What is the CEDAR Study?
Thank you for your interest in the CEDAR Study. This is a clinical study being done to evaluate a new investigational product in adults with HS. HS is a chronic inflammatory skin condition that causes recurrent, painful skin lesions in areas where skin rubs together, like the armpits, groin, and under the breasts. The active study drug is thought to treat HS by reducing a type of inflammation that researchers believe may be involved in the disease.
You may be able to participate if you meet these and other criteria:
Age
Are 18 to 80 years of age
Disease characteristics
Have lesions on at least 2 distinct areas of the body
Diagnosis
Have a diagnosis of moderate or severe HS for at least 6 months
Who can participate?
To be considered for this study, you must meet these and other criteria:
Age
Are 18 to 80 years of age
Diagnosis
Have a diagnosis of moderate or severe HS for at least 6 months
Have lesions on at least 2 distinct areas of the body
What happens
during the study?
Before any study procedures, you need to understand the study and sign an Informed Consent Form, which contains all the details of the study. Throughout the study, you will have visits to check on your health. The study lasts up to 61 weeks and has 4 parts or periods.
20 total in-person study visits
Screening Period
5 weeks
The study team will collect information about your health and run tests to see if you qualify.
Study Treatment Period 1
16 weeks
You will have clinic visits every 2 weeks for health checks and tests.
Study Treatment Period 2
36 weeks
You will have clinic visits every 4 weeks for health checks and tests.
Follow-up Period
4 weeks
You will have 1 more visit to check on your health.
What is the study treatment?
The study treatment is a tablet taken orally (by mouth) once a day. 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.
1 tablet each day
What kind of health checks and tests can you expect?
During the study, you will visit the clinic for health checks and tests. You will not have every test at each visit.
Physical exam
Blood test
Urine test
Vital signs
Heart activity (ECG)
Questionnaires
Pregnancy test
(if needed)
HS disease assessment
Heart activity (ECG)
Questionnaires
Pregnancy test
(if needed)
HS disease assessment
Assessment of skin pain
Side effects check
Tissue sample for PD substudy (optional)
Medicine review
ECG = electrocardiogram; HS = hidradenitis suppurativa; PD = pharmacodynamics.
Find a Study Site
Below is a list of sites that are participating in this study. Please review to see if there is a location near you.