RecruitingPHASE2INTERVENTIONAL

Efficacy and Safety of IMVT-1402 in Adult Participants With Primary Sjogren's Disease With Moderate to Severe Systemic Disease Activity

This research is looking at a new medicine called IMVT-1402 for adults who have Primary Sjögren's Syndrome. This condition causes your immune system to mistakenly attack your body, leading to symptoms like extremely dry eyes and mouth, and sometimes affecting other organs. The study wants to find out if IMVT-1402 is safe and effective in reducing the symptoms and how active the disease is. Participants will receive either the new drug or a placebo (a treatment with no active medicine) without knowing which one they are getting. Doctors will then compare how both groups change over 24 weeks, focusing on improvements in disease activity. The study will last up to 105 weeks in total for each person.

At a glance

Status

Recruiting

Phase

PHASE2

Sponsor

Immunovant Sciences GmbH

Enrolment target

180

Start

30 Jun 2025

Estimated completion

01 Jul 2029

Primary Sjögren's Syndrome

What is this study about?

This study is investigating a new treatment, called IMVT-1402, for people diagnosed with Primary Sjögren's Syndrome. Sjögren's Syndrome is a long-term condition where your body's immune system, which normally fights off infections, starts to attack healthy parts of your own body, particularly the glands that produce tears and saliva. This can lead to very dry eyes and mouth, and it can also cause problems in other areas like joints, muscles, nerves, and organs.

For this study, researchers are focusing on adults who have a `moderate to severe` form of Sjögren's Syndrome, meaning their symptoms are significant and affect their daily lives. The main goal is to understand if IMVT-1402 can help reduce these symptoms and lessen the overall activity of the disease. They will also be carefully checking for any side effects the drug might cause, to make sure it's safe to use.

Participants will be placed into one of two groups by chance: one group will receive the new drug, IMVT-1402, and the other will receive a placebo – a treatment that looks identical but contains no active medicine. Neither you nor your study doctor will know which treatment you are getting. This helps ensure the results are as fair and accurate as possible. Over 24 weeks, the study team will track how your Sjögren's Syndrome symptoms and disease activity change. The entire study commitment for each person could last for up to 105 weeks.

Key takeaways

This study is for adults aged 18-74 with moderate to severe Primary Sjögren's Syndrome.
It tests a new drug, IMVT-1402, against a dummy drug (placebo).
The main goal is to see if the new drug can make symptoms better and is safe over 24 weeks.
Participation could last up to 105 weeks, with regular clinic visits.
You have the right to leave the study at any time.

Who may be eligible?

To join this study, you need to be an adult between 18 and 74 years old and have been diagnosed with Primary Sjögren's Syndrome for at least 12 months. Your condition should be considered `moderate to severe`, meaning it's causing significant problems. You must also have specific markers in your blood related to Sjögren's Syndrome and produce a certain amount of saliva.

You cannot join if you have other conditions that might be confused with Sjögren's Syndrome, like some other autoimmune diseases. Also, if you have certain blood cancers, a history of cancer within the last five years, or other serious health issues, you might not be able to take part. The study team will review your full medical history very carefully.

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 between 18 and 74 years old?
Have you been diagnosed with Primary Sjögren's Syndrome for at least one year?
Do you have moderate to severe symptoms from your Sjögren's Syndrome?
Do you have a specific blood marker for Sjögren's Syndrome?
Do you currently produce some saliva, even if it's a small amount?
Do you have any other autoimmune conditions like rheumatoid arthritis or lupus?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you'll be involved in the study for up to 105 weeks (about two years). During this time, you will have regular visits to the clinic where the study team will carry out various checks. These will likely include blood tests, physical examinations, and questions about how you are feeling and how your symptoms are changing. You will either receive the new medicine or a dummy medicine (placebo) as part of the study. You won't know which one you're getting. Importantly, you can choose to leave the study at any time.

Potential risks and benefits

Taking part in a clinical trial offers potential benefits, such as access to a new treatment before it's widely available and closer monitoring of your condition. However, there are also potential risks, including side effects from the study drug, unknown effects, or inconvenience from study visits and procedures. You might receive the placebo and not the active drug. Your participation is always voluntary, and you have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (121)

Site Number - 1027
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Covina, United States· Recruiting
Site Number - 1007
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El Cajon, United States· Recruiting
Site Number - 1016
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Menifee, United States· Recruiting
Site Number - 1029
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Thousand Oaks, United States· Recruiting
Site Number - 1026
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Upland, United States· Recruiting
Site Number - 1014
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Fort Collins, United States· Recruiting
Site Number - 1018
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Hollywood, United States· Recruiting
Site Number - 1021
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Jupiter, United States· Recruiting
Site Number - 1002
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Miami, United States· Recruiting
Site Number - 1004
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Tamarac, United States· Recruiting
Site Number - 1025
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Tampa, United States· Recruiting
Site Number - 1012
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Chicago, United States· Recruiting

Common questions

What is Primary Sjögren's Syndrome?

It's a long-term condition where your immune system attacks healthy parts of your body, often leading to very dry eyes and mouth, and sometimes affecting other organs.

What is the new drug being tested?

The new drug is called IMVT-1402. This study wants to see if it helps with Sjögren's symptoms and is safe.

What does 'placebo' mean?

A placebo is a substance that looks exactly like the study drug but doesn't have any active medicine in it. It helps researchers compare the effects of the real drug.

How long will I be in the study?

The total time you could be involved in the study is up to 105 weeks, which is about two years.

Can I leave the study if I change my mind?

Yes, you can choose to stop participating in the study at any time, for any reason, and it won't affect your regular medical care.

How to find out more

Central Study Contact

clinicaltrials@immunovant.com 18007970414 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.