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|---|---|---|---|
| VELA-2 | Other Identifier | Sponsor |
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This is a study to evaluate the clinical efficacy and safety of sonelokimab administered subcutaneously compared with placebo in the treatment of adult participants with moderate to severe hidradenitis suppurativa. Participants will be randomized 2:1 to either sonelokimab or matching placebo up to Week 16.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| sonelokimab | Experimental | Subjects randomized to this arm will receive sonelokimab 120 mg Q2W from Weeks 0 to 6 then 120 mg Q4W starting at Week 8 up to Week 48. |
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| Placebo | Placebo Comparator | Subjects randomized to this arm will receive placebo Q2W from Weeks 0 to 6 then Q4W starting at Week 8 up to Week 16. They will receive sonelokimab 120 mg Q2W for 4 doses from Weeks 16 to 22 then Q4W from Week 24 up to Week 48 |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sonelokimab | Drug | Sonelokimab |
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Hidradenitis Suppurativa Clinical Response 75 | Percentage of participants achieving Hidradenitis Suppurativa Clinical Response 75 (HiSCR75), where HiSCR75 is defined as at least a 75% reduction from baseline in abscess and inflammatory nodule (AN) count, with no increase from baseline in abscess or draining fistula count. | Week 16 |
| Measure | Description | Time Frame |
|---|---|---|
| Hidradenitis Suppurativa Clinical Response 50 (HiSCR50) | Percentage of participants achieving HiSCR50 | Week 16 |
| Change in International Hidradenitis Suppurativa Severity Score System | Absolute change from baseline in International Hidradenitis Suppurativa Severity Score System (IHS4) The IHS4 score is calculated as follows: number of nodules (multiplied by 1) + number of abscesses (multiplied by 2) + number of draining tunnels (multiplied by 4). A total score of 3 or less signifies mild, 4 to 10 signifies moderate, and 11 or higher signifies severe disease. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Prof Kristian Reich, M.D., Ph.D. (equ.) | MoonLake Immunotherapeutics AG | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinical Site | Birmingham | Alabama | 35244 | United States | ||
| Clinical Site |
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| Drug |
Placebo |
|
| Week 16 |
| Dermatology Life Quality Index (DLQI) | Percentage of participants achieving a DLQI total reduction of ≥4 minimal clinically important difference among participants with a baseline DLQI ≥4. DLQI produces a numeric score that can range from 0 to 30. A higher score indicates greater health related quality of life impairment. | Week 16 |
| Reduction from Numerical Rating Scale (NRS30 & NRS50) in Patient's Global Assessment of Skin Pain (PGA Skin Pain) | Percentage of participants achieving at least ≥30% (and ≥50%) reduction and at least 2-unit reduction from Baseline in Numerical Rating Scale (NRS30 & NRS50) in Patient's Global Assessment of Skin Pain (PGA Skin Pain) among subjects with Baseline NRS ≥3 | week 16 |
| Patient Global Impression - Severity of Illness - Hidradenitis Suppurativa at Week 16 | Percentage of participants with minimal or absent symptoms using the Patient Global Impression - Severity of Illness - Hidradenitis Suppurativa at Week 16. Participants choose the response that best describes the severity of their disease. The question is rated on a 7-point scale ranging from 0 to 6 (0=absent; 1=minimal; 2=mild; 3=moderate; 4=moderately severe; 5=severe; 6=very severe). | Week 16 |
| Resolution of draining tunnels (DT100) | Percentage of participants with zero draining tunnels in the subgroup of participants with at least one draining tunnel at baseline (DT100) | Week 16 and Week 52 |
| North Little Rock |
| Arkansas |
| 72117 |
| United States |
| Clinical Site | Fountain Valley | California | 92708 | United States |
| Clinical Site | Santa Monica | California | 90404 | United States |
| Clinical Site | Aventura | Florida | 33180 | United States |
| Clinical Site | Hialeah | Florida | 33012 | United States |
| Clinical Site | Miami | Florida | 33136 | United States |
| Clinical Site | Ocala | Florida | 34470 | United States |
| Clinical Site | Tampa | Florida | 33613 | United States |
| Clinical Site | Skokie | Illinois | 60077 | United States |
| Clinical Site | Plainfield | Indiana | 46168 | United States |
| Clinical Site | Murray | Kentucky | 42071 | United States |
| Clinical Site | Baton Rouge | Louisiana | 70809 | United States |
| Clinical Site | Baltimore | Maryland | 21287 | 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 | 89145 | United States |
| Clinical Site | New York | New York | 10003 | United States |
| Clinical Site | Fargo | North Dakota | 58103 | United States |
| Clinical Site | Columbus | Ohio | 43213 | United States |
| Clinical Site | Murfreesboro | Tennessee | 37130 | United States |
| Clinical Site | Dallas | Texas | 75390-8565 | United States |
| Clinical Site | Plano | Texas | 75025 | United States |
| Clinical Site | San Antonio | Texas | 78213 | United States |
| Clinical Site | Morgantown | West Virginia | 26505 | United States |
| Clinical Site | Milwaukee | Wisconsin | 53226 | United States |
| Clinical Site | Ghent | 9000 | Belgium |
| Clinical Site | Leuven | 3000 | Belgium |
| Clinical Site | Liège | 4000 | Belgium |
| Clinical Site | Woluwe-Saint-Lambert | 1200 | Belgium |
| Clinical Site | Sofia | 1431 | Bulgaria |
| Clinical Site | Sofia | 1463 | Bulgaria |
| Clinical Site | Sofia | 1510 | Bulgaria |
| Clinical Site | Sofia | 1606 | Bulgaria |
| Clinical Site | Stara Zagora | 6003 | Bulgaria |
| Clinical Site | Calgary | Alberta | T3E 0B2 | Canada |
| Clinical Site | Edmonton | Alberta | T6G 1C3 | Canada |
| Clinical Site | Guelph | Ontario | N1L 0B7 | Canada |
| Clinical Site | Peterborough | Ontario | K9J 5K2 | Canada |
| Clinical Site | Richmond Hill | Ontario | L4B 1A5 | Canada |
| Clinical Site | Toronto | Ontario | M4E 1R7 | Canada |
| Clinical Site | Windsor | Ontario | N8W 1E6 | Canada |
| Clinical Site | Saskatoon | Saskatchewan | S7K 2C1 | Canada |
| Clinical Site | Ostrava | 708 52 | Czechia |
| Clinical Site | Prague | 110 00 | Czechia |
| Clinical Site | Prague | 15006 | Czechia |
| Clinical Site | Antony | 92160 | France |
| Clinical Site | Besançon | 25030 | France |
| Clinical SIte | Brest | 29200 | France |
| Clinical Site | Dijon | 21000 | France |
| Clinical Site | Le Mans | 72037 | France |
| Clinical Site | Lyon | 69003 | France |
| Clinical Site | Montpellier | 34295 | France |
| Clinical Site | Rouen | 76031 | France |
| Clinical Site | Saint-Mandé | 94160 | France |
| Clinical Site | Saint-Priest-en-Jarez | 42270 | France |
| Clinical Site | Toulouse | 31400 | France |
| Clinical Site | Augsburg | 86179 | Germany |
| Clinical Site | Bad Bentheim | 48455 | Germany |
| Clinical Site | Berlin | 10117 | Germany |
| Clinical Site | Bielefeld | 33647 | Germany |
| Clinical Site | Bochum | 44791 | Germany |
| Clinical Site | Bramsche | 49565 | Germany |
| Clinical Site | Darmstadt | 64283 | Germany |
| Clinical Site | Dresden | 01307 | Germany |
| Clinical Site | Gera | 07548 | Germany |
| Clinical Site | Hamburg | 20246 | Germany |
| Clinical Site | Kiel | 24105 | Germany |
| Clinical Site | Lübeck | 23538 | Germany |
| Clinical Site | Würzburg | 97080 | Germany |
| Clinical Site | Dublin | D04 T6F4 | Ireland |
| Clinical Site | Rotterdam | 3015 GD | Netherlands |
| Clinical Site | Chorzów | 41-500 | Poland |
| Clinical Site | Katowice | 40-611 | Poland |
| Clinical Site | Kielce | 25-316 | Poland |
| Clinical Site | Olsztyn | 10-229 | Poland |
| Clinical Site | Poznan | 61-731 | Poland |
| Clinical Site | Szczecin | 70-332 | Poland |
| Clinical Site | Warsaw | 02-953 | Poland |
| Clinical Site | Wroclaw | 50566 | Poland |
| Clinical Site | Trnava | 91702 | Slovakia |
| Clinical Site | Alcorcón | 28922 | Spain |
| Clinical Site | Alicante | 03010 | Spain |
| Clinical Site | Badalona | 08916 | Spain |
| Clinical Site | Barcelona | 08003 | Spain |
| Clinical Site | Barcelona | 08036 | Spain |
| Clinical Site | Barcelona | 08041 | 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 | 28007 | 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 |
| 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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