New shot could shrink nasal polyps and ease breathing
NCT ID NCT07313917
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.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 150 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Jan 2026
An estimate. Start dates often move.
- Expected to finish
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Sep 2027
An estimate. End dates often move.
- Lead sponsor
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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
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18 to 75 years
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Beijing Tongren Hospital Affiliated to Capital Medical University
Beijing, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- New study tests tezepelumab for chronic sinusitis sufferers