
  • Hospital Universitario Virgen del Rocio — Seville
  • Clinica Universidad de Navarra — Pamplona
  • Hospital Gregorio Maranon — Madrid
  • Hospital Universitario 12 de Octubre — Madrid
  • Hospital Regional Universitario de Malaga — Málaga
South Korea · 4 centers
  • Hallym University Sacred Heart Hospital — Anyang-si
  • Seoul National University Hospital — Seoul
  • Samsung Medical Center — Seoul
  • Yonsei University College of Medicine, Severance Hospital — Seoul
Taiwan · 4 centers
  • Changhua Christian Hospital — Changhua
  • Taichung General Veterans Hospital — Taichung
  • National Taiwan University Hospital — Taipei
  • Taipei Veterans General Hospital — Taipei
United States · 2 centers
  • Mayo Clinic — Rochester
  • Baylor College of Medicine — Houston
Germany · 2 centers
  • University Hospital Regensburg — Regensburg
  • University Medical Center of the Johannes Gutenberg-University Mainz — Mainz
France · 1 center
  • Centre Hospitalier Universitaire (CHU) Bordeaux — Bordeaux

Identifiers

NCT: NCT06975787 · R5459-1979-LN-2459 · 2024-518288-37-00

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗