A Study to Evaluate the Efficacy and Safety of LP-003 Injection in Patients With Chronic Rhinosinusitis With Nasal Polyps (CRSwNP)

Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorLongbio Pharma

About this trial

This is a multicenter, randomized, double-blind, placebo-controlled, parallel-group Phase II clinical trial. Its primary objective is to explore and preliminarily evaluate the efficacy and safety of LP-003 Injection in the treatment of participants with chronic rhinosinusitis with nasal polyps (CRSwNP), as well as to investigate its pharmacokinetic (PK), pharmacodynamic (PD) profiles, and immunogenicity.

Eligibility criteria

Qualifiers

Capable of understanding the study and voluntarily signing the Informed Consent Form (ICF);

Aged 18 to 75 years (inclusive) at the time of signing the ICF, regardless of gender;

Diagnosis of bilateral chronic rhinosinusitis with nasal polyps (CRSwNP);

Nasal congestion;

Disqualifiers

Concurrent other nasal diseases or nasal symptoms;

Acute upper respiratory tract infection at screening, which the investigator assesses may affect nasal symptom scoring;

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;

Concurrent active parasitic infection (e.g., helminths) or suspected parasitic infection;

Trial design

Treatments tested in this trial

  • LP-003 Injection
  • Placebo of LP-003

Treatment groups

150 Participants
are divided into 3 treatment groups

Sponsors and collaborators