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Clinical Trials in the USA / NCT07384975
Recruiting Phase 2

A Study to Assess NAV-240 in Adult Participants With Hidradenitis Suppurativa

NCT07384975 · tracked via the Priya Life Science USA tracker
Sponsor
Navigator Medicines, Inc.
Phase
Phase 2
Started
2026-01-05
Last updated
2026-07-22

Condition(s) studied

Hidradenitis Suppurativa (HS)

Investigational drug(s) / intervention(s)

NAV-240Placebo to match NAV-240

NAV-240: NAV-240 for Intravenous Infusion

Placebo to match NAV-240: Placebo to match NAV-240 for Intravenous Infusion

Study 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

Sex
ALL
Min age
18 Years
Max age
70 Years
Healthy volunteers
No
Inclusion Criteria: * 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 Exclusion Criteria: * \> 20 draining tunnel count * Active skin disease (bacterial, fungal, viral infection) that, in the opinion of the Investigator, could interfere with assessment of HS or requires treatment with antibiotic(s) also used to treat HS. * Has had major surgery, including HS surgery, within 12 weeks prior to Day 1 * History of alcohol or drug abuse within the past 2 years. * A positive urine drug screen at Screening * History or evidence of human immunodeficiency virus (HIV), hepatitis B or hepatitis C virus (HCV), or a positive test at Screening * History or current diagnosis of active or latent pulmonary or extrapulmonary TB infection or a positive test at Screening * History of moderate to severe heart failure or recent (within past 6 months) cerebrovascular accident, myocardial infarction, or coronary stenting. * Any history of malignancy (including lymphoma and leukemia) other than a successfully treated and considered cured non-metastatic cutaneous squamous cell carcinoma, basal cell carcinoma or localized carcinoma in situ * History of immune deficiency

Primary outcome measure(s)

Trial sites (41)

FacilityCityRegionStatus
Medical Dermatology Specialist Phoenix Arizona Recruiting
Scottsdale Clinical Trials Scottsdale Arizona Recruiting
Accel Research Sites Network Maitland Florida Recruiting
Floridian Research Institute Miami Florida Recruiting
Cordova Research Institute Miami Florida Recruiting
Ziaderm Research, LLC North Miami Beach Florida Recruiting
FWD Clinical Research Tamarac Florida Recruiting
MplusM - D&H Tamarac Research Center Tamarac Florida Recruiting
ForCare Clinical Research Tampa Florida Recruiting
Kentucky Advanced Medical Research LLC Murray Kentucky Recruiting
Beth Israel Deaconess Medical Center Boston Massachusetts Recruiting
SKY Integrative Medical Center Ridgeland Mississippi Recruiting
StracSkin, PLLC Portsmouth New Hampshire Recruiting
Equity Medical, LLC The Bronx New York Recruiting
Medical Center Medconsult Pleven Lovech Bulgaria Recruiting
MC Medconsult Pleven Pleven Bulgaria Recruiting
Ambulatory for Specialized Medical Help - skin and venereal diseases Sofia Bulgaria Recruiting
Diagnostic Consultative Center Fokus-5 Medical Establishment for Outpatient Care EOOD Sofia Bulgaria Recruiting
FACET Dermatology Toronto Ontario Recruiting
Research Toronto Toronto Ontario Recruiting
Centre de Recherche Saint-Louis (Quebec) Montreal Quebec Recruiting
LTD Aversi Clinic - Dermatology Tbilisi Georgia Recruiting
LTD Israel-Georgian Medical Research Clinic Healthycore Tbilisi Georgia Recruiting
LTD MediClub Georgia Tbilisi Georgia Recruiting
LTD Multiprofile Clinic Consilium Medulla Tbilisi Georgia Not Yet Recruiting
St. Josef Hospital Bochum - Dermatologie, Venerologie und Allergologie Bochum Germany Recruiting
J. W. Goethe Universitaet Frankfurt Zentrum f. Dermatologie Frankfurt Germany Recruiting
Universitaetsklinikum Schleswig-Holstein (UKSH) - Campus Kiel - Klinik fuer Dermatologie, Venerologie und Allergologie Kiel Germany Recruiting
Universitaetsklinikum Schleswig-Holstein (UKSH) - Campus Luebeck Lübeck Germany Recruiting
BAG Dres. med. Quist PartG Mainz Germany Recruiting
Debreceni Egyetem Klinikai Központ - Dermatology Debrecen Hungary Recruiting
Pécsi Tudományegyetem Klinikai Központ - Bőr-, Nemikórtani és Onkoderma Pécs Hungary Recruiting
Holsamed Katowice Poland Recruiting
Dermedic Jacek Zdybski Kielce Poland Recruiting
Labderm Essence Ossy Poland Recruiting
Klinika Ambroziak Dermatologia Warsaw Poland Recruiting
OT CO Zdrowie Warsaw Poland Recruiting
Centrum Columbus Wroclaw Poland Recruiting
Futuremeds Romania - Brasov - Dermatology Brasov Romania Recruiting
Spitalul Clinic Colentina - Dermatology II Bucharest Romania Recruiting

+ 1 more sites — see the full list on the official registry below.

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07384975 on ClinicalTrials.gov ↗ ← All trials in the USA