Clinical trial NCT06685835: A Study of the Efficacy and Safety of Brensocatib in Adults With Moderate to Severe Hidradenitis Suppurativa (HS)
Official title: A Phase 2b, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study of the Efficacy and Safety of Brensocatib in Adults With Moderate to Severe Hidradenitis Suppurativa - The CEDAR Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Hidradenitis Suppurativa
Keywords: HS
Lead sponsor: Insmed Incorporated
Sponsor class: INDUSTRY
First posted: 2024-11-13
Enrollment: 204
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The primary purpose of the study is evaluate the effect of brensocatib compared with placebo.


Eligibility criteria: 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/Exclusion criteria may apply.

Primary outcomes:
measure: Percent Change From Baseline in Total Abscess and Inflammatory Nodule (AN) Count at Week 16
timeFrame: Baseline and Week 16
Secondary outcomes:
measure: Percentage of Participants Achieving Hidradenitis Suppurativa Clinical Response 50 (HiSCR50) at Week 16
timeFrame: Week 16
measure: Percentage of Participants Achieving HiSCR75 at Week 16
timeFrame: Week 16
measure: Percentage of Participants Achieving ≥2-point Decrease From Baseline in Hidradenitis Suppurativa - Investigator's Global Assessment (HS-IGA) at Week 16
timeFrame: Week 16
measure: Change From Baseline in Draining Tunnel Count at Week 16
timeFrame: Baseline and Week 16
measure: Percentage of Participants Remaining Free from HS Flare by Week 16
timeFrame: Week 16
measure: Change From Baseline in International Hidradenitis Suppurativa Severity Score System (IHS4) Score at Week 16
timeFrame: Baseline and Week 16
measure: Percentage of Participants Achieving IHS4-55 at Week 16
timeFrame: Week 16
measure: Change From Baseline on Dermatology Life Quality Index (DLQI) Global Score at Week 16
timeFrame: Baseline and Week 16
measure: Percentage of Participants Achieving Numeric Rating Scale 30 (NRS30) at Week 16 with a Baseline NRS Score ≥3
timeFrame: Week 16
measure: Number of Participants who Experienced at Least One Adverse Event (AE)
timeFrame: Up to Week 56
measure: Plasma Concentration of Brensocatib
timeFrame: Pre-dose and at multiple timepoints post-dose up to Week 56
Other outcomes:
Locations:
city: Sacramento
country: United States
facility: USA007
state: California
city: Coral Gables
country: United States
facility: USA026
state: Florida
city: Margate
country: United States
facility: USA021
state: Florida
city: Ocala
country: United States
facility: USA025
state: Florida
city: Tampa
country: United States
facility: USA004
state: Florida
city: Weston
country: United States
facility: USA010
state: Florida
city: Sandy Springs
country: United States
facility: USA011
state: Georgia
city: Plainfield
country: United States
facility: USA003
state: Indiana
city: Baton Rouge
country: United States
facility: USA002
state: Louisiana
city: Fort Gratiot
country: United States
facility: USA024
state: Michigan
city: Lebanon
country: United States
facility: USA013
state: New Hampshire
city: Springfield
country: United States
facility: USA016
state: Ohio
city: Dallas
country: United States
facility: USA005
state: Texas
city: Dallas
country: United States
facility: USA023
state: Texas
city: Spokane
country: United States
facility: USA008
state: Washington
city: Darlinghurst
country: Australia
facility: AUS003
state: New South Wales
city: Kogarah
country: Australia
facility: AUS004
state: New South Wales
city: Brisbane
country: Australia
facility: AUS001
state: Queensland
city: Lovech
country: Bulgaria
facility: BGR001
city: Pleven
country: Bulgaria
facility: BGR003
city: Sofia
country: Bulgaria
facility: BGR004
city: Stara Zagora
country: Bulgaria
facility: BGR002
city: Guelph
country: Canada
facility: CAN006
state: Ontario
city: Peterborough
country: Canada
facility: CAN007
state: Ontario
city: Richmond Hill
country: Canada
facility: CAN009
state: Ontario
city: Lyon
country: France
facility: FRA001
state: Auvergne-Rhône-Alpes
city: Toulouse
country: France
facility: FRA004
state: Haute-Garonne
city: Antony
country: France
facility: FRA002
city: Paris
country: France
facility: FRA003
city: Rouen
country: France
facility: FRA005
city: Langenau
country: Germany
facility: DEU007
state: Baden-Wurttemberg
city: Darmstadt
country: Germany
facility: DEU002
state: Hessen
city: Bochum
country: Germany
facility: DEU001
state: North Rhine-Westphalia
city: Dresden
country: Germany
facility: DEU003
state: Sachsen
city: Dessau-RoÃŸlau
country: Germany
facility: DEU006
city: Lübeck
country: Germany
facility: DEU005
city: Athina
country: Greece
facility: GRC002
state: Attiki
city: Chaidari
country: Greece
facility: GRC004
state: Attiki
city: N. Efkapria-Pavlos Melas
country: Greece
facility: GRC001
state: Thessaloniki
city: Thessaloniki
country: Greece
facility: GRC003
city: Rotterdam
country: Netherlands
facility: NLD001
city: Wroclaw
country: Poland
facility: POL006
state: Lower Silesia
city: Warsaw
country: Poland
facility: POL008
state: Mazowieckie
city: Rzeszów
country: Poland
facility: POL002
state: Podkarpackie
city: Kraków
country: Poland
facility: POL004
city: Warszawa
country: Poland
facility: POL007
city: Warszawa
country: Poland
facility: POL001
city: Wroclaw
country: Poland
facility: POL005
city: Wrocław
country: Poland
facility: POL003
city: Badalona
country: Spain
facility: ESP006
state: Barcelona
city: Las Palmas De Gran Canaria
country: Spain
facility: ESP004
state: Las Palmas Provincia
city: Manises
country: Spain
facility: ESP001
state: Valencia
city: Madrid
country: Spain
facility: ESP002
city: Madrid
country: Spain
facility: ESP005
city: Madrid
country: Spain
facility: ESP003
Study officials:
References: