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Hidradenitis Suppurativa (HS)Phase 2MainsailNCT07384975

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

A Phase 2 study testing NAV-240 in people with Hidradenitis Suppurativa (HS), run by Navigator Medicines, Inc. at 41 sites in 8 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial 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… Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Hidradenitis Suppurativa (HS)
What is being tested?
NAV-240
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
150 participants
Where
41 sitesin 8 countries
Study dates
5 Jan 2026to Oct 2027
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • > 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
Show all 10Show fewer
  • 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

Trial locations and contacts

41 sites in 8 countries. Contact the study team or a site near you to ask about taking part.

Associate Director, Clinical Operations contact

+1 415 251 7753

info@navigatormeds.com

Vice President, Development Operations contact

41 sites in 8 countries

United States14 sites, 14 recruiting

  • Beth Israel Deaconess Medical Center

    Boston, Massachusetts, 02215

    Recruiting

  • Accel Research Sites Network

    Maitland, Florida, 32751

    Recruiting

  • Floridian Research Institute

    Miami, Florida, 33179

    Recruiting

  • Cordova Research Institute

    Miami, Florida, 33182

    Recruiting

  • Kentucky Advanced Medical Research LLC

    Murray, Kentucky, 42071

    Recruiting

  • Ziaderm Research, LLC

    North Miami Beach, Florida, 33162

    Recruiting

  • Medical Dermatology Specialist

    Phoenix, Arizona, 85006

    Recruiting

  • StracSkin, PLLC

    Portsmouth, New Hampshire, 03801

    Recruiting

  • SKY Integrative Medical Center

    Ridgeland, Mississippi, 39157

    Recruiting

  • Scottsdale Clinical Trials

    Scottsdale, Arizona, 85260

    Recruiting

  • FWD Clinical Research

    Tamarac, Florida, 33321

    Recruiting

  • MplusM - D&H Tamarac Research Center

    Tamarac, Florida, 33321

    Recruiting

  • ForCare Clinical Research

    Tampa, Florida, 33613

    Recruiting

  • Equity Medical, LLC

    The Bronx, New York, 10455

    Recruiting

Other trials in United States

Poland6 sites, 6 recruiting

  • Holsamed

    Katowice

    Recruiting

  • Dermedic Jacek Zdybski

    Kielce

    Recruiting

  • Labderm Essence

    Ossy

    Recruiting

  • Klinika Ambroziak Dermatologia

    Warsaw

    Recruiting

  • OT CO Zdrowie

    Warsaw

    Recruiting

  • Centrum Columbus

    Wroclaw

    Recruiting

Other trials in Poland

Germany5 sites, 5 recruiting

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

    Bochum

    Recruiting

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

    Frankfurt

    Recruiting

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

    Kiel

    Recruiting

  • Universitaetsklinikum Schleswig-Holstein (UKSH) - Campus Luebeck

    Lübeck

    Recruiting

  • BAG Dres. med. Quist PartG

    Mainz

    Recruiting

Other trials in Germany

Bulgaria4 sites, 4 recruiting

  • Medical Center Medconsult Pleven

    Lovech

    Recruiting

  • MC Medconsult Pleven

    Pleven

    Recruiting

  • Ambulatory for Specialized Medical Help - skin and venereal diseases

    Sofia

    Recruiting

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

    Sofia

    Recruiting

Other trials in Bulgaria

Georgia4 sites, 4 recruiting

  • LTD Aversi Clinic - Dermatology

    Tbilisi

    Recruiting

  • LTD Israel-Georgian Medical Research Clinic Healthycore

    Tbilisi

    Recruiting

  • LTD MediClub Georgia

    Tbilisi

    Recruiting

  • LTD Multiprofile Clinic Consilium Medulla

    Tbilisi

    Not yet recruiting

Other trials in Georgia

Canada3 sites, 3 recruiting

  • Centre de Recherche Saint-Louis (Quebec)

    Montreal, Quebec, QC H1Y 3L1

    Recruiting

  • FACET Dermatology

    Toronto, Ontario, M4E 1R7

    Recruiting

  • Research Toronto

    Toronto, Ontario, M4W 2N2

    Recruiting

Other trials in Canada

Romania3 sites, 3 recruiting

  • Futuremeds Romania - Brasov - Dermatology

    Brasov

    Recruiting

  • Spitalul Clinic Colentina - Dermatology II

    Bucharest

    Recruiting

  • Futuremeds Romania - Galati - Dermatology

    Galati

    Recruiting

Other trials in Romania

Hungary2 sites, 2 recruiting

  • Debreceni Egyetem Klinikai Központ - Dermatology

    Debrecen

    Recruiting

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

    Pécs

    Recruiting

Other trials in Hungary

About this study

Official title: A Phase 2a, Multicenter, Randomized, Double-blind, Placebo-controlled Study of NAV-240 in Adult Participants With Moderate-to-Severe Hidradenitis Suppurativa

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.
Being tested
NAV-240, Placebo to match NAV-240
Keywords
NAV-240, HS, Hidradenitis Suppurativa, Phase 2, Moderate-to-Severe HS
Medical subject headings
Hidradenitis Suppurativa

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • NAV-240Drug

    NAV-240 for Intravenous Infusion

  • Placebo to match NAV-240Drug

    Placebo to match NAV-240 for Intravenous Infusion

Study groups in NCT07384975
Study groupRoleWhat they receive
NAV-240 Dose 1ExperimentalNAV-240 Dose 1
Receives: Drug: NAV-240
NAV-240 Dose 2ExperimentalNAV-240 Dose 2
Receives: Drug: NAV-240
PlaceboPlacebo comparatorPlacebo
Receives: Drug: Placebo to match NAV-240

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Proportion of participants achieving Hidradenitis Suppurativa Clinical Response (HiSCR) 75

    HiSCR75 is defined as at least a 75% reduction in total abscess and inflammatory nodule count (AN count) with no increase in abscess count and no increase in draining tunnel count relative to baseline.

    Measured: Baseline to Week 16

Secondary outcomes (7)

  1. Proportion of participants achieving skin pain numeric rating scale (NRS) 30 response

    NRS30 is defined as a ≥ 30% reduction and at least a 2-unit reduction from baseline in skin pain on the NRS, for participants with a baseline skin pain NRS ≥ 3, based on the weekly average of the worst skin pain in a 24-hour recall period (maximal daily pain). The skin pain NRS is a single-item measure designed to capture information on self-reported skin pain severity by rating "the worst level of skin pain in the past 24 hours" as a number on a numerical rating scale from 0 (no pain) to 10 (worst pain imaginable).

    Measured: Baseline to Week 16

  2. Proportion of participants achieving HiSCR50

    HiSCR50 is defined as at least a 50% reduction in total AN count with no increase in abscess count and no increase in draining tunnel count relative to baseline.

    Measured: Baseline to Week 16

  3. Proportion of participants achieving a Dermatology Life Quality Index (DLQI) improvement (reduction) of ≥ 4 points among participants with DLQI ≥ 4 at baseline

    The DLQI is a simple validated 10-item, dermatology-specific, quality-of-life (QoL) questionnaire. Each item in the questionnaire can receive an impairment degree on a 4-point-scale (0 - not at all, 3 - very much), and the higher the score, the greater the impairment of QoL.

    Measured: Baseline to Week 16

  4. Proportion of participants with HS flare

    Measured: Baseline to Week 16

  5. Change in the International Hidradenitis Suppurativa Severity Score System (IHS4) scores

    The IHS4 score is arrived at by the number of nodules (multiplied by 1) plus the number of abscesses (multiplied by 2) plus the number of draining tunnels (multiplied by 4). A total score of 3 or less is a mild disease, 4-10 signifies moderate disease and 11 or higher signifies severe disease.

    Measured: Baseline to Week 16

  6. Change from baseline in AN count

    Measured: Baseline to Week 16

  7. Change from baseline in the number of draining tunnels

    Measured: Baseline to Week 16

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Feb 2026
  2. Study start5 Jan 2026
  3. Primary completionSep 2027 (estimated)
  4. Study completionOct 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
150 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07384975
Sponsor's protocol ID
NAV-240-201
Other IDs
2025-523557-33-00, 2025
Acronym
Mainsail
Status last verified
Jul 2026
First submitted
26 Jan 2026
Last updated
22 Jul 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing NAV-240 in people with Hidradenitis Suppurativa (HS), run by Navigator Medicines, Inc. at 41 sites in 8 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 22 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 41 sites in United States, Poland, Germany, Bulgaria, Georgia and 3 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Associate Director, Clinical Operations (+1 415 251 7753, info@navigatormeds.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Proportion of participants achieving Hidradenitis Suppurativa Clinical Response (HiSCR) 75 (time frame: Baseline to Week 16). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07384975.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jul 2026.

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