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A study to evaluate the safety of dazodalibep in patients with Sjögren's Syndrome over a long period of time

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This study is looking at Sjögren's Syndrome, a condition where the body's immune system attacks its own moisture-producing glands, leading to dryness in the eyes and mouth, along with other symptoms throughout the body. The treatment being studied is Dazodalibep, which is also known by the code names HZN-4920, MEDI4920, and VIB4920. This medication is given as a solution for infusion, which means it is delivered directly into the bloodstream through a vein. The purpose of this study is to evaluate the long-term safety and how well people tolerate dazodalibep when used over an extended period.

This is an extension study, which means it is designed for people who have already participated in and completed earlier studies of dazodalibep for Sjögren's Syndrome. Those who join this study will continue to receive dazodalibep treatment for a longer time so that researchers can observe how safe the medication is when used over many months or years. The study will track any unwanted effects that occur during treatment, including any serious health problems that might develop. Researchers will also check if the body develops any immune responses against the medication by looking for anti-drug antibodies, which are proteins the body might make in reaction to the treatment.

Throughout the study, blood samples will be collected to measure the amount of dazodalibep in the bloodstream, which helps researchers understand how the medication moves through and stays in the body. The study is open-label, meaning both the participants and doctors will know that everyone is receiving the active medication rather than placebo. This long-term study allows researchers to gather important information about the ongoing safety of dazodalibep in people with Sjögren's Syndrome over an extended treatment period.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Entry into the extension study

    This is a long-term extension study, which means it follows after completion of a previous study. To enter this extension study, you must have completed one of the earlier phase 3 studies with dazodalibep (study HZNP-DAZ-301 or HZNP-DAZ-303) and received the study medication in that previous study.

    You will provide informed consent before any study activities begin. Informed consent is a document you sign to confirm you understand the study and agree to participate.

    You should receive your first dose in this extension study before the end of the previous study you participated in.

  2. Step 2

    Treatment phase

    During this study, you will receive dazodalibep, which is given as a solution for infusion. An infusion means the medication is delivered directly into your vein through a needle over a period of time.

    This is an open-label study, which means both you and your doctor will know that you are receiving dazodalibep, not a placebo.

    The study will continue for a long period of time to assess the safety of the medication. The estimated end date for the study is April 2029.

    Specific details about the exact dosage, frequency, and duration of dazodalibep administration are not provided in the available information.

  3. Step 3

    Safety monitoring

    Throughout the study, your health will be monitored to evaluate the safety and tolerability of dazodalibep over the long term.

    Any adverse events will be recorded. Adverse events are unwanted medical occurrences that happen during the study, whether or not they are related to the medication.

    Particular attention will be given to serious adverse events, which are medical problems that require hospitalization, are life-threatening, or cause significant disability.

    Adverse events of special interest will also be monitored. These are specific side effects that are of particular concern for this medication.

  4. Step 4

    Laboratory assessments

    Blood samples will be taken during the study to measure the plasma concentration of dazodalibep. This means the amount of medication present in the liquid part of your blood will be measured.

    Testing will be performed to check if your body develops anti-drug antibodies, also called ADAs. These are proteins your immune system might create in response to the medication, which could affect how the medication works.

    The specific timing and frequency of these blood tests are not detailed in the available information.

Who can join the trial?

5 criteria

  • You must have agreed to take part in the study and signed a consent form before any study activities begin.
  • You must have been allowed to receive and have received the study medication, which could have been either dazodalibep (the medicine being tested) or placebo (an inactive substance used for comparison), and you must have completed one of the earlier studies called HZNP-DAZ-301 or HZNP-DAZ-303.
  • You must not have stopped taking the study medication early in the previous study.
  • You must be able to receive your first dose in this long-term extension study before a certain time after finishing the previous study.
  • If you cannot receive your first dose within the usual time window, you may still be allowed to join the study if your doctor discusses your situation with the study medical monitor.

Who cannot join the trial?

4 criteria

  • The specific exclusion criteria, which are reasons why someone cannot join this study, have not been provided in the available information.
  • Generally, exclusion criteria are conditions or situations that would make it unsafe for a person to participate in the study or that might affect the study results.
  • These criteria typically include things like other serious health problems, certain medications being taken, pregnancy or breastfeeding, recent participation in other studies, or specific test results that fall outside acceptable ranges.
  • For this particular study about Sjögren's Syndrome, which is a condition where the body's immune system attacks glands that make moisture like tears and saliva, the detailed list of who cannot participate is not available in the current data.
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Investigated drugs

Dazodalibep is an investigational medication being studied for the treatment of Sjögren's Syndrome. Sjögren's Syndrome is a condition where the body's immune system attacks glands that produce moisture, leading to symptoms like dry eyes and dry mouth. This medication works by targeting specific parts of the immune system to help reduce the abnormal immune response that causes these symptoms. In this study, dazodalibep is being evaluated over a long period of time to see how safe it is and how well people tolerate it when used for an extended duration.

What is already known about the treatment

Dazodalibep – Dazodalibep is an experimental medication currently being studied in clinical trials for the treatment of Sjögren's Syndrome, a chronic autoimmune disease that causes dry eyes and dry mouth. This drug is administered as an infusion or injection and works by blocking a specific protein called CD40 ligand, which plays a key role in the immune system's overactivity that damages moisture-producing glands in the body. The medication belongs to a class of drugs called immunomodulators, which help regulate the immune system's response. Long-term safety studies are ongoing to determine if dazodalibep can be used as an effective treatment option for patients suffering from this condition.

Investigated diseases

Sjögren's Syndrome – Sjögren's Syndrome is a chronic autoimmune disease where the body's immune system mistakenly attacks its own moisture-producing glands. The condition primarily affects the glands that produce tears and saliva, leading to dry eyes and dry mouth as the most common symptoms. As the disease progresses, it can affect other parts of the body including joints, skin, and internal organs. Patients often experience fatigue, joint pain, and swelling in the glands around the face and neck. The dryness can become severe enough to cause difficulty swallowing, speaking, and an increased risk of dental cavities. Women are more commonly affected than men, and the condition typically develops in middle age.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-517513-32-00Protocol code20230050Estimated enrolment844 patientsSponsorAmgen Inc.

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On this site, “treatment” means an investigational medicine being studied in a clinical trial. Its safety and efficacy for the use being studied have not yet been confirmed, some participants may receive a placebo or a comparator medicine, and taking part does not guarantee any health benefit. The decision to take part is made by the doctor at the research site. This site is for information only and does not replace medical advice.

This service is not affiliated with the European Commission, the EMA, or the official CTIS system. Most information comes from publicly available international clinical-trial registries, supplemented by data from academic sites, national regulators and commercial sponsors. On this site, “treatment” and “therapy” mean a medicine being tested in a clinical trial. Its safety and effectiveness in the use being studied are not yet confirmed, some participants may receive a placebo or a comparator, and taking part does not guarantee a health benefit. The doctor at the research site decides who can take part. This site provides information, not medical advice. Certain content and visual elements on this website have been generated or enhanced using artificial intelligence (AI).