Phase II Study of LP-003 Injection to Treat Moderate to Severe Persistent Allergic Asthma in Adults

What this Trial Is About

Researchers are evaluating the LP-003 injection in a Phase II clinical trial for adults with moderate to severe persistent allergic asthma. This trial aims to assess the effectiveness, safety, and how the body processes LP-003 compared to placebo and an active drug called Omalizumab. The study involves multiple centers and uses a randomized, masked design to carefully compare outcomes among different treatment groups. Participants receive subcutaneous injections of LP-003 at doses of 150 mg, 300 mg, or 450 mg every 4 weeks, or Omalizumab injections at doses based on IgE levels and body weight, also every 4 weeks. A placebo group receives matching injections on the same schedule. Treatment lasts for 24 weeks, followed by an additional 24 weeks of follow-up to monitor longer-term effects. Throughout the study, participants will attend scheduled visits for lung function tests, asthma symptom diaries, quality of life questionnaires, and blood tests to measure immune markers and drug levels. Researchers will monitor asthma exacerbations, lung function changes, medication use, and any adverse events for up to about 52 weeks. Participants must be able to complete diaries and use devices to track their asthma during the study period.

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