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New IV drug NAV-240 aims to calm painful skin bumps in hidradenitis suppurativa

NCT ID NCT07384975

Disease control Sponsor: Navigator Medicines, Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jul 23, 2026 · Updated 3 times

Summary

This study tests whether NAV-240, given as an IV infusion, works better than a placebo for adults with moderate-to-severe hidradenitis suppurativa (HS). HS causes painful, inflamed bumps and tunnels under the skin. The main goal is to see if NAV-240 can reduce these bumps by at least 75% after 16 weeks. About 150 participants will receive either NAV-240 or placebo and be monitored for 22 weeks.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
NAV-240 (given as an intravenous infusion)
What this could lead to
If successful, this could point toward a new treatment option that reduces painful skin bumps and draining tunnels in people with hidradenitis suppurativa.
What could go wrong
This is an early Phase 2a study with only 150 participants, so results may not apply to everyone. The drug may not work better than placebo, and side effects are still being evaluated.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 150 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jan 2026

Expected to finish

Oct 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 70 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

hidradenitis suppurativa

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Hidradenitis suppurativa (HS)

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    41 sites in 8 countries. The list below names each one and where it is.

  3. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  4. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Study contacts

  • Contact

    Email: •••••@•••••

Locations

  • Accel Research Sites Network

    RECRUITING

    Maitland, Florida, 32751, United States

  • Ambulatory for Specialized Medical Help - skin and venereal diseases

    RECRUITING

    Sofia, Bulgaria

  • BAG Dres. med. Quist PartG

    RECRUITING

    Mainz, Germany

  • Beth Israel Deaconess Medical Center

    RECRUITING

    Boston, Massachusetts, 02215, United States

  • Centre de Recherche Saint-Louis (Quebec)

    RECRUITING

    Montreal, Quebec, QC H1Y 3L1, Canada

  • Centrum Columbus

    RECRUITING

    Wroclaw, Poland

  • Cordova Research Institute

    RECRUITING

    Miami, Florida, 33182, United States

  • Debreceni Egyetem Klinikai Központ - Dermatology

    RECRUITING

    Debrecen, Hungary

  • Dermedic Jacek Zdybski

    RECRUITING

    Kielce, Poland

  • Diagnostic Consultative Center Fokus-5 Medical Establishment for Outpatient Care EOOD

    RECRUITING

    Sofia, Bulgaria

  • Equity Medical, LLC

    RECRUITING

    The Bronx, New York, 10455, United States

  • FACET Dermatology

    RECRUITING

    Toronto, Ontario, M4E 1R7, Canada

  • FWD Clinical Research

    RECRUITING

    Tamarac, Florida, 33321, United States

  • Floridian Research Institute

    RECRUITING

    Miami, Florida, 33179, United States

  • ForCare Clinical Research

    RECRUITING

    Tampa, Florida, 33613, United States

  • Futuremeds Romania - Brasov - Dermatology

    RECRUITING

    Brasov, Romania

  • Futuremeds Romania - Galati - Dermatology

    RECRUITING

    Galati, Romania

  • Holsamed

    RECRUITING

    Katowice, Poland

  • J. W. Goethe Universitaet Frankfurt Zentrum f. Dermatologie

    RECRUITING

    Frankfurt, Germany

  • Kentucky Advanced Medical Research LLC

    RECRUITING

    Murray, Kentucky, 42071, United States

  • Klinika Ambroziak Dermatologia

    RECRUITING

    Warsaw, Poland

  • LTD Aversi Clinic - Dermatology

    RECRUITING

    Tbilisi, Georgia

  • LTD Israel-Georgian Medical Research Clinic Healthycore

    RECRUITING

    Tbilisi, Georgia

  • LTD MediClub Georgia

    RECRUITING

    Tbilisi, Georgia

  • LTD Multiprofile Clinic Consilium Medulla

    NOT_YET_RECRUITING

    Tbilisi, Georgia

  • Labderm Essence

    RECRUITING

    Ossy, Poland

  • MC Medconsult Pleven

    RECRUITING

    Pleven, Bulgaria

  • Medical Center Medconsult Pleven

    RECRUITING

    Lovech, Bulgaria

  • Medical Dermatology Specialist

    RECRUITING

    Phoenix, Arizona, 85006, United States

  • MplusM - D&H Tamarac Research Center

    RECRUITING

    Tamarac, Florida, 33321, United States

  • OT CO Zdrowie

    RECRUITING

    Warsaw, Poland

  • Pécsi Tudományegyetem Klinikai Központ - Bőr-, Nemikórtani és Onkoderma

    RECRUITING

    Pécs, Hungary

  • Research Toronto

    RECRUITING

    Toronto, Ontario, M4W 2N2, Canada

  • SKY Integrative Medical Center

    RECRUITING

    Ridgeland, Mississippi, 39157, United States

  • Scottsdale Clinical Trials

    RECRUITING

    Scottsdale, Arizona, 85260, United States

  • Spitalul Clinic Colentina - Dermatology II

    RECRUITING

    Bucharest, Romania

  • St. Josef Hospital Bochum - Dermatologie, Venerologie und Allergologie

    RECRUITING

    Bochum, Germany

  • StracSkin, PLLC

    RECRUITING

    Portsmouth, New Hampshire, 03801, United States

  • Universitaetsklinikum Schleswig-Holstein (UKSH) - Campus Kiel - Klinik fuer Dermatologie, Venerologie und Allergologie

    RECRUITING

    Kiel, Germany

  • Universitaetsklinikum Schleswig-Holstein (UKSH) - Campus Luebeck

    RECRUITING

    Lübeck, Germany

  • Ziaderm Research, LLC

    RECRUITING

    North Miami Beach, Florida, 33162, United States

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