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New treatment option for Lupus Erythematosus, Systemic
Official title A Study of Nipocalimab in Adults With Moderate to Severe Systemic Lupus Erythematosus
ClinicalTrials.gov ID: NCT07438496
What this study is testing
What is Nipocalimab?
Nipocalimab is an investigational medicine, being studied as a potential treatment for lupus erythematosus, systemic.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The purpose of this study is to evaluate how well nipocalimab works as compared to placebo in participants with moderate to severe Systemic lupus erythematosus (SLE, a long-term disease where the immune system mistakenly attacks its own healthy tissues, causing swelling and redness in various organs).
- Phase 3: a large, late-stage study
- You might receive a placebo (an inactive treatment) instead of the study drug.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- Medically stable on the basis of physical examination, medical history, vital signs and 12-lead electrocardiogram (ECG) performed at screening
- Clinical diagnosis of systemic lupus erythematosus (SLE) for more than or equal to (\>=) 24 weeks prior to screening and meeting european league...
- Must have a systemic lupus erythematosus disease activity index 2000 (SLEDAI-2K) score \>= 6 and a clinical SLEDAI-2K \>= 4 at screening, AND a...
- Participants of childbearing potential must have a negative serum beta human chorionic gonadotropin (β-hCG) test at screening and a negative urine...
- Has at least 1 BILAG-2004 A score or 2 BILAG-2004 B scores observed at screening
You likely can't join if
- History of severe, progressive and/or uncontrolled hepatic, gastrointestinal, renal, pulmonary, cardiovascular, psychiatric, neurological or...
- Any unstable or progressive manifestation of SLE that is likely to warrant escalation in therapy beyond permitted background medications
- Confirmed or suspected clinical immunodeficiency syndrome not related to treatment of SLE or has a family history of congenital or hereditary...
- Has shown a previous severe immediate hypersensitivity reaction, such as anaphylaxis, to therapeutic proteins
- Suspected or known allergies, hypersensitivity, or intolerance to nipocalimab or its excipients, or excipients used in the placebo formulation
The study team makes the final eligibility decision.
Where it's taking place
- Beverly Hills, California, United States
- Fullerton, California, United States
- Hemet, California, United States
- La Palma, California, United States
- Torrance, California, United States
- Tustin, California, United States
- Upland, California, United States
- Aventura, Florida, United States
- Clearwater, Florida, United States
- Hialeah, Florida, United States
- Miami, Florida, United States
- Miami Gardens, Florida, United States
- Miami Lakes, Florida, United States
- Plantation, Florida, United States
- Tampa, Florida, United States
- Marietta, Georgia, United States
- Willowbrook, Illinois, United States
- Lake Charles, Louisiana, United States
- Sterling Heights, Michigan, United States
- Voorhees Township, New Jersey, United States
+ 174 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Beverly Hills, California, United States; Fullerton, California, United States; Hemet, California, United States; La Palma, California, United States; Torrance, California, United States; Tustin, California, United States and 188 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.