A Study Evaluating BFB759 in Moderate to Severe Hidradenitis Suppurativa
NCT ID: NCT07287644
Last Updated: 2025-12-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
PHASE2/PHASE3
210 participants
INTERVENTIONAL
2025-11-03
2027-08-01
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Active - high dose
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).
BFB759
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.
Active - low dose
BFB759 loading dose followed by BFB759 maintenance mid-dose Q2W through Week 14 (inclusive).
BFB759
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.
Placebo
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
* Cross 1 will receive BFB759 loading dose followed by BFB759 maintenance low-dose Q2W through Week 30 (inclusive).
* Cross 2 will receive BFB759 loading dose followed by BFB759 maintenance mid-dose Q2W through Week 30 (inclusive).
Placebo for BFB759
Placebo for BFB759
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
BFB759
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.
Placebo for BFB759
Placebo for BFB759
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Have moderate to severe disease not well controlled by systemic antibiotic treatment.
* Are willing to follow study instructions, attend regular visits, and avoid certain other medications during the study.
Exclusion Criteria
* Recently used medications that could interfere with the study.
* Are pregnant or breastfeeding.
18 Years
75 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Bluefin Biomedicine, Inc.
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Skin Care Research
Boca Raton, Florida, United States
Ziaderm Research LLC
North Miami Beach, Florida, United States
Clinical Trials Management, LLC
Tampa, Florida, United States
Clinical Trials Management, LLC
Metairie, Louisiana, United States
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
CL-BFB759-003
Identifier Type: -
Identifier Source: org_study_id
COMPASS 2-HS
Identifier Type: OTHER
Identifier Source: secondary_id