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

Insmed

Status and phase: Active, not recruiting; Phase 2

Conditions: Hidradenitis Suppurativa

Treatments: Drug: Brensocatib; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT06685835

INS1007-231

2024-515959-38-00 (Other Identifier)

Details and patient eligibility

About

The primary purpose of the study is to evaluate the effect of brensocatib compared with placebo.

Full 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.

Enrollment: 214 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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214 participants in 4 patient groups, including a placebo group

Brensocatib 10 mg

Experimental group

Description:

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

Treatment:

Drug: Brensocatib

Brensocatib 40 mg

Experimental group

Description:

Participants will receive brensocatib 40 mg tablet, QD, orally for 52 weeks.

Treatment:

Drug: Brensocatib

Placebo Followed by Brensocatib 10 mg

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebo

Drug: Brensocatib

Placebo Followed by Brensocatib 40 mg

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebo

Drug: Brensocatib