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This is a study to evaluate the pharmacokinetic (PK) and safety of sonelokimab in adolescent patients with HS.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| sonelokimab | Experimental | Subjects will receive sonelokimab 120mg subcutaneously (SC) as an induction regimen of 4 doses, followed by sonelokimab SC every 4 weeks maintenance dose starting at Week 8 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sonelokimab | Drug | Open label |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics (PK) of sonelokimab in adolescents | PK (trough concentrations) of sonelokimab over 24 weeks of treatment | Week 24 |
| Adverse events (AEs) following treatment with sonelokimab in adolescents | Incidence, relatedness, severity and seriousness of all AEs over 24 weeks of treatment from baseline | Week 24 |
| Discontinuation of sonelokimab treatment due to AEs | Number of participants discontinued from sonelokimab treatment due to AE over 24 weeks of treatment from baseline | Week 24 |
| Clinically significant changes in clinical laboratory parameters | Number of participants with clinically significant changes in hematology, biochemistry and urinalysis from baseline | Week 24 |
| Clinically significant changes in vital signs | Number of participants with clinically significant changes in vital signs from baseline | Week 24 |
| Clinically significant changes in standard 12-lead electrocardiogram (ECG) intervals | Number of participants with clinically significant changes in 12-lead ECG intervals from baseline | Week 24 |
| Measure | Description | Time Frame |
|---|---|---|
| Hidradenitis Suppurativa Clinical Response (HiSCR)75 | Percentage of participants achieving a HiSCR75 response over time | Week 24 |
| Hidradenitis Suppurativa Clinical Response (HiSCR) 50 | Percentage of participants achieving a HiSCR50 response over time |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinical Site | North Little Rock | Arkansas | 72117 | United States | ||
| Clinical Site |
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| Week 24 |
| International Hidradenitis Suppurativa Severity Score System (IHS4) | Absolute change in IHS4 score over time | Week 24 |
| Children's Dermatology Life Quality Index (CDLQI) | Percentage of participants achieving a CDLQI total reduction of ≥2.5 over time among participants with a baseline CDLQI ≥2.5 | Week 24 |
| Numerical Rating Scale (NRS) 30 | Percentage of participants achieving a ≥30% reduction and a ≥2-unit reduction over time in the NRS30 for pain in PGA among participants with a baseline NRS ≥3 | Week 24 |
| Stanford |
| California |
| 94304 |
| United States |
| Clinical Site | Washington D.C. | District of Columbia | 20010 | United States |
| Clinical Site | Hollywood | Florida | 33201 | United States |
| Clinical Site | Miami | Florida | 33136 | United States |
| Clinical Site | Macon | Georgia | 31217 | United States |
| Clinical Site | Sandy Springs | Georgia | 30328 | United States |
| Clinical Site | Chicago | Illinois | 60611 | United States |
| Clinical Site | Columbus | Indiana | 47201 | United States |
| Clinical Site | Murray | Kentucky | 42071 | United States |
| Clinical Site | Waterford | Michigan | 48328 | United States |
| Clinical Site | Fargo | North Dakota | 58103 | United States |
| Clinical Site | Charleston | South Carolina | 29425 | United States |
| Clinical Site | Dallas | Texas | 75246 | United States |
| Clinical Site | Dallas | Texas | 75390-8575 | United States |
| Clinical Site | San Antonio | Texas | 78218 | United States |
| Clinical Site | Norfolk | Virginia | 23502 | United States |
| Clinical Site | Seattle | Washington | 98105 | United States |
| 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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