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| ID | Type | Description | Link |
|---|---|---|---|
| I7P-MC-DSAF | Other Identifier | Eli Lilly and Company | |
| 2023-505608-43-00 | Other Identifier | EU Trial Number | |
| U1111-1292-6255 | Other Identifier | UTN Number |
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This study aims to find the appropriately safe and effective dose and dosing frequency for eltrekibart in adults with moderate-to-severe hidradenitis suppurativa (HS) for further clinical development. The study will last approximately 62 weeks and may include up to 31 visits.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Eltrekibart Dose 1 | Experimental | Eltrekibart will be given subcutaneously (SC). |
|
| Eltrekibart Dose 2 | Experimental | Eltrekibart will be given SC. |
|
| Eltrekibart Dose 3 | Experimental | Eltrekibart will be given SC. |
|
| Placebo | Placebo Comparator | Placebo will be given. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Eltrekibart | Drug | Administered SC |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participant Achieving Hidradenitis Suppurativa Clinical Response 50 (HiSCR50) | Week 16 |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Change from Baseline in Total Number of Abscesses and Inflammatory Nodules | Baseline, Week 16 | |
| Mean Change from Baseline in HS-related Average Skin Pain Numerical Rating Scale (NRS) | Baseline, Week 16 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST) | Eli Lilly and Company | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medical Dermatology Specialists | Phoenix | Arizona | 85006 | United States | ||
| Saguaro Dermatology Associates, LLC - Probity - PPDS |
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| Label | URL |
|---|---|
| A Study of Eltrekibart (LY3041658) in Adult Participants With Moderate to Severe Hidradenitis Suppurativa | View source |
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Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.
Data are available 6 months after the primary publication and approval of the indication studied in the US and European Union (EU), whichever is later. Data will be indefinitely available for requesting.
A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
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Phase 2b
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| Placebo | Drug | Administered SC |
|
| Pharmacokinetics (PK): Plasma Concentrations of Eltrekibart | Baseline through Week 16 |
| Phoenix |
| Arizona |
| 85008 |
| United States |
| Arkansas Research Trials, LLC | North Little Rock | Arkansas | 72117 | United States |
| Northwest Arkansas Clinical Trials Center | Rogers | Arkansas | 72758 | United States |
| First OC Dermatology Research Inc | Fountain Valley | California | 92708 | United States |
| Center For Dermatology Clinical Research, Inc. | Fremont | California | 94538 | United States |
| Dermatology Research Associates | Los Angeles | California | 90045 | United States |
| Dermatology Institute and Skin Care Center | Santa Monica | California | 90404 | United States |
| University of Connecticut | Farmington | Connecticut | 06032 | United States |
| Direct Helpers Research Center | Hialeah | Florida | 33012 | United States |
| University of Miami | Miami | Florida | 33125 | United States |
| Skin Research of South Florida | Miami | Florida | 33173-1407 | United States |
| ForCare Clinical Research | Tampa | Florida | 33613-1244 | United States |
| Alliance Clinical Research of Tampa | Tampa | Florida | 33615 | United States |
| Olympian Clinical Research | Tampa | Florida | 33615 | United States |
| Advanced Medical Research, PC | Sandy Springs | Georgia | 30328 | United States |
| NorthShore Medical Group Dermatology - Skokie | Skokie | Illinois | 60077-1049 | United States |
| Dawes Fretzin Clinical Research Group, LLC | Indianapolis | Indiana | 46250 | United States |
| Equity Medical - Bowling Green | Bowling Green | Kentucky | 42104 | United States |
| Derm Research LLC | Louisville | Kentucky | 40217 | United States |
| Care Access-Marriottsville | Marriottsville | Maryland | 21104 | United States |
| Beth Israel Deaconess Medical Center | Boston | Massachusetts | 02215 | United States |
| Revival Research Institute - Troy | Troy | Michigan | 48084 | United States |
| Washington University School of Medicine | St Louis | Missouri | 63110 | United States |
| Skin Specialists, P.C | Omaha | Nebraska | 68144 | United States |
| ActivMed Practices & Research, Inc. | Portsmouth | New Hampshire | 03801 | United States |
| Darst Dermatology | Charlotte | North Carolina | 28277-8014 | United States |
| Dermatology Specialists of Charlotte | Charlotte | North Carolina | 28277 | United States |
| Duke University Medical Center | Durham | North Carolina | 27710-3038 | United States |
| University Hospitals Cleveland Medical Center | Cleveland | Ohio | 44106 | United States |
| Apex Clinical Research Center | Mayfield Heights | Ohio | 44124 | United States |
| DermDox Centers for Dermatology | Camp Hill | Pennsylvania | 17011 | United States |
| DermDox Dermatology Centers | Sugarloaf | Pennsylvania | 18249 | United States |
| Medical University of South Carolina | Charleston | South Carolina | 29425 | United States |
| Columbia Dermatology & Aesthetics | Columbia | South Carolina | 29212-8623 | United States |
| International Clinical Research - Tennessee (IC Research) | Murfreesboro | Tennessee | 37130 | United States |
| Advanced Research Experts | Nashville | Tennessee | 37211 | United States |
| Modern Research Associates | Dallas | Texas | 75231 | United States |
| North Texas Clinical Research | Frisco | Texas | 75034 | United States |
| Jordan Valley Dermatology Center | South Jordan | Utah | 84095 | United States |
| Dermatology Specialists of Spokane | Spokane | Washington | 99202-1332 | United States |
| Medical College of Wisconsin | Milwaukee | Wisconsin | 53226 | United States |
| East Sydney Doctors | Darlinghurst | New South Wales | 2010 | Australia |
| Westmead Hospital | Westmead | New South Wales | 2145 | Australia |
| Sunshine Coast University Hospital | Birtinya | Queensland | 4575 | Australia |
| Sinclair Dermatology - East Melbourne | East Melbourne | Victoria | 3002 | Australia |
| Alfred Hospital | Melbourne | Victoria | 3004 | Australia |
| Fremantle Dermatology | Fremantle | Western Australia | 6160 | Australia |
| Holdsworth House Medical Practice | Sydney | 2010 | Australia |
| Beacon Dermatology | Calgary | Alberta | T3E 0B2 | Canada |
| Alberta Dermasurgery Centre | Edmonton | Alberta | T6G 1C3 | Canada |
| Wiseman Dermatology Research Inc. | Winnipeg | Manitoba | R3M 3Z4 | Canada |
| Brunswick Dermatology Center | Fredericton | New Brunswick | E3B 1G9 | Canada |
| Simcoderm Medical & Surgical Dermatology Centre | Barrie | Ontario | L4M 7G1 | Canada |
| DermEffects - Probity - PPDS | London | Ontario | N6H 5L5 | Canada |
| Center de Recherche St Louis | Québec | Quebec | G1W 4R4 | Canada |
| Hautklinik Erlangen | Erlangen | Bavaria | 91054 | Germany |
| Hautarztpraxis Mahlow | Blankenfelde-Mahlow | Brandenburg | 15827 | Germany |
| Universitätsklinikum Frankfurt | Frankfurt am Main | Hesse | 60596 | Germany |
| Universitaetsklinikum der Ruhr-Universitaet Bochum (UKRUB) - St. Josef-Hospital | Bochum | North Rhine-Westphalia | 44791 | Germany |
| Universitätsklinikum Bonn | Bonn | North Rhine-Westphalia | 53127 | Germany |
| Universitätsklinikum Münster - Albert Schweitzer Campus | Münster | Westfalen | 48149 | Germany |
| Hautzentrum Friedrichshain - Dermatologie | Berlin | 10247 | Germany |
| Universitaetsklinikum Hamburg-Eppendorf | Hamburg | 20251 | Germany |
| Hospital of Venereal and Skin Diseases A.Syggros | Athens | Attica | 16121 | Greece |
| University General Hospital of Heraklion Loc. 1 | Heraklion | Irakleío | 711 10 | Greece |
| Papageorgiou General Hospital of Thessaloniki | Thessaloniki | Thessaloníki | 56429 | Greece |
| Cityclinic Przychodnia Lekarsko Psychologiczna Matusiak Spółka Partnerska | Wroclaw | Lower Silesian Voivodeship | 50-566 | Poland |
| Wro Medica | Wroclaw | Lower Silesian Voivodeship | 51-685 | Poland |
| Panstwowy Instytut Medyczny Ministerstwa Spraw Wewnetrznych i Administracji | Warsaw | Masovian Voivodeship | 02-507 | Poland |
| Uniwersyteckie Centrum Kliniczne | Gdansk | Pomeranian Voivodeship | 80-214 | Poland |
| Klinika Badawcza Centrum Badan Klinicznych Wojciech Brzezicki | Malbork | Pomeranian Voivodeship | 82-200 | Poland |
| Centrum Medyczne Pratia Katowice | Katowice | Silesian Voivodeship | 40-081 | Poland |
| Dermoklinika-Centrum Medyczne s.c | Lodz | Łódź Voivodeship | 90-436 | Poland |
| ID | Term |
|---|---|
| D017497 | Hidradenitis Suppurativa |
| ID | Term |
|---|---|
| D017192 | Skin Diseases, Bacterial |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
| D012874 | Skin Diseases, Infectious |
| D013492 | Suppuration |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D016575 | Hidradenitis |
| D013543 | Sweat Gland Diseases |
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