Hidradenitis Suppurativa
Conditions
Keywords
HS
Brief summary
The primary purpose of the study is to evaluate the effect of brensocatib compared with placebo.
Interventions
DRUGBrensocatib
Film-coated Oral tablet
DRUGPlacebo
Film-coated Oral tablet
Sponsors
Insmed Incorporated
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Diagnosis of HS (confirmed by a dermatologist), with a history of signs and symptoms consistent with HS for at least 6 months before the Screening Visit. * Moderate or severe HS defined as a total of ≥6 inflammatory lesions (inflammatory nodules and/or abscesses) for at least 8 weeks before the Baseline Visit. * HS lesions in at least 2 distinct anatomic areas, 1 of which must be at least Hurley Stage II or Hurley Stage III at both the Screening and Baseline Visits.
Exclusion criteria
* Draining tunnel count of ≥20 at the Baseline Visit. * Surgical or laser intervention for an HS lesion during the Screening Period. * Clinical diagnosis of Papillon-Lefèvre Syndrome. * Participants with an absolute neutrophil count \<1,000/mm3 at the Screening Visit. * Participants having active liver disease or hepatic dysfunction. * Have diagnosed periodontal disease under active management by a dentist or expected to have periodontal disease-related procedures within the study period. * Received systemic (intravenous or orally \[PO\]) antibiotic therapy within 8 weeks before the Baseline Visit a. Doxycycline or minocycline up to 100 mg twice daily is permitted provided the dosing regimen being stable for at least 8 weeks before the Baseline Visit and is expected to continue. * Received PO or transdermal opioid analgesics (except tramadol) for any reason within 4 weeks before the Baseline Visit. * Permitted analgesics for HS-related pain have not been at a stable dose regimen for at least 4 weeks before the Baseline Visit. * Received prescription topical therapies for the treatment of HS within 2 weeks before the Baseline Visit. * Received any anti-tumor necrosis factor (TNF)-α/other biologics treatment within 12 weeks or 5 elimination half-lives, whichever is longer, before the Baseline Visit. * Received systemic nonbiologic therapies (eg, corticosteroids and retinoids) for HS within 4 weeks before the Baseline Visit. * Received any immunomodulatory agents within 4 weeks before the Baseline Visit. Note: Other Inclusion/
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percent Change From Baseline in Total Abscess and Inflammatory Nodule (AN) Count at Week 16 | Baseline and Week 16 |
Secondary
| Measure | Time frame |
|---|---|
| Percentage of Participants Achieving Hidradenitis Suppurativa Clinical Response 50 (HiSCR50) at Week 16 | Week 16 |
| Percentage of Participants Achieving HiSCR75 at Week 16 | Week 16 |
| Percentage of Participants Achieving ≥2-point Decrease From Baseline in Hidradenitis Suppurativa - Investigator's Global Assessment (HS-IGA) at Week 16 | Week 16 |
| Change From Baseline in Draining Tunnel Count at Week 16 | Baseline and Week 16 |
| Percentage of Participants Remaining Free from HS Flare by Week 16 | Week 16 |
| Change From Baseline in International Hidradenitis Suppurativa Severity Score System (IHS4) Score at Week 16 | Baseline and Week 16 |
| Percentage of Participants Achieving IHS4-55 at Week 16 | Week 16 |
| Change From Baseline on Dermatology Life Quality Index (DLQI) Global Score at Week 16 | Baseline and Week 16 |
| Percentage of Participants Achieving Numeric Rating Scale 30 (NRS30) at Week 16 with a Baseline NRS Score ≥3 | Week 16 |
| Number of Participants who Experienced at Least One Adverse Event (AE) | Up to Week 56 |
| Plasma Concentration of Brensocatib | Pre-dose and at multiple timepoints post-dose up to Week 56 |
Countries
Australia, Bulgaria, Canada, France, Germany, Greece, Netherlands, Poland, Spain, United States
Outcome results
None listed