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Molecular Characteristics of Brodalumab in Hidradenitis Suppurativa

Primary Purpose

Hidradenitis Suppurativa, Acne Inversa

Status

Completed

Phase

Early Phase 1

Locations

United States

Study Type

Interventional

Intervention

Brodalumab

About this trial

This is an interventional basic science trial for Hidradenitis Suppurativa focused on measuring Hidradenitis Suppurativa, Acne Inversa, Brodalumab

Eligibility Criteria

18 Years - 99 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

The Rockefeller University

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Brodalumab treated moderate-to-severe HS patients

Arm Description

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

Outcomes

Primary Outcome Measures

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

Percentage change in saturation

Secondary Outcome Measures

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

In Brodalumab treated participants at week 12 compared with baseline

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

Full Information

NCT ID

NCT04979520

First Posted

July 9, 2021

Last Updated

July 26, 2022

Sponsor

Rockefeller University

1. Study Identification

Unique Protocol Identification Number

NCT04979520

Brief Title

Molecular Characteristics of Brodalumab in Hidradenitis Suppurativa

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

July 2022

Overall Recruitment Status

Completed

Study Start Date

August 5, 2021 (Actual)

Primary Completion Date

July 25, 2022 (Actual)

Study Completion Date

July 25, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Rockefeller University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Yes

Data Monitoring Committee

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hidradenitis Suppurativa, Acne Inversa

Keywords

Hidradenitis Suppurativa, Acne Inversa, Brodalumab

7. Study Design

Primary Purpose

Basic Science

Study Phase

Early Phase 1

Interventional Study Model

Single Group Assignment

Model Description

Open label

Masking

None (Open Label)

Allocation

N/A

Enrollment

4 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Brodalumab treated moderate-to-severe HS patients

Arm Type

Experimental

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Brodalumab

Other Intervention Name(s)

Siliq

Intervention Description

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

Primary Outcome Measure Information:

Title

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

Description

Percentage change in saturation

Time Frame

12 weeks

Secondary Outcome Measure Information:

Title

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

Description

In Brodalumab treated participants at week 12 compared with baseline

Time Frame

12 weeks

Title

Description

In Brodalumab treated participants at week 12 compared with baseline

Time Frame

12 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

99 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Yael Renert-Yuval, MD

Organizational Affiliation

The Rockefeller University

Official's Role

Principal Investigator

Facility Information:

Facility Name

The Rockefeller University

City

New York

State/Province

New York

ZIP/Postal Code

10065

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Molecular Characteristics of Brodalumab in Hidradenitis Suppurativa

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