A Study of Nipocalimab in Adults With Moderate to Severe Systemic Lupus Erythematosus
This research study is investigating a new medication called nipocalimab for adults who have moderate to severe Systemic Lupus Erythematosus (SLE), often just called lupus. Lupus is a long-term condition where your immune system mistakenly attacks healthy parts of your body, causing inflammation and redness in various organs. The main goal of this study is to find out how effective nipocalimab is compared to a placebo (a treatment with no active medicine) in managing lupus symptoms and disease activity. Participants will also continue their standard lupus treatments. It's a Phase 3 study, meaning it's a later stage of research that tests the treatment in a larger group of people to confirm its effectiveness and monitor for side effects.
Em resumo
Sobre o que é este estudo?
This study is investigating a new treatment called nipocalimab for a condition known as Systemic Lupus Erythematosus, or lupus. Lupus is an autoimmune disease, which means your body's immune system, which normally fights off infections, starts attacking your own healthy tissues instead. This can lead to swelling, pain, and damage in various parts of the body, including joints, skin, kidneys, and other organs.
The main purpose of this study is to see if nipocalimab can help people with moderate to severe lupus. Researchers want to compare its effects against a placebo, which is a treatment that looks identical but contains no active medicine. This comparison helps them understand if any improvements seen are due to the new medicine or other factors. All participants will also continue to receive their usual lupus care.
By taking part, you would be helping doctors and scientists better understand lupus and potentially find new ways to manage it. This kind of research is crucial for developing better treatments for chronic conditions like lupus, aiming to improve the quality of life for those affected.
Pontos principais
- New medicine (nipocalimab) for moderate to severe lupus being tested.
- Compares nipocalimab against a dummy treatment (placebo).
- Participants continue their usual lupus care.
- For adults aged 18-75 with an existing lupus diagnosis.
- Involves regular clinic visits for health checks and monitoring.
Quem pode ser elegível?
To join this study, you would need to be an adult between 18 and 75 years old and have a confirmed diagnosis of lupus for at least 24 weeks (about six months) before the study starts. Your lupus symptoms need to be currently active and considered moderate to severe by the study doctors. You should also be generally stable and healthy otherwise, based on a medical check-up, medical history, and heart test (ECG).
There are also certain conditions that would prevent you from taking part. For example, if you have severe, uncontrolled, or rapidly worsening problems with your liver, kidneys, heart, or other major organs, or other serious health issues. You also couldn't join if you have a known problem with your immune system not related to lupus, or a history of severe allergic reactions to medicines similar to nipocalimab or its ingredients. If your lupus is currently unstable and likely needs immediate changes to your usual treatment, you wouldn't be able to participate either.
Este estudo pode ser adequado para você?
Responda a estas perguntas rápidas para ver se você pode ser elegível. Este é apenas um guia — a decisão final é da equipe de pesquisa.
- Você tem entre 18 e 75 anos?
- Have you been diagnosed with lupus for at least 6 months?
- Do you currently have moderate to severe lupus symptoms?
- Are you generally stable and healthy, aside from your lupus?
- Do you NOT have a severe, uncontrolled health problem affecting your liver, heart, or other major organs?
O que envolve a participação?
If you decide to take part in this study, you would receive either the study medicine (nipocalimab) or a placebo, in addition to your current lupus treatments. You would have regular visits to the clinic for medical examinations, blood tests, and to discuss how you're feeling. These visits help the study team monitor your health, how your lupus is responding, and check for any side effects.
The total duration of your participation in the study is not specified in detail here, but these types of studies typically involve multiple study visits over several months to over a year. You would be given a detailed schedule of visits and what to expect at each appointment before you agree to join. All study medicines and care directly related to the research will be provided by the study team.
Riscos e benefícios potenciais
Locations (260)
- David S Hallegua MD A Professional CorporationCódigo postal verificadoBeverly Hills, Estados Unidos· Recrutamento
- Fundação Médica ProvidenceCódigo postal verificadoFullerton, Estados Unidos· Recrutamento
- Southland Arthritis and Osteoporosis Medical Center Inc dba Southland ArthritisCódigo postal verificadoHemet, United States· Recrutamento
- Advanced Medical ResearchCódigo postal verificadoLa Palma, United States· Recrutamento
- Medvin Clinical Research San LeandroCódigo postal verificadoSan Leandro, United States· Recrutamento
- Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical CenterCódigo postal verificadoTorrance, Estados Unidos· Recrutamento
- Solace Clinical Research CaliforniaCódigo postal verificadoTustin, United States· Recrutamento
- Inland Rheumatology Clinical Trials Inc.Código postal verificadoUpland, United States· Recrutamento
- Denver Arthritis ClinicCódigo postal verificadoDenver, Estados Unidos· Recrutamento
- Arthritis & Rheumatic Disease SpecialtiesCódigo postal verificadoAventura, Estados Unidos· Recrutamento
- Clinical Research of West Florida 1Código postal verificadoClearwater, Estados Unidos· Recrutamento
- Avanti Clinical Research CorpCódigo postal verificadoHialeah, Estados Unidos· Recrutamento
Perguntas frequentes
What is lupus (Systemic Lupus Erythematosus)?
Lupus is a long-term condition where your immune system mistakenly attacks healthy parts of your own body, causing inflammation and damage to various organs and tissues.
What is nipocalimab?
Nipocalimab is an experimental medicine being tested in this study to see if it can help manage moderate to severe lupus symptoms.
O que é um placebo?
A placebo is a treatment that looks exactly like the study medicine but doesn't contain any active drug. It helps researchers compare the effects of the active medicine.
Will I still take my regular lupus medicines?
Yes, participants in this study will continue to receive their standard lupus treatments alongside either nipocalimab or the placebo.
Posso sair do estudo se mudar de ideia?
Yes, you are free to withdraw from the study at any time, for any reason, and this will not affect your usual medical care.
Como saber mais
Contato para Estudo
Sempre consulte seu médico ou especialista antes de decidir participar de um estudo.
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Discussão
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Desenvolvido pelo nosso fórum em community.patient.info. Por favor, seja respeitoso — isto não é um conselho médico.