NCT06046391

Efficacy and Safety of LP-003 in Moderate-to-severe Seasonal Allergic Rhinitis Adult

A 12 Weeks,Multi-center,Randomized,Double-blind,Placebo-controlled Phase II Study to Evaluate the Efficacy and Safety of LP-003 in Adult Patients With Inadequately Controlled Moderate to Severe Seasonal Allergic Rhinitis Despite the Current Recommended Therapies

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 180 (actual)
• Sponsor: Longbio Pharma · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

Allergic rhinitis (AR) affects large population worldwide, the most commonly used medication include anti-histamine, nasal spray and anti-LTRAs inhibitors (leukotriene receptor antagonists), Even after those first-line treatment, there is still a large number of patient (\~20%) are not well/adequately controlled. Anti-IgE antibody has been approved to treat moderate to severe AR by PMDA/Japan in 2020, demonstrating the efficacy of IgE blockade in the treatment of allergic rhinitis. The current study presents a novel anti-IgE antibody (LP-003) with higher affinity to IgE, stronger efficacy and longer half-life.

Detailed description

The purpose of this study was to evaluate the efficacy and safety of LP-003 in combination with SoC (nasal corticosteroids and/or anti-histamine) in adult patients with Moderate to Severe Seasonal Allergic Rhinitis, whose symptoms were inadequately controlled despite the current recommended therapies (nasal corticosteroids and/or anti-histamine) in the previous 2 pollen seasons.

Conditions

• Seasonal Allergic Rhinitis

Interventions

Type	Name	Description
BIOLOGICAL	LP-003 dose 1	Liquid in vial
BIOLOGICAL	LP-003 dose 2	Liquid in vial
BIOLOGICAL	Placebo	Liquid in vial

Timeline

• Start date: 2023-07-06
• Primary completion: 2023-10-19
• Completion: 2024-08-06
• First posted: 2023-09-21
• Last updated: 2025-12-15

Locations

17 sites across 1 country: China