OPN-375 Nasal Spray for Chronic Sinusitis

(Re-Open 3 Trial)

Recruiting at 18 trial locations

Overseen By Kim Koob

Age: < 18

Sex: Any

Trial Phase: Phase 3

Sponsor: Optinose US Inc.

Must not be taking: XHANCE, Monoclonal antibodies, CYP3A4 inhibitors

Disqualifiers: Pregnancy, Nasal polyps, Nasal tumors, others

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

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

Compensation: Varies

Number of Visits: 4

Duration: 12 weeks

84 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This is a 12-Week randomized, double-blind, placebo-controlled, parallel-group, multicenter study evaluating the efficacy and safety of intranasal administration of 186 µg of OPN-375 twice a day (BID) in adolescent subjects with chronic rhinosinusitis without nasal polyps. The total planned number of subjects is approximately 84 adolescents (12-17 years of age) who will be randomly assigned to receive 1 of 2 study treatments using a 1:1 ratio (OPN-375 186 µg:placebo). The study includes a PK sub-study, in which up 14 subjects will be enrolled to obtain 10 completers.

Who Is on the Research Team?

Kim Koob

Principal Investigator

Optinose US Inc.

Are You a Good Fit for This Trial?

This trial is for adolescents aged 12-17 with chronic rhinosinusitis without nasal polyps. They must have symptoms like reduced smell, nasal congestion or discharge, and facial pain. Participants need evidence of sinus issues via endoscopy or CT scan and can't be pregnant. Girls who can get pregnant must use birth control or be abstinent.

Inclusion Criteria

I am using effective birth control, am surgically sterile, or am abstinent.

I am a woman who can have children and my pregnancy test was negative.

I have a runny nose.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-3 weeks

1 visit (in-person)

Treatment

Participants receive intranasal administration of OPN-375 or placebo twice a day

12 weeks

3 visits (in-person), 2 calls (telephone)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• OPN-375

Trial Overview The study tests the effectiveness and safety of OPN-375 nasal spray compared to a placebo in treating chronic rhinosinusitis over 12 weeks. It's randomized and double-blind, meaning neither the researchers nor participants know who gets the real treatment versus placebo.

How Is the Trial Designed?

Group I: OPN-375 186 µg BID Active Control 1 Intervention

Double-Blind Treatment Phase: Intranasal administration of OPN-375 186 µg x 12 weeks

Group II: Placebo BID Placebo Group 1 Intervention

Double-Blind Treatment Phase: Intranasal administration of matching placebo BID x 12 weeks

Who Is Running the Clinical Trial?

Optinose US Inc.

Lead Sponsor

Trials

13

Recruited

2,600+