A Study to Assess NAV-240 in Adult Participants With Hidradenitis Suppurativa

Official title

A Phase 2a, Multicenter, Randomized, Double-blind, Placebo-controlled Study of NAV-240 in Adult Participants With Moderate-to-Severe Hidradenitis Suppurativa

Overview

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.

Interventions

• Drug NAV-240
  NAV-240 for Intravenous Infusion
• Drug Placebo to match NAV-240
  Placebo to match NAV-240 for Intravenous Infusion

Primary outcome measures

• Proportion of participants achieving Hidradenitis Suppurativa Clinical Response (HiSCR) 75 [Time frame: Baseline to Week 16]

Secondary outcome measures (7)

• Proportion of participants achieving skin pain numeric rating scale (NRS) 30 response [Time frame: Baseline to Week 16]
• Proportion of participants achieving HiSCR50 [Time frame: Baseline to Week 16]
• Proportion of participants achieving a Dermatology Life Quality Index (DLQI) improvement (reduction) of ≥ 4 points among participants with DLQI ≥ 4 at baseline [Time frame: Baseline to Week 16]
• Proportion of participants with HS flare [Time frame: Baseline to Week 16]
• Change in the International Hidradenitis Suppurativa Severity Score System (IHS4) scores [Time frame: Baseline to Week 16]
• Change from baseline in AN count [Time frame: Baseline to Week 16]
• Change from baseline in the number of draining tunnels [Time frame: Baseline to Week 16]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Quadruple blind

Primary purpose

Treatment

Study locations

United States · 14 centers

• Medical Dermatology Specialist — Phoenix
• Scottsdale Clinical Trials — Scottsdale
• Accel Research Sites Network — Maitland
• Floridian Research Institute — Miami
• Cordova Research Institute — Miami
• Ziaderm Research, LLC — North Miami Beach
• FWD Clinical Research — Tamarac
• MplusM - D&H Tamarac Research Center — Tamarac
• … and 6 more centers

Poland · 6 centers

• Holsamed — Katowice
• Dermedic Jacek Zdybski — Kielce
• Labderm Essence — Ossy
• Klinika Ambroziak Dermatologia — Warsaw
• OT CO Zdrowie — Warsaw
• Centrum Columbus — Wroclaw

Germany · 5 centers

• St. Josef Hospital Bochum - Dermatologie, Venerologie und Allergologie — Bochum
• J. W. Goethe Universitaet Frankfurt Zentrum f. Dermatologie — Frankfurt
• Universitaetsklinikum Schleswig-Holstein (UKSH) - Campus Kiel - Klinik fuer Dermatologie, — Kiel
• Universitaetsklinikum Schleswig-Holstein (UKSH) - Campus Luebeck — Lübeck
• BAG Dres. med. Quist PartG — Mainz

Bulgaria · 4 centers

• Medical Center Medconsult Pleven — Lovech
• MC Medconsult Pleven — Pleven
• Ambulatory for Specialized Medical Help - skin and venereal diseases — Sofia
• Diagnostic Consultative Center Fokus-5 Medical Establishment for Outpatient Care EOOD — Sofia

Georgia · 4 centers

• LTD Aversi Clinic - Dermatology — Tbilisi
• LTD Israel-Georgian Medical Research Clinic Healthycore — Tbilisi
• LTD MediClub Georgia — Tbilisi
• LTD Multiprofile Clinic Consilium Medulla — Tbilisi

Canada · 3 centers

• FACET Dermatology — Toronto
• Research Toronto — Toronto
• Centre de Recherche Saint-Louis (Quebec) — Montreal

Romania · 3 centers

• Futuremeds Romania - Brasov - Dermatology — Brasov
• Spitalul Clinic Colentina - Dermatology II — Bucharest
• Futuremeds Romania - Galati - Dermatology — Galati

Hungary · 2 centers

• Debreceni Egyetem Klinikai Központ - Dermatology — Debrecen
• Pécsi Tudományegyetem Klinikai Központ - Bőr-, Nemikórtani és Onkoderma — Pécs

Identifiers

NCT: NCT07384975 · NAV-240-201 · 2025-523557-33-00

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗