RecruitingPhase 2NCT07342803

Efficacy, Safety, and Pharmacokinetics of LP-003 Injection in Allergic Asthma Patients

A Multicenter, Randomized, Double-Blind, Active Drug and Placebo-Controlled Phase II Clinical Trial to Evaluate the Efficacy, Safety, and Pharmacokinetics of LP-003 Injection in the Treatment of Patients With Moderate to Severe Persistent Allergic Asthma.


Sponsor

Longbio Pharma

Enrollment

200 participants

Start Date

Jan 25, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

This is a multicenter, randomized, masked, active and placebo controlled, Phase II clinical study to evaluate the efficacy, safety, and pharmacokinetics of LP-003 injection in adult patients with moderate to severe persistent allergic asthma.


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study is testing the safety, effectiveness, and drug behaviour of LP-003, a new injectable drug for people with allergic asthma that is not adequately controlled despite using medium-to-high dose inhaled corticosteroids. Allergic asthma is triggered by allergens like dust mites, pollen, or pet dander. **You may be eligible if...** - You are 18–75 years old - You have been diagnosed with allergic asthma for at least 1 year, with at least one flare-up in the past year - You have a positive allergy test (skin prick or blood test) for a relevant allergen - Your asthma is still not well-controlled despite being on medium-to-high dose inhaled steroids for at least 8 weeks - You have an ACT (Asthma Control Test) score of 19 or below **You may NOT be eligible if...** - You have non-allergic asthma or no confirmed allergen trigger - Your asthma is well-controlled on your current medications - You do not meet the minimum dose of inhaled steroids required for the study Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BIOLOGICALLP-003 Injection

s.c. injection, Q12W

BIOLOGICALOmalizumab

s.c. injection, Q4W

BIOLOGICALPlacebo

s.c. injection, Q4W


Locations(1)

Ruijin Hospital

Shanghai, China

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NCT07342803


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