NCT03960268

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for early_phase_1

Timeline
Completed

Started May 2019

Shorter than P25 for early_phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 20, 2019

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 23, 2019

Completed
5 days until next milestone

Study Start

First participant enrolled

May 28, 2019

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2020

Completed
Last Updated

June 4, 2020

Status Verified

June 1, 2020

Enrollment Period

1 year

First QC Date

May 20, 2019

Last Update Submit

June 3, 2020

Conditions

Hidradenitis Suppurativa

Keywords

Hidradenitis SuppurativaAcne InversaBrodalumab

Outcome Measures

Primary Outcomes (3)

  • Biomarkers at Week 12

    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

    Week 12 compared with baseline.

  • Biomarkers at Week 24

    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

    Week 24 compared with baseline.

  • Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]

    Incidence of Grade 2/3 adverse events during the study

    Week 0 to Week 24

Secondary Outcomes (6)

  • Clinical Response at Week 12 (as measured by HiSCR)

    Week 12 compared with Baseline

  • Clinical Response at Week 12 (as measured by modified Sartorius Score)

    Week 12 compared with Baseline

  • Clinical Response at Week 12 (as measured by IHS4)

    Week 12 compared with Baseline

  • Clinical Response at Week 24 (as measured by HiSCR)

    Week 24 compared with Baseline

  • Clinical Response at Week 24 (as measured by modified Sartorius Score)

    Week 24 compared with Baseline

  • +1 more secondary outcomes

Study Arms (1)

Intervention

EXPERIMENTAL

Brodalumab 210mg subcutaneously every 2 weeks for 24 weeks

Drug: Brodalumab

Interventions

BrodalumabDRUG

interleukin 17 receptor A antagonist

Also known as: Siliq
Intervention

Eligibility Criteria

Age18 Years - 99 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rockefeller Unviersity

New York, New York, 10065, United States

Location

Related Publications (1)

  • Navrazhina K, Frew JW, Gilleaudeau P, Sullivan-Whalen M, Garcet S, Krueger JG. Epithelialized tunnels are a source of inflammation in hidradenitis suppurativa. J Allergy Clin Immunol. 2021 Jun;147(6):2213-2224. doi: 10.1016/j.jaci.2020.12.651. Epub 2021 Feb 3.

    PMID: 33548397DERIVED

MeSH Terms

Conditions

Hidradenitis Suppurativa

Interventions

brodalumab

Condition Hierarchy (Ancestors)

Skin Diseases, BacterialBacterial InfectionsBacterial Infections and MycosesInfectionsSkin Diseases, InfectiousSuppurationSkin DiseasesSkin and Connective Tissue DiseasesHidradenitisSweat Gland Diseases

Study Officials

  • John W Frew, MD

    Rockefeller University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Model Details: Open Label Single Arm Study
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 20, 2019

First Posted

May 23, 2019

Study Start

May 28, 2019

Primary Completion

June 1, 2020

Study Completion

June 1, 2020

Last Updated

June 4, 2020

Record last verified: 2020-06

Data Sharing

IPD Sharing
Will not share

Locations

US(1)