Health TrialsbyHealthPanel

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

ConditionLupus Nephritis (LN)
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-60
SponsorRegeneron Pharmaceuticals

About this trial

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)

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Sequential

Treatments tested in this trial

  • Vonsetamig

    Drug

    Administered as per the protocol

  • Odronextamab

    Drug

    Administered as per the protocol

Treatment groups

90 Participants
are divided into 2 treatment groups
Group A: Experimental Arm 1: VonsetamigExperimental treatment 1 intervention
Group B: Experimental Arm 2: OdronextamabExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Occurrence of Dose Limiting Toxicities (DLT)

Time frame
Up to 56 days
2

Occurrence of Treatment Emergent Adverse Events (TEAEs)

Time frame
Through week 76
3

Severity of TEAEs

Time frame
Through week 76

Secondary outcomes

1

Proportion of participants no longer receiving a corticosteroid

Time frame
At 6 months
2

Cumulative total exposure to corticosteroids

Time frame
At 76 weeks
3

Absolute values of urine Protein-Creatinine Ratio (uPCR)

Time frame
Through week 76
4

Percent change from baseline of uPCR

Time frame
Through week 76

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Regeneron Pharmaceuticals

Lead sponsor

Source ClinicalTrials.gov
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