Molecular Characteristics of Brodalumab in Hidradenitis Suppurativa

Hidradenitis Suppurativa Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04979520
• Other study ID #: YYU1014
• Status: Completed
• Phase: Early Phase 1
• Start date: August 5, 2021
• Est. completion date: July 25, 2022

Study information

• Verified date: July 2022
• Source: Rockefeller University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 4
• Est. completion date: July 25, 2022
• Est. primary completion date: July 25, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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

Related Conditions & MeSH terms

• Acne Inversa
• Hidradenitis
• Hidradenitis Suppurativa

Intervention

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

Locations

Country	Name	City	State
United States	The Rockefeller University	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Rockefeller University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Interleukin-17 receptor A (IL-17RA) saturation during brodalumab administration at week 12 vs baseline	Percentage change in saturation	12 weeks
Secondary	Change in levels of IL-17A, IL-17C, IL-17, CXCL1, and CXCL8	In Brodalumab treated participants at week 12 compared with baseline	12 weeks
Secondary	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	12 weeks