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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
2026-07-22
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 (41)
Medical Dermatology Specialist
Phoenix, Arizona, United States
Scottsdale Clinical Trials
Scottsdale, 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
Ziaderm Research, LLC
North Miami Beach, Florida, United States
FWD Clinical Research
Tamarac, 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
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States
SKY Integrative Medical Center
Ridgeland, Mississippi, United States
StracSkin, PLLC
Portsmouth, New Hampshire, United States
Equity Medical, LLC
The Bronx, New York, United States
Medical Center Medconsult Pleven
Lovech, Bulgaria
MC Medconsult Pleven
Pleven, Bulgaria
Ambulatory for Specialized Medical Help - skin and venereal diseases
Sofia, Bulgaria
Diagnostic Consultative Center Fokus-5 Medical Establishment for Outpatient Care EOOD
Sofia, Bulgaria
FACET Dermatology
Toronto, Ontario, Canada
Research Toronto
Toronto, Ontario, Canada
Centre de Recherche Saint-Louis (Quebec)
Montreal, Quebec, Canada
LTD Aversi Clinic - Dermatology
Tbilisi, Georgia
LTD Israel-Georgian Medical Research Clinic Healthycore
Tbilisi, Georgia
LTD MediClub Georgia
Tbilisi, Georgia
LTD Multiprofile Clinic Consilium Medulla
Tbilisi, Georgia
St. Josef Hospital Bochum - Dermatologie, Venerologie und Allergologie
Bochum, Germany
J. W. Goethe Universitaet Frankfurt Zentrum f. Dermatologie
Frankfurt, Germany
Universitaetsklinikum Schleswig-Holstein (UKSH) - Campus Kiel - Klinik fuer Dermatologie, Venerologie und Allergologie
Kiel, Germany
Universitaetsklinikum Schleswig-Holstein (UKSH) - Campus Luebeck
Lübeck, Germany
BAG Dres. med. Quist PartG
Mainz, Germany
Debreceni Egyetem Klinikai Központ - Dermatology
Debrecen, Hungary
Pécsi Tudományegyetem Klinikai Központ - Bőr-, Nemikórtani és Onkoderma
Pécs, Hungary
Holsamed
Katowice, Poland
Dermedic Jacek Zdybski
Kielce, Poland
Labderm Essence
Ossy, Poland
Klinika Ambroziak Dermatologia
Warsaw, Poland
OT CO Zdrowie
Warsaw, Poland
Centrum Columbus
Wroclaw, Poland
Futuremeds Romania - Brasov - Dermatology
Brasov, Romania
Spitalul Clinic Colentina - Dermatology II
Bucharest, Romania
Futuremeds Romania - Galati - Dermatology
Galati, Romania