Do you have lupus symptoms that need better control? Learn more about the Sunflower Study of an investigational approach to treating lupus.
The SUNFLOWER Study is conducted in multiple countries to find out how well anifrolumab SC (subcutaneous, under the skin self-injection) works in adult patients with lupus, who take antimalarial medication with or without steroid, and have not been treated with biologic or immunosuppressant medication. We would like to find out if lupus symptoms can be treated earlier with anifrolumab under the skin self-injection, with or without the need for steroid medication).
By joining the SUNFLOWER Study, you’ll make a significant contribution to our understanding of treating lupus. Your experience may help others living with the same condition.
If you qualify and decide to take part, you will get:
- The study medicine, anifrolumab SC (subcutaneous, under the skin injection)
- Close medical care and follow-up throughout the study
- Reimbursement for reasonable study-related expenses (travel and meals)
You may be able to join if you:
- Are 18 through 70 years old (male or female)
- Have been diagnosed with lupus for at least 3 months, confirmed by a rheumatologist and blood tests
- Are receiving standard treatment with antimalarials with or without oral steroids
- Have NOT received any other lupus-related therapies
In this study, all participants will receive anifrolumab SC (subcutaneous, under the skin injection) once a week. There is no placebo. The study team will teach you or someone to help you administer the study drug under the skin. You will continue to take your antimalarial medication, and agree to slowly taper your steroid dose per the protocol-tapering schedule (in case steroid is used).
The study lasts over one year (up to 69 weeks), involves approximately 15 study site visits, and includes:
Screening (5 weeks/35 days): Assessments and tests to see if you qualify for the study.
Weeks 0-4: Start anifrolumab and a temporary increase of steroid for up to 4 weeks if required. As you begin the anifrolumab, the study team will lower the steroid dose.
Weeks 5-40: Receive weekly anifrolumab while gradually reducing the steroid.
Weeks 41-52: Receive anifrolumab; within this period, your steroid dose will not be reduced further.
Follow up: For patients not continuing anifrolumab: 12 weeks after the last dose of anifrolumab, check any side effects and monitor your condition.
If you stop the anifrolumab under the skin self-injection treatment at the last study site visit, the study doctor will call you 12 weeks later to check on how you are doing and find out what medications you have been taking.
Lupus is a long-term autoimmune disease where the immune system attacks healthy tissues, causing pain, swelling, and fatigue. Symptoms can affect many parts of the body, including the skin, joints, and organs (such as the lungs, heart, and kidney). Symptoms may come and go. While medicines like antimalarials and oral steroids help manage lupus, some people need additional treatment to control their symptoms better and improve daily life.
A clinical research study (also called a clinical trial) is carefully supervised research that is done before an investigational drug becomes available to the public, or for the purpose of finding new indications and benefits of an already approved medication.
- Clinical studies follow specific rules to protect the safety, rights, well-being, and privacy of participants.
- The results help doctors and researchers decide if an investigational medication or medication being studied for a new indication is safe and should be made available to patients.
- Clinical studies are the only way to develop new medical treatments to improve patient care.
Joining the SUNFLOWER Study is entirely voluntary (which means that the decision to participate is completely up to you). If you choose not to take part in this study, it will not impact your usual medical care now or in the future. If you participate, you can decide to leave the study at any time and for any reason.
Frequently asked questions
Yes. In addition to continuing your antimalarial medication (and possibly an oral glucocorticoid medicine if you are already taking one), all participants receive anifrolumab SC (subcutaneous, under the skin self-injection) once a week. The study team will teach you how to give yourself the study drug.
At a typical study site visit, you will:
- Talk about your medical history, including discussing your lupus symptoms and treatment
- Go over all previous and/or current medications
- Have a physical exam
- Have vital signs checked and weight measured
- On some visits have an electrocardiogram (ECG) to check your heart rhythm
- On some visits have a chest x-ray (or provide a recent chest CT scan) to look at your lungs and chest area
- Give blood and urine samples for testing
- Take pregnancy test (if appropriate)
- Answer questionnaires and assessments at home using a mobile application
- Take weekly under the skin self-injections of study medicine.
- You will receive the first and second dose of study medication at the study site and then you will be asked to administer the study medication at home each week. On some visits, you will be asked to self-administer the study medication at the study site (you may also ask your caregiver to administer the injection for you). The study team will watch your technique (or that of your caregiver) and make sure you are receiving the study medication properly.
Participation in any clinical study is completely voluntary. Your decision to participate—or not participate—in this clinical study will have no effect on the medical care that you receive now or in the future. If you are eligible and choose to participate in the study, you may leave the clinical study at any time, and for any reason.
AstraZeneca will reimburse all study participants for study-related travel and expenses. For more information, please speak with a member of the study team during your study visits.
You’ll first be asked some general questions (here) that help us determine whether you meet the basic criteria of the study. If you do meet these requirements, you may be asked to come in for a study visit. At that visit, you’ll be screened to see if you fit the specific qualifications for the study.
There are many reasons to participate in clinical research. For starters, it allows participants to play a more proactive role in their own health by receiving an investigational treatment for an ongoing disease or condition. Participants also play an important part in bringing much-needed medicines to market, benefiting thousands of people who also have the disease or condition. In many cases, this can improve quality of life. In addition to benefiting those with the disease, participants may be compensated for their time and travel expenses. As a participant in this study, you will have access to a biological treatment typically reserved for patients who have not responded to several other medications, even from the early stages of the disease.
Participants like you really help make a difference. See if you prequalify for this research study.
Every clinical trial must be reviewed, and is continually monitored, by a regulatory review and ethics committees to ensure the risks are as low as possible and are worth any potential benefits to the study participant. As a volunteer, you have the right to discontinue your participation and leave the study at any time and for any reason, with no penalty or loss of benefits to which you are otherwise entitled.
AstraZeneca, working with ICON (a contract research organization), is responsible for conducting this clinical study.
