Actively Recruiting
A Phase 2a, Multicenter, Randomized, Double-blind, Placebo-controlled Study of NAV-240 in Adults With Moderate-to-Severe Hidradenitis Suppurativa
Led by Navigator Medicines, Inc. · Updated on 2026-02-03
150
Participants Needed
10
Research Sites
4 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying NAV-240 to see if it works better than a placebo for adults with moderate-to-severe Hidradenitis Suppurativa (HS), a skin condition involving painful bumps and tunnels under the skin. This Phase 2a trial aims to measure how many participants achieve a significant improvement called HiSCR 75 by Week 16, which means at least a 75% reduction in inflamed skin bumps without worsening abscesses or draining tunnels. Participants receive one of three treatments: two different doses of NAV-240 or a placebo, all given through intravenous infusion. The study is randomized and includes up to nine clinic visits over 22 weeks. Participants also keep a daily diary to record skin pain. Oral antibiotics are allowed if the dosage remains stable through Week 16, and topical antiseptics can be used consistently if already in use. During the study, participants will have regular checkups and tests to monitor their skin condition, including counts of lesions and draining tunnels, skin pain levels, and quality of life measures. The main outcome is tracked from the start of the study until Week 16. Safety and response to treatment will be closely observed throughout the 22-week period to evaluate NAV-240's impact compared to placebo.
CONDITIONS
Brief 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 Hidradenitis Suppurativa for at least 6 months
- Five or more abscesses and inflammatory nodules
- Inflammatory HS lesions in at least 2 different body areas, including one Hurley Stage II or III
- Inadequate response to at least one course of antibiotics
- Use of a single topical antiseptic consistently through Week 16 if already in use
- Stable dose and regimen of allowed oral antibiotics (doxycycline, minocycline, or tetracycline) through Week 16
- Negative pregnancy test for females of childbearing potential
- Use of highly effective contraception for participants of reproductive potential
You will not qualify if you...
- More than 20 draining tunnels
- Active skin infection that could interfere with HS assessment or requires antibiotics used for HS
- Major surgery, including HS surgery, within 12 weeks before Day 1
- History of alcohol or drug abuse in the past 2 years
- Positive urine drug screen at Screening
- History or evidence of HIV, hepatitis B, or hepatitis C, or positive test at Screening
- History or current active tuberculosis, untreated latent TB infection, or treatment for latent TB
- History of moderate to severe heart failure or recent stroke, heart attack, or coronary stenting within 6 months
- History of immune deficiency
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Baseline to Week 16
Participants receive NAV-240 or placebo through intravenous infusion to treat moderate-to-severe Hidradenitis Suppurativa.
Multiple visits during treatment period for infusions and assessments
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
V
Vice President, Development Operations
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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