Home › Trials › NCT07287644

BFB759 for moderate to severe hidradenitis suppurativa

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

Phase2; Phase3 Interventional Bluefin Biomedicine, Inc. · NCT07287644

This trial will test whether BFB759 can reduce symptoms in adults (18–75) with moderate to severe hidradenitis suppurativa.

Quick facts

PhasePhase2; Phase3
Study typeInterventional
Enrollment210 (estimated)
Ages18 Years to 75 Years
SexAll
SponsorBluefin Biomedicine, Inc. Industry-sponsored
Locations33 sites (Phoenix, Arizona and 32 other locations)
Trial IDNCT07287644 on ClinicalTrials.gov

What this trial studies

This is a randomized, double-blind, placebo-controlled phase 2/3 trial comparing BFB759 against placebo over about 36 to 40 weeks. Adults with a confirmed diagnosis of hidradenitis suppurativa for at least one year and moderate to severe disease not well controlled by systemic antibiotics are eligible. The study tracks both safety and efficacy outcomes, with regular in-person visits and restrictions on certain concomitant medications. People with certain infections, immune conditions, recent conflicting treatments, or who are pregnant or breastfeeding are excluded.

Who should consider this trial

Good fit: Adults aged 18–75 with a confirmed HS diagnosis for at least one year, moderate to severe disease not controlled by systemic antibiotics, and who can attend scheduled visits and avoid prohibited medications are ideal candidates.

Not a fit: People who are pregnant or breastfeeding, have certain chronic infections or immune disorders, recently used interfering medications, or who have only mild disease are unlikely to benefit from this trial.

Why it matters

Potential benefit: If successful, BFB759 could reduce inflammation and flare frequency, improving pain and quality of life for people with moderate to severe HS.

How similar studies have performed: Other biologic therapies have helped some patients with HS, but BFB759 is a newer agent and prior clinical data for this specific drug are limited.

Eligibility criteria

Show full inclusion / exclusion criteria 
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.

Where this trial is running

Phoenix, Arizona and 32 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Hidradenitis Suppurativaacne inversa
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.