Back to resultsAn Alternative Dose Interval Study in Participants With Hidradenitis Suppurativa Receiving Brodalumab
Primary Purpose
Hidradenitis Suppurativa
Status
Withdrawn
Phase
Early Phase 1
Locations
United States
Study Type
Interventional
Intervention
Brodalumab
Sponsored by
About this trial
This is an interventional basic science trial for Hidradenitis Suppurativa focused on measuring Hidradenitis Suppurativa, Acne Inversa, Brodalumab
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
- Previously enrolled in JFR-0989
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
Sites / Locations
- Rockefeller University Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Brodalumab
Arm Description
Brodalumab 210mg subcutaneously every week 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
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
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
NCT ID
NCT04249713
First Posted
January 29, 2020
Last Updated
September 2, 2020
Sponsor
Rockefeller University
1. Study Identification
Unique Protocol Identification Number
NCT04249713
Brief Title
An Alternative Dose Interval Study in Participants With Hidradenitis Suppurativa Receiving Brodalumab
Official Title
An Alternative Dose Interval Study to Examine Safety and Identify Potential Biomarkers in Participants With Hidradenitis Suppurativa Receiving Brodalumab
Study Type
Interventional
2. Study Status
Record Verification Date
September 2020
Overall Recruitment Status
Withdrawn
Why Stopped
Biomarker Samples Not Collected
Study Start Date
February 3, 2020 (Actual)
Primary Completion Date
July 2020 (Anticipated)
Study Completion Date
September 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Rockefeller University
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 an alternative dosing interval 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 an alternative dosing interval of Brodalumab in patients with moderate to severe Hidradenitis Suppurativa. Consisting of n=10 patients receiving 210mg subcutaneously every week 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
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Brodalumab
Arm Type
Experimental
Arm Description
Brodalumab 210mg subcutaneously every week 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
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
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
Previously enrolled in JFR-0989
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
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 University Hospital
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
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An Alternative Dose Interval Study in Participants With Hidradenitis Suppurativa Receiving Brodalumab
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