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A Study to Assess NAV-240 in Adult Participants With Hidradenitis Suppurativa
Sponsor: Navigator Medicines, Inc.
Summary
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.
Official title: A Phase 2a, Multicenter, Randomized, Double-blind, Placebo-controlled Study of NAV-240 in Adult Participants With Moderate-to-Severe Hidradenitis Suppurativa
Key Details
Gender
All
Age Range
18 Years - 70 Years
Study Type
INTERVENTIONAL
Enrollment
150
Start Date
2026-01-05
Completion Date
2027-10
Last Updated
2026-02-03
Healthy Volunteers
No
Conditions
Interventions
NAV-240
NAV-240 for Intravenous Infusion
Placebo to match NAV-240
Placebo to match NAV-240 for Intravenous Infusion
Locations (10)
Medical Dermatology Specialist
Phoenix, Arizona, United States
Accel Research Sites Network
Maitland, Florida, United States
Floridian Research Institute
Miami, Florida, United States
Cordova Research Institute
Miami, Florida, United States
Tory Sullivan MD PA - Dermatology
North Miami Beach, Florida, United States
MplusM - D&H Tamarac Research Center
Tamarac, Florida, United States
ForCare Clinical Research
Tampa, Florida, United States
Kentucky Advanced Medical Research LLC
Murray, Kentucky, United States
ActivMed Practices & Research, LLC
Portsmouth, New Hampshire, United States
Equity Medical, LLC
The Bronx, New York, United States