Efficacy and Safety Evaluation of Dazodalibep in Patients with Moderate-to-Severe Systemic Sjögren’s Syndrome: A Phase 3 Randomized, Double-Blind, Placebo-Controlled Study
This clinical trial is focused on studying a condition known as Sjögren’s Syndrome, which is characterized by moderate-to-severe systemic disease activity. The study aims to evaluate the effectiveness and safety of a treatment called Dazodalibep. Dazodalibep is a solution for infusion, meaning it is administered directly into the bloodstream through a vein. The study will compare the effects of Dazodalibep with a placebo, which is a substance with no active medication, to determine how well the treatment works in managing the symptoms of Sjögren’s Syndrome.
The purpose of the study is to assess how Dazodalibep affects the systemic manifestations, or widespread symptoms, of Sjögren’s Syndrome in participants who have moderate-to-severe disease activity. Participants in the study will receive either Dazodalibep or a placebo over a period of time, and their health will be monitored to observe any changes in their condition. The study will last for several weeks, and participants will undergo regular assessments to track their progress and any side effects they may experience.
Throughout the study, researchers will collect data on various health indicators, such as changes in disease activity scores and other symptoms related to Sjögren’s Syndrome. This information will help determine the potential benefits and risks of using Dazodalibep as a treatment option for this condition. The study is designed to provide valuable insights into the management of Sjögren’s Syndrome and to explore new possibilities for improving the quality of life for those affected by this disease.
Who Can Join the Study?
You must be an adult, at least 18 years of age, and able to provide your own legal consent to participate.
You must be able to complete Patient-Reported Outcomes, which are forms or questionnaires that you fill out yourself to describe your symptoms and how you feel.
You must have a confirmed diagnosis of Sjögren’s Syndrome, a condition where the immune system attacks the body’s own moisture-producing glands, based on specific medical criteria.
If your diagnosis is based on the presence of anti-Ro autoantibodies (proteins in the blood that indicate an immune response), this must be confirmed by a central laboratory.
You must have a certain level of disease activity, measured by a score called ESSDAI, which is a tool doctors use to track how much the disease is affecting your body’s systems. Your score must be 5 or higher.
You must test positive for either anti-Ro autoantibodies or rheumatoid factor (a protein in the blood often seen in inflammatory conditions) during testing at a central laboratory.
Women who are able to become pregnant must use highly effective contraception (methods to prevent pregnancy, such as hormonal birth control or an intrauterine device) and must have regular negative pregnancy tests.
Men who are sexually active with a female partner who can become pregnant must use a condom with spermicide (a substance that kills sperm) and follow specific precautions.
You must have received a COVID-19 vaccination at least 4 weeks before starting the study, unless you choose not to be vaccinated.
You must not have active tuberculosis (a serious bacterial infection that usually affects the lungs) and must have a negative interferon gamma release assay, which is a blood test used to check if you have been infected with tuberculosis.
You must not have had recent close contact with anyone who has active tuberculosis.
A chest radiograph (an X-ray of the lungs) must be performed and show no signs of active tuberculosis or other significant lung issues.
Who Cannot Join the Study?
You cannot participate if you have had a deep venous thrombosis (a blood clot in a deep vein), a pulmonary embolism (a blood clot in the lung), or an arterial thromboembolism (a blood clot in an artery) within the last 2 years.
You cannot participate if you have an active malignancy (cancer) or have had cancer in the last 5 years, except for certain successfully treated skin or cervical cancers.
You cannot participate if you are pregnant, lactating (breastfeeding), planning to become pregnant, or donating eggs during the study or for 3 months after your last dose of the investigational product (the study drug).
You cannot participate if you have a severe allergy to any part of the study drug or to other biologic therapies (medicines made from living organisms).
You cannot participate if you have a severe or life-threatening condition affecting your heart, lungs, hormones, digestion, blood, nerves, mental health, or overall body systems.
You cannot participate if the doctor believes you are unable or unwilling to follow the study rules, such as using alcohol or drugs, or if you cannot keep a required health diary.
You cannot participate if you test positive for hepatitis B, hepatitis C (liver infections), or HIV (a virus that affects the immune system).
For hepatitis C, you can only join if you have been successfully treated and the virus is no longer detectable in your blood, and you do not have advanced liver scarring.
You cannot participate if you test positive for SARS-CoV-2 (the virus that causes COVID-19) on the day you are assigned to the study.
You cannot participate if you have used injectable corticosteroids (steroid medicine given by injection) or high doses of oral steroid medicine like prednisone within 6 weeks before starting.
You cannot participate if you used steroid medicines for conditions other than Sjögren’s, rheumatoid arthritis, or lupus for more than 2 weeks in the last 6 months.
You cannot participate if you had an opportunistic infection (an infection that occurs more easily in people with weakened immune systems) in the last 12 months, unless it was a minor infection like a cold sore or yeast infection.
You cannot participate if you have an active infection that requires medicine or if you needed multiple rounds of IV antibiotics (medicine given through a vein) in the last year.
You cannot participate if you have received a live vaccine (a vaccine containing a weakened form of a germ) in the 4 weeks before the study or plan to get one during the study.
You cannot participate if you have used other experimental medicines or biologics (complex medicines targeting specific parts of the immune system) recently.
You cannot participate if you have used specific B-cell-depleting therapies (medicines that reduce certain white blood cells) within the last 3 to 12 months.
You cannot participate if you have recently started or changed the dose of certain DMARDs (medicines used to change the course of autoimmune diseases), such as methotrexate or azathioprine.
You cannot participate if you use certain eye drops or herbal remedies for your condition that may interfere with the study.
You cannot participate if you have ever used anti-CD40L compounds (a specific type of medicine).
You cannot participate if your blood tests show abnormal levels of liver enzymes, bilirubin (a substance made from old red blood cells), hemoglobin (protein in red blood cells that carries oxygen), neutrophils or lymphocytes (types of white blood cells), platelets (cells that help blood clot), or INR (a measure of how long it takes blood to clot).
You cannot participate if you have or have had polymyositis, dermatomyositis, or systemic sclerosis (conditions affecting muscles, skin, or connective tissues).
Dazodalibep is a medication given through an intravenous infusion to see if it can help improve the body-wide symptoms in people living with Sjögren’s Syndrome.
Sjögren’s Syndrome – This is an autoimmune condition where the immune system mistakenly attacks the body’s own healthy cells, particularly those in the glands that produce moisture. It often begins with dryness in the eyes and mouth due to decreased saliva and tear production. As the condition progresses, it can affect various parts of the body beyond these glands. This may include inflammation or damage to the joints, skin, lungs, or other organs. The severity of the symptoms can vary significantly among different individuals.
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