A New Direction for Graves’ Disease   

Join our innovative clinical trial evaluating an investigational medicine, BHV-1300, that is being researched to potentially treat Graves’ disease. 

Those who qualify and choose to participate may be compensated for 13 in-clinic visits and 1 telephone visit over approximately 34 weeks. 

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About the Study 

This study is designed to evaluate the safety, effectiveness, and tolerability of BHV-1300, an investigational medicine, for adults with Graves’ disease. BHV-1300 is thought to break down the harmful antibodies driving Graves’ disease, potentially treating the root autoimmune cause while preserving normal immune defense and avoiding some side effects seen with antithyroid drugs.  

The study is randomized, double-blind, and placebo-controlled to ensure high-quality, unbiased results. If you qualify and choose to participate, there is a 67% chance you will receive the study treatment and a 33% chance you will receive a placebo. A placebo is an inactive material that looks like the study drug but does not contain any active ingredient. If you qualify and choose to participate in the optional long term extension of this study, you will receive the study drug. 

You will be in this study for approximately 34 weeks which will include a screening period, a treatment period, and a follow up period. The study will require up to 13 in-clinic visits and 1 telephone visit. If you qualify and choose to participate, you may be compensated for your study-related time and travel. Your participation is entirely voluntary, and you can leave the study at any time. 

Why Should I Participate?

Those who qualify and choose to participate could receive: 

Access to the investigational study drug at no cost 

Access to our top-tier study team of board-certified physicians at no cost 

 

 Compensation for 13 in-clinic visits & 1 telephone visit over approximately 34 weeks 

Study Criteria 

To qualify to participate you must: 

  • Be aged 18-70 years old
  • Have Graves’ disease and currently be hyperthyroid
  • Have a BMI of 18-35
  •  Additional criterion applies  
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Frequently asked questions

What is a research study or clinical trial?

A research study or clinical trial is the process a potential new drug, device, procedure, or process goes through to prove that it is safe, tolerable and effective for the condition it is being studied for. Research studies are the only way to advance medicine for future generations. 

Who can participate in a research study?

Each study has its own set of inclusion and exclusion criteria that a participant must meet before they are allowed to participate in a study. Patients from all backgrounds and walks of life are encouraged to participate 

What is Informed Consent?

Every participant in every research study must go through the informed consent process. During this, the trial doctor and research team go over what will happen in the study, what treatments you might get, how long the trial is expected to last, what happens during visits, the potential risks and benefits, and many other important facts about the study. Participants may withdraw their consent and discontinue the study at any time for any reason. 

What is a Placebo?

A placebo looks like a treatment but does not have any active medicine in it. Researchers use placebos to help make sure any changes in the participants’ health are actually caused by the study treatment. You do not get to choose if you get the study treatment or the placebo, and you may not know if you get the placebo until after the study. Not all research studies use a placebo. 

Why is Diversity Important?

If studies do not include diverse participants, we cannot know if treatments work for everyone who needs them. Studies only tell researchers how something works for the participants of that study, and they may not work the same in people of different races, ethnicities, ages, or sexes. 

How am I Protected?

All research studies must follow federal laws and ethical guidelines, including HIPAA. Studies must also be reviewed by a group called an institutional review board (IRB) that helps make sure the trial is fair and as safe as possible, and that any risks to the participants are worth the potential benefits.