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Biomarkers In Hidradenitis Suppurativa Participants Receiving Brodalumab

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ClinicalTrials.gov Identifier: NCT03960268
Recruitment Status : Recruiting
First Posted : May 23, 2019
Last Update Posted : June 4, 2019
Sponsor:
Collaborator:
Valeant Pharmaceuticals
Information provided by (Responsible Party):
Rockefeller University

Brief Summary:
Phase 0 Study 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 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Intervention Model: Single Group Assignment
Intervention Model Description: Open Label Single Arm Study
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: A Pilot Study of Safety and Biomarkers In Hidradenitis Suppurativa Participants Receiving Brodalumab
Actual Study Start Date : May 28, 2019
Estimated Primary Completion Date : February 28, 2020
Estimated Study Completion Date : June 30, 2020

Resource links provided by the National Library of Medicine

Drug Information available for: Brodalumab

Arm Intervention/treatment
Experimental: Intervention
Brodalumab 210mg subcutaneously every 2 weeks 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 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 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)



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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

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

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): NCT03960268


Contacts
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Contact: Recruitment Office 1-800-782-2737 rucares@rocekfeller.edu

Locations
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United States, New York
Rockefeller Unviersity Recruiting
New York, New York, United States, 10065
Contact: John W Frew, MD    212-327-7153    jfrew@rockefeller.edu   
Principal Investigator: John W Frew, MD         
Sponsors and Collaborators
Rockefeller University
Valeant Pharmaceuticals
Investigators
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Principal Investigator: John W Frew, MD Rockefeller University

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Responsible Party: Rockefeller University
ClinicalTrials.gov Identifier: NCT03960268     History of Changes
Other Study ID Numbers: JFR-0989
First Posted: May 23, 2019    Key Record Dates
Last Update Posted: June 4, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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:
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Sweat Gland Diseases
Hidradenitis
Hidradenitis Suppurativa
Skin Diseases
Skin Diseases, Bacterial
Bacterial Infections
Skin Diseases, Infectious
Infection
Suppuration
Brodalumab
Antibodies, Monoclonal
Dermatologic Agents
Immunologic Factors
Physiological Effects of Drugs