NCT07287644

Brief 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
210

participants targeted

Target at P75+ for phase_2

Timeline
15mo left

Started Nov 2025

Geographic Reach
1 country

4 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress29%
Nov 2025Aug 2027

Study Start

First participant enrolled

November 3, 2025

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

November 13, 2025

Completed
1 month until next milestone

First Posted

Study publicly available on registry

December 17, 2025

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2027

Last Updated

December 17, 2025

Status Verified

December 1, 2025

Enrollment Period

1.7 years

First QC Date

November 13, 2025

Last Update Submit

December 12, 2025

Conditions

Hidradenitis Suppurativa (HS)

Keywords

Hidradenitis Suppurativaacne inversa

Outcome Measures

Primary Outcomes (1)

  • Efficacy of BFB759 in HS

    To evaluate the efficacy of BFB759 in adult male and female participants with HS as measured by the change in the number of abscesses and inflammatory nodules (AN count).

    Baseline to Week 16 and baseline to Week 32

Secondary Outcomes (5)

  • Evaluate the clinical activity of BFB759 using HiSCR50

    Baseline to Week 16 and baseline to Week 32

  • Evaluate the safety/tolerability of BFB759

    routinely over 21 months (about 22 visits during the course of study)

  • To evaluate the clinical activity of BFB759 using the International Hidradenitis Suppurativa Severity Score System (IHS4)

    Baseline to Week 16 and baseline to Week 32

  • To evaluate the clinical activity of BFB759 using the Skin Pain Numerical Rating Scale (NRS)

    Baseline to Week 16 and baseline to Week 32

  • To evaluate the clinical activity of BFB759 using the Hidradenitis Suppurativa-Investigator Global Assessment (HS-IGA)

    Baseline to Week 16 and baseline to Week 32

Study Arms (3)

Active - high dose

EXPERIMENTAL

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).

Biological: BFB759

Active - low dose

EXPERIMENTAL

BFB759 loading dose followed by BFB759 maintenance mid-dose Q2W through Week 14 (inclusive).

Biological: BFB759

Placebo

PLACEBO COMPARATOR

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).

Other: Placebo for BFB759

Interventions

BFB759BIOLOGICAL

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 - high doseActive - low dose
Placebo for BFB759OTHER

Placebo for BFB759

Placebo

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • Have certain infections or other immune conditions.
  • Recently used medications that could interfere with the study.
  • Are pregnant or breastfeeding.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Skin Care Research

Boca Raton, Florida, 33021, United States

RECRUITING

Ziaderm Research LLC

North Miami Beach, Florida, 33126, United States

RECRUITING

Clinical Trials Management, LLC

Tampa, Florida, 33607, United States

RECRUITING

Clinical Trials Management, LLC

Metairie, Louisiana, 70006, United States

RECRUITING

MeSH Terms

Conditions

Hidradenitis Suppurativa

Condition Hierarchy (Ancestors)

Skin Diseases, BacterialBacterial InfectionsBacterial Infections and MycosesInfectionsSkin Diseases, InfectiousSuppurationSkin DiseasesSkin and Connective Tissue DiseasesHidradenitisSweat Gland Diseases

Central Study Contacts

Rob Eichelkraut

CONTACT

+1-214-728-6505Reichelkraut@bluefinbiomed.com

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
Placebo
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 13, 2025

First Posted

December 17, 2025

Study Start

November 3, 2025

Primary Completion (Estimated)

August 1, 2027

Study Completion (Estimated)

August 1, 2027

Last Updated

December 17, 2025

Record last verified: 2025-12

Data Sharing

IPD Sharing
Will not share

Locations

US(4)