A Study to Assess NAV-240 in Adult Participants With Hidradenitis Suppurativa
Key facts
- Where
- Katowice, Kielce, Ozarowice, Sosnowiec, Warsaw, and Wroclaw, PolandSee the 8 sites
- Phase
- Phase 2
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 70 years old?
Source: NCT07384975, who can take part
Where in Poland
- Gyncentrum Sp. z o.o.Katowice, PolandTaking people
- DERMEDIC Jacek ZdybskiKielce, PolandTaking people
- Labderm Essence Sp. z o.o.Ozarowice, PolandTaking people
- Centrum Zdrowia Dziecka i Rodziny im Jana Pawla II w Sosnowcu Sp z o oSosnowiec, PolandTaking people
- Klinika Ambroziak Sp. z o.o.Warsaw, PolandTaking people
- OT Co Zdrowie Sp. z o.o.Warsaw, PolandTaking people
- dermMedica Sp. z o.oWroclaw, PolandTaking people
- WroMedica I Bielicka A Strzalkowska s cWroclaw, PolandTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial details
- Who runs it
- Navigator Medicines, Inc.
- Trial code
- NCT07384975EU 2025-523557-33-00
- Record updated
- 22 July 2026
- Original description
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).Read full original descriptionShow less
A Phase 2a, Multicenter, Randomized, Double-blind, Placebo-controlled Study of NAV-240 in Adult Participants With Moderate-to-Severe Hidradenitis Suppurativa
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).
Participants will:
* Receive NAV-240 dose 1, NAV-240 dose 2 or placebo as a drip into the veins (intravenous infusion). * Visit the clinic up to 9 times for checkups and tests over 22 weeks. * Complete a daily diary about their skin pain.
Inclusion: 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: 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; A positive urine drug screen at Screening; History of alcohol or drug abuse within the past 2 years; 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; > 20 draining tunnel count.