NAV-240 for adults with moderate-to-severe hidradenitis suppurativa

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

Inclusion 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

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 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

Where it's running

• Medical Dermatology Specialist
  Phoenix, Arizona, United States Recruiting
• Scottsdale Clinical Trials
  Scottsdale, 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
• Ziaderm Research, LLC
  North Miami Beach, Florida, United States Recruiting

Study contacts

• Study coordinator: Associate Director, Clinical Operations
• Email: info@navigatormeds.com
• Phone: +1 415 251 7753

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Soquelitinib in adults with hidradenitis suppurativa

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• ORKA-002 versus placebo for moderate-to-severe hidradenitis suppurativa

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• SPY072 in adults with moderate to severe hidradenitis suppurativa

  This study tests whether SPY072 can help adults with moderate to severe hidradenitis suppurativa when added to their current care, compared with a placebo over 16 weeks.

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• Brain activity patterns in people with hidradenitis suppurativa and how treatments may relate to changes

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• Roflumilast 0.3% Foam for Hidradenitis Suppurativa in Teens and Adults

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• Global health study on hidradenitis suppurativa

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.