Hidradenitis Suppurativa (HS)
Conditions
Keywords
NAV-240, HS, Hidradenitis Suppurativa, Phase 2, Moderate-to-Severe HS
Brief summary
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
DRUGNAV-240
NAV-240 for Intravenous Infusion
DRUGPlacebo to match NAV-240
Placebo to match NAV-240 for Intravenous Infusion
Sponsors
Navigator Medicines, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of participants achieving Hidradenitis Suppurativa Clinical Response (HiSCR) 75 | 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
| Measure | Time frame | Description |
|---|---|---|
| Proportion of participants achieving skin pain numeric rating scale (NRS) 30 response | 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). |
| Proportion of participants achieving HiSCR50 | 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. |
| Proportion of participants achieving a Dermatology Life Quality Index (DLQI) improvement (reduction) of ≥ 4 points among participants with DLQI ≥ 4 at baseline | 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. |
| Proportion of participants with HS flare | Baseline to Week 16 | — |
| Change in the International Hidradenitis Suppurativa Severity Score System (IHS4) scores | 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. |
| Change from baseline in AN count | Baseline to Week 16 | — |
| Change from baseline in the number of draining tunnels | Baseline to Week 16 | — |
Countries
Bulgaria, Canada, Georgia, Germany, Hungary, Poland, Romania, United States
Contacts
CONTACTAssociate Director, Clinical Operations
CONTACTVice President, Development Operations
STUDY_DIRECTORLara Pupim, MD, MSCI
Navigator Medicines, Inc.
Outcome results
None listed