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This is a study to demonstrate the clinical efficacy and safety of the nanobody® sonelokimab administered subcutaneously (sc) compared with placebo in the treatment of adult participants with moderate to severe hidradenitis suppurativa.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| sonelokimab dose 1 | Experimental | Subjects randomized to this arm will receive assigned sonelokimab dosage regimen and placebo to maintain the blinding with adalimumab and placebo arms during the Treatment Period. |
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| sonelokimab dose 2 | Experimental | Subjects randomized to this arm will receive assigned sonelokimab dosage regimen and placebo to maintain the blinding with adalimumab and placebo arms during the Treatment Period. |
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| Placebo | Placebo Comparator | Subjects randomized to this arm will receive placebo during the Double-Blind Treatment Period and will be re-randomized to receive a sonelokimab dosage regimen during Part B. |
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| adalimumab | Active Comparator | Subjects randomized to this arm will receive adalimumab during the Double-Blind Treatment Period and will be reallocated to receive sonelokimab dosage regimen during Part B. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sonelokimab (M1095) | Drug | randomized treatment; parallel-group |
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| 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 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Hidradenitis Suppurativa Clinical Response 50 | Proportion of participants achieving HiSCR50 | Week 12 |
| Change in International Hidradenitis Suppurativa Severity Score System | Change from baseline in International Hidradenitis Suppurativa Severity Score System (IHS4) The IHS4 score is calculated as follows: 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, 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 | Fountain Valley | California | 92708 | United States | ||
| Clinical Site |
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| Adalimumab | Drug | randomized treatment; parallel-group |
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| Placebo | Other | randomized treatment; parallel-group |
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| Week 12 |
| Dermatology Life Quality Index (DLQI) | Proportion of participants achieving a Dermatology Life Quality Index (DLQI) total score of ≤5 The DLQI produces a numeric score that can range from 0 to 30. A higher score indicates greater health-related quality of life impairment. | Week 12 |
| Reduction from Numerical Rating Scale (NRS30) in Patient's Global Assessment of Skin Pain (PGA Skin Pain) | Proportion of participants achieving at least 30% reduction and at least 2-unit reduction from Baseline in Numerical Rating Scale (NRS30) in Patient's Global Assessment of Skin Pain (PGA Skin Pain) among subjects with Baseline NRS ≥3 The NRS is a numeric scale in which the respondent selects a whole number (0-10 integers) that best reflects the intensity of their pain ranging from 0 (no skin pain) to 10 (skin pain as bad as you can imagine). | Week 12 |
| Los Angeles |
| California |
| 90056 |
| United States |
| Clinical Site | Miami | Florida | 33136 | United States |
| Clinical Site | Ormond Beach | Florida | 32127 | United States |
| Clinical Site | St. Petersburg | Florida | 33709 | United States |
| Clinical Site | Tampa | Florida | 33613 | United States |
| Clinical Site | Indianapolis | Indiana | 46250 | United States |
| Clinical Site | Beverly | Massachusetts | 01915 | United States |
| Clinical Site | Boston | Massachusetts | 02215 | United States |
| Clinical Site | Omaha | Nebraska | 68144 | United States |
| Clinical Site | New York | New York | 10003 | United States |
| Clinical Site | Philadelphia | Pennsylvania | 19103 | United States |
| Clinical Site | Charleston | South Carolina | 29425 | United States |
| Clinical Site | Nashville | Tennessee | 37215 | United States |
| Clinical Site | Bellaire | Texas | 77401 | United States |
| Clinical Site | Sofia | 1407 | Bulgaria |
| Clinical Site | Sofia | 1431 | Bulgaria |
| Clinical Site | Sofia | 1463 | Bulgaria |
| Clinical Site | Stara Zagora | 6000 | Bulgaria |
| Clinical Site | Calgary | Alberta | T3E 0B2 | Canada |
| Clinical Site | Winnipeg | Manitoba | R3M 3Z4 | Canada |
| Clinical Site | Fredericton | New Brunswick | E3B 1G9 | Canada |
| Clinical Site | St. John's | Newfoundland and Labrador | A1A 4Y3 | Canada |
| Clinical Site | Hamilton | Ontario | L8L 3C3 | Canada |
| Clinical Site | London | Ontario | N6H 5L5 | Canada |
| Clinical Site | Markham | Ontario | L3P 1X2 | Canada |
| Clinical Site | Newmarket | Ontario | L3Y 5G8 | Canada |
| Clinical Site | Peterborough | Ontario | K9J 5K2 | Canada |
| Clinical Site | Saskatoon | Saskatchewan | S7K 2C1 | Canada |
| Clinical Site | Bad Bentheim | 48455 | Germany |
| Clinical Site | Berlin | 10117 | Germany |
| Clinical Site | Berlin | 10789 | Germany |
| Clinical Site | Berlin | 13595 | Germany |
| Clinical Site | Bochum | 44791 | Germany |
| Clinical Site | Darmstadt | 64283 | Germany |
| Clinical Site | Dresden | 01307 | Germany |
| Clinical Site | Frankfurt | 60590 | Germany |
| Clinical Site | Hamburg | 20246 | Germany |
| Clinical Site | Kiel | 24105 | Germany |
| Clinical Site | Lübeck | 23538 | Germany |
| Clinical Site | Mahlow | 15831 | Germany |
| Clinical Site | München | 80337 | Germany |
| Clinical Site | Münster | 48149 | Germany |
| Clinical Site | Dublin | D04 T6F4 | Ireland |
| Clinical Site | Bergen op Zoom | 4624 | Netherlands |
| Clinical Site | Rotterdam | 3015 GD | Netherlands |
| Clinical Site | Gdansk | 80-214 | Poland |
| Clinical Site | Krakow | 31-033 | Poland |
| Clinical Site | Lodz | 90-265 | Poland |
| Clinical Site | Olsztyn | 10-341 | Poland |
| Clinical Site | Ossy | 42-624 | Poland |
| Clinical Site | Ostrowiec Świętokrzyski | 27-400 | Poland |
| Clinical Site | Poznan | 60-681 | Poland |
| Clinical Site | Warsaw | 02-507 | Poland |
| Clinical Site | Warsaw | 02-692 | Poland |
| Clinical Site | Wroclaw | 50566 | Poland |
| Clinical Site | Wroclaw | 51318 | Poland |
| ID | Term |
|---|---|
| D017497 | Hidradenitis Suppurativa |
| D016575 | Hidradenitis |
| D013543 | Sweat Gland Diseases |
| D012871 | Skin Diseases |
| D017192 | Skin Diseases, Bacterial |
| D013492 | Suppuration |
| D005499 | Folliculitis |
| 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 |
| D006201 | Hair Diseases |
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| ID | Term |
|---|---|
| C000720946 | sonelokimab |
| D000068879 | Adalimumab |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
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