Hidradenitis Suppurativa (HS)Phase 2/3COMPASS 2-HSNCT07287644
A Study Evaluating BFB759 in Moderate to Severe Hidradenitis Suppurativa
A Phase 2/3 study testing BFB759 in people with Hidradenitis Suppurativa (HS), run by Bluefin Biomedicine, Inc. at 64 sites in 7 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Hidradenitis Suppurativa (HS)
- What is being tested?
- BFB759
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 210 participants
- Where
- 64 sitesin 7 countries
- Study dates
- 3 Nov 2025to 1 Aug 2027
- Phase
- Phase 2/3
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Have certain infections or other immune conditions.
- Recently used medications that could interfere with the study.
- Are pregnant or breastfeeding.
Trial locations and contacts
64 sites in 7 countries.
64 sites in 7 countries
United States35 sites
DelRicht Research
Atlanta, Georgia, 30329
Oakland Hills Dermatology
Auburn Hills, Michigan, 48326
Optima Research - Boardman
Boardman, Ohio, 44512
Skin Care Research
Boca Raton, Florida, 33021
Apex Clinical Research Center, LLC
Canton, Ohio, 44718
Medical Univ of SC Department of Dermatology
Charleston, South Carolina, 29425
Dermatology Treatment & Research Center
Dallas, Texas, 75230
Southeast Research Specialist LLC
Douglasville, Georgia, 30135
Encino Research Center
Encino, California, 91436
Center for Skin Science and Innovation
Fort Lauderdale, Florida, 33308
VAST Clinical Research LLC
Frisco, Texas, 75033
Schweiger Dermatology, PC
Hackensack, New Jersey, 07601
Marvel Clinical Research LLC
Huntington Beach, California, 92647
JDR Dermatology Research LLC
Las Vegas, Nevada, 89145
DS Research of Kentucky
Louisville, Kentucky, 40241
Martha Stewart
Mandeville, Louisiana, 70448
Gsi Clinical Research
Margate, Florida, 33063
Apex Clinical Research Center, LLC
Mayfield Heights, Ohio, 44124
Clinical Trials Management, LLC
Metairie, Louisiana, 70006
DelRicht Research
Mt. Pleasant, South Carolina, 29464
DelRicht Research
New Orleans, Louisiana, 70115
Ziaderm Research LLC
North Miami Beach, Florida, 33126
MI Skin Innovations
Northville, Michigan, 48167
Saguaro Dermatology
Phoenix, Arizona, 85008
UPMC Department of Dermatology
Pittsburgh, Pennsylvania, 15213
The Indiana Clinical Trials Center, PC
Plainfield, Indiana, 46168
DelRicht Research
Prosper, Texas, 75078
Skin Cancer and Dermatology Institute
Reno, Nevada, 89509
Clinical Science Institute
Santa Monica, California, 90404
DelRicht Research
Smyrna, Tennessee, 37167
Stryde Research-Epiphany Dermatology
Southlake, Texas, 76092
Dermatology Specialists of Spokane
Spokane, Washington, 99202
Clinical Trials Management, LLC
Tampa, Florida, 33607
Equity Medical LLC
The Bronx, New York, 10455
DelRicht Research
Wildwood, Missouri, 63040
Germany6 sites
St. Josef-Hospital Bochum
Bochum
Universitatsklinikum Frankfurt Klinik fur Dermatologie, Venerologie und Allergologie
Frankfurt
University Clinic Dermatology Heidelberg
Heidelberg
University Hospital, Leipzig
Leipzig
University of Luebeck
Lübeck
Klinik und Poliklinik fur Dermatologie und Allergologie
Munich
Spain6 sites
Hospital Universitario Virgen De Las Nieves
Granada
Hospital Asil de Granollers
Granollers
Hospital Universitario de Gran Canaria Doctor Negrin
Las Palmas de Gran Canaria
Hospital Gregorio Maranon
Madrid
Complejo Hospitalario Universitario de Pontevedra
Pontevedra
Hospital de Manises
Valencia
Bulgaria5 sites
Medical Center Medconsult Burgas EOOD
Burgas
Medical Center Medconsult Pleven-Lovech Branch
Lovech
Medical Center Medconsult Pleven OOD
Pleven
Medical Center Etika Ambulatory For Specialized Outpatient Medical Care OOD
Plovdiv
Medical Center Rusemed
Rousse
Poland5 sites
NZOZ Specjal. Osrodek Dermatologiczny DERMAL
Bialystok
Luxderm Specjalistyczny Gabinet Dermatologiczny prof. dr hab. n. med. Dorota Krasowska
Lublin
Melita Medical
Wroclaw
Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego we Wrocławiu
Wroclaw
Wojewódzki Szpital Specjalistyczny we Wrocławi,Oddział Dermatologiczny
Wroclaw
Canada4 sites
Laser Rejuvenation Clinics Edmonton D.T. Inc.
Edmonton, Alberta, AB T5J 3S9
Centre de Recherche Saint-Louis (Quebec)
Québec, Quebec, QC G1W 4R4
York Dermatology Clinical and Research Centre
Richmond Hill, Ontario, L4B 1L1
North York Research Inc.
Toronto, Ontario, M2N 3A6
Czechia3 sites
CCR Ostrava s.r.o.
Ostrava
Pratia Pardubice a.s.
Pardubice
Sanatorium of Professor Arenbergera
Prague
About this study
Official title: 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.
- Conditions
- Hidradenitis Suppurativa (HS)
- Being tested
- BFB759, Placebo for BFB759
- Keywords
- Hidradenitis Suppurativa, acne inversa
- Medical subject headings
- Hidradenitis Suppurativa
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
Placebo for BFB759Other
Placebo for BFB759
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Biological: BFB759 |
| Active - low dose | Experimental | BFB759 loading dose followed by BFB759 maintenance mid-dose Q2W through Week 14 (inclusive). Receives: 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). Receives: Other: Placebo for BFB759 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Baseline to Week 16 and baseline to Week 32
Secondary outcomes (5)
Evaluate the clinical activity of BFB759 using HiSCR50
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.
Measured: Baseline to Week 16 and baseline to Week 32
Evaluate the safety/tolerability of BFB759
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)
Measured: 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)
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].
Measured: Baseline to Week 16 and baseline to Week 32
To evaluate the clinical activity of BFB759 using the Skin Pain Numerical Rating Scale (NRS)
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.
Measured: 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)
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).
Measured: Baseline to Week 16 and baseline to Week 32
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2025
- Study start3 Nov 2025
- Primary completion1 Aug 2027 (estimated)
- Study completion1 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hidradenitis Suppurativa (HS)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 210 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bluefin Biomedicine, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07287644
- Sponsor's protocol ID
- CL-BFB759-003
- Other IDs
- COMPASS 2-HS
- Acronym
- COMPASS 2-HS
- Status last verified
- Oct 2026
- First submitted
- 13 Nov 2025
- Last updated
- 14 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No