Acne Inversa, Hidradenitis Suppurativa
Conditions
Keywords
Hidradenitis Suppurativa, Acne Inversa, Brodalumab
Brief summary
Hidradenitis suppurativa is a disease involving skin folds, causing swelling of the skin and surrounding tissues, pain, and foul-smelling discharges. Effective treatment options are lacking. Recently, clinical trials conducted in our lab found Brodalumab was an effective drug for this disease. Weekly dosing achieved superior therapeutic outcomes compared to a dosing given once in every other week. Brodalumab was safe in both regimens, but blood and tissue studies to better understand this response are still needed. By performing this small pilot study and collecting blood and tissue samples from participants treated with Brodalumab once weekly we would like to better characterize the molecular response to this treatment, identify blood and tissue markers reflecting disease severity, and better understand disease mechanisms.
Interventions
DRUGBrodalumab
Subcutaneously Brodalumab/Siliq, 210mg/1.5ml once a week
Sponsors
Rockefeller University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE
Intervention model description
Open label
Eligibility
Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
No
Inclusion criteria
* Confirmed clinical diagnosis of Hidradenitis Suppurativa by the Principal Investigator * Age 18 to 99 years old * Moderate to severe Hidradenitis Suppurativa with draining tunnels (Hidradenitis Suppurativa Severity Score System/IHS4\>4) * Must have medical insurance that is willing to pay for the study drug throughout the duration of the study
Exclusion criteria
* Inflammatory Bowel Disease * HIV Positive * Active Hepatitis B or C Infection * Pregnant or Breastfeeding * No concurrent use of any systemic antibiotics/retinoids/immunosuppressants/biologics (require washout period of \>5 half-lives) * A Score of \>10 on the Beck's Depression Inventory (BDI) or on the Patient Health Questionnaire (PHQ)-9 * History of Keloid Scarring * Any medical, psychological or social condition that, in the opinion of the Investigator, would jeopardize the health or well-being of the participant during any study procedures or the integrity of the data
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Interleukin-17 receptor A (IL-17RA) saturation during brodalumab administration at week 12 vs baseline | 12 weeks | Percentage change in saturation |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in levels of IL-17A, IL-17C, IL-17, CXCL1, and CXCL8 | 12 weeks | In Brodalumab treated participants at week 12 compared with baseline |
| Correlate IL-17R saturation (measured by the frequencies of immune cells positive to IL-17RA by flow cytometry) with clinical measures, such as pain or the Hidradenitis Suppurativa Severity Score System (IHS4) | 12 weeks | In Brodalumab treated participants at week 12 compared with baseline |
Countries
United States
Outcome results
None listed