A Study Evaluating BFB759 in Moderate to Severe Hidradenitis Suppurativa

Part of paid clinical trials in Phoenix, Arizona.

Sponsor
Bluefin Biomedicine, Inc.
Study ID
NCT07287644
Phase
PHASE2/PHASE3
Status
Recruiting
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Conditions

  • Hidradenitis Suppurativa (HS)

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • 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 hidradenitis suppurativa.
  • Placebo for BFB759 — OTHER
    Placebo for BFB759

Study Details

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.

Key Dates

Start date
Nov 3, 2025
Status verified
May 2026
Primary completion
Aug 1, 2027
Completion
Aug 1, 2027

Study Design

Enrollment
210 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • 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).

Primary Outcome Measure

Efficacy of BFB759 in HS [ Time Frame: Baseline to Week 16 and baseline to Week 32 ]

Central Contacts

Locations (31)

FacilityCityStateZIPSite coordinators
Saguaro DermatologyPhoenixArizona85008-
Encino Research CenterEncinoCalifornia91436-
Clinical Science InstituteSanta MonicaCalifornia90404-
Skin Care ResearchBoca RatonFlorida33021-
Center for Skin Science and InnovationFort LauderdaleFlorida33308-
Ziaderm Research LLCNorth Miami BeachFlorida33126-
Clinical Trials Management, LLCTampaFlorida33607-
DelRicht ResearchAtlantaGeorgia30329-
Southeast Research Specialist LLCDouglasvilleGeorgia30135-
The Indiana Clinical Trials Center, PCPlainfieldIndiana46168-
DS Research of KentuckyLouisvilleKentucky40241-
Martha StewartMandevilleLouisiana70448-
Clinical Trials Management, LLCMetairieLouisiana70006-
DelRicht ResearchNew OrleansLouisiana70115-
Oakland Hills DermatologyAuburn HillsMichigan48326-
MI Skin InnovationsNorthvilleMichigan48167-
DelRicht ResearchWildwoodMissouri63040-
JDR Dermatology Research LLCLas VegasNevada89145-
Skin Cancer and Dermatology InstituteRenoNevada89509-
Schweiger Dermatology, PCHackensackNew Jersey07601-
Equity Medical LLCThe BronxNew York10455-
Optima Research - BoardmanBoardmanOhio44512-
Apex Clinical Research Center, LLCCantonOhio44718-
Apex Clinical Research Center, LLCMayfield HeightsOhio44124-
UPMC Department of DermatologyPittsburghPennsylvania15213-
Medical Univ of SC Department of DermatologyCharlestonSouth Carolina29425-
DelRicht ResearchMt. PleasantSouth Carolina29464-
DelRicht ResearchSmyrnaTennessee37167-
DelRicht ResearchProsperTexas75078-
Stryde Research-Epiphany DermatologySouthlakeTexas76092-
Dermatology Specialists of SpokaneSpokaneWashington99202-

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By research site
Saguaro Dermatology· Phoenix, AZEncino Research Center· Encino, CAClinical Science Institute· Santa Monica, CASkin Care Research· Boca Raton, FLCenter for Skin Science and Innovation· Fort Lauderdale, FLZiaderm Research LLC· North Miami Beach, FL

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