A Phase 2, Dose Ranging, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of BFB759 in Patients With Moderate to Severe Hidradenitis Suppurativa
Status: Recruiting
Location: See all (4) locations...
Intervention Type: Biological, Other
Study Type: Interventional
Study Phase: Phase 2/Phase 3
SUMMARY
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:
• Are adults (18 to 75 years) with a diagnosis of hidradenitis suppurativa for at least one year.
• 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.
Locations
United States
Florida
Skin Care Research
RECRUITING
Boca Raton
Ziaderm Research LLC
RECRUITING
North Miami Beach
Clinical Trials Management, LLC
RECRUITING
Tampa
Louisiana
Clinical Trials Management, LLC
RECRUITING
Metairie
Contact Information
Primary
Rob Eichelkraut
Reichelkraut@bluefinbiomed.com
+1-214-728-6505
Time Frame
Start Date: 2025-11-03
Estimated Completion Date: 2027-08-01
Participants
Target number of participants: 210
Treatments
Experimental: 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).
Experimental: Active - low dose
BFB759 loading dose followed by BFB759 maintenance mid-dose Q2W through Week 14 (inclusive).
Placebo_comparator: 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).
Related Therapeutic Areas
Sponsors
Leads: Bluefin Biomedicine, Inc.