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New shot could shrink nasal polyps and ease breathing

NCT ID NCT07313917

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 This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 experimental drug called LP-003 for people with long-term sinus inflammation and nasal polyps (growths in the nose). The goal is to see if it can shrink polyps and reduce stuffiness. About 150 adults will receive either the drug or a placebo, and their progress will be tracked for 24 weeks.

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 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 150 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Jan 2026

An estimate. Start dates often move.

Expected to finish

Sep 2027

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: 1. Capable of understanding the study and voluntarily signing the Informed Consent Form (ICF); 2. Aged 18 to 75 years (inclusive) at the time of signing the ICF, regardless of gender; 3. Diagnosis of bilateral chronic rhinosinusitis with nasal polyps (CRSwNP); 4. Persistence of the following symptoms for ≥ 4 weeks prior to the screening/run-in period: * Nasal congestion; * Any one of the other symptoms: mucoid or mucopurulent nasal discharge, head and facial distension/pain, hyposmia or anosmia; 5. Nasal Polyp Score (NPS) ≥ 5 points, with each nasal cavity scoring at least ≥ 2 points during the screening/run-in period and prior to randomization; 6. Participants report moderate to severe nasal congestion during the screening/run-in period and prior to randomization: * Nasal Congestion Score (NCS) of 2 or 3 points at the screening/run-in period (Visit 1, V1); * Mean weekly NCS ≥ 2 points prior to randomization; 7. With bilateral CRSwNP despite prior treatment with systemic corticosteroids (SCS) such as oral corticosteroids (OCS) within 2 years prior to screening; and/or has contraindications to SCS treatment or is intolerant to SCS; and/or has undergone nasal polypectomy within 6 months prior to screening, with persistent bilateral CRSwNP. 8. Has been on a stable dosage of intranasal corticosteroids (INCS) for at least 4 weeks prior to screening; 9. Demonstrates ≥80% adherence to mometasone furoate nasal spray (MFNS) administration during the run-in period (with a minimum of 14 days of use). Exclusion Criteria: 1. Concurrent other nasal diseases or nasal symptoms; 2. Acute upper respiratory tract infection at screening, which the investigator assesses may affect nasal symptom scoring; 3. Severe infection requiring intravenous antibiotics and/or hospitalization within 4 weeks prior to randomization that has not yet resolved, or active infection requiring oral antibiotics within 2 weeks prior to randomization that has not yet resolved; the investigator assesses that enrollment of the participant may pose uncontrollable risks; 4. Concurrent active parasitic infection (e.g., helminths) or suspected parasitic infection; 5. Known or suspected history of immunosuppression, including a history of invasive opportunistic infections (e.g., histoplasmosis, listeriosis, coccidioidomycosis, pneumocystosis, aspergillosis); or participants with a history of such infections that have resolved but are assessed by the investigator as likely to recur frequently; 6. Any severe or unstable disease that the investigator believes may affect the participant's safety during the study and/or hinder the participant from completing the study; 7. Has any severe or unstable disease that, in the investigator's judgment, may affect the safety of the trial participant during the study and/or preclude the participant from completing the study, including but not limited to cardiovascular, gastrointestinal, hepatic, renal, neurological, musculoskeletal, infectious, endocrine, metabolic, autoimmune, hematological, or psychiatric disorders. 8. Current or prior receipt of the following treatments: * Use of traditional Chinese medicine (TCM) or proprietary Chinese medicines for chronic rhinosinusitis within 1 week prior to screening; * Use of medium- or short-acting systemic corticosteroids (SCS) within 4 weeks prior to randomization, or long-acting SCS within 6 weeks prior to randomization; * Receipt of any systemic monoclonal antibody therapy \[e.g., Stapokibart, Dupilumab, Mepolizumab, Omalizumab, Tezepelumab, etc.\] within 10 weeks prior to randomization or within 5 half-lives (whichever is longer); * Use of systemic immunosuppressants within 4 weeks prior to randomization or within 5 half-lives (whichever is longer); * Initiation of leukotriene receptor antagonist (LTRA) therapy within 4 weeks prior to randomization (participants who have been receiving stable-dose LTRA therapy for at least 4 weeks prior to randomization are eligible for enrollment); 9. For participants with concurrent asthma, the forced expiratory volume in 1 second (FEV1) as a percentage of predicted value ≤ 50% during the screening/run-in period; 10. Known allergy or intolerance to any component of the investigational product and/or mometasone furoate nasal spray; 11. Pregnant or lactating females; 12. Any other conditions that the investigator deems inappropriate for the participant to participate in the study.

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As listed by the trial registrant

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

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

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Contacts and locations

Locations

  • Beijing Tongren Hospital Affiliated to Capital Medical University

    Beijing, China

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