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Molecular Characteristics of Brodalumab in Hidradenitis Suppurativa

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04979520
Recruitment Status : Completed
First Posted : July 28, 2021
Last Update Posted : July 27, 2022
Sponsor:
Information provided by (Responsible Party):
Yael Renert-Yuval, Rockefeller University

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.

Condition or disease Intervention/treatment Phase
Hidradenitis Suppurativa Acne Inversa Drug: Brodalumab Early Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 4 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: Open label
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: A Small Pilot Study to Develop Biomarkers of Weekly Brodalumab Administration in Hidradenitis Suppurativa Patients
Actual Study Start Date : August 5, 2021
Actual Primary Completion Date : July 25, 2022
Actual Study Completion Date : July 25, 2022

Resource links provided by the National Library of Medicine

Drug Information available for: Brodalumab

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 Name: Siliq




Primary Outcome Measures :
  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 Outcome Measures :
  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



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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04979520


Locations
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United States, New York
The Rockefeller University
New York, New York, United States, 10065
Sponsors and Collaborators
Rockefeller University
Investigators
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Principal Investigator: Yael Renert-Yuval, MD The Rockefeller University
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Responsible Party: Yael Renert-Yuval, Instructor in clinical investigation, Rockefeller University
ClinicalTrials.gov Identifier: NCT04979520    
Other Study ID Numbers: YYU1014
First Posted: July 28, 2021    Key Record Dates
Last Update Posted: July 27, 2022
Last Verified: July 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Keywords provided by Yael Renert-Yuval, Rockefeller University:
Hidradenitis Suppurativa
Acne Inversa
Brodalumab
Additional relevant MeSH terms:
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Hidradenitis Suppurativa
Hidradenitis
Sweat Gland Diseases
Skin Diseases
Skin Diseases, Bacterial
Bacterial Infections
Bacterial Infections and Mycoses
Infections
Skin Diseases, Infectious
Suppuration
Brodalumab
Dermatologic Agents