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NCT Number: NCT07384975

A Study to Assess NAV-240 in Adult Participants With 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.

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Key information

Conditions

Hidradenitis Suppurativa (HS) Bacterial Infections Bacterial Infections and Mycoses Hidradenitis Hidradenitis Suppurativa Infections Skin Diseases Skin Diseases, Bacterial Skin Diseases, Infectious Skin and Connective Tissue Diseases Suppuration Sweat Gland Diseases

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Medical Center Medconsult Pleven, Lovech, Bulgaria

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

NAV-240

Drug

NAV-240 for Intravenous Infusion

Placebo to match NAV-240

Drug

Placebo to match NAV-240 for Intravenous Infusion

Primary outcomes

  1. Proportion of participants achieving Hidradenitis Suppurativa Clinical Response (HiSCR) 75

    Time frame: Baseline to Week 16

    HiSCR75 is defined as at least a 75% reduction in total abscess and inflammatory nodule count (AN count) with no increase in abscess count and no increase in draining tunnel count relative to baseline.

Secondary outcomes

  1. Proportion of participants achieving skin pain numeric rating scale (NRS) 30 response

    Time frame: Baseline to Week 16

    NRS30 is defined as a ≥ 30% reduction and at least a 2-unit reduction from baseline in skin pain on the NRS, for participants with a baseline skin pain NRS ≥ 3, based on the weekly average of the worst skin pain in a 24-hour recall period (maximal daily pain). The skin pain NRS is a single-item measure designed to capture information on self-reported skin pain severity by rating "the worst level of skin pain in the past 24 hours" as a number on a numerical rating scale from 0 (no pain) to 10 (worst pain imaginable).

  2. Proportion of participants achieving HiSCR50

    Time frame: Baseline to Week 16

    HiSCR50 is defined as at least a 50% reduction in total AN count with no increase in abscess count and no increase in draining tunnel count relative to baseline.

  3. 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

    The DLQI is a simple validated 10-item, dermatology-specific, quality-of-life (QoL) questionnaire. Each item in the questionnaire can receive an impairment degree on a 4-point-scale (0 - not at all, 3 - very much), and the higher the score, the greater the impairment of QoL.

  4. Proportion of participants with HS flare

    Time frame: Baseline to Week 16

  5. Change in the International Hidradenitis Suppurativa Severity Score System (IHS4) scores

    Time frame: Baseline to Week 16

    The IHS4 score is arrived at by the number of nodules (multiplied by 1) plus the number of abscesses (multiplied by 2) plus the number of draining tunnels (multiplied by 4). A total score of 3 or less is a mild disease, 4-10 signifies moderate disease and 11 or higher signifies severe disease.

  6. Change from baseline in AN count

    Time frame: Baseline to Week 16

  7. Change from baseline in the number of draining tunnels

    Time frame: Baseline to Week 16

Other outcomes

  1. Incidence of TEAEs, SAEs and adverse events of special interest (AESIs)

    Time frame: Baseline to Week 16

Study contacts

Contact information is provided by the study sponsor or research team.

Associate Director, Clinical Operations

CONTACT

[email protected]

+1 415 251 7753

Vice President, Development Operations

CONTACT

Sponsors and collaborators

Lead sponsor

Navigator Medicines, Inc.

Industry

Registry information

Official study title

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

Acronym: Mainsail

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Feb 3, 2026
Registry last updated
Jul 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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