A Phase 2 interventional study of NAV-240 and Placebo to match NAV-240 in Hidradenitis Suppurativa (HS), sponsored by Navigator Medicines, Inc.. Recruiting at 41 sites in 8 countries. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2026-07-22.
Sponsored by Navigator Medicines, Inc. · Phase 2, Interventional, and Treatment
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:
277 studies on the registry are indexed under Hidradenitis Suppurativa; 88 are open to participants now.
This study's planned enrollment of 150 is above the median of 45 across 195 interventional studies indexed under Hidradenitis Suppurativa.
Browse Hidradenitis Suppurativa studies →Navigator Medicines, Inc. is the lead sponsor of 3 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
NAV-240 Dose 1
Drug: NAV-240
NAV-240 Dose 2
Drug: NAV-240
Placebo
Drug: Placebo to match NAV-240
NAV-240 for Intravenous Infusion
Placebo to match NAV-240 for Intravenous Infusion
Proportion of participants achieving Hidradenitis Suppurativa Clinical Response (HiSCR) 75
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.
Time frame: Baseline to Week 16
Proportion of participants achieving skin pain numeric rating scale (NRS) 30 response
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).
Time frame: Baseline to Week 16
Proportion of participants achieving HiSCR50
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.
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
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.
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
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.
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
Incidence of TEAEs, SAEs and adverse events of special interest (AESIs)
Time frame: Baseline to Week 16
Plan to share: No
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Navigator Medicines, Inc.