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| ID | Type | Description | Link |
|---|---|---|---|
| 2024-519736-17-00 | EU Trial (CTIS) Number |
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The study is a Phase 2, multi-center, randomized, double-blind, placebo-controlled study to evaluate the effects of tibulizumab over 16 weeks (Period 1) in adults with hidradenitis suppurativa, followed by a 16-week open-label extension period in which all participants will receive tibulizumab (Period 2)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tibulizumab Dose A | Experimental | Subcutaneous injection |
|
| Tibulizumab Dose B | Experimental | Subcutaneous injection |
|
| Placebo | Placebo Comparator | Subcutaneous injection |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tibulizumab Dose A | Biological | Anti BAFF/IL-17 antibody. ZB-106 |
| |
| Measure | Description | Time Frame |
|---|---|---|
| [Period 1] Percent change from baseline in abscess and inflammatory nodule (AN) count at 16 weeks | AN count is calculated based on the sum of the abscesses and inflammatory nodules across different anatomical areas | Week 16 |
| Measure | Description | Time Frame |
|---|---|---|
| [Period 1] Achieving HiSCR50 at Week 16 | HiSCR50 is defined as at least a 50% decrease in total abscess and inflammatory nodule (AN) count with no increase from baseline in abscess and/or draining fistula count | Week 16 |
| [Period 1] Achieving HiSCR75 at Week 16 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medical Dermatology Specialists (Phoenix) | Phoenix | Arizona | 85006 | United States | ||
| First OC Dermatology Research, Inc. |
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| Tibulizumab Dose B |
| Biological |
Anti BAFF/IL-17 antibody. ZB-106 |
|
| Placebo | Other | ZB-106 Placebo |
|
HiSCR75 is defined as at least a 75% decrease in total abscess and inflammatory nodule (AN) count with no increase from baseline in abscess and/or draining fistula count |
| Week 16 |
| [Period 1] Absolute change from baseline in Dermatology Life Quality Index (DLQI) score at Week 16 | The DLQI is a validated general dermatology questionnaire that consists of 10 items that assess subject health-related quality of life (daily activities, personal relationships, symptoms and feelings, leisure, work and school, and treatment). Each item uses a scale from 0 (not at all) to 3 (very much), with a total score being the sum of each question. The higher the total score the more a patient's life is affected by their skin condition. | Week 16 |
| [Period 1] Absolute change from baseline in Patient's Global Assessment of Hidradenitis Suppurativa (HS-PtGA) score at Week 16 | The HS-PtGA is a single item measure that asks the individual to rate the overall impact of HS on their quality of life, capturing their comprehensive perception of disease severity and treatment response. | Week 16 |
| [Period 1] Absolute change from baseline in Skin Pain Numeric Rating Scale (NRS) at Week 16 | The Skin Pain NRS is a single-item measure in which the participant rates the worst level of skin pain in the previous 24 hours on a scale from 0 (no pain) to 10 (worst pain imaginable). | Week 16 |
| [Period 1] Safety and tolerability of tibulizumab | Assessed by the incidence of all treatment-emergent adverse events (TEAEs), as well as changes from baseline in vital signs, electrocardiogram (ECG) parameters, and laboratory results. | Week 16 |
| Irvine |
| California |
| 92614 |
| United States |
| Wallace Medical Group, Inc. | Los Angeles | California | 90056 | United States |
| Northridge Clinical Trials | Northridge | California | 91325 | United States |
| NorCal Clinical Research | Rocklin | California | 95765 | United States |
| Florida Academic Dermatology Center | Coral Gables | Florida | 33134 | United States |
| Skin Care Research, LLC | Hollywood | Florida | 33021 | United States |
| Georgia Skin & Cancer Clinic | Savannah | Georgia | 31419 | United States |
| Indiana University School of Medicine | Indianapolis | Indiana | 46202 | United States |
| The Indiana Clinical Trials Center | Plainfield | Indiana | 46168 | United States |
| Equity Medical LLC (Kentucky) | Bowling Green | Kentucky | 42104 | United States |
| DS Research of Kentucky, LLC | Louisville | Kentucky | 40241 | United States |
| DelRicht LLC | Baton Rouge | Louisiana | 70809 | United States |
| Clinical Trials Management, LLC | Metairie | Louisiana | 70006 | United States |
| Beth Israel Deaconess Medical Center | Boston | Massachusetts | 02215 | United States |
| MediSearch Clinical Trials | Saint Joseph | Missouri | 64506 | United States |
| Skin Cancer and Dermatology Institute | Reno | Nevada | 89509 | United States |
| Equity Medical | New York | New York | 10023 | United States |
| OptiSkin Medical | New York | New York | 10128 | United States |
| Red River Research Partners | Fargo | North Dakota | 58103 | United States |
| Optima Research | Boardman | Ohio | 44512 | United States |
| ClinOhio Research Services | Columbus | Ohio | 43213 | United States |
| Apex Clinical Research Center | Mayfield Heights | Ohio | 44124 | United States |
| Best Skin Research LLC | Camp Hill | Pennsylvania | 17011 | United States |
| Palmetto Clinical Trial Services | Anderson | South Carolina | 29625 | United States |
| DelRicht Research | Mt. Pleasant | South Carolina | 29464 | United States |
| International Clinical Research - Tennessee LLC | Murfreesboro | Tennessee | 37130 | United States |
| Dermatology Treatment and Research Center | Dallas | Texas | 75230 | United States |
| BRCR Global Texas | Katy | Texas | 77450 | United States |
| DelRicht Research | Prosper | Texas | 75078 | United States |
| Progressive Clinical Research | San Antonio | Texas | 78213 | United States |
| Frontier Dermatology | Mill Creek | Washington | 98012 | United States |
| University of Washington Medical Center | Seattle | Washington | 98164 | United States |
| Dermatology Specialists of Spokane | Spokane | Washington | 99202 | United States |
| Ryan Clinical Research Inc. | Newmarket | Ontario | L3Y 5G8 | Canada |
| North York Research Inc | North York | Ontario | M2J 5B2 | Canada |
| York Dermatology Clinic & Research Centre | Richmond Hill | Ontario | L4B 1L1 | Canada |
| Centre de recherche Saint-Louis | Québec | Quebec | G1W 4R4 | Canada |
| Saskatoon Dermatology Centre | Saskatoon | Saskatchewan | S7T 0G3 | Canada |
| Fachklinik Bad Bentheim | Bad Bentheim | 48455 | Germany |
| Katholische Klinikum Bochum gGmbH | Bochum | 44791 | Germany |
| Klinikum Darmstadt | Darmstadt | 64283 | Germany |
| University Hospital Dresden | Dresden | 01307 | Germany |
| Versorgungsforschung in der Dermatologie und bei Pflegeberufen (IVDP) | Hamburg | 20251 | Germany |
| University Clinic Dermatology Heidelberg | Heidelberg | 69120 | Germany |
| Klinik und Poliklinik für Dermatologie und Allergologie | München | 80337 | Germany |
| University Hospital Muenster - Münster | Münster | 48149 | Germany |
| Semmelweis University | Budapest | 1085 | Hungary |
| University of Debrecen | Debrecen | 4032 | Hungary |
| University of Szeged | Szeged | 6720 | Hungary |
| RENEW Clinic | Bialystok | 15-797 | Poland |
| Provita Centrum Medyczne Sp. z o.o. Katowice | Katowice | 40-611 | Poland |
| Provita Sp. z o. o. | Katowice | 40-611 | Poland |
| Centrum Badawcze Panaceum Agnieszka Brzezicka, Magdalena Lenkiewicz Sp z .o.o | Malbork | 82200 | Poland |
| SOLUMED | Poznan | 60-425 | Poland |
| Laser Clinic S.C. | Szczecin | 70-332 | Poland |
| Manufaktura Zdrowia i Urody | Warsaw | 02-922 | Poland |
| Edificio IMIBIC, Reina Sofia University Hospital | Córdoba | 14004 | Spain |
| Gregorio Marañón General University Hospital | Madrid | 28007 | Spain |
| Hospital Universitario La Paz | Madrid | 28046 | Spain |
| Hospital Universitario Miguel Servet | Zaragoza | 50009 | Spain |
| ID | Term |
|---|---|
| D017497 | Hidradenitis Suppurativa |
| D012871 | Skin Diseases |
| D003872 | Dermatitis |
| D013543 | Sweat Gland Diseases |
| D017192 | Skin Diseases, Bacterial |
| D016575 | Hidradenitis |
| D000152 | Acne Vulgaris |
| ID | Term |
|---|---|
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
| D012874 | Skin Diseases, Infectious |
| D013492 | Suppuration |
| D017437 | Skin and Connective Tissue Diseases |
| D017486 | Acneiform Eruptions |
| D012625 | Sebaceous Gland Diseases |
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