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Clinical trial

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

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Last updated:20th Sep 2023
Identifier: NCT06046391
Efficacy and Safety of LP-003 in Moderate-to-severe Seasonal Allergic Rhinitis Adult ID: NCT06046391
Sponsor: Longbio Pharma
Information provided by: Longbio Pharma (Responsible Party)
Last Update Posted: 2023-09-21

Brief 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.

Official Title:
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

Intervention / Treatment:
- Biological: LP-003 dose 1
- Biological: LP-003 dose 2
- Biological: Placebo

Category Value
Study Start (Actual) 2023-07-06
Primary Completion (Estimated) 2024-07-30
Study Completion (Estimated) 2024-12-30
Enrollment (Estimated) 180
Study Type Interventional
Phase Phase 2
Other Study ID Numbers


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