IMVT-1402 for Sjogren's Syndrome
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests an experimental treatment called IMVT-1402 for individuals with primary Sjogren's syndrome, a condition where the immune system mistakenly attacks parts of the body, causing dry mouth and eyes, among other symptoms. Researchers aim to determine if IMVT-1402 can safely reduce symptoms in moderate to severe cases. Participants will be divided into groups, with some receiving different doses of the treatment and others receiving a placebo, a harmless pill with no effect. This trial suits individuals who have had primary Sjogren's syndrome for over a year, experience noticeable symptoms, and have specific antibodies related to this condition. As a Phase 2 trial, this research focuses on measuring the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to important early findings.
Do I have to stop taking my current medications for the trial?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
Is there any evidence suggesting that IMVT-1402 is likely to be safe for humans?
Research shows that IMVT-1402 is being tested for safety in people with Sjogren's syndrome. Detailed safety information for this specific use is not yet available, but the ongoing Phase 2 trial suggests that earlier tests were promising enough to continue. Generally, Phase 2 trials follow Phase 1 trials that have demonstrated a treatment's safety, indicating that IMVT-1402 likely showed good safety results in earlier tests or for other conditions. However, unknown side effects may still exist, highlighting the importance of these trials. Concerns should be discussed with a healthcare provider for more personalized information.12345
Why do researchers think this study treatment might be promising?
Most treatments for Sjogren's Syndrome focus on relieving symptoms and include options like artificial tears, saliva substitutes, and medications that increase saliva production. However, IMVT-1402 is unique because it targets the underlying immune response associated with the disease. Researchers are excited about IMVT-1402 because it works by modulating specific pathways in the immune system, potentially reducing inflammation and providing more comprehensive relief than current treatments. This could lead to improved quality of life for patients by addressing the root cause rather than just managing symptoms.
What evidence suggests that IMVT-1402 might be an effective treatment for Sjogren's Syndrome?
Research suggests that IMVT-1402 might help treat autoimmune diseases. Although specific information about its effects on Sjogren's Syndrome is limited, similar treatments from the same company have shown good results in other autoimmune diseases, such as Myasthenia Gravis. These treatments adjust the immune system to lessen disease symptoms. Early findings indicate that this approach might also alleviate symptoms of Sjogren's Syndrome. More research is needed to confirm these effects for Sjogren's, but the initial results appear promising.12346
Are You a Good Fit for This Trial?
Adults with primary Sjogren's Disease showing moderate to severe symptoms can join this trial. They must have had the disease for at least a year, test positive for specific antibodies, and still produce some saliva. The study is not open to those who don't meet these criteria or have conditions that are outlined in the full protocol.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive IMVT-1402 or placebo for 24 weeks to assess efficacy and safety
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- IMVT-1402
Find a Clinic Near You
Who Is Running the Clinical Trial?
Immunovant Sciences GmbH
Lead Sponsor