The main objective of this study is to determine if NAV-240 works more effectively than a dummy treatment (placebo) for participants with moderate-to-severe HS. The main endpoint of this study is the percentage of participants achieving Hidradenitis Suppurativa Clinical Response (HiSCR) 75 at Week 16, meaning at least a 75% reduction in inflamed skin bumps (abscess and inflammatory nodule (AN) count) with no increase in number of abscesses or draining tunnels (channels under the skin that leak fluid or pus) compared to the baseline (start of the study). Participants will: * Receive NAV-240 dose 1, NAV-240 dose 2 or placebo as a drip into the veins (intravenous infusion). * Visit the clinic up to 9 times for checkups and tests over 22 weeks. * Complete a daily diary about their skin pain.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
150
NAV-240 for Intravenous Infusion
Placebo to match NAV-240 for Intravenous Infusion
Medical Dermatology Specialist
Phoenix, Arizona, United States
RECRUITINGAccel Research Sites Network
Maitland, Florida, United States
RECRUITINGFloridian Research Institute
Miami, Florida, United States
RECRUITINGCordova Research Institute
Miami, Florida, United States
RECRUITINGTory Sullivan MD PA - Dermatology
North Miami Beach, Florida, United States
RECRUITINGMplusM - D&H Tamarac Research Center
Tamarac, Florida, United States
RECRUITINGForCare Clinical Research
Tampa, Florida, United States
RECRUITINGKentucky Advanced Medical Research LLC
Murray, Kentucky, United States
RECRUITINGActivMed Practices & Research, LLC
Portsmouth, New Hampshire, United States
RECRUITINGEquity Medical, LLC
The Bronx, New York, United States
RECRUITINGProportion of participants achieving Hidradenitis Suppurativa Clinical Response (HiSCR) 75
HiSCR75 is defined as at least a 75% reduction in total abscess and inflammatory nodule count (AN count) with no increase in abscess count and no increase in draining tunnel count relative to baseline.
Time frame: Baseline to Week 16
Proportion of participants achieving skin pain numeric rating scale (NRS) 30 response
NRS30 is defined as a ≥ 30% reduction and at least a 2-unit reduction from baseline in skin pain on the NRS, for participants with a baseline skin pain NRS ≥ 3, based on the weekly average of the worst skin pain in a 24-hour recall period (maximal daily pain).
Time frame: Baseline to Week 16
Proportion of participants achieving HiSCR50
HiSCR50 is defined as at least a 50% reduction in total AN count with no increase in abscess count and no increase in draining tunnel count relative to baseline.
Time frame: Baseline to Week 16
Proportion of participants achieving a Dermatology Life Quality Index (DLQI) improvement (reduction) of ≥ 4 points among participants with DLQI ≥ 4 at baseline
Time frame: Baseline to Week 16
Proportion of participants with HS flare
Time frame: Baseline to Week 16
Change in the International Hidradenitis Suppurativa Severity Score System (IHS4) scores
Time frame: Baseline to Week 16
Change from baseline in AN count
Time frame: Baseline to Week 16
Change from baseline in the number of draining tunnels
Time frame: Baseline to Week 16
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