Efficacy and Safety of LP-003 Injection in Patients With Moderate to Severe Seasonal Allergic Rhinitis

A Randomized, Double-blind, Placebo-controlled Phase III Clinical Study to Evaluate the Efficacy and Safety of LP-003 Injection in Patients With Moderate to Severe Seasonal Allergic Rhinitis Inadequately Controlled by Standard-of-care

This is a multicenter, randomized, double-blind, placebo-controlled phase III clinical study to evaluate the efficacy and safety of LP-003 injection in patients with moderate to severe seasonal allergic rhinitis inadequately controlled by standard-of-care.

Study Overview

• Status: Active, not recruiting
• Conditions: Seasonal Allergic Rhinitis
• Intervention / Treatment: Biological: LP-003; Biological: Placebo

• Study Type: Interventional
• Enrollment (Actual): 546
• Phase: Phase 3

Contacts and Locations

Study Locations

• China
  • Beijing, China
    • Beijing Shijitan Hospital, Capital Medical University (the formerly Beijing Railway General Hospital)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Male or female, aged 18 to 65 years
• Subjects with SAR for at least 2 years
• At least one serum-specific IgE test for an allergen associated with the onset of allergic rhinitis during the current season or the same period
• Subjects who did not achieve satisfactory efficacy from Standard-of-Care prior to screening
• Subjects who experienced nasal symptoms for ≥ 2 days, or nasal and ocular symptoms for ≥ 1 day; with rTNSS ≥ 1 prior to randomization

Exclusion Criteria:

• Combined with non-allergic rhinitis, such as drug-induced rhinitis, vasomotor rhinitis, non-allergic rhinitis with eosinophilia syndrome, a history of acute or chronic sinusitis
• Subjects with perennial allergic rhinitis (PAR)
• Underwent any nasal or sinus surgery within 1 year prior to screening
• Presence of glaucoma, cataract, ocular herpes simplex, infectious conjunctivitis, or other ocular infections
• Clinically significant conditions upon the judgement of investigator
• Subjects with concomitant asthma who, upon the judgement of investigator, require inhaled corticosteroid treatment during the study
• The laboratory results at screening: a) white blood cell (WBC) < 2.5×10^9/L; b) aspartate aminotransferase (AST) or alanine aminotransferase (ALT) > 2.0 ×upper limit of normal (ULN) or total bilirubin > 1.5 ×ULN; c) Serum creatinine (Cr) > 1.5 × ULN
• Received treatment with similar drugs (e.g., Omalizumab) or used LP-003 Injection within 6 months prior to screening
• Received systemic glucocorticoids within 4 weeks prior to screening
• Received intranasal glucocorticoids, mast cell membrane stabilizers, tricyclic antidepressants, leukotriene receptor antagonists, or antihistamine medications within 1 week prior to randomization
• Received traditional Chinese medicine treatment for allergic rhinitis within the 7 days prior to randomization
• Received allergen immunotherapy within 6 months prior to screening (for those who have not completed the therapy), or within 3 years prior to screening (for those who have completed the therapy)
• Subjects for whom exposure to allergens in the home or work environment are expected to undergo significant changes during the trial, as assessed by the investigator, which may interfere with the evaluation of efficacy
• Subjects planning to travel outside their area of residence during the trial to an area without pathogenic pollen, for either 2 consecutive days or a total duration exceeding three days

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental: LP-003; Participants received subcutaneous of LP-003 Injection at a dose of 100 mg once every 4 weeks.	Biological: LP-003; Participants were administered LP-003 via subcutaneous injection every 4 weeks.
Placebo Comparator: Placebo Comparator：Placebo; Participants received subcutaneous of Placebo Injection once every 4 weeks.	Biological: Placebo; Participants were administered Placebo via subcutaneous injection every 4 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean daily reflective total nasal symptom score (rTNSS) during the pollen peak period (PPP)	The rTNSS is a patient self-reported questionnaire of four nasal symptoms: nasal itching, nasal congestion, sneezing and rhinorrhea. Patients will report their symptoms reflected or felt over the last 12 hours. Each symptom is scored on a 0-3 scale (0 = no symptoms, 1 = mild, 2 = moderate, 3 = severe). The total score is the sum of the four items, ranging from 0 to 12, with higher scores indicating greater symptom severity.	Up to 4 Months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean daily rTNSS during the pollen period (PP)		Up to 4 Months
Mean daily instantaneous total nasal symptom score (iTNSS) during the PPP		Up to 4 Months
Mean daily iTNSS during the PP		Up to 4 Months
Incidence of adverse events (AEs)		Up to Week 28
Mean daily rTNSS combined with rescue medication score (DNSMS) during the PPP	Integrates daily rTNSS (4 nasal symptoms, 0-3 each, total 0-12) and rescue medication score (0 for no rescue use and 1 for rescue use).	Up to 4 Months
Mean daily total ocular symptom score (TOSS) during the PPP	It is derived from 2 individual ocular symptoms (itching/burning/redness, and tearing/watering), and each symptom is scored on a 0-3 scale. The daily TOSS is the sum of the two items, ranging from 0 (no symptoms) to 6 (maximum severity) per day.	Up to 4 Months
Mean daily TOSS combined with rescue medication score (DNOMS) during the PPP	Integrates daily TOSS (2 individual ocular symptoms, 0-3 each, total 0-6) and rescue medication score (0 for no rescue use and 1 for rescue use).	Up to 4 Months
Mean daily rescue medication score (RMS) during the PPP	The RSM is assessed based on the usage of montelukast sodium tablets, with a scoring rule of 0 points for no use and 1 point for use on the day. The mean daily RSM during the PPP is calculated as the sum of the cumulative RSM during the PPP divided by the number of days in the PPP.	Up to 4 Months

Collaborators and Investigators

• Sponsor: Longbio Pharma
• Investigators: Principal Investigator: Xueyan Wang, Beijing Shijitan Hospital, Capital Medical University (the formerly Beijing Railway General Hospital)

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2024
• Primary Completion (Estimated): March 31, 2026
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: December 5, 2025
• First Submitted That Met QC Criteria: December 5, 2025
• First Posted (Estimated): December 18, 2025

Study Record Updates

• Last Update Posted (Actual): December 26, 2025
• Last Update Submitted That Met QC Criteria: December 19, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Immune System Diseases; Respiratory Tract Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Nose Diseases; Otorhinolaryngologic Diseases; Rhinitis; Rhinitis, Allergic; Rhinitis, Allergic, Seasonal
• Other Study ID Numbers: P10-LP003-04

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No