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| ID | Type | Description | Link |
|---|---|---|---|
| VELA-OLE | Other Identifier | Sponsor |
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This is a study to evaluate the long-term safety, tolerability, and efficacy of sonelokimab in participants with moderate to severe hidradenitis suppurativa who were previously enrolled in a parental study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental: sonelokimab | Experimental | All participants will receive sonelokimab 120 mg Q4W for up to 2 years |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sonelokimab | Drug | Sonelokimab |
|
| Measure | Description | Time Frame |
|---|---|---|
| Long-term safety and tolerability of sonelokimab: Adverse events (AEs) following treatment with sonelokimab | Incidence, relatedness, severity and seriousness of all AEs | 2.5-3 years |
| Long-term safety and tolerability of sonelokimab: Treatment emergent adverse events (TEAEs) | Incidence, relatedness, severity and seriousness of all TEAEs | 2.5-3 years |
| Long-term safety and tolerability of sonelokimab: Adverse events of special interest (AESIs) | Incidence, relatedness, severity and seriousness of all AESIs | 2.5-3 years |
| Long-term safety and tolerability of sonelokimab: Discontinuation of sonelokimab treatment due to AEs | Number of participants discontinued from sonelokimab treatment due to AEs | 2.5-3 years |
| Long-term safety and tolerability of sonelokimab: Clinically significant changes in clinical laboratory parameters | Number of participants with clinically significant changes in hematology, biochemistry and urinalysis from baseline | 2.5-3 years |
| Long-term safety and tolerability of sonelokimab: Clinically significant changes in vital signs and standard 12-lead electrocardiogram | Number of participants with clinically significant changes in vital signs and 12-lead ECG intervals from baseline | 2.5-3 years |
| Measure | Description | Time Frame |
|---|---|---|
| Long-term efficacy of sonelokimab: Hidradenitis Suppurativa Clinical Response 75 (HiSCR75) | Percentage of participants achieving a HiSCR75 response over time | 2.5 - 3 years |
| Long-term efficacy of sonelokimab: Hidradenitis Suppurativa Clinical Response 90 (HiSCR90) and 50 (HiSCR50) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinical Site | Birmingham | Alabama | 35244 | United States | ||
| Clinical Site |
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Percentage of participants achieving a HiSCR90 and HiSCAR50 response over time |
| 2.5 - 3 years |
| Long-term efficacy of sonelokimab: International Hidradenitis Suppurativa Severity Score System (IHS4) | Absolute change in IHS4 score over time | 2.5 - 3 years |
| Long-term efficacy of sonelokimab: Number of abscesses, draining fistulas/tunnels; inflammatory nodules | Absolute change in number of abscesses, draining fistulas/tunnels; inflammatory nodules | 2.5 - 3 years |
| Long-term efficacy of sonelokimab: Dermatology Life Quality Index (DLQI) | Change in DLQI total score | 2.5 - 3 years |
| Long-term efficacy of sonelokimab: Hidradenitis Suppurativa Quality of Life (HiSQOL) | Change in HiSQOL total score | 2.5 - 3 years |
| North Little Rock |
| Arkansas |
| 72117 |
| United States |
| Clinical Site | Los Angeles | California | 90404 | United States |
| Clinical Site | Northridge | California | 91325 | United States |
| Clinical Site | Aventura | Florida | 33180 | United States |
| Clinical Site | Coral Gables | Florida | 33134 | United States |
| Clinical Site | Hialeah | Florida | 33012 | United States |
| Clinical Site | Hollywood | Florida | 33021-6746 | United States |
| Clinical Site | Miami | Florida | 33136 | United States |
| Clinical Site | Miami | Florida | 33163 | United States |
| Clinical Site | Ocala | Florida | 34471 | United States |
| Clinical Site | Tampa | Florida | 33607 | United States |
| Clinical Site | Tampa | Florida | 33613 | United States |
| Clinical Site | Macon | Georgia | 31217 | United States |
| Clinical Site | Sandy Springs | Georgia | 30328 | United States |
| Clinical Site | Skokie | Illinois | 60077 | United States |
| Clinical Site | West Dundee | Illinois | 60118 | United States |
| Clinical Site | Columbus | Indiana | 47201 | United States |
| Clinical Site | New Albany | Indiana | 47150 | United States |
| Clinical Site | Plainfield | Indiana | 46168 | United States |
| Clinical Site | Louisville | Kentucky | 40241 | United States |
| Clinical Site | Murray | Kentucky | 42071 | United States |
| Clinical Site | Metairie | Louisiana | 70006 | United States |
| Clinical Site | Boston | Massachusetts | 02116 | United States |
| Clinical Site | Boston | Massachusetts | 02215 | United States |
| Clinical Site | Ann Arbor | Michigan | 48109-5314 | United States |
| Clinical Site | Canton | Michigan | 48187 | United States |
| Clinical Site | Clarkston | Michigan | 48346 | United States |
| Clinical Site | Waterford | Michigan | 48328 | United States |
| Clinical Site | New Brighton | Minnesota | 55112 | United States |
| Clinical Site | Omaha | Nebraska | 68144 | United States |
| Clinical Site | Las Vegas | Nevada | 89148 | United States |
| Clinical Site | New York | New York | 10003 | United States |
| Clinical Site | New York | New York | 10012 | United States |
| Clinical Site | The Bronx | New York | 10467 | United States |
| Clinical Site | Fargo | North Dakota | 58103 | United States |
| Clinical Site | Boardman | Ohio | 44512 | United States |
| Clinical Site | Columbus | Ohio | 43213 | United States |
| Clinical Site | Dayton | Ohio | 45324 | United States |
| Clinical Site | Oklahoma City | Oklahoma | 73118 | United States |
| Clinical Site | Murfreesboro | Tennessee | 37130 | United States |
| Clinical Site | Dallas | Texas | 75235 | United States |
| Clinical Site | Dallas | Texas | 75246 | United States |
| Clinical Site | Houston | Texas | 77004 | United States |
| Clinical Site | San Antonio | Texas | 78213 | United States |
| Clinical Site | San Antonio | Texas | 78218 | United States |
| Clinical Site | South Jordan | Utah | 84095 | United States |
| Clinical Site | Mill Creek | Washington | 98012 | United States |
| Clinical Site | Morgantown | West Virginia | 26505 | United States |
| Clinical Site | Ghent | 9000 | Belgium |
| Clinical Site | Leuven | 3000 | Belgium |
| Clinical Site | Pleven | Ontario | 5800 | Bulgaria |
| Clinical Site | Sofia | Ontario | 1463 | Bulgaria |
| Clinical Site | Stara Zagora | Ontario | 6003 | Bulgaria |
| Clinical Site | Sofia | 1407 | Bulgaria |
| Clinical Site | Sofia | 1431 | Bulgaria |
| Clinical Site | Sofia | 1510 | Bulgaria |
| Clinical Site | Sofia | 1606 | Bulgaria |
| Clinical Site | Calgary | Alberta | T3E 0B2 | Canada |
| Clinical Site | Edmonton | Alberta | T6G 1C3 | Canada |
| Clinical Site | Edmonton | Alberta | T6H 4J8 | Canada |
| Clinical Site | Sherwood Park | Alberta | T8H 0P1 | Canada |
| Clinical Site | Winnipeg | Manitoba | R3M 3Z4 | Canada |
| Clinical Site | Fredericton | New Brunswick | E3B 1G9 | Canada |
| Clinical Site | Barrie | Ontario | L4M 7G1 | Canada |
| Clinical Site | Guelph | Ontario | N0B 2J0 | Canada |
| Clinical Site | London | Ontario | N6H 5L5 | Canada |
| Clinical Site | Markham | Ontario | L3P 1X3 | Canada |
| Clinical Site | Newmarket | Ontario | L3Y 5G8 | Canada |
| Clinical Site | Peterborough | Ontario | K9J 5K2 | Canada |
| Clinical Site | Toronto | Ontario | M2N 3A6 | Canada |
| Clinical Site | Toronto | Ontario | M4E 1R7 | Canada |
| Clinical Site | Toronto | Ontario | M5A3R6 | Canada |
| Clinical Site | Montreal | Quebec | H1Y 3L1 | Canada |
| Clinical Site | Québec | Quebec | G1W 4R4 | Canada |
| Clinical Site | Saskatoon | Saskatchewan | S7K 2C1 | Canada |
| Clinical Site | Ostrava | 708 52 | Czechia |
| Clinical Site | Prague | 110 00 | Czechia |
| Clinical Site | Brest | 29200 | France |
| Clinical Site | Lyon | 69003 | France |
| Clinical Site | Saint-Mandé | 94160 | France |
| Clinical Site | Saint-Priest-en-Jarez | 42270 | France |
| Clinical Site | Halle | Saale | 06108 | Germany |
| Clinical Site | Augsburg | 86179 | Germany |
| Clinical Site | Bad Bentheim | 48455 | Germany |
| Clinical Site | Berlin | 10117 | Germany |
| Clinical Site | Berlin | 10789 | Germany |
| Clinical Site | Bielefeld | 33647 | Germany |
| Clinical Site | Bochum | 44791 | Germany |
| Clinical Site | Bochum | 44793 | Germany |
| Clinical Site | Bramsche | 49565 | Germany |
| Clinical Site | Darmstadt | 64283 | Germany |
| Clinical Site | Dresden | 01307 | Germany |
| Clinical Site | Erlangen | 91054 | Germany |
| Clinical Site | Frankfurt | 60590 | Germany |
| Clinical Site | Hanover | 30159 | Germany |
| Clinical Site | Kiel | 24105 | Germany |
| Clinical Site | Langenau | 89129 | Germany |
| Clinical Site | Lübeck | 23538 | Germany |
| Clinical Site | Mahlow | 15831 | Germany |
| Clinical Site | Münster | 48149 | Germany |
| Clinical Site | Wuppertal | 42283 | Germany |
| Clinical Site | Würzburg | 97080 | Germany |
| Clinical Site | Debrecen | 4026 | Hungary |
| Clinical Site | Debrecen | 4032 | Hungary |
| Clinical Site | Pécs | 7632 | Hungary |
| Clinical Site | Catania | 95123 | Italy |
| Clinical Site | Chieti | 66013 | Italy |
| Clinical Site | Cona | 44124 | Italy |
| Clinical Site | Florence | 50122 | Italy |
| Clinical Site | Milan | 20122 | Italy |
| Clinical Site | Modena | 41126 | Italy |
| Clinical Site | Naples | 80131 | Italy |
| Clinical Site | Perugia | 06129 | Italy |
| Clinical Site | Pisa | 56126 | Italy |
| Clinical Site | Roma | 00168 | Italy |
| Clinical Site | Rozzano | 20089 | Italy |
| Clinical Site | Torino | 10126 | Italy |
| Clinical Site | Torrette | 60126 | Italy |
| Clinical Site | Rotterdam | 3015 GD | Netherlands |
| Clinical Site | Oslo | 0424 | Norway |
| Clinical Site | Bialystok | 15-453 | Poland |
| Clinical Site | Chorzów | 41-516 | Poland |
| Clinical Site | Gdansk | 80-214 | Poland |
| Clinical Site | Katowice | 40-611 | Poland |
| Clinical Site | Kielce | 25-316 | Poland |
| Clinical Site | Krakow | 30-002 | Poland |
| Clinical Site | Krakow | 30-727 | Poland |
| Clinical Site | Lodz | 90-265 | Poland |
| Clinical Site | Lodz | 90-436 | Poland |
| Clinical Site | Lublin | 20-573 | Poland |
| Clinical Site | Ossy | 42-624 | Poland |
| Clinical Site | Poznan | 60-539 | Poland |
| Clinical Site | Poznan | 60-848 | Poland |
| Clinical Site | Sosnowiec | 41-200 | Poland |
| Clinical Site | Szczecin | 70-332 | Poland |
| Clinical Site | Szczecin | 71-270 | Poland |
| Clinical Site | Warsaw | 00-710 | Poland |
| Clinical Site | Warsaw | 02-507 | Poland |
| Clinical Site | Warsaw | 02-692 | Poland |
| Clinical Site | Warsaw | 02-953 | Poland |
| Clinical Site | Wroclaw | 50566 | Poland |
| Clinical Site | Wroclaw | 51-503 | Poland |
| Clinical Site | Lisbon | 1169-050 | Portugal |
| Clinical Site | Lisbon | 1649-035 | Portugal |
| Clinical Site | Porto | 4050-342 | Portugal |
| Clinical Site | Trnava | 91775 | Slovakia |
| Clinical Site | Alicante | 03010 | Spain |
| Clinical Site | Badalona | 08916 | Spain |
| Clinical Site | Barcelona | 08003 | Spain |
| Clinical Site | Cadiz | 11009 | Spain |
| Clinical Site | Córdoba | 14004 | Spain |
| Clinical Site | Granada | 18012 | Spain |
| Clinical Site | Granada | 18014 | Spain |
| Clinical Site | Granollers | 08402 | Spain |
| Clinical Site | Madrid | 28006 | Spain |
| Clinical Site | Madrid | 28041 | Spain |
| Clinical Site | Madrid | 28046 | Spain |
| Clinical Site | Manises | 46940 | Spain |
| Clinical Site | Málaga | 29010 | Spain |
| Clinical Site | Santiago de Compostela | 15706 | Spain |
| Clinical Site | Seville | 41009 | Spain |
| Clinical Site | Valencia | 46014 | Spain |
| Clinical Site | Valencia | 46026 | Spain |
| Clinical Site | Leeds | LS9 7TF | United Kingdom |
| Clinical Site | Salford | M6 8HD | United Kingdom |
| ID | Term |
|---|---|
| D017497 | Hidradenitis Suppurativa |
| D016575 | Hidradenitis |
| D013543 | Sweat Gland Diseases |
| D012871 | Skin Diseases |
| D017192 | Skin Diseases, Bacterial |
| D013492 | Suppuration |
| ID | Term |
|---|---|
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
| D012874 | Skin Diseases, Infectious |
| D017437 | Skin and Connective Tissue Diseases |
| D007249 | Inflammation |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| C000720946 | sonelokimab |
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