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

Recruiting now · Phase 2 · Has a placebo group

Conditions studied: Hidradenitis Suppurativa (HS)

In brief

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.

Key facts

Study ID

NCT07384975

Run by

Navigator Medicines, Inc.

People needed

150

Starts

2026-01-05

Expected to finish

2027-10-01

Last updated by the study team

2026-07-22

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• > 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

Where it is running

• Futuremeds Romania - Galati - Dermatology — Galati, Romania (enrolling)
• Scottsdale Clinical Trials — Scottsdale, Arizona, United States (enrolling)
• Accel Research Sites Network — Maitland, Florida, United States (enrolling)
• Floridian Research Institute — Miami, Florida, United States (enrolling)
• Cordova Research Institute — Miami, Florida, United States (enrolling)
• Ziaderm Research, LLC — North Miami Beach, Florida, United States (enrolling)
• FWD Clinical Research — Tamarac, Florida, United States (enrolling)
• MplusM - D&H Tamarac Research Center — Tamarac, Florida, United States (enrolling)
• ForCare Clinical Research — Tampa, Florida, United States (enrolling)
• Kentucky Advanced Medical Research LLC — Murray, Kentucky, United States (enrolling)
• Beth Israel Deaconess Medical Center — Boston, Massachusetts, United States (enrolling)
• SKY Integrative Medical Center — Ridgeland, Mississippi, United States (enrolling)
• StracSkin, PLLC — Portsmouth, New Hampshire, United States (enrolling)
• Equity Medical, LLC — The Bronx, New York, United States (enrolling)
• Medical Center Medconsult Pleven — Lovech, Bulgaria (enrolling)
• MC Medconsult Pleven — Pleven, Bulgaria (enrolling)
• Ambulatory for Specialized Medical Help - skin and venereal diseases — Sofia, Bulgaria (enrolling)
• Diagnostic Consultative Center Fokus-5 Medical Establishment for Outpatient Care EOOD — Sofia, Bulgaria (enrolling)
• FACET Dermatology — Toronto, Ontario, Canada (enrolling)
• Research Toronto — Toronto, Ontario, Canada (enrolling)
• Centre de Recherche Saint-Louis (Quebec) — Montreal, Quebec, Canada (enrolling)
• LTD Aversi Clinic - Dermatology — Tbilisi, Georgia (enrolling)
• LTD Israel-Georgian Medical Research Clinic Healthycore — Tbilisi, Georgia (enrolling)
• LTD MediClub Georgia — Tbilisi, Georgia (enrolling)
• Medical Dermatology Specialist — Phoenix, Arizona, United States (enrolling)

Full record on ClinicalTrials.gov

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