Actively Recruiting
A Study to Assess NAV-240 in Adult Participants With Hidradenitis Suppurativa
Led by Navigator Medicines, Inc. · Updated on 2026-02-03
150
Participants Needed
10
Research Sites
90 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
A Study to Assess NAV-240 in Adult Participants With Hidradenitis Suppurativa
Who Can Participate
Eligibility Criteria
You may qualify if you...
- History of HS for ≥ 6 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 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 will not qualify if you...
- > 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 tuberculosis (TB), untreated latent TB infection (LTBI), or undergoing current treatment for LTBI, determined by positive TB test
- History of moderate to severe heart failure or recent (within past 6 months) cerebrovascular accident, myocardial infarction, or coronary stenting.
- History of immune deficiency
AI-Screening
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Trial Site Locations
Total: 10 locations
1
Medical Dermatology Specialist
Phoenix, Arizona, United States, 85006
Actively Recruiting
2
Accel Research Sites Network
Maitland, Florida, United States, 32751
Actively Recruiting
3
Floridian Research Institute
Miami, Florida, United States, 33179
Actively Recruiting
4
Cordova Research Institute
Miami, Florida, United States, 33182
Actively Recruiting
5
Tory Sullivan MD PA - Dermatology
North Miami Beach, Florida, United States, 33162
Actively Recruiting
6
MplusM - D&H Tamarac Research Center
Tamarac, Florida, United States, 33321
Actively Recruiting
7
ForCare Clinical Research
Tampa, Florida, United States, 33613
Actively Recruiting
8
Kentucky Advanced Medical Research LLC
Murray, Kentucky, United States, 42071
Actively Recruiting
9
ActivMed Practices & Research, LLC
Portsmouth, New Hampshire, United States, 03801
Actively Recruiting
10
Equity Medical, LLC
The Bronx, New York, United States, 10455
Actively Recruiting
Research Team
A
Associate Director, Clinical Operations
CONTACT
V
Vice President, Development Operations
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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