A Phase 3, Randomized, Double-blind, Placebo-controlled, Multicenter Study of Nipocalimab in Adults with Moderate to Severe Systemic Lupus Erythematosus
Study Title:
A Phase 3, Randomized, Double-blind, Placebo-controlled, Multicenter Study of Nipocalimab in Adults with Moderate to Severe Systemic Lupus Erythematosus
Sponsor Name:
Johnson & Johnson
Purpose of Study:
The purpose of this study is to evaluate how the investigational medication, nipocalimab, works 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 inflammation and potentially damaging various organs. The safety and efficacy of the investigational medication have not been established.
What Does this Study Involve? Is there compensation/reimbursement and/or support?
Participants will be randomly assigned to receive either the investigational medication or a placebo (a substance that looks like the investigational medication, but contains no active ingredients), both of which are given as a subcutaneous (under the skin) injection. The investigational medicine will be taken along with standard of care treatment.
The main part of the study lasts about 1 year, with an option for a 2-year extension study. During the extension study, all participants will receive the investigational medication, even those who receive placebo during the main study.
Taking part in studies that include a placebo group helps researchers accurately measure the effects of investigational medications. By participating, individuals may contribute valuable information that could help improve understanding of lupus care.
If you choose to take part in this study, all study-required visits, tests, and medication (investigational medication or placebo) will be provided at no cost to you. You will be closely monitored by the study doctor and study team. Reimbursement for study-required travel may also be provided.
You may participate in the study if you are:
- 18 to 75 years old
- Have been diagnosed with lupus for at least 24 weeks
- Are currently taking medication to treat lupus
There are other criteria you will need to meet to qualify, which the study staff will discuss with you prior to being enrolled. Not everyone may qualify to participate in this clinical research study.
Study Type:
A Phase 3, Randomized, Double-blind, Placebo-controlled, Multicenter Study
Learn More
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. If you are a person living with lupus and you want to learn more about clinical trials and other research opportunities that may be right for you, sign up for the Lupus Foundation of America’s Research Accelerated by You (RAY®).
Already part of RAY? To stay connected, reactivate your account today at ray.lupus.org. Sign in with the email linked to your RAY account, update your password, verify your email, and review your profile and consent form.
Need help? We're here at RAYcoordinator@lupus.org.