Molecular Characteristics of Brodalumab in Hidradenitis Suppurativa

NCT04979520 | Completed Early Phase 1 FDA Drug

• 1 other identifier: YYU1014
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 1

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.

Conditions

Hidradenitis Suppurativa; Acne Inversa

Keywords

Hidradenitis Suppurativa; Acne Inversa; Brodalumab

Outcome Measures

Primary Outcomes (1)

• Interleukin-17 receptor A (IL-17RA) saturation during brodalumab administration at week 12 vs baseline

  Percentage change in saturation

  12 weeks

Secondary Outcomes (2)

• Change in levels of IL-17A, IL-17C, IL-17, CXCL1, and CXCL8

  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)

  12 weeks

Study Arms (1)

Brodalumab treated moderate-to-severe HS patients

EXPERIMENTAL

Weekly Brodalumab treatment 210mg/1.5ml, given subcutaneously for 12 weeks.

Drug: Brodalumab

Interventions

Brodalumab DRUG

Subcutaneously Brodalumab/Siliq, 210mg/1.5ml once a week

Also known as: Siliq

Brodalumab treated moderate-to-severe HS patients

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Rockefeller University: lead

Study Sites (1)

The Rockefeller University

New York, New York, 10065, United States

Location

MeSH Terms

Conditions

Hidradenitis Suppurativa

Interventions

brodalumab

Condition Hierarchy (Ancestors)

Skin Diseases, Bacterial; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Skin Diseases, Infectious; Suppuration; Skin Diseases; Skin and Connective Tissue Diseases; Hidradenitis; Sweat Gland Diseases

Study Officials

• Yael Renert-Yuval, MD

  The Rockefeller University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Instructor in clinical investigation

Model Details: Open label

Study Record Dates

• First Submitted: July 9, 2021
• First Posted: July 28, 2021
• Study Start: August 5, 2021
• Primary Completion: July 25, 2022
• Study Completion: July 25, 2022
• Last Updated: July 27, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)