NAV-240 for Moderate-to-severe Hidradenitis suppurativa

Inclusion criteria

• {"criterion_text":"- Participants aged 18 to 70 years at the time of consent.\n- Participants must have had HS for at least 6 months before joining the study.\n- Have at least 5 AN and inflamed skin lesions in at least 2 different areas of the body, one of which must have moderate to severe symptoms (classified as Hurley Stage II or Hurley Stage III).\n- Inadequate response to at least one course of antibiotics, as determined by the study doctor."}

Exclusion criteria

• {"criterion_text":"- Participants have more than 20 draining tunnels.\n- Have an active skin infection (bacterial, fungal, or viral) or inflammatory condition that could make it difficult to properly evaluate HS.\n- Has undergone major surgery, including surgery for HS or has plans for major surgery during the study period."}

Primary endpoints

• {"endpoint_text":"- 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).","definition_or_measurement_approach":"HiSCR75 at Week 16 defined as 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 compared with baseline."}

Secondary endpoints

• {"endpoint_text":"- Percentage of participants achieving skin pain numeric rating scale (NRS) 30 response at Week 16, meaning at least 30% and 2-point reduction in pain scores from baseline, for those with initial NRS scores of 3 or higher.","definition_or_measurement_approach":"Skin pain NRS30 response at Week 16: at least 30% and 2-point reduction in pain scores from baseline for participants with baseline NRS ≥3."}
• {"endpoint_text":"- Percentage of participants achieving HiSCR 50 at Week 16 (50% fewer inflamed skin bumps with no increase in abscesses or draining tunnels).","definition_or_measurement_approach":"HiSCR50 at Week 16: 50% reduction in inflamed skin bumps (AN count) with no increase in abscesses or draining tunnels compared with baseline."}
• {"endpoint_text":"- Percentage of participants achieving meaningful improvement in quality of life [Dermatology Life Quality Index (DLQI) reduction (improvement) of 4 or more points] at Week 16 among those with initial DLQI scores of 4 or higher.","definition_or_measurement_approach":"DLQI improvement defined as reduction of 4 or more points at Week 16 among participants with baseline DLQI ≥4."}
• {"endpoint_text":"- Percentage of participants experiencing a HS flare (worsening) at Week 16, defined as at least 25% increase in AN Count with an absolute increase of 2 or more compared to baseline.","definition_or_measurement_approach":"HS flare at Week 16 defined as ≥25% increase in AN count with an absolute increase of ≥2 vs baseline."}
• {"endpoint_text":"- Change in disease severity (measured by the International Hidradenitis Suppurativa Severity Score System or IHS4) from baseline to Week 16.","definition_or_measurement_approach":"Change in IHS4 score from baseline to Week 16."}
• {"endpoint_text":"- Change in AN count and the number of draining tunnels from baseline to Week 16.","definition_or_measurement_approach":"Change in absolute AN count and number of draining tunnels from baseline to Week 16."}
• {"endpoint_text":"- Number of participants with treatment-related side effects, serious side effects, and specific side effects of special concern.","definition_or_measurement_approach":"Safety assessment: counts of participants with treatment-related adverse events, serious adverse events, and pre-specified AEs of special interest."}

Methods

• Country-specific recruitment procedure documents (K1) available for Bulgaria, Germany, Hungary, Romania and Poland describing local recruitment arrangements (documents: K1_BGR, K1_DEU, K1_HUN, K1_ROU, K1_POL).
• Recruitment brochures and disease fact sheets (K2) in local languages (K2 documents present in Bulgarian, German, Hungarian, Romanian, Polish and English) for patient-facing information.
• Poland-specific digital/social media recruitment assets (K2_505): recruitment brochures, social media graphics and social media text for posts and stories targeted for Poland.

Bulgaria

Earliest CTIS Part Ii Submission Date

27-02-2026

Latest Decision Or Authorization Date

26-03-2026

Processing Time Days

27

Number Of Sites

4

Number Of Participants

40

Germany

Earliest CTIS Part Ii Submission Date

02-03-2026

Latest Decision Or Authorization Date

25-03-2026

Processing Time Days

23

Number Of Sites

8

Number Of Participants

40

Hungary

Earliest CTIS Part Ii Submission Date

26-02-2026

Latest Decision Or Authorization Date

30-03-2026

Processing Time Days

32

Number Of Sites

2

Number Of Participants

9

Romania

Earliest CTIS Part Ii Submission Date

27-02-2026

Latest Decision Or Authorization Date

30-03-2026

Processing Time Days

31

Number Of Sites

3

Number Of Participants

21

Poland

Earliest CTIS Part Ii Submission Date

10-03-2026

Latest Decision Or Authorization Date

27-03-2026

Processing Time Days

17

Number Of Sites

6

Number Of Participants

35

Primary sponsor

Full Name

Navigator Medicines Inc.

Organisation Type

Pharmaceutical company

Country Of Registered Address

United States

Contract research organisations

Name

Parexel International (IRL) Limited

Responsibilities

1,10,11,13,14,2,5,6,7,8

Name

Syneos Health Clinique Inc.

Responsibilities

4

Name

Eresearchtechnology Inc.

Responsibilities

7

Third parties

• {"country":"Belgium","full_name":"MyData-TRUST SA","duties_or_roles":"Data Protection Officer (DPO)","organisation_type":"Industry"}
• {"country":"France","full_name":"MyData-TRUST France","duties_or_roles":"Data Protection Representative (DPR)","organisation_type":"Industry"}
• {"country":"United States","full_name":"Eurofins Central Laboratory LLC","duties_or_roles":"4","organisation_type":"Laboratory/Research/Testing facility"}
• {"country":"United States","full_name":"Labcorp Esoterix","duties_or_roles":"4","organisation_type":"Educational Institution"}
• {"country":"Canada","full_name":"Syneos Health Clinique Inc.","duties_or_roles":"4","organisation_type":"Hospital/Clinic/Other health care facility"}
• {"country":"Ireland","full_name":"Parexel International (IRL) Limited","duties_or_roles":"1,10,11,13,14,2,5,6,7,8","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Bioagilytix Labs LLC","duties_or_roles":"4","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Eresearchtechnology Inc.","duties_or_roles":"7","organisation_type":"Pharmaceutical company"}
• {"country":"Netherlands","full_name":"Eurofins Central Laboratory B.V.","duties_or_roles":"4","organisation_type":"Pharmaceutical company"}
• {"country":"Netherlands","full_name":"Xerimis B.V.","duties_or_roles":"Site of Importation and QP release for EU, Site of Packaging and Labelling","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"The Rockefeller University","duties_or_roles":"4","organisation_type":"Educational Institution"}
• {"country":"France","full_name":"Cerba","duties_or_roles":"4","organisation_type":"Laboratory/Research/Testing facility"}