Actively Recruiting
A Phase 2-3, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of BFB759 in Moderate to Severe Hidradenitis Suppurativa
Led by Bluefin Biomedicine, Inc. · Updated on 2026-05-29
210
Participants Needed
58
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and effectiveness of BFB759, a human monoclonal antibody that targets multiple inflammatory cytokines, in adults with moderate to severe hidradenitis suppurativa (HS) that is not well controlled by systemic antibiotics. This double-blind, placebo-controlled study involves participants aged 18 to 75 years and aims to understand how well BFB759 works compared to a placebo over approximately 36 to 40 weeks. Participants will be randomly assigned to one of several groups. Some will receive a loading dose of BFB759 followed by either a high or mid maintenance dose every two weeks through Week 14. Others will receive a placebo every two weeks for 14 weeks, then, if still enrolled, be re-randomized to receive either a low or mid dose of BFB759 every two weeks from Week 16 through Week 30. This design allows comparison of different dosing regimens and the placebo effect. During the study, participants will attend about 22 visits over 21 months to monitor safety and effectiveness. Researchers will measure clinical activity using scales such as HiSCR50, the International Hidradenitis Suppurativa Severity Score System (IHS4), Skin Pain Numerical Rating Scale, and the Hidradenitis Suppurativa-Investigator Global Assessment (HS-IGA). Participants are expected to follow study instructions carefully, attend regular visits, and avoid certain medications. The primary outcomes focus on efficacy at Weeks 16 and 32, with ongoing safety assessments throughout the study.
CONDITIONS
Brief Title
A Study Evaluating BFB759 in Moderate to Severe Hidradenitis Suppurativa
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 to 75 years
- Diagnosed with hidradenitis suppurativa for at least one year
- Have moderate to severe hidradenitis suppurativa not well controlled by systemic antibiotic treatment
- Willing to follow study instructions and attend regular visits
- Agree to avoid certain medications during the study
You will not qualify if you...
- Have certain infections or immune conditions that may affect the study
- Recently used medications that could interfere with the study results
- Are pregnant or breastfeeding
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 doses every 2 weeks with possible dose adjustments and re-randomization at Week 16 depending on initial assignment.
Biweekly visits through Week 30
Duration - Up to approximately 21 months
Participants are monitored for safety and tolerability with routine visits after treatment completion.
Approximately 22 visits over the course of the study
Trial Site Locations
Total: 58 locations
1
Saguaro Dermatology
Phoenix, Arizona, United States, 85008
Actively Recruiting
2
Encino Research Center
Encino, California, United States, 91436
Actively Recruiting
3
Clinical Science Institute
Santa Monica, California, United States, 90404
Actively Recruiting
4
Skin Care Research
Boca Raton, Florida, United States, 33021
Actively Recruiting
5
Center for Skin Science and Innovation
Fort Lauderdale, Florida, United States, 33308
Actively Recruiting
6
Ziaderm Research LLC
North Miami Beach, Florida, United States, 33126
Actively Recruiting
7
Clinical Trials Management, LLC
Tampa, Florida, United States, 33607
Actively Recruiting
8
DelRicht Research
Atlanta, Georgia, United States, 30329
Actively Recruiting
9
Southeast Research Specialist LLC
Douglasville, Georgia, United States, 30135
Actively Recruiting
10
The Indiana Clinical Trials Center, PC
Plainfield, Indiana, United States, 46168
Actively Recruiting
11
DS Research of Kentucky
Louisville, Kentucky, United States, 40241
Actively Recruiting
12
Martha Stewart
Mandeville, Louisiana, United States, 70448
Actively Recruiting
13
Clinical Trials Management, LLC
Metairie, Louisiana, United States, 70006
Actively Recruiting
14
DelRicht Research
New Orleans, Louisiana, United States, 70115
Actively Recruiting
15
Oakland Hills Dermatology
Auburn Hills, Michigan, United States, 48326
Actively Recruiting
16
MI Skin Innovations
Northville, Michigan, United States, 48167
Actively Recruiting
17
DelRicht Research
Wildwood, Missouri, United States, 63040
Actively Recruiting
18
JDR Dermatology Research LLC
Las Vegas, Nevada, United States, 89145
Actively Recruiting
19
Skin Cancer and Dermatology Institute
Reno, Nevada, United States, 89509
Actively Recruiting
20
Schweiger Dermatology, PC
Hackensack, New Jersey, United States, 07601
Actively Recruiting
21
Equity Medical LLC
The Bronx, New York, United States, 10455
Actively Recruiting
22
Optima Research - Boardman
Boardman, Ohio, United States, 44512
Actively Recruiting
23
Apex Clinical Research Center, LLC
Canton, Ohio, United States, 44718
Actively Recruiting
24
Apex Clinical Research Center, LLC
Mayfield Heights, Ohio, United States, 44124
Actively Recruiting
25
UPMC Department of Dermatology
Pittsburgh, Pennsylvania, United States, 15213
Actively Recruiting
26
Medical Univ of SC Department of Dermatology
Charleston, South Carolina, United States, 29425
Actively Recruiting
27
DelRicht Research
Mt. Pleasant, South Carolina, United States, 29464
Actively Recruiting
28
DelRicht Research
Smyrna, Tennessee, United States, 37167
Actively Recruiting
29
DelRicht Research
Prosper, Texas, United States, 75078
Actively Recruiting
30
Stryde Research-Epiphany Dermatology
Southlake, Texas, United States, 76092
Actively Recruiting
31
Dermatology Specialists of Spokane
Spokane, Washington, United States, 99202
Actively Recruiting
32
Medical Center Medconsult Burgas EOOD
Burgas, Bulgaria
Actively Recruiting
33
Medical Center Medconsult Pleven-Lovech Branch
Lovech, Bulgaria
Actively Recruiting
34
Medical Center Medconsult Pleven OOD
Pleven, Bulgaria
Actively Recruiting
35
Medical Center Etika Ambulatory For Specialized Outpatient Medical Care OOD
Plovdiv, Bulgaria
Actively Recruiting
36
Medical Center Rusemed
Rousse, Bulgaria
Actively Recruiting
37
York Dermatology Clinical and Research Centre
Richmond Hill, Ontario, Canada, L4B 1L1
Actively Recruiting
38
North York Research Inc.
Toronto, Ontario, Canada, M2N 3A6
Actively Recruiting
39
CCR Ostrava s.r.o.
Ostrava, Czechia
Actively Recruiting
40
Pratia Pardubice a.s.
Pardubice, Czechia
Actively Recruiting
41
Sanatorium of Professor Arenbergera
Prague, Czechia
Actively Recruiting
42
St. Josef-Hospital Bochum
Bochum, Germany
Actively Recruiting
43
Universitatsklinikum Frankfurt Klinik fur Dermatologie, Venerologie und Allergologie
Frankfurt, Germany
Actively Recruiting
44
University Clinic Dermatology Heidelberg
Heidelberg, Germany
Actively Recruiting
45
University Hospital, Leipzig
Leipzig, Germany
Actively Recruiting
46
University of Luebeck
Lübeck, Germany
Actively Recruiting
47
Klinik und Poliklinik fur Dermatologie und Allergologie
Munich, Germany
Actively Recruiting
48
NZOZ Specjal. Osrodek Dermatologiczny DERMAL
Bialystok, Poland
Actively Recruiting
49
Luxderm Specjalistyczny Gabinet Dermatologiczny prof. dr hab. n. med. Dorota Krasowska
Lublin, Poland
Actively Recruiting
50
Melita Medical
Wroclaw, Poland
Actively Recruiting
51
Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego we Wrocławiu
Wroclaw, Poland
Actively Recruiting
52
Wojewódzki Szpital Specjalistyczny we Wrocławi,Oddział Dermatologiczny
Wroclaw, Poland
Actively Recruiting
53
Hospital Universitario Virgen De Las Nieves
Granada, Spain
Actively Recruiting
54
Hospital Asil de Granollers
Granollers, Spain
Actively Recruiting
55
Hospital Universitario de Gran Canaria Doctor Negrin
Las Palmas de Gran Canaria, Spain
Actively Recruiting
56
Hospital Gregorio Maranon
Madrid, Spain
Actively Recruiting
57
Complejo Hospitalario Universitario de Pontevedra
Pontevedra, Spain
Actively Recruiting
58
Hospital de Manises
Valencia, 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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