NAV-240 for adults with moderate-to-severe hidradenitis suppurativa
A Phase 2a, Multicenter, Randomized, Double-blind, Placebo-controlled Study of NAV-240 in Adult Participants With Moderate-to-Severe Hidradenitis Suppurativa
This trial will test whether NAV-240 given by IV can reduce inflamed bumps and skin pain in adults with moderate-to-severe hidradenitis suppurativa compared with a placebo.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 150 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Sponsor | Navigator Medicines, Inc. Industry-sponsored |
| Locations | 10 sites (Phoenix, Arizona and 9 other locations) |
| Trial ID | NCT07384975 on ClinicalTrials.gov |
What this trial studies
Adults with moderate-to-severe hidradenitis suppurativa will be assigned to receive one of two doses of NAV-240 or a matching placebo delivered by intravenous infusion and will be followed for 22 weeks with up to 9 clinic visits. The primary outcome is the proportion of participants achieving HiSCR75 (at least 75% reduction in abscess and inflammatory nodule count with no worsening of abscesses or draining tunnels) at Week 16. Participants will complete a daily pain diary and may remain on a stable regimen of certain oral antibiotics if required. Key eligibility includes disease duration ≥6 months, lesion count ≥5, involvement of at least two body regions with at least one region Hurley stage II or III, and prior inadequate response to at least one antibiotic.
Who should consider this trial
Good fit: Adults with moderate-to-severe HS (≥6 months disease, ≥5 abscesses/inflammatory nodules, involvement of ≥2 body regions with at least one region Hurley II/III) who have had an inadequate response to at least one course of antibiotics and can comply with study visits and contraception requirements are ideal candidates.
Not a fit: Patients with very extensive disease such as more than 20 draining tunnels or active skin infections that would interfere with assessment are unlikely to benefit from or be eligible for this protocol.
Why it matters
Potential benefit: If successful, NAV-240 could help many patients achieve large reductions in inflamed lesions and reduce pain compared with placebo.
How similar studies have performed: NAV-240 is an investigational agent and prior data for this specific drug are limited, while established biologic therapies (for example anti-TNF agents) have demonstrated effectiveness in HS.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion 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 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 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
Where this trial is running
Phoenix, Arizona and 9 other locations
- Medical Dermatology Specialist — Phoenix, Arizona, United States (Recruiting)
- Accel Research Sites Network — Maitland, Florida, United States (Recruiting)
- Floridian Research Institute — Miami, Florida, United States (Recruiting)
- Cordova Research Institute — Miami, Florida, United States (Recruiting)
- Tory Sullivan MD PA - Dermatology — North Miami Beach, Florida, United States (Recruiting)
- MplusM - D&H Tamarac Research Center — Tamarac, Florida, United States (Recruiting)
- ForCare Clinical Research — Tampa, Florida, United States (Recruiting)
- Kentucky Advanced Medical Research LLC — Murray, Kentucky, United States (Recruiting)
- ActivMed Practices & Research, LLC — Portsmouth, New Hampshire, United States (Recruiting)
- Equity Medical, LLC — The Bronx, New York, United States (Recruiting)
Study contacts
- Study coordinator: Associate Director, Clinical Operations
- Email: info@navigatormeds.com
- Phone: +1 415 251 7753
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.