A Study to Assess NAV-240 in Adult Participants With Hidradenitis Suppurativa
ConditionHidradenitis Suppurativa (HS)
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-70
SponsorNavigator Medicines, Inc.
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
> 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.
Trial design
Design model
Parallel
Treatments tested in this trial
NAV-240
DrugNAV-240 for Intravenous Infusion
Placebo to match NAV-240
DrugPlacebo to match NAV-240 for Intravenous Infusion
Treatment groups
150 Participants
are divided into 3 treatment groupsGroup A: NAV-240 Dose 1Experimental treatment 1 intervention
Group B: NAV-240 Dose 2Experimental treatment 1 intervention
Group C: PlaceboPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
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 16Secondary outcomes
1
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 162
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 163
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 164
Proportion of participants with HS flare
Time frame
Baseline to Week 16Other outcomes
1
Incidence of TEAEs, SAEs and adverse events of special interest (AESIs)
Time frame
Baseline to Week 16Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov