Ongoing, recruitingTherapeutic exploratory (Phase II)Interventional

A Phase 2 Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of HZN-1116 in Participants With Sjögren’s Syndrome.

This study is looking into a new treatment called HZN-1116 for Sjögren's Syndrome. Sjögren's Syndrome is a long-term condition that can cause dryness, pain, and tiredness. The main goal is to find out if HZN-1116 helps lessen the symptoms and improve how people feel overall. Researchers will also be checking if the medicine is safe and if it causes any unwanted side effects. To make sure the results are reliable, some participants will receive HZN-1116, while others will be given a 'dummy' treatment (a placebo) that looks the same but contains no active medicine. This allows doctors to compare the effects of the new medicine fairly. Participants will be aged 18 or over and can be male or female.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic exploratory (Phase II)

Sponsor

Horizon Therapeutics Ireland Designated Activity Company

Enrolment target

151

Start

08 Oct 2024

Sjögren’s Syndrome

What is this study about?

Sjögren's Syndrome is a condition that affects your immune system, which is your body's defence against illness. It often causes very dry eyes and mouth, but can also lead to tiredness, joint pain, and other issues throughout the body. There isn't a cure for Sjögren's Syndrome yet, so treatments usually focus on managing the symptoms.

This study is a Phase 2 trial, which means it's an important step in developing new medicines. Its main purpose is to see if a new medicine called HZN-1116 can make a real difference for people with Sjögren's Syndrome. Researchers will carefully check if the medicine helps to reduce symptoms and improve the overall quality of life for those taking part. They will also pay close attention to any side effects to make sure the medicine is safe.

The study involves comparing HZN-1116 with a 'placebo', which is a look-alike substance that has no active medicine in it. Neither you nor your doctor will know if you are receiving the active medicine or the placebo. This is a common way to test new treatments, as it helps doctors accurately measure how well the new medicine works compared to no treatment at all. All results will be carefully analysed to understand the potential of HZN-1116.

Key takeaways

This study is testing a new medicine (HZN-1116) for Sjögren's Syndrome.
It aims to see if the medicine improves symptoms and is safe to use.
Participants will receive either the new medicine or a dummy treatment (placebo).
It is for adults (18+) with Sjögren's Syndrome.
Regular clinic visits and assessments will be part of taking part.
You can stop participating at any time.

Who may be eligible?

To take part in this study, you need to be at least 18 years old. There is no upper age limit, meaning older adults can also participate. The study is open to both men and women.

Beyond these basic requirements, there will be more specific health checks to make sure the study is suitable for you and that you meet all the criteria for safety and accurate results. For example, your doctors will need to confirm your diagnosis of Sjögren's Syndrome and check if you have any other medical conditions that might affect your participation.

It's important to discuss your full medical history with the study team. They will explain all the details and help you understand if this study is the right fit for you.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 18 years old or older?
Do you have a diagnosis of Sjögren's Syndrome?
Are you able to attend regular clinic appointments?
Are you comfortable with receiving injections?
Do you understand that you might receive a placebo?
Are you prepared to discuss your full medical history with the study team?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you would receive either the study medicine, HZN-1116, or a placebo (a dummy treatment) through injections under your skin. These injections will be given at regular intervals over a set period. You won't know whether you're getting the active medicine or the placebo.

Throughout the study, you would attend regular appointments at the clinic. During these visits, doctors and nurses would perform various assessments to monitor your health, check your Sjögren's symptoms, and look for any side effects. These assessments might include physical exams, blood tests, questionnaires about how you are feeling, and checks of your joint pain or fatigue levels.

The study will last for a specific duration, which will be fully explained to you. Even after you stop receiving the treatment, there will likely be follow-up appointments to continue monitoring your health and record any longer-term effects. The total commitment from start to finish, including any follow-up, will be made clear before you join.

Potential risks and benefits

Taking part in a clinical trial offers the potential benefit of accessing a new treatment before it's widely available, which might improve your Sjögren's symptoms. However, like all medicines, HZN-1116 may have side effects, and it's also possible you could receive the placebo and not the active drug. The study team will explain all known or potential risks to you in detail. You have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (11)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

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Unverified
Austria
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Unverified
Germany
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Unverified
Spain
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Unverified
Poland
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Unverified
Greece
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Unverified
Bulgaria
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Unverified
Hungary
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Unverified
Italy
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Unverified
Portugal
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Unverified
France
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Unverified
Ireland

Common questions

What is Sjögren's Syndrome?

It's a long-term condition where your body's immune system mistakenly attacks healthy cells, often causing dry eyes and mouth, and sometimes joint pain or tiredness.

What is HZN-1116?

HZN-1116 is a new medicine being tested as a potential treatment for Sjögren's Syndrome.

What is a 'placebo'?

A placebo is a 'dummy' treatment that looks just like the real medicine but contains no active ingredients. It helps researchers compare the true effects of the new medicine.

Will I know if I'm getting the real medicine?

No, neither you nor your doctor will know if you are receiving HZN-1116 or the placebo. This is called 'double-blind' and is a standard way to ensure fair results.

How long will the study last?

The full duration of your participation, including treatment and follow-up, will be explained by the study team, but typically these types of studies last for several months.