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Molecular Characteristics of Brodalumab in Hidradenitis Suppurativa

Sponsor
Rockefeller University (Other)
Overall Status
Completed
CT.gov ID
NCT04979520
Collaborator
(none)
4
Enrollment
1
Location
1
Arm
11.6
Actual Duration (Months)
0.3
Patients Per Site Per Month

Study Details

Study Description

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
Early Phase 1

Study Design

Study Type:
Interventional
Actual Enrollment :
4 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Intervention Model Description:
Open labelOpen 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 :
Aug 5, 2021
Actual Primary Completion Date :
Jul 25, 2022
Actual Study Completion Date :
Jul 25, 2022

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

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

      Percentage change in saturation

    Secondary Outcome Measures

    1. Change in levels of IL-17A, IL-17C, IL-17, CXCL1, and CXCL8 [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) [12 weeks]

      In Brodalumab treated participants at week 12 compared with baseline

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 99 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 The Rockefeller University New York New York United States 10065

    Sponsors and Collaborators

    • Rockefeller University

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Yael Renert-Yuval, Instructor in clinical investigation, Rockefeller University
    ClinicalTrials.gov Identifier:
    NCT04979520
    Other Study ID Numbers:
    • YYU1014
    First Posted:
    Jul 28, 2021
    Last Update Posted:
    Jul 27, 2022
    Last Verified:
    Jul 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    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, Instructor in clinical investigation, Rockefeller University
    Hidradenitis Suppurativa
    Acne Inversa
    Brodalumab
    Additional relevant MeSH terms:
    Hidradenitis Suppurativa
    Hidradenitis
    Brodalumab

    Study Results

    No Results Posted as of Jul 27, 2022