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Completed

NCT Number: NCT03960268

Biomarkers In Hidradenitis Suppurativa Participants Receiving Brodalumab

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

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Key information

Conditions

Hidradenitis Suppurativa Bacterial Infections Bacterial Infections and Mycoses Hidradenitis Infections Skin Diseases Skin Diseases, Bacterial Skin Diseases, Infectious Skin and Connective Tissue Diseases Suppuration Sweat Gland Diseases

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

Rockefeller Unviersity

New York, 10065, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Brodalumab

Drug

interleukin 17 receptor A antagonist

Other names: Siliq

Primary outcomes

  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 outcomes

  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)

Sponsors and collaborators

Lead sponsor

Rockefeller University

Other

Collaborators

  • Valeant Pharmaceuticals

Registry information

Official study title

A Pilot Study of Safety and Biomarkers In Hidradenitis Suppurativa Participants Receiving Brodalumab

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
May 23, 2019
Registry last updated
Jun 4, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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