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RecruitingPhase 1

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

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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years to 60 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests several experimental drugs in adults with lupus nephritis, a kidney disease caused by lupus. Each smaller study tests a different drug given for a short time. The main goal is to check safety and how well people handle the drugs over long-term follow-up.

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)

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Have systemic lupus erythematosus (SLE), also called lupus, and lupus nephritis.
  • Have disease that has not responded to treatment or has come back.

Who can't join

  • Have or have had severe or unstable brain or mental health problems caused by lupus that are likely to need urgent care or a hospital stay.
  • Have active lupus along with mixed connective tissue disease or systemic sclerosis during screening or in the 12 months before it. These diseases affect tissues that support the body; systemic sclerosis can also harden skin.
  • Have severe or life-threatening antiphospholipid syndrome during screening or in the 12 months before it. This condition can cause harmful blood clots.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

Key General Inclusion Criteria: 1. Diagnosis of Systemic Lupus Erythematosus (SLE) and LN, as described in the protocol 2. Participant must have refractory or relapsed disease, as described in the protocol Key General Exclusion Criteria: 1. History of or active severe or unstable lupus-associated neuropsychiatric disease that is likely to require acute or emergent medical treatment or hospitalization 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 NOTE: Other protocol defined inclusion/exclusion criteria apply

Study sites (3)

CA

MN

TX