Evaluation of Dazodalibep Efficacy and Safety in Patients with Moderate-to-Severe Sjögren’s Syndrome: A Phase 3 Randomized, Double-Blind, Placebo-Controlled Study
This clinical trial is focused on studying Sjögren’s Syndrome, a condition that affects the body’s moisture-producing glands, leading to symptoms like dry mouth and eyes. The study will evaluate a treatment called Dazodalibep, also known by its code name HZN-4920. This treatment is given as a solution for infusion, which means it is administered directly into the bloodstream through a vein.
The purpose of the study is to assess how well Dazodalibep works in reducing the symptoms of Sjögren’s Syndrome in people who experience moderate to severe symptoms. Participants in the study will receive either the treatment or a placebo, which is a substance with no active medication. The study will last for several weeks, during which participants will have regular check-ups to monitor their symptoms and overall health.
Throughout the study, participants will be asked to report on their symptoms and any changes they experience. The goal is to determine if Dazodalibep can provide relief from the symptoms of Sjögren’s Syndrome and to ensure that it is safe for use. The study will help researchers understand the potential benefits and any side effects of the treatment.
Who Can Join the Study?
You must be an adult, meaning at least 18 years old at the time you agree to join the study.
You must have a confirmed diagnosis of Sjögren’s syndrome, an autoimmune condition where the body attacks its own moisture-producing glands.
Your diagnosis must be confirmed by specific medical criteria, which may include testing for anti-Ro autoantibodies (proteins in your blood that indicate an immune system issue) or rheumatoid factor (a protein often found in people with autoimmune diseases).
You must have a score of 5 or higher on the ESSPRI, which is a tool used to measure how much symptoms like dry eyes or dry mouth affect your daily life.
You must have a score of less than 5 on the ESSDAI, which is a tool used to measure how much the disease is affecting your body’s organs and systems.
You must still have some level of salivary gland function, meaning your mouth is still able to produce a certain amount of saliva when stimulated.
You must be able to complete patient-reported outcomes, which are forms where you describe your own symptoms and health status, without needing help from others.
You must be able to provide informed consent, which means you understand the study details and agree to participate in writing.
Women who are able to become pregnant must use highly effective contraception (methods to prevent pregnancy, such as birth control pills, an IUD, or other reliable methods) and must have regular pregnancy tests to confirm they are not pregnant.
You must not have active tuberculosis (TB), a serious bacterial infection that usually affects the lungs.
You must not have latent tuberculosis (a sleeping form of the infection) unless you have already finished the required medical treatment for it.
You must have had no recent close contact with anyone who has active tuberculosis.
You must have a negative Interferon Gamma Release Assay (IGRA), which is a specific blood test used to check if you have been infected with tuberculosis.
You must have a clear chest radiograph (an X-ray of your chest) that shows no signs of current tuberculosis or other significant lung issues.
Who Cannot Join the Study?
People who have had a blood clot in a deep vein (deep venous thrombosis), a blockage in the lung (pulmonary embolism), or a blockage in an artery (arterial thromboembolism) within the last 2 years.
People with a history of or currently having polymyositis, dermatomyositis (muscle and skin inflammation diseases), or systemic sclerosis (a condition that causes hardening of the skin and tissues).
People with active cancer or a history of cancer within the last 5 years, except for certain types of skin or cervical cancer that were successfully treated.
People who are pregnant, breastfeeding, planning to become pregnant, or planning to donate eggs during the study or for 3 months after the last dose.
People who test positive for Hepatitis B, Hepatitis C, or HIV (a virus that affects the immune system). This includes people with advanced scarring of the liver (cirrhosis) caused by Hepatitis C.
People who test positive for SARS-CoV-2 (the virus that causes COVID-19) on the day they are chosen to start the study.
People who have had certain infections in the last 12 months, such as opportunistic infections (infections that happen more easily in people with weakened immune systems), or people currently fighting an infection that requires systemic treatment (medicine that travels through the whole body).
People with a known severe allergy to any part of the study medication or to other biologic therapies (medicines made from living organisms).
People with severe or life-threatening issues regarding the heart (cardiovascular), lungs (respiratory), hormones (endocrine), digestion (gastrointestinal), blood (hematological), nerves (neurological), mental health (psychiatric), or other major body systems.
People who, in the doctor’s opinion, cannot or will not follow the study rules, including those struggling with drug or alcohol abuse.
People who have received a live vaccine (a vaccine containing a weakened form of the germ) in the 4 weeks before the study or plan to get one during the study.
People who have used other experimental drugs or biologic agents (specialized medicines) within 6 months before the study or within specific timeframes for B-cell-targeting therapies (medicines that affect specific immune cells).
People who have used systemic corticosteroids (strong anti-inflammatory medicines that affect the whole body) for reasons other than specific autoimmune diseases for more than 2 weeks in the last 6 months.
People who have recently started or changed the dose of certain medications, including antimalarials, immunosuppressants (medicines that lower the immune system), or nonsteroidal anti-inflammatory drugs (common pain relievers).
People using certain eye drops to treat inflammation or herbal/homeopathic remedies for joint and muscle conditions within a few weeks of starting the study.
People who have ever used anti-CD40L compounds (a specific type of medicine used to affect the immune system).
People whose blood tests show abnormal levels of liver enzymes (AST and ALT), bilirubin (a substance related to liver function), hemoglobin (a protein in red blood cells), 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).
Sjögren’s syndrome – This is a chronic condition where the body’s immune system mistakenly attacks its own healthy cells, specifically targeting the glands that produce moisture. It often results in a significant reduction in saliva and tear production. As the condition progresses, individuals may experience persistent dryness in the mouth and eyes. This can lead to discomfort, fatigue, and various aches or pains throughout the body. The severity of these symptoms can fluctuate over time.
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