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| ID | Type | Description | Link |
|---|---|---|---|
| COMPASS 2-HS | Other Identifier | Sponsor |
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This is a double-blind, placebo-controlled study where subjects are participating for approximately 36 to 40 weeks. The study compares how well BFB759 works and how safe it is compared with a placebo.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active - high dose | Experimental | BFB759 loading dose followed by BFB759 maintenance high dose every 2 weeks (Q2W) through Week 14 (inclusive), which is followed by placebo Q2W at Weeks 16 through 30 (inclusive). |
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| Active - low dose | Experimental | BFB759 loading dose followed by BFB759 maintenance mid-dose Q2W through Week 14 (inclusive). |
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| Placebo | Placebo Comparator | Placebo Q2W for 14 weeks. At Week 16, participants in Placebo group who are still enrolled in the study and receiving treatment will be re-randomized (1:1) into 2 groups (Cross 1 and Cross 2) to receive BFB759
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BFB759 | Biological | BFB759 is a human mAb that inhibits multiple pro-inflammatory cytokines that contribute to the pathogenesis of multiple disease processes characterized by aberrant inflammation, including hidradenitis suppurativa. |
| Measure | Description | Time Frame |
|---|---|---|
| Efficacy of BFB759 in HS | To evaluate the efficacy of BFB759 in adult male and female participants with HS as measured by the change in the number of abscesses and inflammatory nodules (AN count). | Baseline to Week 16 and baseline to Week 32 |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluate the clinical activity of BFB759 using HiSCR50 | The HiSCR50 is defined as at least a 50% reduction in inflammatory lesion count [the sum of Abscesses and Inflammatory Nodules (AN)] and no increase in abscess count and no increase in draining fistula count relative to baseline. The threshold of 50% reduction in AN count is the defined level that is clinically appropriate and meaningful to the patient regarding improvement in quality of life and pain level. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Rob Eichelkraut | Contact | +1-214-728-6505 | Reichelkraut@bluefinbiomed.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Saguaro Dermatology | Recruiting | Phoenix | Arizona | 85008 | United States | |
| Encino Research Center |
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Placebo
| Placebo for BFB759 | Other | Placebo for BFB759 |
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| Baseline to Week 16 and baseline to Week 32 |
| Evaluate the safety/tolerability of BFB759 | Record how well participants tolerate the treatment over time by recording the incidence and severity of treatment-emergent adverse events (as described by CTCAE Version 5.0) | routinely over 21 months (about 22 visits during the course of study) |
| To evaluate the clinical activity of BFB759 using the International Hidradenitis Suppurativa Severity Score System (IHS4) | The IHS4 is a validated tool to dynamically assess HS severity that can be used both in real-life and the clinical trials setting (Zouboulis, 2017). It is calculated by counting nodules, abscesses and dTs/sinus tracts, and calculating a total score. IHS4 = (number of nodules multiplied by 1) + (number of abscesses multiplied by 2) + [number of dTs multiplied by 4]. | Baseline to Week 16 and baseline to Week 32 |
| To evaluate the clinical activity of BFB759 using the Skin Pain Numerical Rating Scale (NRS) | The Skin Pain NRS is a single self-reported item designed to measure skin pain severity over the previous 24 hours. The following question is asked, and the response is marked on an 11 point scale where 0 equals no pain and 10 equals the worst pain imaginable. | Baseline to Week 16 and baseline to Week 32 |
| To evaluate the clinical activity of BFB759 using the Hidradenitis Suppurativa-Investigator Global Assessment (HS-IGA) | The HS IGA is a HS-specific global assessment. It is a 6 point ordinal scale based on objective lesion counts (Garg, 2022). Scores are calculated by the sum of abscesses, nodules (inflammatory or noninflammatory) and tunnels (draining or nondraining) in either the upper body regions or the lower body regions, whichever is greater. Scores are assigned as follows: 0 (0 1 lesions), 1 (2 5 lesions), 2 (6 10 lesions), 3 (11 15 lesions), 4 (16 20 lesions), and 5 (>20 lesions). | Baseline to Week 16 and baseline to Week 32 |
| Recruiting |
| Encino |
| California |
| 91436 |
| United States |
| Clinical Science Institute | Recruiting | Santa Monica | California | 90404 | United States |
| Skin Care Research | Recruiting | Boca Raton | Florida | 33021 | United States |
| Center for Skin Science and Innovation | Recruiting | Fort Lauderdale | Florida | 33308 | United States |
| Ziaderm Research LLC | Recruiting | North Miami Beach | Florida | 33126 | United States |
| Clinical Trials Management, LLC | Recruiting | Tampa | Florida | 33607 | United States |
| DelRicht Research | Recruiting | Atlanta | Georgia | 30329 | United States |
| Southeast Research Specialist LLC | Recruiting | Douglasville | Georgia | 30135 | United States |
| The Indiana Clinical Trials Center, PC | Recruiting | Plainfield | Indiana | 46168 | United States |
| DS Research of Kentucky | Recruiting | Louisville | Kentucky | 40241 | United States |
| Martha Stewart | Recruiting | Mandeville | Louisiana | 70448 | United States |
| Clinical Trials Management, LLC | Recruiting | Metairie | Louisiana | 70006 | United States |
| DelRicht Research | Recruiting | New Orleans | Louisiana | 70115 | United States |
| Oakland Hills Dermatology | Recruiting | Auburn Hills | Michigan | 48326 | United States |
| MI Skin Innovations | Recruiting | Northville | Michigan | 48167 | United States |
| DelRicht Research | Recruiting | Wildwood | Missouri | 63040 | United States |
| JDR Dermatology Research LLC | Recruiting | Las Vegas | Nevada | 89145 | United States |
| Skin Cancer and Dermatology Institute | Recruiting | Reno | Nevada | 89509 | United States |
| Schweiger Dermatology, PC | Recruiting | Hackensack | New Jersey | 07601 | United States |
| Equity Medical LLC | Recruiting | The Bronx | New York | 10455 | United States |
| Optima Research - Boardman | Recruiting | Boardman | Ohio | 44512 | United States |
| Apex Clinical Research Center, LLC | Recruiting | Canton | Ohio | 44718 | United States |
| Apex Clinical Research Center, LLC | Recruiting | Mayfield Heights | Ohio | 44124 | United States |
| UPMC Department of Dermatology | Recruiting | Pittsburgh | Pennsylvania | 15213 | United States |
| Medical Univ of SC Department of Dermatology | Recruiting | Charleston | South Carolina | 29425 | United States |
| DelRicht Research | Recruiting | Mt. Pleasant | South Carolina | 29464 | United States |
| DelRicht Research | Recruiting | Smyrna | Tennessee | 37167 | United States |
| DelRicht Research | Recruiting | Prosper | Texas | 75078 | United States |
| Stryde Research-Epiphany Dermatology | Recruiting | Southlake | Texas | 76092 | United States |
| Dermatology Specialists of Spokane | Recruiting | Spokane | Washington | 99202 | United States |
| Medical Center Medconsult Burgas EOOD | Recruiting | Burgas | Bulgaria |
| Medical Center Medconsult Pleven-Lovech Branch | Recruiting | Lovech | Bulgaria |
| Medical Center Medconsult Pleven OOD | Recruiting | Pleven | Bulgaria |
| Medical Center Etika Ambulatory For Specialized Outpatient Medical Care OOD | Recruiting | Plovdiv | Bulgaria |
| Medical Center Rusemed | Recruiting | Rousse | Bulgaria |
| York Dermatology Clinical and Research Centre | Recruiting | Richmond Hill | Ontario | L4B 1L1 | Canada |
| North York Research Inc. | Recruiting | Toronto | Ontario | M2N 3A6 | Canada |
| CCR Ostrava s.r.o. | Recruiting | Ostrava | Czechia |
| Pratia Pardubice a.s. | Recruiting | Pardubice | Czechia |
| Sanatorium of Professor Arenbergera | Recruiting | Prague | Czechia |
| St. Josef-Hospital Bochum | Recruiting | Bochum | Germany |
| Universitatsklinikum Frankfurt Klinik fur Dermatologie, Venerologie und Allergologie | Recruiting | Frankfurt | Germany |
| University Clinic Dermatology Heidelberg | Recruiting | Heidelberg | Germany |
| University Hospital, Leipzig | Recruiting | Leipzig | Germany |
| University of Luebeck | Recruiting | Lübeck | Germany |
| Klinik und Poliklinik fur Dermatologie und Allergologie | Recruiting | Munich | Germany |
| NZOZ Specjal. Osrodek Dermatologiczny DERMAL | Recruiting | Bialystok | Poland |
| Luxderm Specjalistyczny Gabinet Dermatologiczny prof. dr hab. n. med. Dorota Krasowska | Recruiting | Lublin | Poland |
| Melita Medical | Recruiting | Wroclaw | Poland |
| Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego we Wrocławiu | Recruiting | Wroclaw | Poland |
| Wojewódzki Szpital Specjalistyczny we Wrocławi,Oddział Dermatologiczny | Recruiting | Wroclaw | Poland |
| Hospital Universitario Virgen De Las Nieves | Recruiting | Granada | Spain |
| Hospital Asil de Granollers | Recruiting | Granollers | Spain |
| Hospital Universitario de Gran Canaria Doctor Negrin | Recruiting | Las Palmas de Gran Canaria | Spain |
| Hospital Gregorio Maranon | Recruiting | Madrid | Spain |
| Complejo Hospitalario Universitario de Pontevedra | Recruiting | Pontevedra | Spain |
| Hospital de Manises | Recruiting | Valencia | Spain |
| 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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