Molecular Characteristics of Brodalumab in Hidradenitis Suppurativa
Purpose
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.
Conditions
- Hidradenitis Suppurativa
- Acne Inversa
Eligibility
- Eligible Ages
- Between 18 Years and 99 Years
- Eligible Genders
- All
- Accepts 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
Study Design
- Phase
- Early Phase 1
- Study Type
- Interventional
- Allocation
- N/A
- Intervention Model
- Single Group Assignment
- Intervention Model Description
- Open label
- Primary Purpose
- Basic Science
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Brodalumab treated moderate-to-severe HS patients |
Weekly Brodalumab treatment 210mg/1.5ml, given subcutaneously for 12 weeks. |
|
More Details
- Status
- Completed
- Sponsor
- Rockefeller University