Hidradenitis Suppurativa study: NAV-240
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?
an investigational intravenous infusion being studied as a potential treatment for moderate-to-severe 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
- This study is testing whether NAV-240 works better than a pretend treatment. It looks at how well it reduces painful skin bumps.
- Who it's for
- You may be able to join if you have moderate to severe hidradenitis suppurativa.
- What's involved
- You would get NAV-240 or a pretend treatment as a drip into your veins. You would also keep a daily diary about your skin pain.
- Time commitment
- The study lasts 22 weeks and requires up to 9 clinic visits.
- 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
- 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.
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
- 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
- \> 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
The study team makes the final eligibility decision.
Where it is enrolling
- Phoenix, Arizona, United States
- Scottsdale, 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
- Boston, Massachusetts, United States
- Ridgeland, Mississippi, United States
- Portsmouth, New Hampshire, United States
- The Bronx, New York, United States
- Lovech, Bulgaria
- Pleven, Bulgaria
- Sofia, Bulgaria
- Toronto, Ontario, Canada
- Montreal, Quebec, Canada
- Tbilisi, Georgia
- Bochum, Germany
- Frankfurt, Germany
+ 13 more site(s).
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, but 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?
This study is enrolling now at Phoenix, Arizona, United States; Scottsdale, Arizona, United States; Maitland, Florida, United States; Miami, Florida, United States; North Miami Beach, Florida, United States; Tamarac, Florida, United States and 27 more locations. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.