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New treatment option for Hidradenitis Suppurativa (HS)
Official title A Study to Assess NAV-240 in Adult Participants With Hidradenitis Suppurativa
ClinicalTrials.gov ID: NCT07384975
What this study is testing
What is NAV-240?
NAV-240 is an investigational medicine, given as an once-daily infusion into a vein, being studied as a potential treatment for hidradenitis suppurativa (hs).
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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).
- Phase 2: a mid-size study of how well it works
- Time commitment: about 22 weeks
- You might receive a placebo (an inactive treatment) instead of the study drug.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 70
You may be able to join if
- 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.
You likely can't join 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...
- 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
See the full eligibility criteria
- 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
- \> 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
The study team makes the final eligibility decision.
Where it's taking place
- Phoenix, Arizona, United States
- Maitland, Florida, United States
- Miami, Florida, United States
- North Miami Beach, Florida, United States
- Tamarac, Florida, United States
- Tampa, Florida, United States
- Murray, Kentucky, United States
- Portsmouth, New Hampshire, United States
- The Bronx, New York, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 22 weeks per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 70 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Phoenix, Arizona, United States; Maitland, Florida, United States; Miami, Florida, United States; North Miami Beach, Florida, United States; Tamarac, Florida, United States; Tampa, Florida, United States and 3 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.