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

Официальное название

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

Обзор

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)

Вмешательства

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

Первичные конечные точки

• Occurrence of Dose Limiting Toxicities (DLT) [Срок оценки: Up to 56 days]
• Occurrence of Treatment Emergent Adverse Events (TEAEs) [Срок оценки: Through week 76]
• Severity of TEAEs [Срок оценки: Through week 76]

Вторичные конечные точки (12)

• Proportion of participants no longer receiving a corticosteroid [Срок оценки: At 6 months]
• Cumulative total exposure to corticosteroids [Срок оценки: At 76 weeks]
• Absolute values of urine Protein-Creatinine Ratio (uPCR) [Срок оценки: Through week 76]
• Percent change from baseline of uPCR [Срок оценки: Through week 76]
• Absolute values of estimated Glomerular Filtration Rate (eGFR) serum creatinine [Срок оценки: Through week 76]
• Percent change from baseline of eGFR serum creatinine [Срок оценки: Through week 76]
• Absolute values of blood B-cell counts and other immune cell populations [Срок оценки: Through week 76]
• Change from baseline of blood B-cell counts and other immune cell populations [Срок оценки: Through week 76]
• Absolute values of double-stranded DNA (dsDNA) antibodies [Срок оценки: Through week 76]
• Percent change from baseline of dsDNA antibodies [Срок оценки: Through week 76]
• Absolute values of anti-Smith antibodies [Срок оценки: Through week 76]
• Percent change from baseline of anti-Smith antibodies [Срок оценки: Through week 76]

Критерии участия

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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Нерандомизированное

Модель

Последовательный дизайн

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Испания · 5 центров

• 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 центра

• Hallym University Sacred Heart Hospital — Anyang-si
• Seoul National University Hospital — Seoul
• Samsung Medical Center — Seoul
• Yonsei University College of Medicine, Severance Hospital — Seoul

Тайвань · 4 центра

• Changhua Christian Hospital — Changhua
• Taichung General Veterans Hospital — Taichung
• National Taiwan University Hospital — Taipei
• Taipei Veterans General Hospital — Taipei

США · 2 центра

• Mayo Clinic — Rochester
• Baylor College of Medicine — Houston

Германия · 2 центра

• University Hospital Regensburg — Regensburg
• University Medical Center of the Johannes Gutenberg-University Mainz — Mainz

Франция · 1 центр

• Centre Hospitalier Universitaire (CHU) Bordeaux — Bordeaux

Идентификаторы

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

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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