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
Qualifiers
History of HS for ≥ 6 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
Treatments tested in this trial
- NAV-240
- Placebo to match NAV-240
Treatment groups
150 Participants
are divided into 3 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov