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Biomarkers In Hidradenitis Suppurativa Participants Receiving Brodalumab

Primary Purpose

Hidradenitis Suppurativa

Status
Completed
Phase
Early Phase 1
Locations
United States
Study Type
Interventional
Intervention
Brodalumab
Sponsored by
Rockefeller University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Hidradenitis Suppurativa focused on measuring Hidradenitis Suppurativa, Acne Inversa, Brodalumab

Eligibility Criteria

18 Years - 99 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Rockefeller Unviersity

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Intervention

Arm Description

Brodalumab 210mg subcutaneously every 2 weeks for 24 weeks

Outcomes

Primary Outcome Measures

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
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
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Incidence of Grade 2/3 adverse events during the study

Secondary Outcome Measures

Clinical Response at Week 12 (as measured by HiSCR)
Clinical Response compared to baseline as assessed by the HiSCR (Hidradenitis Suppurativa Clinical Response) Defined as a greater than or equal to 50% reduction in inflammatory lesion count (abscesses plus inflammatory nodules), and no increase in abscesses or draining fistulas at Week 12 when compared with baseline
Clinical Response at Week 12 (as measured by modified Sartorius Score)
Clinical Response compared to baseline as assessed by the modified Sartorius Score as follows: Sum of separate scoring for each affected area using the data recorded as follows: a) 3 points per anatomical region involved; b) 6 points for each fistula and 1 point for each nodule or abscess; c) 1 point when the longest distance between two relevant lesions in each affected area is <5 cm; 3 points when it is 5-10 cm; and 9 points when it is >10 cm; d) 9 points when there is no clear separation of lesions from adjacent normal skin and 0 points when there is.
Clinical Response at Week 12 (as measured by IHS4)
Clinical Response compared to baseline as assessed by IHS4 (International Hidradenitis Suppurativa Severity Score) using the scoring system as follows: Total= (Number of nodules x1) + (Number of abscesses x2) + (Number of draining sinuses/fistulae x4)
Clinical Response at Week 24 (as measured by HiSCR)
Clinical Response compared to baseline as assessed by the HiSCR (Hidradenitis Suppurativa Clinical Response) Defined as a greater than or equal to 50% reduction in inflammatory lesion count (abscesses plus inflammatory nodules), and no increase in abscesses or draining fistulas at Week 24 when compared with baseline
Clinical Response at Week 24 (as measured by modified Sartorius Score)
Clinical Response compared to baseline as assessed by the modified Sartorius Score as follows: Sum of separate scoring for each affected area using the data recorded as follows: a) 3 points per anatomical region involved; b) 6 points for each fistula and 1 point for each nodule or abscess; c) 1 point when the longest distance between two relevant lesions in each affected area is <5 cm; 3 points when it is 5-10 cm; and 9 points when it is >10 cm; d) 9 points when there is no clear separation of lesions from adjacent normal skin and 0 points when there is.
Clinical Response at Week 24 (as measured by IHS4)
Clinical Response compared to baseline as assessed by IHS4 (International Hidradenitis Suppurativa Severity Score) using the scoring system as follows: Total= (Number of nodules x1) + (Number of abscesses x2) + (Number of draining sinuses/fistulae x4)

Full Information

First Posted
May 20, 2019
Last Updated
June 3, 2020
Sponsor
Rockefeller University
Collaborators
Valeant Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT03960268
Brief Title
Biomarkers In Hidradenitis Suppurativa Participants Receiving Brodalumab
Official Title
A Pilot Study of Safety and Biomarkers In Hidradenitis Suppurativa Participants Receiving Brodalumab
Study Type
Interventional

2. Study Status

Record Verification Date
June 2020
Overall Recruitment Status
Completed
Study Start Date
May 28, 2019 (Actual)
Primary Completion Date
June 1, 2020 (Actual)
Study Completion Date
June 1, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Rockefeller University
Collaborators
Valeant Pharmaceuticals

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hidradenitis Suppurativa
Keywords
Hidradenitis Suppurativa, Acne Inversa, Brodalumab

7. Study Design

Primary Purpose
Basic Science
Study Phase
Early Phase 1
Interventional Study Model
Single Group Assignment
Model Description
Open Label Single Arm Study
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention
Arm Type
Experimental
Arm Description
Brodalumab 210mg subcutaneously every 2 weeks for 24 weeks
Intervention Type
Drug
Intervention Name(s)
Brodalumab
Other Intervention Name(s)
Siliq
Intervention Description
interleukin 17 receptor A antagonist
Primary Outcome Measure Information:
Title
Biomarkers at Week 12
Description
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
Time Frame
Week 12 compared with baseline.
Title
Biomarkers at Week 24
Description
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
Time Frame
Week 24 compared with baseline.
Title
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Description
Incidence of Grade 2/3 adverse events during the study
Time Frame
Week 0 to Week 24
Secondary Outcome Measure Information:
Title
Clinical Response at Week 12 (as measured by HiSCR)
Description
Clinical Response compared to baseline as assessed by the HiSCR (Hidradenitis Suppurativa Clinical Response) Defined as a greater than or equal to 50% reduction in inflammatory lesion count (abscesses plus inflammatory nodules), and no increase in abscesses or draining fistulas at Week 12 when compared with baseline
Time Frame
Week 12 compared with Baseline
Title
Clinical Response at Week 12 (as measured by modified Sartorius Score)
Description
Clinical Response compared to baseline as assessed by the modified Sartorius Score as follows: Sum of separate scoring for each affected area using the data recorded as follows: a) 3 points per anatomical region involved; b) 6 points for each fistula and 1 point for each nodule or abscess; c) 1 point when the longest distance between two relevant lesions in each affected area is <5 cm; 3 points when it is 5-10 cm; and 9 points when it is >10 cm; d) 9 points when there is no clear separation of lesions from adjacent normal skin and 0 points when there is.
Time Frame
Week 12 compared with Baseline
Title
Clinical Response at Week 12 (as measured by IHS4)
Description
Clinical Response compared to baseline as assessed by IHS4 (International Hidradenitis Suppurativa Severity Score) using the scoring system as follows: Total= (Number of nodules x1) + (Number of abscesses x2) + (Number of draining sinuses/fistulae x4)
Time Frame
Week 12 compared with Baseline
Title
Clinical Response at Week 24 (as measured by HiSCR)
Description
Clinical Response compared to baseline as assessed by the HiSCR (Hidradenitis Suppurativa Clinical Response) Defined as a greater than or equal to 50% reduction in inflammatory lesion count (abscesses plus inflammatory nodules), and no increase in abscesses or draining fistulas at Week 24 when compared with baseline
Time Frame
Week 24 compared with Baseline
Title
Clinical Response at Week 24 (as measured by modified Sartorius Score)
Description
Clinical Response compared to baseline as assessed by the modified Sartorius Score as follows: Sum of separate scoring for each affected area using the data recorded as follows: a) 3 points per anatomical region involved; b) 6 points for each fistula and 1 point for each nodule or abscess; c) 1 point when the longest distance between two relevant lesions in each affected area is <5 cm; 3 points when it is 5-10 cm; and 9 points when it is >10 cm; d) 9 points when there is no clear separation of lesions from adjacent normal skin and 0 points when there is.
Time Frame
Week 24 compared with Baseline
Title
Clinical Response at Week 24 (as measured by IHS4)
Description
Clinical Response compared to baseline as assessed by IHS4 (International Hidradenitis Suppurativa Severity Score) using the scoring system as follows: Total= (Number of nodules x1) + (Number of abscesses x2) + (Number of draining sinuses/fistulae x4)
Time Frame
Week 24 compared with Baseline

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
John W Frew, MD
Organizational Affiliation
Rockefeller University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Rockefeller Unviersity
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
33548397
Citation
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.
Results Reference
derived

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Biomarkers In Hidradenitis Suppurativa Participants Receiving Brodalumab

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