A Study of the Efficacy and Safety of Brensocatib in Adults With Moderate to Severe Hidradenitis Suppurativa (HS)
- Registration Number
- NCT06685835
- Lead Sponsor
- Insmed Incorporated
- Brief Summary
The primary purpose of the study is evaluate the effect of brensocatib compared with placebo.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 204
- 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.
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Draining tunnel count of ≥20 at the Baseline Visit.
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Surgical or laser intervention for an HS lesion during the Screening Period.
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Clinical diagnosis of Papillon-Lefèvre Syndrome.
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Participants with an absolute neutrophil count <1,000/mm3 at the Screening Visit.
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Participants having active liver disease or hepatic dysfunction.
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Have diagnosed periodontal disease under active management by a dentist or expected to have periodontal disease-related procedures within the study period.
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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.
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Received PO or transdermal opioid analgesics (except tramadol) for any reason within 4 weeks before the Baseline Visit.
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Permitted analgesics for HS-related pain have not been at a stable dose regimen for at least 4 weeks before the Baseline Visit.
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Received prescription topical therapies for the treatment of HS within 2 weeks before the Baseline Visit.
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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.
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Received systemic nonbiologic therapies (eg, corticosteroids and retinoids) for HS within 4 weeks before the Baseline Visit.
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Received any immunomodulatory agents within 4 weeks before the Baseline Visit.
Note: Other Inclusion/Exclusion criteria may apply.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- 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
Trial Locations
- Locations (54)
USA007
🇺🇸Sacramento, California, United States
USA026
🇺🇸Coral Gables, Florida, United States
USA021
🇺🇸Margate, Florida, United States
USA025
🇺🇸Ocala, Florida, United States
USA004
🇺🇸Tampa, Florida, United States
USA010
🇺🇸Weston, Florida, United States
USA011
🇺🇸Sandy Springs, Georgia, United States
USA003
🇺🇸Plainfield, Indiana, United States
USA002
🇺🇸Baton Rouge, Louisiana, United States
USA024
🇺🇸Fort Gratiot, Michigan, United States
USA013
🇺🇸Lebanon, New Hampshire, United States
USA016
🇺🇸Springfield, Ohio, United States
USA005
🇺🇸Dallas, Texas, United States
USA023
🇺🇸Dallas, Texas, United States
USA008
🇺🇸Spokane, Washington, United States
AUS004
🇦🇺Kogarah, New South Wales, Australia
AUS001
🇦🇺Brisbane, Queensland, Australia
BGR001
🇧🇬Lovech, Bulgaria
BGR003
🇧🇬Pleven, Bulgaria
BGR004
🇧🇬Sofia, Bulgaria
BGR002
🇧🇬Stara Zagora, Bulgaria
CAN006
🇨🇦Guelph, Ontario, Canada
CAN007
🇨🇦Peterborough, Ontario, Canada
CAN009
🇨🇦Richmond Hill, Ontario, Canada
FRA001
🇫🇷Lyon, Auvergne-Rhône-Alpes, France
FRA004
🇫🇷Toulouse, Haute-Garonne, France
FRA002
🇫🇷Antony, France
FRA003
🇫🇷Paris, France
FRA005
🇫🇷Rouen, France
DEU007
🇩🇪Langenau, Baden-Wurttemberg, Germany
DEU002
🇩🇪Darmstadt, Hessen, Germany
DEU001
🇩🇪Bochum, North Rhine-Westphalia, Germany
DEU003
🇩🇪Dresden, Sachsen, Germany
DEU006
🇩🇪Dessau-Roßlau, Germany
DEU005
🇩🇪Lübeck, Germany
GRC002
🇬🇷Athina, Attiki, Greece
GRC004
🇬🇷Chaidari, Attiki, Greece
GRC001
🇬🇷N. Efkapria-Pavlos Melas, Thessaloniki, Greece
GRC003
🇬🇷Thessaloniki, Greece
NLD001
🇳🇱Rotterdam, Netherlands
POL006
🇵🇱Wroclaw, Lower Silesia, Poland
POL008
🇵🇱Warsaw, Mazowieckie, Poland
POL002
🇵🇱Rzeszow, Podkarpackie, Poland
POL004
🇵🇱Kraków, Poland
POL007
🇵🇱Warszawa, Poland
POL001
🇵🇱Warszawa, Poland
POL005
🇵🇱Wroclaw, Poland
POL003
🇵🇱WrocÅ'aw, Poland
ESP006
🇪🇸Badalona, Barcelona, Spain
ESP004
🇪🇸Las Palmas De Gran Canaria, Las Palmas Provincia, Spain
ESP001
🇪🇸Manises, Valencia, Spain
ESP002
🇪🇸Madrid, Spain
ESP005
🇪🇸Madrid, Spain
ESP003
🇪🇸Madrid, Spain