BHV-1300 for Graves' Disease
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new treatment called BHV-1300 to determine its safety for individuals with Graves' Disease, an autoimmune condition that causes an overactive thyroid. Researchers are also examining how BHV-1300 affects specific markers in the body related to the disease. This trial is for individuals with Graves' Disease confirmed through a blood test. Those with other thyroid issues or who have undergone certain treatments, such as surgery or radioactive iodine, are not eligible. As a Phase 1 trial, this research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new treatment.
Do I need to stop my current medications for the trial?
The trial information does not specify if 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 BHV-1300 is likely to be safe for humans?
Research has shown that BHV-1300 is safe and generally well-tolerated. It reduces autoantibodies, which mistakenly attack the body's tissues in Graves' Disease, without causing significant harm. Studies indicate that BHV-1300 does not lead to many severe side effects, known as Grade 3 or 4 adverse events, suggesting most people handle it well. While this is early evidence, the focus on safety in this ongoing research is encouraging for prospective trial participants.12345
Why do researchers think this study treatment might be promising for Graves' Disease?
Unlike the standard treatments for Graves' Disease, which often involve antithyroid medications like methimazole and propylthiouracil, BHV-1300 is unique because it targets the disease with a novel mechanism of action. Researchers are excited about BHV-1300 because it may offer a more targeted approach, potentially reducing the side effects associated with current therapies. Additionally, BHV-1300 may provide quicker relief from symptoms, which is a big deal for those dealing with the discomfort of this autoimmune condition.
What evidence suggests that BHV-1300 might be an effective treatment for Graves' Disease?
Research shows that BHV-1300, the investigational treatment in this trial, has promising results in lowering total IgG antibodies, proteins in the blood involved in immune responses. Studies have found reductions of up to 84% in these antibodies. This reduction is important for treating Graves' Disease, where the immune system mistakenly attacks the thyroid. By reducing IgG levels, BHV-1300 might help control this immune activity. These early findings suggest potential benefits for people with Graves' Disease, but more research is needed to confirm its effectiveness for this condition.12456
Are You a Good Fit for This Trial?
This clinical trial is for individuals with confirmed Graves' Disease, an autoimmune disorder that affects the thyroid, causing hyperthyroidism. Participants must currently have active symptoms of this condition to join.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Open-label Treatment
Participants receive BHV-1300 to assess safety and effect on disease-specific biomarkers
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- BHV-1300
Trial Overview
The study is testing BHV-1300 to see if it's a safe treatment option for those with Graves' Disease and will also look at how it affects disease-specific markers in the body.
How Is the Trial Designed?
1
Treatment groups
Experimental Treatment
Find a Clinic Near You
Who Is Running the Clinical Trial?
Biohaven Therapeutics Ltd.
Lead Sponsor
Citations
1.
ir.biohaven.com
ir.biohaven.com/news-releases/news-release-details/biohaven-reports-positive-degrader-data-achieving-80-sustainedBiohaven Reports Positive Degrader Data Achieving > 80 ...
Subcutaneously administered BHV-1300 at a dose of 1000 mg weekly achieved rapid, deep and sustained reductions in total IgG of up to 84%, with a median ...
Biohaven Reports Positive Degrader Data Achieving > 80 ...
Optimized subcutaneous administration of BHV-1300 achieved rapid, deep and sustained lowering of IgG, differentiating Biohaven's new small ...
3.
trial.medpath.com
trial.medpath.com/clinical-trial/6084d3983748e110/nct06980649-bhv-1300-graves-disease-biomarkerStudy of BHV-1300 in Graves' Disease - MedPath
The purpose of this study is to determine if BHV-1300 is a safe treatment in participants with Graves' Disease and to explore its effect on disease-specific ...
Biohaven Highlights Innovation and Advancement Across ...
Optimized SC administration of BHV-1300 has continued to demonstrate rapid, deep, and sustained lowering of total IgG in Phase 1 studies.
Graves' Disease Study | Biohaven Clinical Trials
Biohaven is conducting a clinical trial for people with Graves' disease. Learn more about our study of BHV-1300 and how it may help patients.
ANZCTR - Registration
To assess the safety and tolerability of BHV-1300. This objective will be measured by assessing the number of unique subjects with Grade 3 or 4 ...
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