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NCT Number: NCT07287644

A Study Evaluating BFB759 in 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.

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Key information

Conditions

Hidradenitis Suppurativa (HS) Bacterial Infections Bacterial Infections and Mycoses Hidradenitis Hidradenitis Suppurativa Infections Skin Diseases Skin Diseases, Bacterial Skin Diseases, Infectious Skin and Connective Tissue Diseases Suppuration Sweat Gland Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Medical Center Medconsult Burgas EOOD, Burgas, Bulgaria

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Primary outcomes

  1. 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).

Secondary outcomes

  1. 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.

  2. 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)

  3. 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].

  4. 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.

  5. 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).

Study contacts

Contact information is provided by the study sponsor or research team.

Rob Eichelkraut

CONTACT

[email protected]

+1-214-728-6505

Sponsors and collaborators

Lead sponsor

Bluefin Biomedicine, Inc.

Industry

Registry information

Official study 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

Acronym: COMPASS 2-HS

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Dec 17, 2025
Registry last updated
May 29, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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