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NCT Number: NCT04979520

Molecular Characteristics of Brodalumab in Hidradenitis Suppurativa

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.

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Key information

Conditions

Hidradenitis Suppurativa Acne Inversa Bacterial Infections Bacterial Infections and Mycoses Hidradenitis Infections Skin Diseases Skin Diseases, Bacterial Skin Diseases, Infectious Skin and Connective Tissue Diseases Suppuration Sweat Gland Diseases

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

The Rockefeller University

New York, 10065, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Brodalumab

Drug

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

Other names: Siliq

Primary outcomes

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

    Time frame: 12 weeks

    Percentage change in saturation

Secondary outcomes

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

    Time frame: 12 weeks

    In Brodalumab treated participants at week 12 compared with baseline

  2. 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)

    Time frame: 12 weeks

    In Brodalumab treated participants at week 12 compared with baseline

Sponsors and collaborators

Lead sponsor

Rockefeller University

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Jul 28, 2021
Registry last updated
Jul 27, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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