Clinical trial NCT04979520: Molecular Characteristics of Brodalumab in Hidradenitis Suppurativa
Official title: A Small Pilot Study to Develop Biomarkers of Weekly Brodalumab Administration in Hidradenitis Suppurativa Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Hidradenitis Suppurativa
Acne Inversa
Keywords: Hidradenitis Suppurativa
Acne Inversa
Brodalumab
Lead sponsor: Rockefeller University
Sponsor class: OTHER
First posted: 2021-07-28
Enrollment: 4
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Open label
Primary purpose: BASIC_SCIENCE

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.


Eligibility criteria: 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

Primary outcomes:
measure: Interleukin-17 receptor A (IL-17RA) saturation during brodalumab administration at week 12 vs baseline
timeFrame: 12 weeks
Secondary outcomes:
measure: Change in levels of IL-17A, IL-17C, IL-17, CXCL1, and CXCL8
timeFrame: 12 weeks
measure: 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)
timeFrame: 12 weeks
Other outcomes:
Locations:
city: New York
country: United States
facility: The Rockefeller University
state: New York
Study officials:
affiliation: The Rockefeller University
name: Yael Renert-Yuval, MD
role: PRINCIPAL_INVESTIGATOR
References: