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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06685835




Registration number
NCT06685835
Ethics application status
Date submitted
11/11/2024
Date registered
13/11/2024
Date last updated
18/05/2025

Titles & IDs
Public title
A Study of the Efficacy and Safety of Brensocatib in Adults With Moderate to Severe Hidradenitis Suppurativa (HS)
Scientific 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
Secondary ID [1] 0 0
2024-515959-38-00
Secondary ID [2] 0 0
INS1007-231
Universal Trial Number (UTN)
Trial acronym
CEDAR
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hidradenitis Suppurativa 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Brensocatib
Treatment: Drugs - Placebo

Experimental: Brensocatib 10 mg - Participants will receive brensocatib 10 mg tablet, once daily (QD), orally for 52 weeks.

Experimental: Brensocatib 40 mg - Participants will receive brensocatib 40 mg tablet, QD, orally for 52 weeks.

Placebo comparator: Placebo Followed by Brensocatib 10 mg - Participants will receive brensocatib-matching placebo tablet, QD, orally for 16 weeks, and then Brensocatib 10 mg tablet, QD, orally for 36 weeks.

Placebo comparator: Placebo Followed by Brensocatib 40 mg - Participants will receive brensocatib-matching placebo tablet, QD, orally for 16 weeks, and then Brensocatib 40 mg tablet, QD, orally for 36 weeks.


Treatment: Drugs: Brensocatib
Film-coated Oral tablet

Treatment: Drugs: Placebo
Film-coated Oral tablet
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Percent Change From Baseline in Total Abscess and Inflammatory Nodule (AN) Count at Week 16
Timepoint [1] 0 0
Baseline and Week 16
Secondary outcome [1] 0 0
Percentage of Participants Achieving Hidradenitis Suppurativa Clinical Response 50 (HiSCR50) at Week 16
Timepoint [1] 0 0
Week 16
Secondary outcome [2] 0 0
Percentage of Participants Achieving HiSCR75 at Week 16
Timepoint [2] 0 0
Week 16
Secondary outcome [3] 0 0
Percentage of Participants Achieving =2-point Decrease From Baseline in Hidradenitis Suppurativa - Investigator's Global Assessment (HS-IGA) at Week 16
Timepoint [3] 0 0
Week 16
Secondary outcome [4] 0 0
Change From Baseline in Draining Tunnel Count at Week 16
Timepoint [4] 0 0
Baseline and Week 16
Secondary outcome [5] 0 0
Percentage of Participants Remaining Free from HS Flare by Week 16
Timepoint [5] 0 0
Week 16
Secondary outcome [6] 0 0
Change From Baseline in International Hidradenitis Suppurativa Severity Score System (IHS4) Score at Week 16
Timepoint [6] 0 0
Baseline and Week 16
Secondary outcome [7] 0 0
Percentage of Participants Achieving IHS4-55 at Week 16
Timepoint [7] 0 0
Week 16
Secondary outcome [8] 0 0
Change From Baseline on Dermatology Life Quality Index (DLQI) Global Score at Week 16
Timepoint [8] 0 0
Baseline and Week 16
Secondary outcome [9] 0 0
Percentage of Participants Achieving Numeric Rating Scale 30 (NRS30) at Week 16 with a Baseline NRS Score =3
Timepoint [9] 0 0
Week 16
Secondary outcome [10] 0 0
Number of Participants who Experienced at Least One Adverse Event (AE)
Timepoint [10] 0 0
Up to Week 56
Secondary outcome [11] 0 0
Plasma Concentration of Brensocatib
Timepoint [11] 0 0
Pre-dose and at multiple timepoints post-dose up to Week 56

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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)-a/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
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
16/12/2024
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
28/01/2027
Actual
Sample size
Target
204
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD
Recruitment hospital [1] 0 0
AUS004 - Kogarah
Recruitment hospital [2] 0 0
AUS001 - Brisbane
Recruitment postcode(s) [1] 0 0
2217 - Kogarah
Recruitment postcode(s) [2] 0 0
4151 - Brisbane
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Florida
Country [3] 0 0
United States of America
State/province [3] 0 0
Georgia
Country [4] 0 0
United States of America
State/province [4] 0 0
Indiana
Country [5] 0 0
United States of America
State/province [5] 0 0
Louisiana
Country [6] 0 0
United States of America
State/province [6] 0 0
Michigan
Country [7] 0 0
United States of America
State/province [7] 0 0
New Hampshire
Country [8] 0 0
United States of America
State/province [8] 0 0
Ohio
Country [9] 0 0
United States of America
State/province [9] 0 0
Texas
Country [10] 0 0
United States of America
State/province [10] 0 0
Washington
Country [11] 0 0
Bulgaria
State/province [11] 0 0
Lovech
Country [12] 0 0
Bulgaria
State/province [12] 0 0
Pleven
Country [13] 0 0
Bulgaria
State/province [13] 0 0
Sofia
Country [14] 0 0
Bulgaria
State/province [14] 0 0
Stara Zagora
Country [15] 0 0
Canada
State/province [15] 0 0
Ontario
Country [16] 0 0
France
State/province [16] 0 0
Auvergne-Rhône-Alpes
Country [17] 0 0
France
State/province [17] 0 0
Haute-Garonne
Country [18] 0 0
France
State/province [18] 0 0
Antony
Country [19] 0 0
France
State/province [19] 0 0
Paris
Country [20] 0 0
France
State/province [20] 0 0
Rouen
Country [21] 0 0
Germany
State/province [21] 0 0
Baden-Wurttemberg
Country [22] 0 0
Germany
State/province [22] 0 0
Hessen
Country [23] 0 0
Germany
State/province [23] 0 0
North Rhine-Westphalia
Country [24] 0 0
Germany
State/province [24] 0 0
Sachsen
Country [25] 0 0
Germany
State/province [25] 0 0
Dessau-Roßlau
Country [26] 0 0
Germany
State/province [26] 0 0
Lübeck
Country [27] 0 0
Greece
State/province [27] 0 0
Attiki
Country [28] 0 0
Greece
State/province [28] 0 0
Thessaloniki
Country [29] 0 0
Netherlands
State/province [29] 0 0
Rotterdam
Country [30] 0 0
Poland
State/province [30] 0 0
Lower Silesia
Country [31] 0 0
Poland
State/province [31] 0 0
Mazowieckie
Country [32] 0 0
Poland
State/province [32] 0 0
Podkarpackie
Country [33] 0 0
Poland
State/province [33] 0 0
Kraków
Country [34] 0 0
Poland
State/province [34] 0 0
Warszawa
Country [35] 0 0
Poland
State/province [35] 0 0
Wroclaw
Country [36] 0 0
Poland
State/province [36] 0 0
WrocÅ'aw
Country [37] 0 0
Spain
State/province [37] 0 0
Barcelona
Country [38] 0 0
Spain
State/province [38] 0 0
Las Palmas Provincia
Country [39] 0 0
Spain
State/province [39] 0 0
Valencia
Country [40] 0 0
Spain
State/province [40] 0 0
Madrid

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Insmed Incorporated
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Insmed Medical Information
Address 0 0
Country 0 0
Phone 0 0
1-844-446-7633
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT06685835