Dose Escalation Study With Bispecific Antibodies in Adult Patients With Lupus Nephritis
NCT ID: NCT06975787
Last Updated: 2026-01-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1
90 participants
INTERVENTIONAL
2025-12-22
2028-07-23
Brief Summary
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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)
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SEQUENTIAL
TREATMENT
NONE
Study Groups
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Experimental Arm 1: Vonsetamig
Vonsetamig
Administered as per the protocol
Experimental Arm 2: Odronextamab
Odronextamab
Administered as per the protocol
Interventions
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Vonsetamig
Administered as per the protocol
Odronextamab
Administered as per the protocol
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Participant must have refractory or relapsed disease, as described in the protocol
Exclusion Criteria
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
18 Years
60 Years
ALL
No
Sponsors
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Regeneron Pharmaceuticals
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Trial Management
Role: STUDY_DIRECTOR
Regeneron Pharmaceuticals
Locations
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University Medical Center of the Johannes Gutenberg-University Mainz
Mainz, , Germany
Seoul National University Hospital
Seoul, , South Korea
Samsung Medical Center
Seoul, , South Korea
Taipei Veterans General Hospital
Taipei, , Taiwan
Countries
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Central Contacts
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Other Identifiers
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2024-518288-37-00
Identifier Type: CTIS
Identifier Source: secondary_id
R5459-1979-LN-2459
Identifier Type: -
Identifier Source: org_study_id
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