Brivekimig for the Treatment of Moderate to Severe Hidradenitis Suppurativa
ConditionHidradenitis Suppurativa
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorSanofi
About this trial
This is a Phase 2b, global, multicenter, sequential, randomized, double-blind, placebo-controlled, parallel group, dose-ranging study in participants with moderate to severe hidradenitis suppurativa.
The purpose of the main study is to assess the efficacy and safety of brivekimig in a dose-ranging study of participants with moderate to severe HS.
Study details include:
The study duration (per participant) will be up to approximately 164 weeks for participants transitioning into the long-term extension (LTE) period and will be up to approximately 60 weeks for participants not transitioning into the LTE period.
The randomized treatment duration will be up to approximately 152 weeks
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Participants with a diagnosis of moderate to severe hidradenitis suppurativa (HS) for at least 6 months prior to Baseline
Participants must have HS lesions present in at least 2 distinct anatomic areas (eg, left and right axilla; or left axilla and left inguinocrural fold), one of which must be Hurley Stage II or Hurley Stage III.
Participant must have had an inadequate response to a trial of an oral antibiotic for treatment of HS, exhibited recurrence after discontinuation of antibiotics, demonstrated intolerance to antibiotics, or has a contraindication to oral antibiotics for treatment of their HS as assessed by the Investigator through participant interview and review of medical history.
Participants must be either biologic-naive or biologic-experienced.
Disqualifiers
Any other active skin disease or condition (eg, bacterial, fungal, or viral infection) that may interfere with assessment of HS
History of recurrent or recent serious infection
Known history of significant immunosuppression
History of solid organ transplant or stem cell transplant
Trial design
Design model
Parallel
Treatments tested in this trial
Brivekimig
Drug* Pharmaceutical form: Solution for injection in vial * Route of administration: Subcutaneous injection
Placebo
Drug* Pharmaceutical form: Solution for injection in vial * Route of administration: Subcutaneous injection
Treatment groups
208 Participants
are divided into 4 treatment groupsGroup A: Brivekimig dose regimen AExperimental treatment 1 intervention
Group B: Brivekimig dose regimen BExperimental treatment 1 intervention
Group C: Brivekimig dose regimen CExperimental treatment 1 intervention
Group D: PlaceboPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Percentage of participants achieving Hidradenitis Suppurativa Clinical Response 75 (HiSCR75)
Hidradenitis Suppurativa Clinical Response 75 (HiSCR75) is defined as ≥75% reduction from Baseline in the total abscess and inflammatory nodule \[AN\] count, with no increase from Baseline in abscess or draining tunnel count.
Time frame
Up to Week 16Secondary outcomes
1
Percentage of participants achieving Hidradenitis Suppurativa Clinical Response 50 (HiSCR50)
Hidradenitis Suppurativa Clinical Response 50 (HiSCR50) is defined as ≥50% reduction from Baseline in the total AN count, with no increase from Baseline in abscess or draining tunnel count.
Time frame
Up to Week 162
Percentage of participants achieving Hidradenitis Suppurativa Clinical Response 90 (HiSCR90)
Hidradenitis Suppurativa Clinical Response 90 (HiSCR90) is defined as ≥90% reduction from Baseline in the total AN count, with no increase from Baseline in abscess or draining tunnel count.
Time frame
Up to Week 163
Change from Baseline in draining tunnel count at Week 16.
Time frame
From Baseline to Week 164
Change from Baseline in International Hidradenitis Suppurativa Severity Score System (IHS4) at Week 16
The determination of IHS4 requires counting the inflammatory nodules, abscesses and draining tunnels and multiplying each by a specific coefficient. A high score signifies severe disease.
Time frame
From Baseline to Week 16 Source ClinicalTrials.gov