Find Hidradenitis Suppurativa Clinical Trials Near You
A Phase 2a, Multicenter, Randomized, Double-blind, Placebo-controlled Study of NAV-240 in Adult Participants With Moderate-to-Severe Hidradenitis Suppurativa
Status: Recruiting
Location: See all (41) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 70
Healthy Volunteers: f
View:
• Diagnosis of stable HS for ≥ 2 months
• Abscesses and Inflammatory Nodules (lesion) count ≥ 5
• Inflammatory HS lesions in at least 2 different body regions, one of which must be Hurley Stage II or III
• Inadequate response to at least one course of antibiotics
• Topical antiseptics/washes are not required but allowed. If in use, the participant must agree to use one single product consistently through Week 16.
• Use of oral antibiotics is allowed during the study under the following conditions: the dose and regimen must remain stable until Week 16. Allowed oral antibiotics include doxycycline, minocycline, or tetracycline.
• Female participants of childbearing potential must have a negative pregnancy test
• Participants of reproductive potential must use a highly effective method of contraception
Locations
United States
Arizona
Medical Dermatology Specialist
RECRUITING
Phoenix
Scottsdale Clinical Trials
RECRUITING
Scottsdale
Florida
Accel Research Sites Network
RECRUITING
Maitland
Cordova Research Institute
RECRUITING
Miami
Floridian Research Institute
RECRUITING
Miami
Ziaderm Research, LLC
RECRUITING
North Miami Beach
FWD Clinical Research
RECRUITING
Tamarac
MplusM - D&H Tamarac Research Center
RECRUITING
Tamarac
ForCare Clinical Research
RECRUITING
Tampa
Kentucky
Kentucky Advanced Medical Research LLC
RECRUITING
Murray
Massachusetts
Beth Israel Deaconess Medical Center
RECRUITING
Boston
Mississippi
SKY Integrative Medical Center
RECRUITING
Ridgeland
New Hampshire
StracSkin, PLLC
RECRUITING
Portsmouth
New York
Equity Medical, LLC
RECRUITING
The Bronx
Other Locations
Bulgaria
Medical Center Medconsult Pleven
RECRUITING
Lovech
MC Medconsult Pleven
RECRUITING
Pleven
Ambulatory for Specialized Medical Help - skin and venereal diseases
RECRUITING
Sofia
Diagnostic Consultative Center Fokus-5 Medical Establishment for Outpatient Care EOOD
RECRUITING
Sofia
Canada
Centre de Recherche Saint-Louis (Quebec)
RECRUITING
Montreal
FACET Dermatology
RECRUITING
Toronto
Research Toronto
RECRUITING
Toronto
Georgia
LTD Aversi Clinic - Dermatology
RECRUITING
Tbilisi
LTD Israel-Georgian Medical Research Clinic Healthycore
RECRUITING
Tbilisi
LTD MediClub Georgia
RECRUITING
Tbilisi
LTD Multiprofile Clinic Consilium Medulla
NOT_YET_RECRUITING
Tbilisi
Germany
St. Josef Hospital Bochum - Dermatologie, Venerologie und Allergologie
RECRUITING
Bochum
J. W. Goethe Universitaet Frankfurt Zentrum f. Dermatologie
RECRUITING
Frankfurt
Universitaetsklinikum Schleswig-Holstein (UKSH) - Campus Kiel - Klinik fuer Dermatologie, Venerologie und Allergologie
RECRUITING
Kiel
Universitaetsklinikum Schleswig-Holstein (UKSH) - Campus Luebeck
RECRUITING
Lübeck
BAG Dres. med. Quist PartG
RECRUITING
Mainz
Hungary
Debreceni Egyetem Klinikai Központ - Dermatology
RECRUITING
Debrecen
Pécsi Tudományegyetem Klinikai Központ - Bőr-, Nemikórtani és Onkoderma