General Study Questions
How long will I be in the study?
You will be in the study for up to 61 weeks.
How many times will I have to go to the study site?
You will go to the study site 20 times.
What are the benefits of being in the clinical study?
You may or may not directly benefit from being in the clinical study. However, you will have continuous monitoring from doctors with expertise in HS, and any information collected during the study may help doctors learn more about treating others with HS.
Will it cost me anything to be in the study?
No, there will be no cost to you for the study drugs, visits, tests, or supplies related to the study.
Who is sponsoring the study?
The biopharmaceutical company Insmed Incorporated is the sponsor of the CEDAR Study. As sponsor, Insmed provides funding to the study doctor and study site to run the study.
What if I decide to join the study and then change my mind?
Being in the study is voluntary. If you decide to join and then change your mind, you can leave the study at any time.
Study Treatment Questions
What study treatment will I receive during the study?
During Study Treatment Period 1, you will receive either the active study drug or the placebo. The placebo looks just like the study drug but contains no active ingredients. During Study Treatment Period 2, all participants will receive the active study drug at different doses. Neither you nor the study doctor will know which study treatment or dose you will receive.
What does study drug mean?
Study drug means that the safety and effectiveness of the medicine has not been fully evaluated and is not currently approved by country-specific regulatory health authorities for use in treating a specific disease. It is allowed to be used for clinical research purposes only.
How does the study drug work?
The study drug is thought to work by reducing a type of inflammation that researchers believe may be involved in the development of HS.
How are the study treatment groups assigned?
A computer program will be used to assign participants to study treatment groups by chance, like dealing from a shuffled deck of cards. This is called randomization.
Are there any side effects from the study drug?
As with all medicines, there is a chance for side effects, which are unwanted or unintended effects from a medicine. Talk to the study doctor for more information on possible side effects. Your health will be closely monitored throughout the entire study. It is very important to tell the study doctor if you notice any changes in your health or if anything is bothering you.
Is the study drug being studied in other clinical trials?
Yes, the study drug is also being studied in clinical trials for adults and adolescents with non-cystic fibrosis bronchiectasis.