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

Study Overview
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Brief Summary
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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
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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.

Official Title
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An Alternative Dose Interval Study to Examine Safety and Identify Potential Biomarkers in Participants With Hidradenitis Suppurativa Receiving Brodalumab

Conditions
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Hidradenitis Suppurativa

Intervention / Treatment
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* Drug: Brodalumab


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 99 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Intervention Model: Single Group Assignment
Interventional Model Description: Open Label Single Arm Study
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Brodalumab<br>Brodalumab 210mg subcutaneously every week for 24 weeks | Drug: Brodalumab<br>* Interleukin 17 Receptor A Antagonist<br>* Other names: Siliq;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | Week 12 compared with baseline. | 
| 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 | Week 24 compared with baseline. | 
| Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] | Incidence of Grade 2/3 adverse events during the study | Week 0 to Week 24 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | Week 12 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. | Week 12 compared with Baseline | 
| 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) | Week 12 compared with Baseline | 
| 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 | Week 24 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. | Week 24 compared with Baseline | 
| 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) | Week 24 compared with Baseline | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hidradenitis Suppurativa, Acne Inversa, Brodalumab