Evaluating LP-003 for Chronic Spontaneous Urticaria Symptoms

Multi-center,Randomized,Double-blind Phase II Study to Evaluate the Efficacy and Safety of LP-003 in Patients With Chronic Spontaneous Urticaria (CSU) Who Remain Symptomatic Despite Antihistamine (H1) Treatment

This study is testing a new treatment called LP-003 to see if it can help adults with chronic hives who still have symptoms despite taking regular allergy medications.

Quick facts

• Phase: PHASE2
• Study type: Interventional
• Enrollment: 200 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Longbio Pharma (industry)
• Locations: 16 sites (Beijing, Beijing and 15 other locations)
• Trial ID: NCT06228560 on ClinicalTrials.gov

What this trial studies

This Phase II clinical trial is a multicenter, randomized, double-blind study aimed at assessing the efficacy and safety of LP-003, administered subcutaneously, as an add-on therapy for adults aged 18-75 with chronic spontaneous urticaria (CSU) who continue to experience symptoms despite standard antihistamine treatment. Participants must have been symptomatic for at least six weeks and have a high Urticaria Activity Score indicating severe symptoms. The study will compare the effects of LP-003 against a placebo and Omalizumab, another treatment option. The goal is to determine if LP-003 can provide relief for patients who have not responded adequately to existing therapies.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18-75 with chronic spontaneous urticaria symptoms persisting despite high-dose antihistamine treatment.

Not a fit: Patients who have not been diagnosed with chronic spontaneous urticaria or those who respond adequately to antihistamines may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly improve the quality of life for patients suffering from chronic spontaneous urticaria who do not respond to current antihistamine therapies.

How similar studies have performed: Other studies have shown promise with similar approaches, particularly in the use of biologics for treating chronic spontaneous urticaria, indicating potential for success with LP-003.

Eligibility criteria

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 screening visit, subjects had taken double or more than the approved dose, or a combination of two or more H1 antihistamines for the treatment of chronic spontaneous urticaria for at least 2 weeks. Within the 7 days preceding randomization, the Urticaria Activity Score 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 a current record of medication use.
3. Subjects must not miss more than one diary record (morning or night) within 7 days prior to randomization (day 1), and are willing and able to complete daily symptom electronic diary records during the study period;
4. Male participants and their partners or female participants must agree to take one or more non pharmacological contraceptive measures (such as complete abstinence, contraceptive ring, partner ligation, etc.) during the trial period and within 6 months 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 consent form.

Exclusion Criteria:

1. The subject has a primary or sole trigger for chronic urticaria (chronic Induced urticaria), 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 the judgment of the Investigator may affect the evaluation of the study and the results of the study;
4. Subjects with clinically significant conditions such as (but not limited to) unstable ischemic heart disease, NYHA Class III/IV left ventricular failure, cardiac arrhythmias, uncontrolled hypertension, cerebrovascular disease, neurodegenerative, or other neurological disorders, uncontrolled hypothyroidism and hyperthyroidism and other autoimmune disorders, hypokalemia, hyper adrenergic state; past diagnosis of malignancy (other than basal cell carcinoma or squamous cell skin cancer); history of myocardial infarction within 12 months prior to screening;
5. Acute active infections requiring treatment at screening, including but not limited to, pulmonary infections, tuberculosis;
6. Positive hepatitis B surface antigen or hepatitis B core antibody (except for HBV-DNA testing below the lower limit of the research center's test) at screening; positive hepatitis C virus antibody, human immunodeficiency virus (HIV) antibody, and anti-syphilis helical antibody (TP-Ab) (except for those who are negative for RPR or TRUST);
7. Clinically significant cardiovascular, neurological, psychiatric, metabolic, hepatic, or other abnormalities identified during the Screening Period that may affect the interpretation 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, mental retardation, psychiatric disorders, etc.);
9. Major surgery within 8 weeks prior to screening or surgery planned during the study period;
10. Evidence of historical or ongoing alcohol or substance abuse in the 6 months prior to screening;
11. Poor compliance, such as low medication adherence, inability to accurately complete a diary 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 3 months;
14. Those who are considered by the investigator to be unfit to participate in the clinical trial.

Where this trial is running

Beijing, Beijing and 15 other locations

• Beijing Friendship Hospital, Capital Medical University — Beijing, Beijing, China (RECRUITING)
• Peking Union Medical College Hospital, Chinese Academy of Medical Sciences — Beijing, Beijing, China (RECRUITING)
• Peking University Third Hospital — Beijing, Beijing, China (RECRUITING)
• The First Affiliated Hospital of China Medical University — Beijing, Beijing, China (RECRUITING)
• The First Hospital of Peking University — Beijing, Beijing, China (RECRUITING)
• The First Affiliated Hospital of PLA Army Medical University — Chongqing, Chongqing, China (RECRUITING)
• Fujian Medical University Union Hospital — Fuzhou, Fujian, China (RECRUITING)
• Dermatology Hospital of Southern Medical University — Guangzhou, Guangdong, China (RECRUITING)
• The Second Affiliated Hospital of Guangzhou Medical University — Guangzhou, Guangdong, China (RECRUITING)
• Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology — Wuhan, Hubei, China (RECRUITING)
• The Second XiangYa Hospital of Central South University — Changsha, Hunan, China (RECRUITING)
• Hospital of Dermatology, Chinese Academy of Medical Sciences and Peking Union Medical College — Nanjing, Jiangsu, China (RECRUITING)
• Shengjing Hospital of China Medical University — Shenyang, Liaoning, China (RECRUITING)
• Ruijin Hospital Affiliated to Shanghai Jiaotong University School of Medicine — Shanghai, Shanghai, China (RECRUITING)
• Shanghai Skin Disease Hospital — Shanghai, Shanghai, China (RECRUITING)
• the Second Affiliated Hospital of Xi'an Jiaotong University — Xi'an, Shanxi, China (RECRUITING)

Study contacts

• Study coordinator: Hongzhou Yang

Conditions: Chronic Spontaneous Urticaria