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The main purpose of this study is to evaluate the efficacy and safety of AVTX-009 compared with placebo in patients with moderate to severe Hidradenitis Suppurativa (HS).
This is a randomized, double-blind, placebo-controlled, parallel-group, Phase 2 study. Patients will be randomized to one of two AVTX-009 dose regimens or matching placebo in a 1:1:1 ratio.
The study will comprise:
The maximum clinical trial duration for each participant is 24 weeks.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AVTX-009 Regimen 1 | Experimental | Patients will receive AVTX-009 regimen 1. |
|
| AVTX-009 Regimen 2 | Experimental | Patients will receive AVTX-009 regimen 2. |
|
| Placebo | Placebo Comparator | Patients will receive matching placebo. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AVTX-009 Regimen 1 | Drug | AVTX-009 will be administered as a subcutaneous injection every 4 weeks. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of patients achieving Hidradenitis Suppurativa Clinical Response 75 (HiSCR75) | HiSCR75 is defined as at least a 75% reduction in the total abscess and inflammatory nodule count, with no increase in abscess count and no increase in draining fistula count, relative to Baseline. | At Week 16 |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of patients achieving HiSCR50 | HiSCR50 is defined as at least a 50% reduction in the total abscess and inflammatory nodule count, with no increase in abscess count and no increase in draining fistula count, relative to Baseline. | At Week 16 |
| Proportion of patients achieving HiSCR90 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinical Site 1022 | Scottsdale | Arizona | 85260 | United States | ||
| Clinical Site 1037 |
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| AVTX-009 Regimen 2 | Drug | AVTX-009 will be administered as a subcutaneous injection every 2 weeks. |
|
| Placebo | Drug | Matching placebo will be administered as a subcutaneous injection every 2 weeks. |
|
HiSCR90 is defined as at least a 90% reduction in the total abscess and inflammatory nodule count, with no increase in abscess count and no increase in draining fistula count, relative to Baseline. |
| At Week 16 |
| Change from Baseline in International HS Severity Score System (IHS4) | IHS4 score is calculated by the number of nodules (multiplied by 1) plus the number of abscesses (multiplied by 2) plus the number of draining tunnels (multiplied by 4). A total score of 3 or less signifies mild disease, 4 to 10 signifies moderate disease, and 11 or higher signifies severe disease. | Baseline (Day 1) and Week 16 |
| Change from Baseline in total abscess and inflammatory nodule (AN) count | An abscess is a circumscribed collection of purulent exudates frequently associated with swelling, erythema, and other signs of inflammation, such as fluctuance, tenderness, and pain. An inflammatory nodule is a raised, deep-seated, three-dimensional, round nodule, greater than 10 mm in diameter. It is tender and erythematous without evidence of fluctuance. | Baseline (Day 1) and Week 16 |
| Change from Baseline in draining fistula count | Draining fistula is defined as a pathologic passageway connecting to the skin surface from dermis or subcutaneous tissue that drains serous or purulent fluid, either spontaneously or by gentle palpation. | Baseline (Day 1) and Week 16 |
| Percentage of patients achieving at least a 30% reduction and at least a 1-unit reduction from Baseline on a Numerical Rating Scale (NRS) in Patient's Global Assessment of Skin Pain (PGA Skin Pain) among subjects with Baseline NRS ≥3 (NRS30) | The skin pain NRS is a single-item measure to capture the patient's self-reported skin pain severity by rating the worst level of skin pain in the last 24 hours as a number on a numerical rating scale from 0 (no pain) to 10 (worst pain imaginable). | Baseline (Day 1) and Week 16 |
| Percentage of patients with flares | The number of patients with flares will be programmatically calculated based on the assessed lesion counts. A flare is defined as ≥ 25% increase in AN count plus an increase of ≥ 2 in AN count compared to Baseline. | From Baseline (Day 1) to Week 16 |
| AVTX-009 anti-drug antibodies (ADA) | The incidence of patients with AVTX-009 anti-drug antibodies (ADA). | From Baseline (Day 1) to Week 20 |
| Safety and tolerability of AVTX-009 | Incidence of adverse events (AEs). | From Baseline (Day 1) to Week 20 |
| Scottsdale |
| Arizona |
| 85260 |
| United States |
| Clinical Site 1026 | Tucson | Arizona | 85704 | United States |
| Clinical Site 1032 | Northridge | California | 91325 | United States |
| Clinical Site 1019 | Pomona | California | 91767 | United States |
| Clinical Site 1009 | Sacramento | California | 95815 | United States |
| Clinical Site 1034 | Santa Monica | California | 90024 | United States |
| Clinical Site 1011 | Washington D.C. | District of Columbia | 20010 | United States |
| Clinical Site 1029 | Boca Raton | Florida | 33486 | United States |
| Clinical Site 1002 | Coral Gables | Florida | 33134 | United States |
| Clinical Site 1015 | Maitland | Florida | 32751 | United States |
| Clinical Site 1027 | North Miami Beach | Florida | 33162-4708 | United States |
| Clinical Site 1013 | Tampa | Florida | 33613 | United States |
| Clinical Site 1008 | Savannah | Georgia | 31419 | United States |
| Clinical Site 1014 | Chicago | Illinois | 60640 | United States |
| Clinical Site 1028 | West Lafayette | Indiana | 47906 | United States |
| Clinical Site 1031 | Bowling Green | Kentucky | 42104 | United States |
| Clinical Site 1024 | Murray | Kentucky | 42071 | United States |
| Clinical Site 1042 | Boston | Massachusetts | 02115-5804 | United States |
| Clinical Site 1001 | Boston | Massachusetts | 02215 | United States |
| Clinical Site 1030 | Detroit | Michigan | 48201 | United States |
| Clinical Site 1007 | Fort Gratiot | Michigan | 48059 | United States |
| Clinical Site 1041 | Oakland | Michigan | 48328 | United States |
| Clinical Site 1003 | Portsmouth | New Hampshire | 03801 | United States |
| Clinical Site 1036 | Brooklyn | New York | 10023 | United States |
| Clinical Site 1016 | New York | New York | 10003 | United States |
| Clinical Site 1023 | The Bronx | New York | 10467 | United States |
| Clinical Site 1020 | Cincinnati | Ohio | 45219 | United States |
| Clinical Site 1010 | Cleveland | Ohio | 44106 | United States |
| Clinical Site 1017 | Dublin | Ohio | 43016 | United States |
| Clinical Site 1004 | Philadelphia | Pennsylvania | 19103 | United States |
| Clinical Site 1035 | Pittsburgh | Pennsylvania | 15213 | United States |
| Clinical Site 1018 | Johnston | Rhode Island | 02919 | United States |
| Clinical Site 1025 | Providence | Rhode Island | 02903 | United States |
| Clinical Site 1005 | Greenville | South Carolina | 29615 | United States |
| Clinical Site 1012 | Arlington | Texas | 76011 | United States |
| Clinical Site 1203 | Darlinghurst | New South Wales | 2010 | Australia |
| Clinical Site 1201 | Westmead | New South Wales | 2145 | Australia |
| Clinical Site 1204 | Woolloongabba | Queensland | 4102 | Australia |
| Clinical Site 1202 | Carlton | Victoria | 3053 | Australia |
| Clinical Site 1303 | Sofia | Sofia-Grad | 1463 | Bulgaria |
| Clinical Site 1302 | Lovech | 5500 | Bulgaria |
| Clinical Site 1301 | Pleven | 5800 | Bulgaria |
| Clinical Site 1304 | Stara Zagora | 6003 | Bulgaria |
| Clinical Site 1105 | Edmonton | Alberta | T5K 1X3 | Canada |
| Clinical Site 1108 | Edmonton | Alberta | T6W 4V4 | Canada |
| Clinical Site 1103 | Barrie | Ontario | L4M 7G1 | Canada |
| Clinical Site 1104 | Hamilton | Ontario | L8L 3C3 | Canada |
| Clinical Site 1107 | London | Ontario | N6A 2C2 | Canada |
| Clinical Site 1106 | Toronto | Ontario | M2N 3A6 | Canada |
| Clinical Site 1110 | Montreal | Quebec | H1Y 3L1 | Canada |
| Clinical Site 1101 | Saskatoon | Saskatchewan | S7K 2C1 | Canada |
| Clinical Site 1111 | Québec | G1W 4R4 | Canada |
| Clinical Site 1401 | Prague | Prague | 100 34 | Czechia |
| Clinical Site 1402 | Prague | Prague | 150 06 | Czechia |
| Clinical Site 1503 | Antony | Hauts-de-Seine | 92160 | France |
| Clinical Site 1505 | Amiens | Picardie | 80054 | France |
| Clinical Site 1502 | Lyon | Rhône | 69003 | France |
| Clinical Site 1501 | Rouen | Seine-Maritime | 76031 | France |
| Clinical Site 1504 | Paris | Île-de-France Region | 75010 | France |
| Clinical Site 1606 | Erlangen | Bavaria | 91054 | Germany |
| Clinical Site 1604 | Frankfurt am Main | Hesse | 60590 | Germany |
| Clinical Site 1601 | Bochum | North Rhine-Westphalia | 44791 | Germany |
| Clinical Site 1602 | Münster | North Rhine-Westphalia | 48149 | Germany |
| Clinical Site 1605 | Dresden | Saxony | 01307 | Germany |
| Clinical Site 2103 | Athens | Attica | 124 62 | Greece |
| Clinical Site 2101 | Athens | Attica | 16121 | Greece |
| Clinical Site 2102 | Efkarpia | Thessaloniki | 56429 | Greece |
| Clinical Site 1901 | Torrette | Ancona | 60126 | Italy |
| Clinical Site 1903 | Rozzano | Milano | 20089 | Italy |
| Clinical Site 1902 | Ferrara | 44124 | Italy |
| Clinical Site 1908 | Milan | 20122 | Italy |
| Clinical Site 1906 | Pisa | 56126 | Italy |
| Clinical Site 1907 | Roma | 00144 | Italy |
| Clinical Site 1904 | Roma | 168 | Italy |
| Clinical Site 1702 | Wroclaw | Kuyavian-Pomeranian Voivodeship | 51-685 | Poland |
| Clinical Site 1706 | Wroclaw | Lower Silesian Voivodeship | 50-566 | Poland |
| Clinical Site 1703 | Bialystok | Podlaskie Voivodeship | 15-453 | Poland |
| Clinical Site 1701 | Warszawa | Pomeranian Voivodeship | 02-507 | Poland |
| Clinical Site 1705 | Warszawa | Pomeranian Voivodeship | 02-962 | Poland |
| Clinical Site 1704 | Ossy | Silesian Voivodeship | 42-624 | Poland |
| Clinical Site 2202 | Svidník | Presov | 089 01 | Slovakia |
| Clinical Site 2201 | Trnava | Trnava Region | 917 75 | Slovakia |
| Clinical Site 1801 | Manises | Valencia | 46940 | Spain |
| Clinical Site 1802 | Granada | 18012 | Spain |
| Clinical Site 1803 | Madrid | 28034 | Spain |
| Clinical Site 1804 | Seville | 41009 | Spain |
| Clinical Site 2001 | Gaziantep | 27310 | Turkey (Türkiye) |
| Clinical Site 2002 | Samsun | 55270 | Turkey (Türkiye) |
| ID | Term |
|---|---|
| D017497 | Hidradenitis Suppurativa |
| ID | Term |
|---|---|
| D017192 | Skin Diseases, Bacterial |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
| D012874 | Skin Diseases, Infectious |
| D013492 | Suppuration |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D016575 | Hidradenitis |
| D013543 | Sweat Gland Diseases |
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