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

NCT07291284 | Active Not Recruiting Phase 3

• 1 other identifier: P10-LP003-04
• Study Type: interventional
• Target: 546
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Seasonal Allergic Rhinitis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• 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

• Mean daily rTNSS combined with rescue medication score (DNSMS) during the PPP

  Up to 4 Months

• Mean daily total ocular symptom score (TOSS) during the PPP

  Up to 4 Months

Study Arms (2)

Experimental: LP-003

EXPERIMENTAL

Participants received subcutaneous of LP-003 Injection at a dose of 100 mg once every 4 weeks.

Biological: LP-003

Placebo Comparator：Placebo

PLACEBO COMPARATOR

Participants received subcutaneous of Placebo Injection once every 4 weeks.

Biological: Placebo

Interventions

LP-003 BIOLOGICAL

Participants were administered LP-003 via subcutaneous injection every 4 weeks.

Experimental: LP-003

Placebo BIOLOGICAL

Participants were administered Placebo via subcutaneous injection every 4 weeks

Placebo Comparator：Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Longbio Pharma: lead

Study Sites (1)

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

Beijing, China

Location

MeSH Terms

Conditions

Rhinitis, Allergic, Seasonal

Condition Hierarchy (Ancestors)

Rhinitis, Allergic; Rhinitis; Nose Diseases; Respiratory Tract Diseases; Respiratory Hypersensitivity; Otorhinolaryngologic Diseases; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• Xueyan Wang

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 5, 2025
• First Posted: December 18, 2025
• Study Start: August 1, 2024
• Primary Completion: March 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: December 26, 2025

Record last verified: 2025-12

Locations

CN (1)