Molecular Characteristics of Brodalumab in Hidradenitis Suppurativa

NCT ID: NCT04979520

Last Updated: 2022-07-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 4 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-08-05
• Study Completion Date: 2022-07-25

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.

Conditions

Hidradenitis Suppurativa; Acne Inversa

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Brodalumab treated moderate-to-severe HS patients

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

Group Type: EXPERIMENTAL

Brodalumab

Intervention Type: DRUG

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

Interventions

Brodalumab

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

Intervention Type: DRUG

Other Intervention Names

Siliq

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 99 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Rockefeller University

OTHER

Sponsor Role: lead

Responsible Party

Yael Renert-Yuval

Instructor in clinical investigation

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Yael Renert-Yuval, MD

Role: PRINCIPAL_INVESTIGATOR

The Rockefeller University

Locations

The Rockefeller University

New York, New York, United States

Countries

United States

Other Identifiers

YYU1014

Identifier Type: -

Identifier Source: org_study_id