Have you been diagnosed with SLE (lupus)?
The REGINA SLE Clinical Trial is evaluating an investigational medication in people with lupus to see whether it is safe and effective compared to a placebo.
What is the REGINA Study?
The REGINA Study is testing an investigational study drug to see if it may safely and effectively reduce symptoms of moderate to severe lupus in adults. If you are still having lupus symptoms even with your current medication, you may be eligible. You will also continue your 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. If you qualify and decide to take part, you will be in this research study for about 2 years. There will be up to 25 visits to the study site along with 3 phone calls.
Researchers want to learn:
- About the safety of the investigational study drug and any side effect
- If the investigational study drug may work compared to a placebo
NATIONAL TRIAL REFERENCE NUMBER
NCT06161116
When speaking to your doctor or clinical trial representative, please have the trial reference number available.
How to Qualify
You may be able to take part in this research study if you:
- Are aged 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.
If you qualify and decide to participate:
- You will receive the investigational study drug and all study-related medical tests at no cost
- Your lupus and overall health will be closely monitored by a study doctor
- You may be eligible to be reimbursed for study-related travel costs
- You may help researchers learn more about lupus and the investigational study drug
Participation in the research study is voluntary, and you are free to leave the research study at any time. Your privacy will be maintained throughout the research study.
Will I Receive the Investigational Study Drug?
During the treatment period, study participants will be randomly placed (assigned by chance) into 1 of 3 groups. You will have an equal chance of being placed in any of these groups.
- 2 groups will get the investigational study drug
- 1 group will get a placebo. A placebo looks like the study drug but has no active ingredients
During the extension period, all participants will receive the investigational study drug.
What Will Happen During the Research Study?
The research study has 4 parts: screening, treatment, extension, and follow-up.
Screening
(up to 6 weeks)
You will have medical tests to see if you qualify for the research study. You will visit the study site once.
Study Treatment Period
(52 weeks)
You will receive the investigational study drug or a placebo. There will be 18 visits and 2 phone calls.
Extension
(52 weeks)
Everyone will receive the investigational study drug. There will be 7 visits and 1 phone call.
Follow-up
(about 4 weeks after the last injection of investigational study drug)
You will receive a follow-up phone call from the study team.
Study Tests
During the research study, you will undergo different tests to evaluate your lupus and overall health. You will not have every test on every visit.
Tests include, but are not limited to:
- 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
- Blood and urine tests
About Lupus
Lupus is an autoimmune disease. The immune system attacks its own tissues, leading to tissue damage and inflammation. Lupus can impact the skin, joints, kidneys, lungs, blood vessels, and brain.1
Common symptoms include2:
- Fatigue
- Joint pain/swelling
- A “butterfly” rash on the face
- Hair loss
Other symptoms may include sensitivity to the sun, mouth sores, kidney problems, heart problems, and lung problems.1 The appearance of symptoms and diagnosis typically occur between the ages of 15 and 44.3 Although there is no cure for lupus, treatments and lifestyle changes may improve symptoms.1
Trial Locations
Locations shown may have changed in some cases. Please call the number listed in the location results to confirm the nearest study site. Talk with a study site member for more information.
Frequently Asked Questions
About the REGINA Study
The REGINA Study is being conducted to evaluate whether an investigational study drug may help safely and effectively reduce the symptoms of moderate to severe lupus in adults.
There are requirements that must be met in order to take part in this study. The trial doctor or staff will discuss them with you. Before you agree to participate, the study team will review all aspects of the research study with you. If you decide to take part, you will be given a document called an Informed Consent Form that provides, in writing, the research study’s purpose, assessments, procedures, potential benefits and risks, and precautions. You will have the opportunity to ask questions and decide if participating is right for you.
A placebo looks like the investigational study drug but does not contain any active medication. In the first part of this research study, you will be randomly placed (assigned by chance) into 1 of 3 groups. You will have a:
- 2 in 3 chance (67%) of receiving the investigational study drug
- 1 in 3 chance (33%) of receiving the placebo
In the extension part of this research study, everyone will get the investigational study drug.
Privacy, Stopping Participation, Costs, and Permission
The study team respects and protects your privacy and will not share your information except as required by law and will store your personal information with codes that do not identify you. The Informed Consent Form (completed by you prior to participation) will provide more information about how your privacy will be maintained.
Yes, your participation in the research study is entirely voluntary and you may withdraw for any reason, at any time. If you do decide to withdraw early, you will be asked to notify the study team before doing so. You will also be asked to return to the study site at least once to complete a final visit and return any unused study drugs.
No, you will receive the study drugs at no cost. You will also get all study-related medical tests at no cost.
No, your doctor does not have to give permission for you to participate. However, either you or the study doctor, with your permission, may contact your personal doctor to discuss your participation before you begin and keep your doctor up to date about your progress.
About Research Studies
A research study, also known as a clinical trial, tries to answer questions about how medications work in the people who take them. Researchers run research studies to test whether an investigational study drug is safe and effective. These research studies may help doctors find new ways to help prevent, detect, or treat health problems.
Participant safety is the priority. There are rules in place to help protect the rights, safety, and well-being of people who volunteer for research studies. These rules are put in place to make sure research studies follow strict scientific and ethical guidelines.
Before a research study can begin, a review board or ethics committee must review the research study. In the US, this group is called an IRB or Institutional Review Board. An IRB is made up of doctors, scientists, and other members of the community.
Only people who meet all eligibility criteria for a research study may take part. The study team at the site you select will review your medical history and current medical status against the eligibility criteria. They will determine whether you are eligible to participate. You may also be asked to provide information from your medical records to help the study team determine whether you may be eligible.
An investigational study drug is a drug that hasn’t yet been approved for use in the general public. In order to be approved, the investigational study drug must be tested in research studies to see if it is safe and effective for treating the target disease in certain groups of people.
The investigational study drug in the REGINA Study is being tested in people with lupus to see if it may safely and effectively reduce symptoms of lupus.
If you are eligible and choose to participate, the study staff will be available to answer any questions you may have.
For more answers to your questions visit: https://www.merckclinicaltrials.com/faq/
What Can You Do Next?
If you think this research study might be a good fit and you are interested in taking part, take the next step to see if you are eligible.
Discuss with your doctor or care team
Print this page with details about the trial or email it to your doctor to discuss the clinical trial during your next visit.
NATIONAL TRIAL REFERENCE NUMBER
NCT06161116
When speaking to your doctor or clinical trial representative, please have the trial reference number available.
Taking part in a clinical trial is an important decision
If you are considering joining a clinical trial, first learn as much as you can about:
- The investigational study drug that is being evaluated
- The possible risks and benefits for participants
Talk to your doctor about the clinical trial before you decide to join.
Read our “What to Consider” page for more questions to ask and think about
References:
- Systemic lupus erythematosus (SLE). Centers for Disease Control and Prevention. Accessed October 10, 2023. https://www.cdc.gov/lupus/facts/detailed.htm
- Lupus symptoms. Lupus Foundation of America. Updated July 25, 2023. Accessed October 10, 2023. https://www.lupus.org/resources/common-symptoms-of-lupus
- Risk factors for developing lupus. Lupus Foundation of America. Accessed October 10, 2023. https://www.lupus.org/resources/risk-factors-for-developing-lupus