---
title: Biomarkers In Hidradenitis Suppurativa Participants Receiving Brodalumab
nct_id: NCT03960268
overall_status: COMPLETED
phase: EARLY_PHASE1
sponsor: Rockefeller University
study_type: INTERVENTIONAL
primary_condition: Hidradenitis Suppurativa
countries: United States
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT03960268.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT03960268"
ct_last_update_post_date: 2020-06-04
last_seen_at: "2026-05-12T06:51:07.485Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# Biomarkers In Hidradenitis Suppurativa Participants Receiving Brodalumab

**Official Title:** A Pilot Study of Safety and Biomarkers In Hidradenitis Suppurativa Participants Receiving Brodalumab

**NCT ID:** [NCT03960268](https://clinicaltrials.gov/study/NCT03960268)

## Key Facts

- **Status:** COMPLETED
- **Phase:** EARLY_PHASE1
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 10
- **Lead Sponsor:** Rockefeller University
- **Collaborators:** Valeant Pharmaceuticals
- **Conditions:** Hidradenitis Suppurativa
- **Start Date:** 2019-05-28
- **Completion Date:** 2020-06-01
- **CT.gov Last Update:** 2020-06-04

## Brief Summary

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

## Detailed Description

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.

## Eligibility

- **Minimum age:** 18 Years
- **Maximum age:** 99 Years
- **Sex:** ALL
- **Healthy Volunteers:** No

```
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
```

## Arms

- **Intervention** (EXPERIMENTAL) — Brodalumab 210mg subcutaneously every 2 weeks for 24 weeks

## Interventions

- **Brodalumab** (DRUG) — interleukin 17 receptor A antagonist

## Primary Outcomes

- **Biomarkers at Week 12** _(time frame: Week 12 compared with baseline.)_ — Primary Outcomes would be the change in lesional tissue levels of IL-17A, IL-17C, IL-17F and IL-23 measured in pg/mL measured in pg/mL
- **Biomarkers at Week 24** _(time frame: Week 24 compared with baseline.)_ — Primary Outcomes would be the change in lesional tissue levels of IL-17A, IL-17C, IL-17F and IL-23 measured in pg/mL measured in pg/mL
- **Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]** _(time frame: Week 0 to Week 24)_ — Incidence of Grade 2/3 adverse events during the study

## Secondary Outcomes

- **Clinical Response at Week 12 (as measured by HiSCR)** _(time frame: Week 12 compared with Baseline)_
- **Clinical Response at Week 12 (as measured by modified Sartorius Score)** _(time frame: Week 12 compared with Baseline)_
- **Clinical Response at Week 12 (as measured by IHS4)** _(time frame: Week 12 compared with Baseline)_
- **Clinical Response at Week 24 (as measured by HiSCR)** _(time frame: Week 24 compared with Baseline)_
- **Clinical Response at Week 24 (as measured by modified Sartorius Score)** _(time frame: Week 24 compared with Baseline)_
- **Clinical Response at Week 24 (as measured by IHS4)** _(time frame: Week 24 compared with Baseline)_

## Locations (1)

- Rockefeller Unviersity, New York, New York, United States

## Recent Field Changes (last 30 days)

- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.phases` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.maxAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `outcomes.secondary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `sponsor.collaborators` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.rockefeller unviersity|new york|new york|united states` — added _(2026-05-12)_

---

*Canonical: https://parkinsonspathways.com/agent/trials/NCT03960268.md*  
*Source data (authoritative): https://clinicaltrials.gov/study/NCT03960268*  
*This page is a raw mirror with no AI summary, no editorial enrichment, and no Parkinson's-specific filtering.*