A Study of the Efficacy and Safety of Brensocatib in Adults With Moderate to Severe Hidradenitis Suppurativa (HS)

Recruitment & Eligibility

Inclusion Criteria

Diagnosis of HS (confirmed by a dermatologist), with a history of 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 100 mg twice daily 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/Exclusion criteria may apply.

Study & Design

Arm && Interventions

Group	Intervention	Description
Placebo Followed by Brensocatib 10 mg	Placebo	Participants will receive brensocatib-matching placebo tablet, QD, orally for 16 weeks, and then Brensocatib 10 mg tablet, QD, orally for 36 weeks.
Brensocatib 10 mg	Brensocatib	Participants will receive brensocatib 10 mg tablet, once daily (QD), orally for 52 weeks.
Brensocatib 40 mg	Brensocatib	Participants will receive brensocatib 40 mg tablet, QD, orally for 52 weeks.
Placebo Followed by Brensocatib 10 mg	Brensocatib	Participants will receive brensocatib-matching placebo tablet, QD, orally for 16 weeks, and then Brensocatib 10 mg tablet, QD, orally for 36 weeks.
Placebo Followed by Brensocatib 40 mg	Brensocatib	Participants will receive brensocatib-matching placebo tablet, QD, orally for 16 weeks, and then Brensocatib 40 mg tablet, QD, orally for 36 weeks.
Placebo Followed by Brensocatib 40 mg	Placebo	Participants will receive brensocatib-matching placebo tablet, QD, orally for 16 weeks, and then Brensocatib 40 mg tablet, QD, orally for 36 weeks.

Primary Outcome Measures

Name	Time	Method
Percent Change From Baseline in Total Abscess and Inflammatory Nodule (AN) Count at Week 16	Baseline and Week 16

Secondary Outcome Measures

Name	Time	Method
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

Recruitment & Eligibility