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Sponsor Name:

Merck

Purpose of Study

The REGINA SLE clinical trial is testing an investigational study drug to see if it may safely and effectively reduce symptoms of moderate to severe systemic lupus erythematosus in adults.

What Does this Study Involve? 

• Participants will continue their existing lupus medication during the research study.
• The investigational study drug will be compared to a placebo. A placebo looks like a study drug, but has no active ingredients. The investigational study drug or a placebo will be given as an injection (shot) under the skin every 2 weeks.
• The study has 4 parts and will last a little over 2 years.
  • During the Screening Period, participants will have medical tests to see if they qualify for the research study. This phase will last up to 6 weeks. Participants will visit the study site once. 
  • For those who qualify to be in the study, the next step is the Study Treatment Period. Participants will receive the investigational study drug or a placebo. There will be 18 study site visits, which may include tests, and 2 phone calls.
  • The Extension Period will last 52 weeks. Everyone in this phase will receive the investigational drug. There will be 7 study site visits and 1 phone call.
  • The Follow-Up Period will last about 4 weeks after the last injection of the investigational study drug.
• Participants will receive a follow-up phone call from the study team.
• Tests include, but are not limited to, the following: questionnaires about your health and quality of life, photography of your face and body, physical exams, electrocardiograms (ECGs, which check your heart function), chest X-rays, and blood and urine tests.
• The investigational study medicine and all study-related tests are provided at no cost.

Participants who are still having lupus symptoms even with current medication may be eligible.

You may participate in the study if you are:

• Are 18 to 75 years 
• Have been diagnosed with lupus for at least 6 months
• Have moderate to severe lupus symptoms 
• Are taking at least 1 medication for lupus

There are more requirements to participate in this research study. The study doctor will talk with you about all the requirements. 

Study Type:

• Interventional Research Study
• Phase 2A

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 or a caregiver and you want to learn more about clinical trials and other research opportunities that may be right for you or your family member living with lupus, sign up for the Lupus Foundation of America’s Research Accelerated by You (RAY®) online patient and caregiver registry, if you have not already done so. Compensation is available.