Efficacy and Safety of LP-003 in Patients With CSU Who Remain Symptomatic Despite Antihistamine (H1) Treatment

Inclusion Criteria:

1. Aged 18 to 75 years at the screening period.
2. Presence of wheals with itching for ≥ 6 weeks prior to randomization. At the screeningvisit, subjects had taken double or more than the approved dose, or a combination oftwo or more H1 antihistamines for the treatment of chronic spontaneous urticaria forat least 2 weeks. Within the 7 days preceding randomization, the Urticaria ActivityScore 7 (UAS7) was ≥16 (range 0-42), Itch Severity Score 7 (ISS7) was ≥8 (range 0-21),at least one UAS (range 0-6) was ≥4 on any screening visit day, and there must be acurrent record of medication use.
3. Subjects must not miss more than one diary record (morning or night) within 7 daysprior to randomization (day 1), and are willing and able to complete daily symptomelectronic diary records during the study period;
4. Male participants and their partners or female participants must agree to take one ormore non pharmacological contraceptive measures (such as complete abstinence,contraceptive ring, partner ligation, etc.) during the trial period and within 6months after the end of the trial and have no plans for sperm or egg donation.
5. Agree to participate in this clinical trial and voluntarily sign an informed consentform.

Exclusion Criteria:

1. The subject has a primary or sole trigger for chronic urticaria (chronic Inducedurticaria), including artificial urticaria (symptomatic skin scratch disease), cold,heat, sun, pressure, delayed pressure, water, cholinergic, or contact urticaria;
2. Other medical conditions accompanied by symptoms of urticaria or angioedema including,but not limited to, urticarial vasculitis, pigmented urticaria, erythema multiforme,mastocytosis, hereditary urticaria, or drug-induced urticaria;
3. Any other dermatologic condition with chronic itching, such as atopic dermatitis,herpetic pemphigoid, herpetic dermatitis, senile itching, or psoriasis, which in thejudgment of the Investigator may affect the evaluation of the study and the results ofthe study;
4. Subjects with clinically significant conditions such as (but not limited to) unstableischemic heart disease, NYHA Class III/IV left ventricular failure, cardiacarrhythmias, uncontrolled hypertension, cerebrovascular disease, neurodegenerative, orother neurological disorders, uncontrolled hypothyroidism and hyperthyroidism andother autoimmune disorders, hypokalemia, hyper adrenergic state; past diagnosis ofmalignancy (other than basal cell carcinoma or squamous cell skin cancer); history ofmyocardial infarction within 12 months prior to screening;
5. Acute active infections requiring treatment at screening, including but not limitedto, pulmonary infections, tuberculosis;
6. Positive hepatitis B surface antigen or hepatitis B core antibody (except for HBV-DNAtesting below the lower limit of the research center's test) at screening; positivehepatitis C virus antibody, human immunodeficiency virus (HIV) antibody, andanti-syphilis helical antibody (TP-Ab) (except for those who are negative for RPR orTRUST);
7. Clinically significant cardiovascular, neurological, psychiatric, metabolic, hepatic,or other abnormalities identified during the Screening Period that may affect theinterpretation of the study results and/or the safety of the subject;
8. Comorbid neurological or psychiatric disorders that prevent or prevent cooperation;patients with disabilities as defined by law (blindness, deafness, mute, mentalretardation, psychiatric disorders, etc.);
9. Major surgery within 8 weeks prior to screening or surgery planned during the studyperiod;
10. Evidence of historical or ongoing alcohol or substance abuse in the 6 months prior toscreening;
11. Poor compliance, such as low medication adherence, inability to accurately complete adiary card, or use of prohibited medications;
12. Pregnant women, nursing mothers, or those with recent birth plans;
13. Patients who have participated in clinical trials of other drugs within the last 3months;
14. Those who are considered by the investigator to be unfit to participate in theclinical trial.