A Study Evaluating BFB759 in Moderate to Severe Hidradenitis Suppurativa (COMPASS 2-HS)

May 28, 2026 updated by: Bluefin Biomedicine, Inc.

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

210

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Bulgaria
      • Burgas, Bulgaria
        • Recruiting
        • Medical Center Medconsult Burgas EOOD
      • Lovech, Bulgaria
        • Recruiting
        • Medical Center Medconsult Pleven-Lovech Branch
      • Pleven, Bulgaria
        • Recruiting
        • Medical Center Medconsult Pleven OOD
      • Plovdiv, Bulgaria
        • Recruiting
        • Medical Center Etika Ambulatory For Specialized Outpatient Medical Care OOD
      • Rousse, Bulgaria
        • Recruiting
        • Medical Center Rusemed
  • Canada
    • Ontario
      • Richmond Hill, Ontario, Canada, L4B 1L1
        • Recruiting
        • York Dermatology Clinical and Research Centre
      • Toronto, Ontario, Canada, M2N 3A6
        • Recruiting
        • North York Research Inc.
  • Czechia
      • Ostrava, Czechia
        • Recruiting
        • CCR Ostrava s.r.o.
      • Pardubice, Czechia
        • Recruiting
        • Pratia Pardubice a.s.
      • Prague, Czechia
        • Recruiting
        • Sanatorium of Professor Arenbergera
  • Germany
      • Bochum, Germany
        • Recruiting
        • St. Josef-Hospital Bochum
      • Frankfurt, Germany
        • Recruiting
        • Universitatsklinikum Frankfurt Klinik fur Dermatologie, Venerologie und Allergologie
      • Heidelberg, Germany
        • Recruiting
        • University Clinic Dermatology Heidelberg
      • Leipzig, Germany
        • Recruiting
        • University Hospital, Leipzig
      • Lübeck, Germany
        • Recruiting
        • University of Luebeck
      • Munich, Germany
        • Recruiting
        • Klinik und Poliklinik fur Dermatologie und Allergologie
  • Poland
      • Bialystok, Poland
        • Recruiting
        • NZOZ Specjal. Osrodek Dermatologiczny DERMAL
      • Lublin, Poland
        • Recruiting
        • Luxderm Specjalistyczny Gabinet Dermatologiczny prof. dr hab. n. med. Dorota Krasowska
      • Wroclaw, Poland
        • Recruiting
        • Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego we Wrocławiu
      • Wroclaw, Poland
        • Recruiting
        • Melita Medical
      • Wroclaw, Poland
        • Recruiting
        • Wojewódzki Szpital Specjalistyczny we Wrocławi,Oddział Dermatologiczny
  • Spain
      • Granada, Spain
        • Recruiting
        • Hospital Universitario Virgen De Las Nieves
      • Granollers, Spain
        • Recruiting
        • Hospital Asil de Granollers
      • Las Palmas de Gran Canaria, Spain
        • Recruiting
        • Hospital Universitario de Gran Canaria Doctor Negrin
      • Madrid, Spain
        • Recruiting
        • Hospital Gregorio Maranon
      • Pontevedra, Spain
        • Recruiting
        • Complejo Hospitalario Universitario de Pontevedra
      • Valencia, Spain
        • Recruiting
        • Hospital de Manises
  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85008
        • Recruiting
        • Saguaro Dermatology
    • California
      • Encino, California, United States, 91436
        • Recruiting
        • Encino Research Center
      • Santa Monica, California, United States, 90404
        • Recruiting
        • Clinical Science Institute
    • Florida
      • Boca Raton, Florida, United States, 33021
        • Recruiting
        • Skin Care Research
      • Fort Lauderdale, Florida, United States, 33308
        • Recruiting
        • Center for Skin Science and Innovation
      • North Miami Beach, Florida, United States, 33126
        • Recruiting
        • Ziaderm Research LLC
      • Tampa, Florida, United States, 33607
        • Recruiting
        • Clinical Trials Management, LLC
    • Georgia
      • Atlanta, Georgia, United States, 30329
        • Recruiting
        • DelRicht Research
      • Douglasville, Georgia, United States, 30135
        • Recruiting
        • Southeast Research Specialist LLC
    • Indiana
      • Plainfield, Indiana, United States, 46168
        • Recruiting
        • The Indiana Clinical Trials Center, PC
    • Kentucky
      • Louisville, Kentucky, United States, 40241
        • Recruiting
        • DS Research of Kentucky
    • Louisiana
      • Mandeville, Louisiana, United States, 70448
        • Recruiting
        • Martha Stewart
      • Metairie, Louisiana, United States, 70006
        • Recruiting
        • Clinical Trials Management, LLC
      • New Orleans, Louisiana, United States, 70115
        • Recruiting
        • DelRicht Research
    • Michigan
      • Auburn Hills, Michigan, United States, 48326
        • Recruiting
        • Oakland Hills Dermatology
      • Northville, Michigan, United States, 48167
        • Recruiting
        • MI Skin Innovations
    • Missouri
      • Wildwood, Missouri, United States, 63040
        • Recruiting
        • DelRicht Research
    • Nevada
      • Las Vegas, Nevada, United States, 89145
        • Recruiting
        • JDR Dermatology Research LLC
      • Reno, Nevada, United States, 89509
        • Recruiting
        • Skin Cancer and Dermatology Institute
    • New Jersey
      • Hackensack, New Jersey, United States, 07601
        • Recruiting
        • Schweiger Dermatology, PC
    • New York
      • The Bronx, New York, United States, 10455
        • Recruiting
        • Equity Medical LLC
    • Ohio
      • Boardman, Ohio, United States, 44512
        • Recruiting
        • Optima Research - Boardman
      • Canton, Ohio, United States, 44718
        • Recruiting
        • Apex Clinical Research Center, LLC
      • Mayfield Heights, Ohio, United States, 44124
        • Recruiting
        • Apex Clinical Research Center, LLC
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15213
        • Recruiting
        • UPMC Department of Dermatology
    • South Carolina
      • Charleston, South Carolina, United States, 29425
        • Recruiting
        • Medical Univ of SC Department of Dermatology
      • Mt. Pleasant, South Carolina, United States, 29464
        • Recruiting
        • DelRicht Research
    • Tennessee
      • Smyrna, Tennessee, United States, 37167
        • Recruiting
        • DelRicht Research
    • Texas
      • Prosper, Texas, United States, 75078
        • Recruiting
        • DelRicht Research
      • Southlake, Texas, United States, 76092
        • Recruiting
        • Stryde Research-Epiphany Dermatology
    • Washington
      • Spokane, Washington, United States, 99202
        • Recruiting
        • Dermatology Specialists of Spokane

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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).
Biological: 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.
Experimental: Active - low dose
BFB759 loading dose followed by BFB759 maintenance mid-dose Q2W through Week 14 (inclusive).
Biological: 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 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).
Other: Placebo for BFB759
Placebo for BFB759

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Efficacy of BFB759 in HS
Time Frame: Baseline to Week 16 and baseline to Week 32
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluate the clinical activity of BFB759 using HiSCR50
Time Frame: Baseline to Week 16 and baseline to Week 32
The HiSCR50 is defined as at least a 50% reduction in inflammatory lesion count [the sum of Abscesses and Inflammatory Nodules (AN)] and no increase in abscess count and no increase in draining fistula count relative to baseline. The threshold of 50% reduction in AN count is the defined level that is clinically appropriate and meaningful to the patient regarding improvement in quality of life and pain level.
Baseline to Week 16 and baseline to Week 32
Evaluate the safety/tolerability of BFB759
Time Frame: routinely over 21 months (about 22 visits during the course of study)
Record how well participants tolerate the treatment over time by recording the incidence and severity of treatment-emergent adverse events (as described by CTCAE Version 5.0)
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)
Time Frame: Baseline to Week 16 and baseline to Week 32
The IHS4 is a validated tool to dynamically assess HS severity that can be used both in real-life and the clinical trials setting (Zouboulis, 2017). It is calculated by counting nodules, abscesses and dTs/sinus tracts, and calculating a total score. IHS4 = (number of nodules multiplied by 1) + (number of abscesses multiplied by 2) + [number of dTs multiplied by 4].
Baseline to Week 16 and baseline to Week 32
To evaluate the clinical activity of BFB759 using the Skin Pain Numerical Rating Scale (NRS)
Time Frame: Baseline to Week 16 and baseline to Week 32
The Skin Pain NRS is a single self-reported item designed to measure skin pain severity over the previous 24 hours. The following question is asked, and the response is marked on an 11 point scale where 0 equals no pain and 10 equals the worst pain imaginable.
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)
Time Frame: Baseline to Week 16 and baseline to Week 32
The HS IGA is a HS-specific global assessment. It is a 6 point ordinal scale based on objective lesion counts (Garg, 2022). Scores are calculated by the sum of abscesses, nodules (inflammatory or noninflammatory) and tunnels (draining or nondraining) in either the upper body regions or the lower body regions, whichever is greater. Scores are assigned as follows: 0 (0 1 lesions), 1 (2 5 lesions), 2 (6 10 lesions), 3 (11 15 lesions), 4 (16 20 lesions), and 5 (>20 lesions).
Baseline to Week 16 and baseline to Week 32

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bluefin Biomedicine, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 3, 2025

Primary Completion (Estimated)

August 1, 2027

Study Completion (Estimated)

August 1, 2027

Study Registration Dates

First Submitted

November 13, 2025

First Submitted That Met QC Criteria

December 12, 2025

First Posted (Actual)

December 17, 2025

Study Record Updates

Last Update Posted (Actual)

May 29, 2026

Last Update Submitted That Met QC Criteria

May 28, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CL-BFB759-003
  • COMPASS 2-HS (Other Identifier: Sponsor)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Hidradenitis Suppurativa (HS)

Clinical Trials on BFB759

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Slovenia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe