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

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

ArmDescriptionAssigned Intervention
Experimental
Brodalumab treated moderate-to-severe HS patients
Weekly Brodalumab treatment 210mg/1.5ml, given subcutaneously for 12 weeks.
  • Drug: Brodalumab
    Subcutaneously Brodalumab/Siliq, 210mg/1.5ml once a week
    Other names:
    • Siliq

Recruiting Locations

The Rockefeller University
New York, New York 10065
Contact:
Yael Renert-Yuval, MD
212-327-7581
yrenert@rockefeller.edu

More Details

Status
Recruiting
Sponsor
Rockefeller University

Study Contact

Recruitment Office
18007822737
rucares@rockefeller.edu

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.