A Phase 2/3 interventional study of BFB759 and Placebo for BFB759 in Hidradenitis Suppurativa (HS), sponsored by Bluefin Biomedicine, Inc.. Active, not recruiting at 58 sites in 7 countries. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-10-01.
Sponsored by Bluefin Biomedicine, Inc. · Phase 2/3, Interventional, and Treatment
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.
277 studies on the registry are indexed under Hidradenitis Suppurativa; 88 are open to participants now.
This study's planned enrollment of 210 is above the median of 45 across 195 interventional studies indexed under Hidradenitis Suppurativa.
Browse Hidradenitis Suppurativa studies →Bluefin Biomedicine, Inc. is the lead sponsor of 2 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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 loading dose followed by BFB759 maintenance mid-dose Q2W through Week 14 (inclusive).
Biological: BFB759
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
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
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).
Time frame: Baseline to Week 16 and baseline to Week 32
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.
Time frame: 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)
Time frame: 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) + \[number of dTs multiplied by 4\].
Time frame: 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.
Time frame: 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).
Time frame: Baseline to Week 16 and baseline to Week 32
Plan to share: No
No publications or documents are linked to this record.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is active, not recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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Bluefin Biomedicine, Inc.