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.
Överblick
Vad handlar denna studie om?
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.
Viktiga punkter
- 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.
Vem kan vara berättigad?
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.
Kan denna studie passa dig?
Svara på dessa snabba frågor för att se om du kan vara berättigad. Detta är endast en vägledning — forskarteamet fattar det slutgiltiga beslutet.
- Är du mellan 18 och 75 år gammal?
- 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?
Vad innebär deltagande?
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.
Potentiella risker och fördelar
Locations (260)
- David S Hallegua MD A Professional CorporationVerifierat postnummerBeverly Hills, USA· Rekrytering
- Providence Medical FoundationVerifierat postnummerFullerton, USA· Rekrytering
- Southland Arthritis and Osteoporosis Medical Center Inc dba Southland ArthritisVerifierat postnummerHemet, United States· Rekrytering
- Advanced Medical ResearchVerifierat postnummerLa Palma, United States· Rekrytering
- Medvin Clinical Research San LeandroVerifierat postnummerSan Leandro, United States· Rekrytering
- Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical CenterVerifierat postnummerTorrance, USA· Rekrytering
- Solace Clinical Research CaliforniaVerifierat postnummerTustin, USA· Rekrytering
- Inland Rheumatology Clinical Trials Inc.Verifierat postnummerUpland, USA· Rekrytering
- Denver Arthritis ClinicVerifierat postnummerDenver, USA· Rekrytering
- Arthritis & Rheumatic Disease SpecialtiesVerifierat postnummerAventura, USA· Rekrytering
- Clinical Research of West Florida 1Verifierat postnummerClearwater, USA· Rekrytering
- Avanti Clinical Research CorpVerifierat postnummerHialeah, USA· Rekrytering
Vanliga frågor
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.
Vad är nipocalimab?
Nipocalimab is an experimental medicine being tested in this study to see if it can help manage moderate to severe lupus symptoms.
Vad är en 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.
Kan jag lämna studien om jag ändrar mig?
Yes, you are free to withdraw from the study at any time, for any reason, and this will not affect your usual medical care.
Hur du får reda på mer
Studiekontakt
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Diskussion
Gemenskapsdiskussion
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