A study to assess NAV-240 in adult participants with Hidradenitis Suppurativa

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Navigator Medicines Inc.

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Skin and Connective Tissue Diseases [C17]

Trial duration

20 Apr 2026 → ongoing

Decision date (initial)

2026-03-26

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

Yes

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Efficacy

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.

Secondary objectives 2

1. To further examine how NAV-240 works in improving signs and symptoms in participants with HS.
2. To evaluate how safe NAV-240 is and how well participants can tolerate it when used to treat HS.

Conditions and MedDRA coding

Moderate-to-Severe Hidradenitis Suppurativa

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 4

1. Participants aged 18 to 70 years at the time of consent.
2. Participants must have had HS for at least 6 months before joining the study.
3. 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).
4. Inadequate response to at least one course of antibiotics, as determined by the study doctor.

Exclusion criteria 3

1. Participants have more than 20 draining tunnels.
2. Have an active skin infection (bacterial, fungal, or viral) or inflammatory condition that could make it difficult to properly evaluate HS.
3. Has undergone major surgery, including surgery for HS or has plans for major surgery during the study period.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. 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).

Secondary endpoints 7

1. 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.
2. Percentage of participants achieving HiSCR 50 at Week 16 (50% fewer inflamed skin bumps with no increase in abscesses or draining tunnels).
3. 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.
4. 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.
5. Change in disease severity (measured by the International Hidradenitis Suppurativa Severity Score System or IHS4) from baseline to Week 16.
6. Change in AN count and the number of draining tunnels from baseline to Week 16.
7. Number of participants with treatment-related side effects, serious side effects, and specific side effects of special concern.

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Placebo 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Navigator Medicines Inc.

Sponsor organisation

Navigator Medicines Inc.

Address

2525 Smith Street

City

Scotch Plains

Postcode

07076-2034

Country

United States

Scientific contact point

Organisation

Navigator Medicines Inc.

Contact name

Navigator Medicines Study Information Center

Public contact point

Organisation

Navigator Medicines Inc.

Contact name

Navigator Medicines Study Information Center

Third parties 12

Locations

5 EU/EEA countries · 23 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 62 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

1 submissions — initial application plus substantial / non-substantial modifications