Efficacy and Safety of LP-003 in Moderate-to-severe Seasonal Allergic Rhinitis Adult
Efficacy and Safety of LP-003 in Moderate-to-severe Seasonal Allergic Rhinitis Adult
ClinicalTrials.gov 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 |
P10-LP003-02 |