This is a Phase 2b, global, multicenter, sequential, randomized, double-blind, placebo-controlled, parallel group, dose-ranging study in participants with moderate to severe hidradenitis suppurativa. The purpose of the main study is to assess the efficacy and safety of brivekimig in a dose-ranging study of participants with moderate to severe HS. Study details include: The study duration (per participant) will be up to approximately 164 weeks for participants transitioning into the long-term extension (LTE) period and will be up to approximately 60 weeks for participants not transitioning into the LTE period. The randomized treatment duration will be up to approximately 152 weeks
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
208
* Pharmaceutical form: Solution for injection in vial * Route of administration: Subcutaneous injection
* Pharmaceutical form: Solution for injection in vial * Route of administration: Subcutaneous injection
Medical Dermatology Specialists - Site Number: 8400019
Phoenix, Arizona, United States
RECRUITINGMayo Clinic in Arizona - Scottsdale- Site Number : 8400014
Scottsdale, Arizona, United States
RECRUITINGNorthridge Clinical Trials - Northridge- Site Number : 8400005
Northridge, California, United States
RECRUITINGFXM Clinical Research - Miami- Site Number : 8400017
Miami, Florida, United States
Percentage of participants achieving Hidradenitis Suppurativa Clinical Response 75 (HiSCR75)
Hidradenitis Suppurativa Clinical Response 75 (HiSCR75) is defined as ≥75% reduction from Baseline in the total abscess and inflammatory nodule \[AN\] count, with no increase from Baseline in abscess or draining tunnel count.
Time frame: Up to Week 16
Percentage of participants achieving Hidradenitis Suppurativa Clinical Response 50 (HiSCR50)
Hidradenitis Suppurativa Clinical Response 50 (HiSCR50) is defined as ≥50% reduction from Baseline in the total AN count, with no increase from Baseline in abscess or draining tunnel count.
Time frame: Up to Week 16
Percentage of participants achieving Hidradenitis Suppurativa Clinical Response 90 (HiSCR90)
Hidradenitis Suppurativa Clinical Response 90 (HiSCR90) is defined as ≥90% reduction from Baseline in the total AN count, with no increase from Baseline in abscess or draining tunnel count.
Time frame: Up to Week 16
Change from Baseline in draining tunnel count at Week 16.
Time frame: From Baseline to Week 16
Change from Baseline in International Hidradenitis Suppurativa Severity Score System (IHS4) at Week 16
The determination of IHS4 requires counting the inflammatory nodules, abscesses and draining tunnels and multiplying each by a specific coefficient. A high score signifies severe disease.
Time frame: From Baseline to Week 16
Percentage of participants achieving response on the Hidradenitis Suppurativa Skin Pain Numeric Rating Scale from the HS Symptom Assessment Questionnaire (HS-SAQ skin pain NRS) at week 8
The Hidradenitis Suppurativa Symptom Assessment Questionnaire (HS-SAQ) is a 7-item scale comprising unidimensional numeric rating scale (NRS) items assessing symptoms of HS. The HS-SAQ Skin Pain is based on worst skin pain in a 24-hour recall period (daily assessment is averaged over 7-day period). HS-SAQ skin pain NRS response is defined as ≥3-unit reduction from baseline in the weekly average of daily HS-SAQ Skin Pain NRS.
Time frame: From Baseline to Week 8
Change from Baseline in Hidradenitis Suppurativa Quality of Life (HiSQOL) total score at Week 16.
The Hidradenitis Suppurativa Quality of Life is a 17-item content-validated questionnaire with a 7-day recall period. It is scored by summing items to create a total score (0 to 68) with higher score indicating more severe impact on QoL.
Time frame: From Baseline to Week 16
Change from Baseline in Dermatology Life Quality Index (DLQI) total score at Week 16.
The Dermatology Life Quality Index (DLQI) is a 10-item dermatology specific health related quality of life (HRQoL) instrument. Total score ranges from 0 to 30, with higher scores indicating greater detrimental impact on QoL.
Time frame: From Baseline to Week 16
Number of participants with treatment-emergent adverse events (TEAE), serious adverse events (SAE) and laboratory anomalies.
Time frame: Up to End of Study (approximately 164 weeks)
Serum brivekimig concentration throughout the study.
Time frame: From Baseline to Week 160
Incidence of treatment-emergent (TE) anti-drug antibody responses.
Time frame: Up to End of Study (approximately 164 weeks)
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FXM Clinical Research - Miramar- Site Number : 8400004
Miramar, Florida, United States
RECRUITINGAdvanced Medical Research - Atlanta- Site Number : 8400011
Atlanta, Georgia, United States
RECRUITINGGeorgia Skin & Cancer Clinic- Site Number : 8400009
Savannah, Georgia, United States
RECRUITINGThe Iowa Clinic West Des Moines Campus- Site Number : 8400007
West Des Moines, Iowa, United States
RECRUITINGLouisiana Dermatology Associates- Site Number : 8400006
Baton Rouge, Louisiana, United States
RECRUITINGWashington University- Site Number : 8400010
St Louis, Missouri, United States
RECRUITING...and 69 more locations