Ongoing, recruitingTherapeutic exploratory (Phase II)Interventional

ANISE-II; ANIfrolumab treatment for 24 weeks in patients with primary Sjögren’s syndrome – Efficacy and safety assessment in a randomized, double-blind, placebo-controlled phase-IIa proof-of-concept trial

This study, called ANISE-II, is investigating a new medication called Saphnelo for people with Sjogren's disease. The main goal is to find out if Saphnelo can improve symptoms and overall well-being over 24 weeks, and to assess its safety. Participants will be randomly assigned to either receive Saphnelo or a placebo (a dummy medicine with no active ingredients). Researchers will track changes in several key Sjogren's symptoms, such as dry eyes and mouth, and how the disease affects the body more generally. This is a Phase II study, meaning it's an early-stage trial trying to understand if the medicine works and what its side effects might be.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic exploratory (Phase II)

Sponsor

Universitair Medisch Centrum Groningen

Enrolment target

Start

01 Nov 2024

Sjogren's disease

What is this study about?

This research study, called ANISE-II, is focusing on people who have Sjögren's disease. Sjögren's is a long-term condition that mainly causes your immune system to mistakenly attack your body's moisture-producing glands, leading to very dry eyes and mouth. It can also affect other parts of the body, causing fatigue, joint pain, and other issues.

The main aim of this study is to test a new medicine called Saphnelo. Doctors want to see if Saphnelo can help improve the symptoms of Sjögren's disease and make people feel better overall. They will also be carefully watching for any side effects the medicine might cause. To do this fairly, some participants will receive Saphnelo, while others will receive a placebo – a 'dummy' medicine that looks the same but has no active ingredients. This helps researchers understand if any improvements are truly due to Saphnelo or other factors.

The study will last for 24 weeks, which is about six months. During this time, the research team will regularly check how participants are feeling and measure their symptoms using a special system designed for Sjögren's disease. This helps them determine if Saphnelo is making a difference. This is an early-stage study, known as Phase II, which means it's one of the first human trials to explore the effectiveness and safety of this new treatment for Sjögren's.

Key takeaways

Tests Saphnelo for Sjögren's disease over 24 weeks.
Compares Saphnelo to a dummy medicine (placebo).
Aims to check if Saphnelo improves symptoms and is safe.
Involves regular clinic visits and health checks.
Open to adults aged 18 and over with Sjögren's disease.

Who may be eligible?

To join this study, you must be an adult aged 18 years or older. Both men and women are welcome to participate. The study is specifically looking for people who have been diagnosed with primary Sjögren's disease.

There might be other health conditions or medications that could prevent you from taking part, as these trials need very specific groups of people to get clear results. For example, if you have certain other serious health problems or are taking particular medicines, the researchers might determine that the study isn't suitable or safe for you.

It's important to discuss your full medical history with the study team. They will be able to tell you if you meet all the necessary requirements to join this research.

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?
Have you been diagnosed with primary Sjögren's disease?
Are you able to attend regular clinic visits for 24 weeks?
Are you willing to receive either the study drug or a placebo?
Do you have any other serious health conditions that might prevent you from joining?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will be in the study for a total of 24 weeks (about six months). You will receive either the study medication, Saphnelo, or a placebo (a dummy medicine) through an IV drip. You won't know which one you are getting, and neither will your doctors on the study team.

Throughout the 24 weeks, you will have regular visits to the clinic, usually every few weeks. During these visits, the study team will carry out various tests and checks. These will include blood tests, physical examinations, and questions about your symptoms and how you are feeling. They'll also check your eyes and mouth for dryness. The researchers will be particularly interested in how your symptoms change over time and any side effects you might experience. After the 24 weeks of treatment, there will likely be some follow-up visits to ensure your safety and monitor any lasting effects.

Potential risks and benefits

Participating in a clinical trial may offer potential benefits, such as access to a new treatment before it's widely available, and close medical monitoring throughout the study. However, there are also potential risks, including side effects from the medication, which could be mild or more serious, or that the treatment might not help your condition at all. You could also receive the placebo and not the active drug. You have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

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

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Unverified
Netherlands

Common questions

What is Sjögren's disease?

Sjögren's disease is a long-term condition where your immune system mistakenly attacks healthy parts of your body, mainly the glands that produce tears and saliva, leading to very dry eyes and mouth.

What is Saphnelo?

Saphnelo is a new medicine being tested in this study to see if it can help improve the symptoms and overall condition of people with Sjögren's disease.

What is a placebo?

A placebo is a 'dummy' treatment that looks exactly like the study medicine but doesn't contain any active drug. It helps researchers fairly compare the effects of the active medicine.

How long will the study last?

The treatment part of the study will last for 24 weeks, which is about six months, with regular check-ups during that time.

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

Neither you nor your study doctors will know whether you are receiving Saphnelo or the placebo during the study. This helps ensure fair and accurate results.