Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

An Alternative Dose Interval Study in Participants With Hidradenitis Suppurativa Receiving Brodalumab

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04249713
Recruitment Status : Withdrawn (Biomarker Samples Not Collected)
First Posted : January 31, 2020
Last Update Posted : September 4, 2020
Sponsor:
Information provided by (Responsible Party):
Rockefeller University

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.

Condition or disease Intervention/treatment Phase
Hidradenitis Suppurativa Drug: Brodalumab Early Phase 1

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: Open Label Single Arm Study
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: An Alternative Dose Interval Study to Examine Safety and Identify Potential Biomarkers in Participants With Hidradenitis Suppurativa Receiving Brodalumab
Actual Study Start Date : February 3, 2020
Estimated Primary Completion Date : July 2020
Estimated Study Completion Date : September 2020

Resource links provided by the National Library of Medicine

Drug Information available for: Brodalumab

Arm Intervention/treatment
Experimental: Brodalumab
Brodalumab 210mg subcutaneously every week for 24 weeks
Drug: Brodalumab
Interleukin 17 Receptor A Antagonist
Other Name: Siliq




Primary Outcome Measures :
  1. 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

  2. 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

  3. 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 Outcome Measures :
  1. Clinical Response at Week 12 (as measured by HiSCR) [ Time Frame: Week 12 compared with Baseline ]
    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

  2. Clinical Response at Week 12 (as measured by modified Sartorius Score) [ Time Frame: Week 12 compared with Baseline ]
    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.

  3. Clinical Response at Week 12 (as measured by IHS4) [ Time Frame: Week 12 compared with Baseline ]
    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)

  4. Clinical Response at Week 24 (as measured by HiSCR) [ Time Frame: Week 24 compared with Baseline ]
    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

  5. Clinical Response at Week 24 (as measured by modified Sartorius Score) [ Time Frame: Week 24 compared with Baseline ]
    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.

  6. Clinical Response at Week 24 (as measured by IHS4) [ Time Frame: Week 24 compared with Baseline ]
    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)



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04249713


Locations
Layout table for location information
United States, New York
Rockefeller University Hospital
New York, New York, United States, 10065
Sponsors and Collaborators
Rockefeller University
Investigators
Layout table for investigator information
Principal Investigator: John W Frew, MD Rockefeller University
Layout table for additonal information
Responsible Party: Rockefeller University
ClinicalTrials.gov Identifier: NCT04249713    
Other Study ID Numbers: JFR-0999
First Posted: January 31, 2020    Key Record Dates
Last Update Posted: September 4, 2020
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
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
Keywords provided by Rockefeller University:
Hidradenitis Suppurativa
Acne Inversa
Brodalumab
Additional relevant MeSH terms:
Layout table for MeSH terms
Hidradenitis Suppurativa
Hidradenitis
Sweat Gland Diseases
Skin Diseases
Skin Diseases, Bacterial
Bacterial Infections
Skin Diseases, Infectious
Infection
Suppuration
Brodalumab
Dermatologic Agents