NAV-240 for Hidradenitis Suppurativa

(Mainsail Trial)

Recruiting at 9 trial locations

Overseen By Associate Director, Clinical Operations

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Navigator Medicines, Inc.

Must be taking: Oral antibiotics

Disqualifiers: Active skin disease, HIV, TB, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 9

Duration: 16 weeks

150 Participants Needed

What You Need to Know Before You Apply

What is the purpose of 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.

Who Is on the Research Team?

Lara Pupim, MD, MSCI

Principal Investigator

Navigator Medicines, Inc.

Are You a Good Fit for This Trial?

Adults with moderate-to-severe Hidradenitis Suppurativa (HS) who've had it for at least 6 months, have ≥5 inflamed skin bumps, and haven't responded well to antibiotics can join. They must use consistent antiseptics or stable oral antibiotics if any, and effective contraception.

Inclusion Criteria

Participants of reproductive potential must use a highly effective method of contraception

My condition didn't improve after taking antibiotics.

History of HS for ≥ 6 months

Exclusion Criteria

> 20 draining tunnel count

I had major surgery within the last 12 weeks.

History of alcohol or drug abuse within the past 2 years

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive NAV-240 dose 1, NAV-240 dose 2, or placebo via intravenous infusion

16 weeks

Up to 9 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 weeks

What Are the Treatments Tested in This Trial?

Interventions

• NAV-240

Trial Overview

The trial is testing NAV-240 against a placebo to see if it's more effective in reducing HS symptoms. Participants will receive the treatment through an IV drip and attend up to 9 clinic visits over 22 weeks while keeping a daily diary of their skin pain.

How Is the Trial Designed?

Group I: NAV-240 Dose 2 Experimental Treatment 1 Intervention

NAV-240 Dose 2

Group II: NAV-240 Dose 1 Experimental Treatment 1 Intervention

NAV-240 Dose 1

Group III: Placebo Placebo Group 1 Intervention

Placebo

Who Is Running the Clinical Trial?

Navigator Medicines, Inc.

Lead Sponsor