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NCT07384975PHASE2Recruiting

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

Navigator Medicines, Inc.

Start Date

1/5/2026

Completion Date

10/1/2027

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 Criteria

Age Range: 18 years to 70 years

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

Interventions

DRUG

NAV-240

DRUG

Placebo to match NAV-240

Interested in This Trial?

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Conditions

Hidradenitis Suppurativa (HS)

Locations

Medical Dermatology Specialist

Phoenix, Arizona 85006

United States

Scottsdale Clinical Trials

Scottsdale, Arizona 85260

United States

Accel Research Sites Network

Maitland, Florida 32751

United States

Floridian Research Institute

Miami, Florida 33179

United States

Cordova Research Institute

Miami, Florida 33182

United States

Ziaderm Research, LLC

North Miami Beach, Florida 33162

United States

FWD Clinical Research

Tamarac, Florida 33321

United States

MplusM - D&H Tamarac Research Center

Tamarac, Florida 33321

United States

ForCare Clinical Research

Tampa, Florida 33613

United States

Kentucky Advanced Medical Research LLC

Murray, Kentucky 42071

United States

Beth Israel Deaconess Medical Center

Boston, Massachusetts 02215

United States

SKY Integrative Medical Center

Ridgeland, Mississippi 39157

United States

StracSkin, PLLC

Portsmouth, New Hampshire 03801

United States

Equity Medical, LLC

The Bronx, New York 10455

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 M4E 1R7

Canada

Research Toronto

Toronto, Ontario M4W 2N2

Canada

Centre de Recherche Saint-Louis (Quebec)

Montreal, Quebec QC H1Y 3L1

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