Biomarkers In Hidradenitis Suppurativa Participants Receiving Brodalumab

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

EARLY_PHASE1

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-05-28

Study Completion Date

2020-06-01

Brief Summary

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Phase 0 Study of Brodalumab in patients with moderate to severe Hidradenitis Suppurativa to identify biomarkers of disease activity and clinical response.

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Detailed Description

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Phase 0, Open Label study of Brodalumab in patients with moderate to severe Hidradenitis Suppurativa. Consisting of n=10 patients receiving 210mg subcutaneously every 2 weeks for 24 weeks. Patients will be followed for a period of 36 weeks (12 weeks after last dose of Brodalumab) to assess for safety.

Conditions

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Hidradenitis Suppurativa

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Open Label Single Arm Study

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Intervention

Brodalumab 210mg subcutaneously every 2 weeks for 24 weeks

Group Type EXPERIMENTAL

Brodalumab

Intervention Type DRUG

interleukin 17 receptor A antagonist

Interventions

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Brodalumab

interleukin 17 receptor A antagonist

Intervention Type DRUG

Other Intervention Names

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Siliq

Eligibility Criteria

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Inclusion Criteria

* Confirmed Diagnosis of Hidradenitis Suppurativa by the PI
* Age 18 or older
* Moderate to Severe Hidradenitis Suppurativa as determined by the PI

Exclusion Criteria

* Inflammatory Bowel Disease
* HIV Positive
* Active Hepatitis B or C Infection
* Pregnant or Breastfeeding
* no concurrent use of any systemic antibiotics/retinoids/imunosuppressants (require washout period of \>5 half lives)
* Any medical, psychological or social condition that, in the opinion of the investigator, would jeopardize the health or well being go the participant during any study procedures or the integrity of the data
* High Suicide Risk as determined by the Columbia Suicide Severity Rating Scale
* History of Keloid Scarring

Minimum Eligible Age

18 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No