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| ID | Type | Description | Link |
|---|---|---|---|
| 2025-523557-33-00 | EU Trial (CTIS) Number |
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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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| NAV-240 Dose 1 | Experimental | NAV-240 Dose 1 |
|
| NAV-240 Dose 2 | Experimental | NAV-240 Dose 2 |
|
| Placebo | Placebo Comparator | Placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NAV-240 | Drug | NAV-240 for Intravenous Infusion |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline to Week 16 |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | Baseline to Week 16 |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of TEAEs, SAEs and adverse events of special interest (AESIs) | Baseline to Week 16 |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Associate Director, Clinical Operations | Contact | +1 415 251 7753 | info@navigatormeds.com | |
| Vice President, Development Operations | Contact |
| Name | Affiliation | Role |
|---|---|---|
| Lara Pupim, MD, MSCI | Navigator Medicines, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medical Dermatology Specialist | Recruiting | Phoenix | Arizona | 85006 | United States | |
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| Placebo to match NAV-240 |
| Drug |
Placebo to match NAV-240 for Intravenous Infusion |
|
| 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. | 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 | Baseline to Week 16 |
| 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 |
| Change from baseline in AN count | Baseline to Week 16 |
| Change from baseline in the number of draining tunnels | Baseline to Week 16 |
| Accel Research Sites Network |
| Recruiting |
| Maitland |
| Florida |
| 32751 |
| United States |
| Floridian Research Institute | Recruiting | Miami | Florida | 33179 | United States |
| Cordova Research Institute | Recruiting | Miami | Florida | 33182 | United States |
| Tory Sullivan MD PA - Dermatology | Recruiting | North Miami Beach | Florida | 33162 | United States |
| MplusM - D&H Tamarac Research Center | Recruiting | Tamarac | Florida | 33321 | United States |
| ForCare Clinical Research | Recruiting | Tampa | Florida | 33613 | United States |
| Kentucky Advanced Medical Research LLC | Recruiting | Murray | Kentucky | 42071 | United States |
| ActivMed Practices & Research, LLC | Recruiting | Portsmouth | New Hampshire | 03801 | United States |
| Equity Medical, LLC | Recruiting | The Bronx | New York | 10455 | United States |
| ID | Term |
|---|---|
| D017497 | Hidradenitis Suppurativa |
| ID | Term |
|---|---|
| D017192 | Skin Diseases, Bacterial |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
| D012874 | Skin Diseases, Infectious |
| D013492 | Suppuration |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D016575 | Hidradenitis |
| D013543 | Sweat Gland Diseases |
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