Recruiting

Phase 2

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

Sponsor:

Navigator Medicines, Inc.

Code:

NCT07384975

Conditions

Hidradenitis Suppurativa (HS)

Eligibility Criteria

Sex: All

Age: 18 - 70

Healthy Volunteers: Not accepted

Interventions

NAV-240

Placebo to match NAV-240

Study Details

Brief 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.

Conditions

Hidradenitis Suppurativa (HS)

Study ID

NCT07384975

Start date

Jan 5, 2026

Status verified date

Jul, 2026

Completion date

Oct, 2027

Anticipated

Primary completion date

Sep, 2027

Anticipated

Eligibility Criteria

Sex: All

Age: 18 - 70

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

150 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: NAV-240 Dose 1

NAV-240 Dose 1

experimental: NAV-240 Dose 2

NAV-240 Dose 2

placebo comparator: Placebo

Placebo

Interventions

NAV-240

NAV-240 for Intravenous Infusion

Placebo to match NAV-240

Placebo to match NAV-240 for Intravenous Infusion

Primary outcome measure

Proportion of participants achieving Hidradenitis Suppurativa Clinical Response (HiSCR) 75 [ Time Frame: Baseline to Week 16 ]

Central Contacts and Locations

Central contacts

Associate Director, Clinical Operations

+1 415 251 7753 info@navigatormeds.com

Locations

Medical Dermatology Specialist

Recruiting

Phoenix, Arizona, United States, 85006

Scottsdale Clinical Trials

Recruiting

Scottsdale, Arizona, United States, 85260

Accel Research Sites Network

Recruiting

Maitland, Florida, United States, 32751

Floridian Research Institute

Recruiting

Miami, Florida, United States, 33179

Cordova Research Institute

Recruiting

Miami, Florida, United States, 33182

Ziaderm Research, LLC

Recruiting

North Miami Beach, Florida, United States, 33162

FWD Clinical Research

Recruiting

Tamarac, Florida, United States, 33321

MplusM - D&H Tamarac Research Center

Recruiting

Tamarac, Florida, United States, 33321

ForCare Clinical Research

Recruiting

Tampa, Florida, United States, 33613

Kentucky Advanced Medical Research LLC

Recruiting

Murray, Kentucky, United States, 42071

Beth Israel Deaconess Medical Center

Recruiting

Boston, Massachusetts, United States, 02215

SKY Integrative Medical Center

Recruiting

Ridgeland, Mississippi, United States, 39157

StracSkin, PLLC

Recruiting

Portsmouth, New Hampshire, United States, 03801

Equity Medical, LLC

Recruiting

The Bronx, New York, United States, 10455

FACET Dermatology

Recruiting

Toronto, Ontario, Canada, M4E 1R7

Research Toronto

Recruiting

Toronto, Ontario, Canada, M4W 2N2

Centre de Recherche Saint-Louis (Quebec)

Recruiting

Montreal, Quebec, Canada, QC H1Y 3L1

More Information

Sponsor

Navigator Medicines, Inc.

Last update posted

Jul 22, 2026

Last verified

Jul, 2026

Keywords

NAV-240
HS
Hidradenitis Suppurativa
Phase 2
Moderate-to-Severe HS

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Navigator Medicines, Inc. on 2026-07-22.