A Study of the Efficacy and Safety of Brensocatib in Adults With Moderate to Severe Hidradenitis Suppurativa (HS)
Purpose
The primary purpose of the study is to evaluate the effect of brensocatib compared with placebo.
Condition
- Hidradenitis Suppurativa
Eligibility
- Eligible Ages
- Between 18 Years and 80 Years
- Eligible Sex
- All
- Accepts 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/Exclusion criteria may apply.
Study Design
- Phase
- Phase 2
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
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. |
|
Recruiting Locations
More Details
- NCT ID
- NCT06685835
- Status
- Active, not recruiting
- Sponsor
- Insmed Incorporated
Detailed Description
This study includes 4 periods, i.e. Screening Period (35 days), Treatment Period 1 (up to Week 16), Treatment Period 2 (up to Week 36) and Follow-up Period (4 weeks). Participants who will complete 52 weeks of study treatment may be eligible to enroll in a separate open-label extension (OLE) study. In addition to this, participants who will be enrolled in the OLE study at the Week 52 Visit are not required to complete the Follow-up Period or the Week 56 Visit.