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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 high dose Day 1 followed by BFB759 every 2 weeks (Q2W) starting at Week 2 through Week 14 (inclusive), which is followed by placebo Q2W at Weeks 16 through 30 (inclusive) |
|
| 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 two groups (Cross-1 or Cross-2) to receive BFB759 intervention.
|
|
| Active - low dose | Experimental | BFB759 low dose on Day 1 followed by BFB759 every 2 weeks (Q2W) starting at Week 2 through Week 14 (inclusive), which is followed by placebo Q2W at Weeks 16 through 30 (inclusive) |
|
| 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 atopic dermatitis |
| Measure | Description | Time Frame |
|---|---|---|
| Efficacy of BFB759 in AD | To evaluate the efficacy of BFB759 in adult male and female participants with AD as assessed by Eczema Area and Severity Index (EASI) score. Measure improvements in redness, swelling, scratching damage, and roughness. | week 16 and week 32 |
| Measure | Description | Time Frame |
|---|---|---|
| How well the treatment works at Week 16 |
| Week 16 |
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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 |
|---|---|---|---|---|---|---|
| Mountain West Derm - Blackhart PLLC dba Skin Cancer and Dermatology Institute | Recruiting | Phoenix | Arizona | 85008 | United States |
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Parallel-arm, Randomized, Double-blind, Placebo-controlled, Dose-ranging Study
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| Placebo | Drug | Placebo for BFB759 |
|
| How well the treatment works at week 32 |
| Week 32 |
| Safety and tolerability |
| 21 months (about 22 visits during the course of study) |
| Skin Cancer and Dermatology Institute | Recruiting | Phoenix | Arizona | 85008 | United States |
| T. Joseph Raoof Md, Inc | Recruiting | Encino | California | 91436 | United States |
| Marvel Clinical Research | Recruiting | Huntington Beach | California | 92647 | United States |
| Antelope Valley Clinical Trials | Recruiting | Lancaster | California | 93534 | United States |
| Probity Medical Research | Recruiting | Los Angeles | California | 90017 | United States |
| NorCal Clinical Research | Recruiting | Rocklin | California | 95765 | United States |
| Focus Clinical Research, LLC -S | Recruiting | West Hills | California | 91307 | United States |
| Skin Care Research | Recruiting | Boca Raton | Florida | 33486 | United States |
| Florida Academic Dermatology Center Res and Edu, LLC | Recruiting | Coral Gables | Florida | 33134 | United States |
| Center for Skin Science and Innovation | Recruiting | Fort Lauderdale | Florida | 33308 | United States |
| Gsi Clinical Research | Recruiting | Margate | Florida | 33063 | United States |
| Ziaderm Research LLC | Recruiting | North Miami Beach | Florida | 33162 | United States |
| Lenus Research & Medical Group, LLC | Recruiting | Sweetwater | Florida | 33172 | United States |
| Clinical Trials Management - S | Recruiting | Tampa | Florida | 33607 | United States |
| Conquest Research LLC | Recruiting | Winter Park | Florida | 32789 | United States |
| Skin Cancer and Dermatology Institute | Recruiting | Douglasville | Georgia | 30135 | United States |
| Southeast Research Specialists, LLC | Recruiting | Douglasville | Georgia | 30135 | United States |
| The Indiana Clinical Trials Center | Recruiting | Plainfield | Indiana | 46168 | United States |
| Clinical Trials Management - S | Recruiting | Covington | Louisiana | 70433 | United States |
| Clinical Trials Management, LLC | Recruiting | Metairie | Louisiana | 70006 | United States |
| MetroBoston Clinical Partners | Recruiting | Brighton | Massachusetts | 02135 | United States |
| Oakland Hills Dermatology | Recruiting | Auburn Hills | Michigan | 48326 | United States |
| MI Skin Innovations | Recruiting | Northville | Michigan | 48167 | United States |
| Medisearch, LLC | Recruiting | Saint Joseph | Missouri | 64506 | United States |
| Elias Research Associates | Recruiting | Missoula | Montana | 59808 | United States |
| JDR Dermatology Research | Recruiting | Las Vegas | Nevada | 89145 | United States |
| Mountain West Derm - Blackhart PLLC dba Skin Cancer and Dermatology Institute | Recruiting | Reno | Nevada | 89509 | United States |
| Skin Cancer and Dermatology Institute | Recruiting | Reno | Nevada | 89509 | United States |
| Mountain West Derm - Blackhart PLLC dba Skin Cancer and Dermatology Institute | Recruiting | Sparks | Nevada | 89436 | United States |
| Skin Cancer and Dermatology Institute | Recruiting | Sparks | Nevada | 89436 | United States |
| Schweiger Dermatology, PC R.D. | Recruiting | Hackensack | New Jersey | 07601 | United States |
| Bobby Buka, MD (The Dermatology Specialist) | Recruiting | New York | New York | 10012 | United States |
| Bobby Buka, MD | Recruiting | New York | New York | 10012 | United States |
| Equity Medical, LLC | Recruiting | The Bronx | New York | 10455 | United States |
| Vitality Clinical Trials LLC | Recruiting | Woodbury | New York | 11797 | United States |
| DJL Clinical Research | Recruiting | Charlotte | North Carolina | 28277 | 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 | Recruiting | Pittsburgh | Pennsylvania | 15213 | United States |
| International Clinical Research - Tennesee, LLC | Recruiting | Murfreesboro | Tennessee | 37130 | United States |
| Dermatology Treatment & Research Center | Recruiting | Dallas | Texas | 75230 | United States |
| Stride Clinical Research | Recruiting | Missouri City | Texas | 77459 | United States |
| Progressive Clinical Research | Recruiting | San Antonio | Texas | 78213 | United States |
| Stryde Research-Epiphany Dermatology | Recruiting | Southlake | Texas | 76092 | United States |
| Virginia Dermatology & Skin Cancer Center | Recruiting | Norfolk | Virginia | 23502 | United States |
| DBA Dermatology of Seattle & Bellevue -S | Recruiting | Burien | Washington | 98618 | United States |
| Medical Center Medconsult Burgas EOOD | Recruiting | Burgas | Bulgaria |
| Medical Centre Asklepii OOD | Recruiting | Dupnitsa | Bulgaria |
| Medconsult Lovech | Recruiting | Lovech | Bulgaria |
| Dermatology Research Institute | Recruiting | Calgary | Alberta | T2J 7E1 | Canada |
| Vida Clinical Research | Recruiting | Edmonton | Alberta | T6H 4J8 | Canada |
| Probity Medical Research | Recruiting | Mississauga | Ontario | L4Y 4C5 | Canada |
| Probity Medical Research | Recruiting | Richmond Hill | Ontario | L4B 1A5 | Canada |
| York Dermatology | Recruiting | Richmond Hill | Ontario | L4B 3L4 | Canada |
| Centre de Recherche Saint-Louis (Montreal) | Recruiting | Montreal | Quebec | H1Y 3L1 | Canada |
| Saskatoon Dermatology Centre | Recruiting | Saskatoon | Saskatchewan | S7T 0G3 | Canada |
| CCR Ostrava | Recruiting | Ostrava | Czechia |
| Pratia Pardubice | Recruiting | Pardubice | Czechia |
| Clintrial s.r.o. | Recruiting | Prague | Czechia |
| Private Dermatovenerology Practice | Recruiting | Prague | Czechia |
| Fachklinik Bad Bentheim - Dermatology Hospital Bad Bentheim | Recruiting | Bad Bentheim | Germany |
| CRS Clinical Research Services Berlin GmbH | Recruiting | Berlin | Germany |
| Universitaetsmedizin Goettingen | Recruiting | Göttingen | Germany |
| University Hospital Heidelberg Occupational Dermatology Department of Dermatology | Recruiting | Heidelberg | Germany |
| Universitaetsklinikum Muenster (UKM) - Klinik fuer Hautkrankheiten | Recruiting | Münster | Germany |
| ClinicMed Daniluk, Nowak | Recruiting | Bialystok | Poland |
| NZOZ Centrum Medyczne KERmed | Recruiting | Bydgoszcz | Poland |
| DERMAPOLIS Medical Dermatology Center dr n. med. Edyta Gębska | Recruiting | Chorzów | Poland |
| PI House | Recruiting | Gdansk | Poland |
| Synexus Polska Sp. z o.o. | Recruiting | Gdansk | Poland |
| Mazowieckie Centrum Badan Klinicznych | Recruiting | Grodzisk Mazowiecki | Poland |
| Centrum Badan Klinicznych JCI | Recruiting | Krakow | Poland |
| Klinika Badawcza Centrum Badan Klinicznych | Recruiting | Malbork | Poland |
| Klinika Zdybski - Dermedic | Recruiting | Ostrowiec Świętokrzyski | Poland |
| EMC Instytut Medyczny SA - Prywatna Lecznica Certus Szpital i Ambulatorium | Recruiting | Poznan | Poland |
| Centrum Zdrowia Dziecka i Rodziny im. Jana Pawla II w Sosnowcu, Osrodek Badan Klinicznych | Recruiting | Sosnowiec | Poland |
| MICS Centrum Medyczne | Recruiting | Torun | Poland |
| Manufaktura Urody | Recruiting | Warsaw | Poland |
| Prywatna Praktyka Lekarska Ewa Ring | Recruiting | Warsaw | Poland |
| Therapia Nova Sp z o.o | Recruiting | Warsaw | Poland |
| UW Wroclaw | Recruiting | Wroclaw | Poland |
| Hospital General Universitario de Alicante - Instituto de Investigacion Sanitaria y Biomedica de Alicante (ISABIAL) - Fundacion FISABIO | Recruiting | Alicante | Spain |
| Hospital Universitario Reina Sofia | Recruiting | Córdoba | Spain |
| Hospital Asil de Granollers | Recruiting | Granollers | Spain |
| Hospital Clinico San Carlos | Recruiting | Madrid | Spain |
| Hospital Ramón y Cajal and Grupo Pedro Jaén | Recruiting | Madrid | Spain |
| ID | Term |
|---|---|
| D003876 | Dermatitis, Atopic |
| D004485 | Eczema |
| ID | Term |
|---|---|
| D012873 | Skin Diseases, Genetic |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D003872 | Dermatitis |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D017443 | Skin Diseases, Eczematous |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
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