Hidradenitis Suppurativa (HS)
Conditions
Keywords
Hidradenitis Suppurativa, acne inversa
Brief 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.
Interventions
BIOLOGICALBFB759
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.
OTHERPlacebo for BFB759
Placebo for BFB759
Sponsors
Bluefin Biomedicine, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
Placebo
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Efficacy of BFB759 in HS | 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
| Measure | Time frame | Description |
|---|---|---|
| Evaluate the clinical activity of BFB759 using HiSCR50 | 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. |
| Evaluate the safety/tolerability of BFB759 | 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) |
| To evaluate the clinical activity of BFB759 using the International Hidradenitis Suppurativa Severity Score System (IHS4) | 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) + \[number of dTs multiplied by 4\]. |
| To evaluate the clinical activity of BFB759 using the Skin Pain Numerical Rating Scale (NRS) | 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. |
| To evaluate the clinical activity of BFB759 using the Hidradenitis Suppurativa-Investigator Global Assessment (HS-IGA) | 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). |
Countries
Bulgaria, Canada, Czechia, Germany, Poland, Spain, United States
Contacts
CONTACTRob Eichelkraut
Outcome results
None listed