Molecular Characteristics of Brodalumab in Hidradenitis Suppurativa

A Small Pilot Study to Develop Biomarkers of Weekly Brodalumab Administration in Hidradenitis Suppurativa Patients

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.

Study Overview

• Status: Completed
• Conditions: Hidradenitis Suppurativa; Acne Inversa
• Intervention / Treatment: Drug: Brodalumab

• Study Type: Interventional
• Enrollment (Actual): 4
• Phase: Early Phase 1

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10065
      • The Rockefeller University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 99 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Interleukin-17 receptor A (IL-17RA) saturation during brodalumab administration at week 12 vs baseline	Percentage change in saturation	12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in levels of IL-17A, IL-17C, IL-17, CXCL1, and CXCL8	In Brodalumab treated participants at week 12 compared with baseline	12 weeks
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)	In Brodalumab treated participants at week 12 compared with baseline	12 weeks

Collaborators and Investigators

• Sponsor: Rockefeller University
• Investigators: Principal Investigator: Yael Renert-Yuval, MD, The Rockefeller University

Study record dates

Study Major Dates

• Study Start (Actual): August 5, 2021
• Primary Completion (Actual): July 25, 2022
• Study Completion (Actual): July 25, 2022

Study Registration Dates

• First Submitted: July 9, 2021
• First Submitted That Met QC Criteria: July 27, 2021
• First Posted (Actual): July 28, 2021

Study Record Updates

• Last Update Posted (Actual): July 27, 2022
• Last Update Submitted That Met QC Criteria: July 26, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Keywords: Hidradenitis Suppurativa; Acne Inversa; Brodalumab
• Additional Relevant MeSH Terms: Sweat Gland Diseases; Skin Diseases; Infections; Bacterial Infections; Bacterial Infections and Mycoses; Skin Diseases, Infectious; Suppuration; Skin Diseases, Bacterial; Hidradenitis Suppurativa; Hidradenitis; Dermatologic Agents; Brodalumab
• Other Study ID Numbers: YYU1014

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes