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New hope for stuffy noses: experimental drug targets nasal polyps

NCT ID NCT06639295

Disease control Sponsor: Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests an investigational drug called 611 in 243 adults with chronic sinusitis and nasal polyps that haven't been well-controlled by other treatments. The goal is to see if 611 can shrink polyps and ease nasal congestion over 24 weeks. Participants receive either the drug or a placebo, and neither they nor their doctors know which they get.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

243 people

The number who actually took part.

Started

Nov 2024

Expected to finish

Aug 2026

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 75 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Female and male patients aged ≥18 and ≤ 75 years at the time of screening. * Bilateral CRSwNP. * Bilateral NPS of ≥5 with a minimum score of 2 in each nasal cavity * Nasal Congestion Score of 2 at screening and a weekly average severity of 2 at time of randomization. * Patients whose bilateral sino-nasal polyposis remains inadequately controlled despite prior treatment with SCS anytime within the past 2 years; and/or had a medical contraindication/intolerance to SCS; and/or received nasal polyp surgery 6 months before signing the ICF. Exclusion Criteria: * Patients with other nasal diseases or symptoms. * Patients who are taking or have taken the following prohibited therapies as specified, e.g., systemic steroids within 4 weeks prior to screening, less than 3 months or 5 half-lives for biologic therapy prior to screening. * Patients who have active Hepatitis B, Hepatitis C or HIV infections as determined by positive results at Screening. * History of cancer. * Known or suspected history of immunosuppression. * Known with allergic or intolerant to mometasone furoate spray or 611/ placebo

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Conditions

The condition(s) this trial relates to.

nasal cavity polyp sinusitis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Nasal polyps Sinusitis

Contacts and locations

Locations

  • Site 01

    Beijing, Beijing Municipality, 100730, China

More trials for these conditions

Other studies related to the condition(s) this trial covers.