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| Name | Class |
|---|---|
| Valeant Pharmaceuticals | INDUSTRY |
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Phase 0 Study of Brodalumab in patients with moderate to severe Hidradenitis Suppurativa to identify biomarkers of disease activity and clinical response.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention | Experimental | Brodalumab 210mg subcutaneously every 2 weeks for 24 weeks |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Brodalumab | Drug | interleukin 17 receptor A antagonist |
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| 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 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 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| John W Frew, MD | Rockefeller University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rockefeller Unviersity | New York | New York | 10065 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33548397 | Derived | Navrazhina K, Frew JW, Gilleaudeau P, Sullivan-Whalen M, Garcet S, Krueger JG. Epithelialized tunnels are a source of inflammation in hidradenitis suppurativa. J Allergy Clin Immunol. 2021 Jun;147(6):2213-2224. doi: 10.1016/j.jaci.2020.12.651. Epub 2021 Feb 3. |
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| ID | Term |
|---|---|
| D017497 | Hidradenitis Suppurativa |
| ID | Term |
|---|---|
| D017192 | Skin Diseases, Bacterial |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
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| ID | Term |
|---|---|
| C571216 | brodalumab |
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Open Label Single Arm Study
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| 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 |
| D012874 | Skin Diseases, Infectious |
| D013492 | Suppuration |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D016575 | Hidradenitis |
| D013543 | Sweat Gland Diseases |