Actively Recruiting
A Phase 2 Randomized, Double-blind, Placebo-controlled Study Evaluating the Safety and Efficacy of BFB759 in Adults With Moderate to Severe Atopic Dermatitis
Led by Bluefin Biomedicine, Inc. · Updated on 2026-05-29
225
Participants Needed
88
Research Sites
4 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating BFB759, a biological drug that inhibits multiple pro-inflammatory cytokines, in adults with moderate to severe atopic dermatitis. This phase 2, double-blind, placebo-controlled study aims to compare how well BFB759 works and its safety against a placebo over about 36 to 40 weeks. The study is sponsored by Bluefin Biomedicine, Inc. and includes participants aged 18 to 75 years with atopic dermatitis lasting at least one year. Participants are randomly assigned to one of three groups: a high dose of BFB759, a low dose of BFB759, or placebo given every two weeks. The treatment period lasts through Week 14, followed by a placebo period for the active groups from Weeks 16 to 30. Those initially receiving placebo are re-randomized at Week 16 to receive BFB759 through Week 30. This design allows comparison of different doses and assessment of treatment effects over time. During the study, participants attend regular visits for up to 40 weeks to monitor how well the treatment works, assessed at Weeks 16 and 32, as well as to track safety and tolerability over about 21 months with around 22 visits. Researchers will collect data on disease improvement and any side effects. Participants are expected to follow study instructions, attend all visits, and avoid certain medications during the trial to help ensure accurate results.
CONDITIONS
Brief Title
A Study Evaluating BFB759 in Moderate to Severe Atopic Dermatitis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 to 75 years
- Diagnosed with atopic dermatitis for at least one year
- Moderate to severe atopic dermatitis not controlled by topical treatments
- Willing to follow study instructions and attend regular study visits
- Able to avoid certain medications during the study
You will not qualify if you...
- Presence of certain infections or immune conditions
- Recent use of medications that may interfere with the study
- Pregnant or breastfeeding women
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 30 weeks
Participants receive BFB759 or placebo through injections every 2 weeks, with dosing adjustments at Week 16 for some participants.
Biweekly visits for up to 30 weeks
Duration - Up to 21 months
Participants are monitored for safety and tolerability after treatment ends.
Approximately 22 visits during the course of the study
Trial Site Locations
Total: 88 locations
1
Mountain West Derm - Blackhart PLLC dba Skin Cancer and Dermatology Institute
Phoenix, Arizona, United States, 85008
Actively Recruiting
2
Skin Cancer and Dermatology Institute
Phoenix, Arizona, United States, 85008
Actively Recruiting
3
T. Joseph Raoof Md, Inc
Encino, California, United States, 91436
Actively Recruiting
4
Marvel Clinical Research
Huntington Beach, California, United States, 92647
Actively Recruiting
5
Antelope Valley Clinical Trials
Lancaster, California, United States, 93534
Actively Recruiting
6
Probity Medical Research
Los Angeles, California, United States, 90017
Actively Recruiting
7
NorCal Clinical Research
Rocklin, California, United States, 95765
Actively Recruiting
8
Focus Clinical Research, LLC -S
West Hills, California, United States, 91307
Actively Recruiting
9
Skin Care Research
Boca Raton, Florida, United States, 33486
Actively Recruiting
10
Florida Academic Dermatology Center Res and Edu, LLC
Coral Gables, Florida, United States, 33134
Actively Recruiting
11
Center for Skin Science and Innovation
Fort Lauderdale, Florida, United States, 33308
Actively Recruiting
12
Gsi Clinical Research
Margate, Florida, United States, 33063
Actively Recruiting
13
Ziaderm Research LLC
North Miami Beach, Florida, United States, 33162
Actively Recruiting
14
Lenus Research & Medical Group, LLC
Sweetwater, Florida, United States, 33172
Actively Recruiting
15
Clinical Trials Management - S
Tampa, Florida, United States, 33607
Actively Recruiting
16
Conquest Research LLC
Winter Park, Florida, United States, 32789
Actively Recruiting
17
Skin Cancer and Dermatology Institute
Douglasville, Georgia, United States, 30135
Actively Recruiting
18
Southeast Research Specialists, LLC
Douglasville, Georgia, United States, 30135
Actively Recruiting
19
The Indiana Clinical Trials Center
Plainfield, Indiana, United States, 46168
Actively Recruiting
20
Clinical Trials Management - S
Covington, Louisiana, United States, 70433
Actively Recruiting
21
Clinical Trials Management, LLC
Metairie, Louisiana, United States, 70006
Actively Recruiting
22
MetroBoston Clinical Partners
Brighton, Massachusetts, United States, 02135
Actively Recruiting
23
Oakland Hills Dermatology
Auburn Hills, Michigan, United States, 48326
Actively Recruiting
24
MI Skin Innovations
Northville, Michigan, United States, 48167
Actively Recruiting
25
Medisearch, LLC
Saint Joseph, Missouri, United States, 64506
Actively Recruiting
26
Elias Research Associates
Missoula, Montana, United States, 59808
Actively Recruiting
27
JDR Dermatology Research
Las Vegas, Nevada, United States, 89145
Actively Recruiting
28
Mountain West Derm - Blackhart PLLC dba Skin Cancer and Dermatology Institute
Reno, Nevada, United States, 89509
Actively Recruiting
29
Skin Cancer and Dermatology Institute
Reno, Nevada, United States, 89509
Actively Recruiting
30
Mountain West Derm - Blackhart PLLC dba Skin Cancer and Dermatology Institute
Sparks, Nevada, United States, 89436
Actively Recruiting
31
Skin Cancer and Dermatology Institute
Sparks, Nevada, United States, 89436
Actively Recruiting
32
Schweiger Dermatology, PC R.D.
Hackensack, New Jersey, United States, 07601
Actively Recruiting
33
Bobby Buka, MD (The Dermatology Specialist)
New York, New York, United States, 10012
Actively Recruiting
34
Bobby Buka, MD
New York, New York, United States, 10012
Actively Recruiting
35
Equity Medical, LLC
The Bronx, New York, United States, 10455
Actively Recruiting
36
Vitality Clinical Trials LLC
Woodbury, New York, United States, 11797
Actively Recruiting
37
DJL Clinical Research
Charlotte, North Carolina, United States, 28277
Actively Recruiting
38
Optima Research-Boardman
Boardman, Ohio, United States, 44512
Actively Recruiting
39
Apex Clinical Research Center, LLC
Canton, Ohio, United States, 44718
Actively Recruiting
40
Apex Clinical Research Center, LLC
Mayfield Heights, Ohio, United States, 44124
Actively Recruiting
41
UPMC
Pittsburgh, Pennsylvania, United States, 15213
Actively Recruiting
42
International Clinical Research - Tennesee, LLC
Murfreesboro, Tennessee, United States, 37130
Actively Recruiting
43
Dermatology Treatment & Research Center
Dallas, Texas, United States, 75230
Actively Recruiting
44
Stride Clinical Research
Missouri City, Texas, United States, 77459
Actively Recruiting
45
Progressive Clinical Research
San Antonio, Texas, United States, 78213
Actively Recruiting
46
Stryde Research-Epiphany Dermatology
Southlake, Texas, United States, 76092
Actively Recruiting
47
Virginia Dermatology & Skin Cancer Center
Norfolk, Virginia, United States, 23502
Actively Recruiting
48
DBA Dermatology of Seattle & Bellevue -S
Burien, Washington, United States, 98618
Actively Recruiting
49
Medical Center Medconsult Burgas EOOD
Burgas, Bulgaria
Actively Recruiting
50
Medical Centre Asklepii OOD
Dupnitsa, Bulgaria
Actively Recruiting
51
Medconsult Lovech
Lovech, Bulgaria
Actively Recruiting
52
Dermatology Research Institute
Calgary, Alberta, Canada, T2J 7E1
Actively Recruiting
53
Vida Clinical Research
Edmonton, Alberta, Canada, T6H 4J8
Actively Recruiting
54
Probity Medical Research
Mississauga, Ontario, Canada, L4Y 4C5
Actively Recruiting
55
Probity Medical Research
Richmond Hill, Ontario, Canada, L4B 1A5
Actively Recruiting
56
York Dermatology
Richmond Hill, Ontario, Canada, L4B 3L4
Actively Recruiting
57
Centre de Recherche Saint-Louis (Montreal)
Montreal, Quebec, Canada, H1Y 3L1
Actively Recruiting
58
Saskatoon Dermatology Centre
Saskatoon, Saskatchewan, Canada, S7T 0G3
Actively Recruiting
59
CCR Ostrava
Ostrava, Czechia
Actively Recruiting
60
Pratia Pardubice
Pardubice, Czechia
Actively Recruiting
61
Clintrial s.r.o.
Prague, Czechia
Actively Recruiting
62
Private Dermatovenerology Practice
Prague, Czechia
Actively Recruiting
63
Fachklinik Bad Bentheim - Dermatology Hospital Bad Bentheim
Bad Bentheim, Germany
Actively Recruiting
64
CRS Clinical Research Services Berlin GmbH
Berlin, Germany
Actively Recruiting
65
Universitaetsmedizin Goettingen
Göttingen, Germany
Actively Recruiting
66
University Hospital Heidelberg Occupational Dermatology Department of Dermatology
Heidelberg, Germany
Actively Recruiting
67
Universitaetsklinikum Muenster (UKM) - Klinik fuer Hautkrankheiten
Münster, Germany
Actively Recruiting
68
ClinicMed Daniluk, Nowak
Bialystok, Poland
Actively Recruiting
69
NZOZ Centrum Medyczne KERmed
Bydgoszcz, Poland
Actively Recruiting
70
DERMAPOLIS Medical Dermatology Center dr n. med. Edyta Gębska
Chorzów, Poland
Actively Recruiting
71
PI House
Gdansk, Poland
Actively Recruiting
72
Synexus Polska Sp. z o.o.
Gdansk, Poland
Actively Recruiting
73
Mazowieckie Centrum Badan Klinicznych
Grodzisk Mazowiecki, Poland
Actively Recruiting
74
Centrum Badan Klinicznych JCI
Krakow, Poland
Actively Recruiting
75
Klinika Badawcza Centrum Badan Klinicznych
Malbork, Poland
Actively Recruiting
76
Klinika Zdybski - Dermedic
Ostrowiec Świętokrzyski, Poland
Actively Recruiting
77
EMC Instytut Medyczny SA - Prywatna Lecznica Certus Szpital i Ambulatorium
Poznan, Poland
Actively Recruiting
78
Centrum Zdrowia Dziecka i Rodziny im. Jana Pawla II w Sosnowcu, Osrodek Badan Klinicznych
Sosnowiec, Poland
Actively Recruiting
79
MICS Centrum Medyczne
Torun, Poland
Actively Recruiting
80
Manufaktura Urody
Warsaw, Poland
Actively Recruiting
81
Prywatna Praktyka Lekarska Ewa Ring
Warsaw, Poland
Actively Recruiting
82
Therapia Nova Sp z o.o
Warsaw, Poland
Actively Recruiting
83
UW Wroclaw
Wroclaw, Poland
Actively Recruiting
84
Hospital General Universitario de Alicante - Instituto de Investigacion Sanitaria y Biomedica de Alicante (ISABIAL) - Fundacion FISABIO
Alicante, Spain
Actively Recruiting
85
Hospital Universitario Reina Sofia
Córdoba, Spain
Actively Recruiting
86
Hospital Asil de Granollers
Granollers, Spain
Actively Recruiting
87
Hospital Clinico San Carlos
Madrid, Spain
Actively Recruiting
88
Hospital Ramón y Cajal and Grupo Pedro Jaén
Madrid, Spain
Actively Recruiting
Research Team
R
Rob Eichelkraut
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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