A Study Evaluating BFB759 in Moderate to Severe Hidradenitis Suppurativa
ConditionHidradenitis Suppurativa (HS)
Trial statusRecruiting
Trial phasePhase 2, Phase 3
Trial typeInterventional
Biological sexAll
Age18-75
SponsorBluefin Biomedicine, Inc.
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
Have certain infections or other immune conditions.
Recently used medications that could interfere with the study.
Are pregnant or breastfeeding.
Trial design
Design model
Parallel
Treatments tested in this trial
BFB759
Biological/VaccineBFB759 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 interventionPlacebo for BFB759
Treatment groups
210 Participants
are divided into 3 treatment groupsGroup A: Active - high doseExperimental treatment 1 intervention
Group B: Active - low doseExperimental treatment 1 intervention
Group C: PlaceboPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
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 32Secondary outcomes
1
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 322
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)3
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 324
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 32Sponsors and contacts
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Source ClinicalTrials.gov