Diagnosed with
Bullous Pemphigoid (BP)?
Find out about a new clinical study in BP and if you are eligible to participate.
CLINICALTRIALS.GOV ID: NCT05267600
With your participation, you can help researchers investigate a potential treatment for Bullous Pemphigoid
About Bullous Pemphigoid (BP)
Bullous Pemphigoid is a rare skin condition that causes painful and itchy blisters and sores on the skin. It can start with just a few blisters, but can suddenly get worse, becoming widespread, even if you’re being treated for it with medication.
BP is an autoimmune disease
Normally, the human body makes antibodies to fight and prevent infections. In BP the immune system makes harmful antibodies-autoantibodies, that attack the skin cells.
BP is a rare autoimmune disease. In BP these autoantibodies cause the disruption between the top and lower layers of the skin that causes fluid to build up between these two layers of skin.
This can result in crusting, large fluid-filled, sometimes painful and itchy blisters in the skin, which are not easily broken when touched.
About the Investigational Drug
Participants will be given either the investigational drug (active) or a placebo (inactive)*.
A computer will randomly assign participants to either the investigational drug or placebo.
Even if receiving a placebo, each participant will still be treated with the accepted standard of care for BP, oral prednisone.
The investigational drug is currently not approved for use in bullous pemphigoid (BP) by any regulatory agency, as its safety and effectiveness have not been established for the treatment of BP.
*The investigational drug or placebo will be given by subcutaneous injection (under the skin) that takes 1-2 minutes.
If you have blistering lesions, you may be eligible to participate in a study for bullous pemphigoid (BP)
About the Study
Who can participate
To participate in the study, you or the person you care for, must be:
18 years of age or older
Have a confirmed diagnosis of bullous pemphigoid
Have clinical signs of bullous pemphigoid (presence of blisters), with or without itching, scaly eczema-like plaques
There are additional study requirements that patients must meet in order to take part in this study. A study representative will discuss them with you.
How to Participate
The study will last up to 46 weeks (between 10 and 11 months)
Screening for 2-3 weeks
Study treatment for 36 weeks: you will receive two injections of the study drug on weeks 1 & 2, followed by one injection once a week
After 36 weeks, there is an optional 7-week follow-up period, or you can choose to join an extension study where every participant will receive the investigational drug
Some of the visits for treatment will happen at the study site, and some may happen at your home with a visiting nurse, depending on your disease activity
Even if you are given a placebo, you will still be taking medication that is the standard of care for treating BP
You will be closely monitored during the treatment period and your steroid dose may be reduced or eliminated depending on your disease activity
While you are taking the study drug, you will also be taking a standard treatment for BP, an oral corticosteroid
Frequently Asked Questions
What is the purpose of the study?
The main goal of this study is to see if the investigational drug is safe and effective in treating people with bullous pemphigoid (BP). The investigational drug is currently not approved for use in bullous pemphigoid (BP) by any regulatory agency, as safety and effectiveness have not been established.
Who can participate in the study?
To participate in the study, you must have a confirmed diagnosis of bullous pemphigoid (BP), with clinical signs of BP (presence of blisters), with or without itching, scaly eczema-like plaques. There are additional study requirements that patients must meet in order to take part in this study. A study representative will discuss them with you.
What is bullous pemphigoid (BP)?
Normally, the human body makes antibodies to fight and prevent infections. But in BP, antibodies can attack the skin cells. These autoantibodies cause a disruption between the top and lower layers of the skin which results in large, tense blisters on the skin and the life-disrupting itch.
Are there any costs for participating in the study?
There will be no cost to you for being in this study. You will receive all study drugs (including oral corticosteroids), tests, examinations, and medical care related to the study at no cost. You may be reimbursed for travel costs and/or meal costs at longer study visits.
In addition, to help you and your caregiver throughout the study, you will be able to take advantage of a patient concierge service. They will assist with all your study-related responsibilities, like scheduling and reminding you of your study visits and making transportation arrangements for your study visits. You may also contact the concierge at any time if you have questions or need any nonmedical assistance.
Will I have to stop taking my current medicine to participate in the BALLAD study?
You will be given oral corticosteroids to take during the course of the study, and if your symptoms get worse, the study doctor will increase the amount of oral corticosteroid that you take each day. Based on the study doctor’s assessment, your steroid dose may be reduced during the course of the study.
