RecruitingPhase 2

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

United States, Bulgaria, Canada150 participantsStarted 2026-01-05

Plain-language 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.

Who can participate

Age range

18 Years – 70 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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 p…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

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

Timeframe: Baseline to Week 16

Trial details

NCT IDNCT07384975

SponsorNavigator Medicines, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2027-09

Contact for this trial

Associate Director, Clinical Operations

+1 415 251 7753 info@navigatormeds.com

View on ClinicalTrials.gov More Hidradenitis Suppurativa (HS) trials