Active not recruitingPHASE3INTERVENTIONAL

A Study to Evaluate the Efficacy and Safety of Deucravacitinib in Adults With Active Sjögren's Syndrome

This research study is looking at a new medicine called Deucravacitinib for adults living with active Sjögren's Syndrome. Sjögren's is a condition where your immune system mistakenly attacks your own body, often causing extreme dryness. The main goal is to find out if Deucravacitinib is safe and if it helps improve symptoms and how people feel, compared to a placebo (a dummy pill with no active medicine). This is a 'Phase 3' study, which means it's one of the final stages of testing before a medicine might be considered for wider use. It's an important step in potentially offering new hope for people with Sjögren's Syndrome.

At a glance

Status

Active not recruiting

Phase

PHASE3

Sponsor

Bristol-Myers Squibb

Enrolment target

774

Start

11 Sep 2023

Estimated completion

16 Nov 2028

Sjögren's Syndrome

What is this study about?

This study is a clinical trial, which means it's a carefully planned research project to test a new medicine, in this case, Deucravacitinib, for adults who have active Sjögren's Syndrome. Sjögren's Syndrome is an autoimmune disease where your body's defence system mistakenly attacks healthy cells, often leading to severe dryness in the eyes and mouth, and sometimes affecting other organs. 'Active' means that the condition is currently causing noticeable problems and symptoms.

The main purpose of this study is to explore two key things: first, if Deucravacitinib is safe for people with Sjögren's Syndrome, and second, if it's effective at reducing their symptoms or improving their overall health. To do this, some participants will receive the active medicine, while others will receive a 'placebo' – a pill that looks the same but contains no active drug. This comparison helps researchers understand if any changes are due to the medicine or other factors.

Finding new and effective treatments for Sjögren's Syndrome is very important because current options don't work for everyone, and the condition can significantly impact daily life. This study is a crucial step in potentially offering more choices and better quality of life for those living with this condition.

Key takeaways

This study tests a new medicine for active Sjögren's Syndrome.
It aims to find out if the medicine is safe and helps improve symptoms.
Participants will receive either the study medicine or a placebo.
The study is for adults generally aged 18 and over.
Close medical monitoring is provided for all participants.
You can withdraw from the study at any time without affecting your care.

Who may be eligible?

This study is looking for adults aged 18 and over who have Sjögren's Syndrome. To be considered, your Sjögren's must be active, meaning it's currently causing symptoms, and you should have been diagnosed for at least 16 weeks.

There are also specific checks: your condition needs to be medium to severely active, and you should have had Sjögren's for 10 years or less. You'll also need a certain level of saliva flow and a positive blood test for 'anti-Ro/SSA', which is common in Sjögren's.

However, you might not be able to join if you have other autoimmune diseases like rheumatoid arthritis or lupus, or if you have uncontrolled fibromyalgia. Also, if you've previously taken medicines similar to Deucravacitinib, you won't be eligible.

Quick self-check

Are you 18 years old or older?
Do you have an active diagnosis of Sjögren's Syndrome?
Has your Sjögren's Syndrome been diagnosed for at least 16 weeks but generally no more than 10 years?
Do you have a positive blood test for 'anti-Ro/SSA'?
Are you generally in good health apart from your Sjögren's, with no other major autoimmune diseases like lupus?

This is a guide only — the research team will confirm whether you can take part.

What does participation involve?

If you decide to take part in this study, you would first go through a thorough screening process to make sure the study is right for you. If eligible, you would likely receive either the study medicine (Deucravacitinib) or a placebo (a dummy pill) taken regularly, as instructed by the study team. You would have regular visits to the clinic for various assessments, which might include blood tests, physical examinations, and questionnaires about your symptoms and how you are feeling. These visits are important for monitoring your health, checking how the medicine is working, and ensuring your safety. The total duration of your participation in the study, including follow-up, would be fully explained by the study team before you make any decisions.

Potential risks and benefits

Participating in a study like this could offer potential benefits, such as access to a new medicine that isn't widely available, which might improve your symptoms or quality of life if it's effective. You would also receive close medical monitoring. However, there are potential risks, including side effects from the study medicine, or the possibility that the medicine may not help you, or you might receive the placebo. All potential risks will be explained in detail by the study team, and you have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (199)

Local Institution - 0228
Fullerton, United States
Local Institution - 0222
La Palma, United States
Local Institution - 0218
San Francisco, United States
Local Institution - 0203
Santa Monica, United States
Local Institution - 0067
Denver, United States
Local Institution - 0049
Clearwater, United States
Local Institution - 0226
Cooper City, United States
Local Institution - 0223
Sarasota, United States
Local Institution - 0140
Augusta, United States
Local Institution - 0229
Lawrenceville, United States
Local Institution - 0174
Skokie, United States
Local Institution - 0016
Kansas City, United States

+187 more sites — see the official record for the full list.

Common questions

What is Sjögren's Syndrome?

Sjögren's Syndrome is an autoimmune disease where your body's immune system attacks healthy parts of your body, often causing extreme dryness in the eyes and mouth.

What is Deucravacitinib?

Deucravacitinib is the new investigational medicine being tested in this study to see if it can help people with Sjögren's Syndrome.

What is a 'Phase 3' study?

Phase 3 is one of the final steps in testing a new medicine. It means the medicine has already shown some promise and is now being tested on a larger group of people to confirm its safety and effectiveness.

Will I definitely get the actual medicine if I join?

Not necessarily. In this type of study, participants are usually randomly assigned to receive either the active medicine or a placebo (a dummy pill). Your study team will explain how this works.

Can I leave the study if I change my mind?

Yes, absolutely. You can withdraw from the study at any time, for any reason, without it affecting your medical care.