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Study on the Effects of HZN-1116 for Patients with Sjögren’s Syndrome

Fast replyInvestigationalNo placebo
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What is this trial about?

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

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 HZN-1116, which is a solution for injection. The purpose of the study is to assess how effective and safe HZN-1116 is for people with this condition.

Participants in the study will receive either the HZN-1116 treatment or a placebo, which is a substance with no active medication. The study will be conducted over a period of time, during which participants will receive regular injections and attend follow-up visits to monitor their health and any changes in their symptoms. The study aims to understand how HZN-1116 affects the overall symptoms and quality of life for those with moderate to severe Sjögren’s Syndrome.

Throughout the study, participants will be closely monitored by healthcare professionals to ensure their safety and to gather information on how the treatment impacts their condition. The study will help determine if HZN-1116 can be a beneficial treatment option for people living with Sjögren’s Syndrome.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Upon joining the study, you will be randomly assigned to one of two groups. One group will receive the investigational medication HZN-1116, and the other group will receive a placebo, which is a substance with no active medication. This process is called a double-blind study, meaning neither you nor the study team will know which group you are in.

  2. Step 2

    Medication administration

    If you are in the group receiving HZN-1116, the medication will be administered as a solution for injection under the skin, known as subcutaneous use. The frequency and dosage will be determined by the study protocol, and you will be informed of the schedule during your visits.

    If you are in the placebo group, you will receive a commercially available saline solution administered in the same manner.

  3. Step 3

    Regular visits

    You will be required to attend regular visits to the study site. During these visits, your health will be monitored, and various assessments will be conducted to evaluate the effects of the treatment. These assessments may include physical examinations, blood tests, and questionnaires about your symptoms and overall well-being.

  4. Step 4

    Monitoring and assessments

    Throughout the study, your progress will be closely monitored. This includes tracking any changes in your symptoms of Sjögren’s Syndrome, such as dryness, pain, and fatigue. You will be asked to report any side effects or changes in your condition to the study team.

  5. Step 5

    End of study

    At the end of the study period, you will have a final visit where comprehensive assessments will be conducted. This will help determine the overall impact of the treatment on your condition. You will be informed about the next steps and any follow-up care that may be necessary.

Who can join the trial?

10 criteria

  • Adults aged between 18 and 75 years old can participate. Participants must be able to give their own consent to join the study.
  • Must have been diagnosed with Sjögren’s Syndrome according to specific medical criteria. If the diagnosis is based on a positive test for anti-Ro autoantibodies, this must be confirmed by a central laboratory.
  • For Population #1: Must have a score of 5 or more on the ESSDAI test, which measures disease activity, even after using treatments like nonsteroidal anti-inflammatory drugs (NSAIDs) or local therapies. Some areas of the body will be checked but won't count towards the score needed to join.
  • For Population #2: Must have a score of 5 or more on the ESSPRI test, which measures symptoms reported by the patient, and a score of less than 5 on the ESSDAI test.
  • Must test positive for either anti-Ro autoantibodies or rheumatoid factor (RF), or both, at the screening.
  • Must have some remaining function in the salivary glands, shown by a saliva flow rate of more than 0.1 mL per minute, or some remaining function in the tear glands, shown by a Schirmer’s test result of 5 mm or more in 5 minutes.
  • Females who can have children and are sexually active with a male partner must use a highly effective method of birth control from the time they sign the consent form until the end of the study or 4 months after leaving the study. They must also agree not to donate eggs during this time.
  • Nonsterilized males who are sexually active with a female partner who can have children must use a condom with spermicide until the end of the study and must not donate sperm during this time and for at least 90 days after the last dose of the study medication.
  • Must provide written informed consent and any other required authorizations before any study-related procedures are performed.
  • Must be fully vaccinated against COVID-19 according to local guidelines at least 2 weeks before screening, unless they refuse vaccination. Vaccination is allowed during the study but not during the screening period or within 2 weeks after the first dose of the study medication.

Who cannot join the trial?

8 criteria

  • Patients with other autoimmune diseases that are not well controlled. Autoimmune diseases are conditions where the body's immune system attacks its own tissues.
  • Patients who have had a recent infection that required treatment with antibiotics or antiviral medications.
  • Patients who have received any live vaccines within the last 4 weeks. Live vaccines contain a small amount of the actual virus or bacteria.
  • Patients who are currently pregnant or breastfeeding.
  • Patients with a history of severe allergic reactions to medications or vaccines.
  • Patients who have participated in another clinical trial within the last 4 weeks.
  • Patients with a history of drug or alcohol abuse within the past year.
  • Patients with any other medical condition that the study doctors believe would make it unsafe for them to participate.
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Investigated drugs

HZN-1116 is a medication being studied for its potential to help people with Sjögren’s Syndrome, a condition where the body’s immune system attacks its own moisture-producing glands. This can lead to symptoms like dry mouth and dry eyes, as well as other systemic issues. In this clinical trial, researchers are looking at how well HZN-1116 can reduce the overall disease activity in people who have moderate to severe symptoms. They are also interested in seeing if it can improve the symptoms that patients report, especially for those who feel their symptoms are not well managed. The goal is to find out if HZN-1116 can make a meaningful difference in the lives of people living with this condition.

What is already known about the treatment

HZN-1116 – HZN-1116 is administered in a form suitable for clinical trials, typically as an oral or injectable medication, though the exact form is not specified here. It is currently being studied in a Phase 2 clinical trial to assess its effectiveness and safety for treating Sjögren’s Syndrome, a condition characterized by dry mouth and eyes due to immune system dysfunction. The main therapeutic indication for HZN-1116 is to alleviate systemic symptoms and improve the quality of life for patients with moderate-to-severe Sjögren’s Syndrome. At the molecular level, HZN-1116 likely works by modulating the immune response, though specific details of its mechanism are not provided. It falls under the pharmacological classification of immunomodulatory agents, which are drugs that adjust the immune system's activity.

Investigated diseases

Sjögren’s Syndrome – Sjögren’s Syndrome is an autoimmune disorder characterized by the body's immune system mistakenly attacking its own moisture-producing glands. This leads to symptoms such as dry mouth and dry eyes. Over time, the disease can also affect other parts of the body, including the joints, skin, and organs like the kidneys and lungs. The progression of the disease can vary, with some individuals experiencing mild symptoms while others may develop more severe systemic manifestations. As the disease progresses, patients may experience fatigue, joint pain, and swelling. The condition can also lead to complications such as dental decay and oral infections due to reduced saliva production.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IITrial ID2023-507680-19-00Protocol codeHZNP-HZN-1116-201Estimated enrolment312 patientsSponsorHorizon Therapeutics Ireland Designated Activity Company

sourced from the EU Clinical Trials Register and site verification

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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).