A Clinical Trial of HRS-3095 in Patients With Chronic Spontaneous Urticaria

Inclusion criteria

• Participants must be between 18 and 70 years of age, inclusive, at the time of signing the Informed Consent Form (ICF), with no restriction on gender.
• Participants must have a history of chronic spontaneous urticaria (CSU) with a disease duration of at least 6 months prior to screening.
• Participants must be diagnosed with H1-antihistamine-inadequately-controlled CSU at screening, defined as: having had persistent symptoms of pruritus and wheals for ≥6 weeks prior to screening, despite regular use of second-generation H1-antihistamines during that period.
• At randomization, the UAS7 score must be ≥16 (range: 0-42) and the HSS7 score ≥ 8 (range: 0-21).
• Participants must have been on a stable dose of the specified second-generation H1-antihistamine for at least 3 days prior to the first UAS score at screening.
• Participants must be willing and able to complete logbook entries as required during the study and must have no missing daily UAS scores during the 7 days before randomization.
• Participants must voluntarily sign the Informed Consent Form (ICF) before any study-related procedures, be able to communicate effectively with the investigator, and be willing to strictly adhere to the requirements of the study protocol.
• Female participants of childbearing potential or male participants with a female partner of childbearing potential must agree to avoid donating sperm or ova and must agree to take highly effective contraceptive measures from the time of signing the ICF until 3 months after the last dose.

Exclusion criteria

• Any skin disease that could interfere with study assessment (e.g., chronic inducible urticaria, urticarial vasculitis, atopic dermatitis, psoriasis).
• Use of systemic or topical medications with therapeutic or immunomodulatory effects on the study disease during the relevant washout period prior to screening.
• Use of investigational drugs or medical devices within 8 weeks or 5 half-lives (if known), whichever is longer, or within 30 days (for small molecules) prior to screening.
• Vaccination or exposure to live or attenuated vaccines within 3 months prior to screening or participation in a vaccine-related clinical trial within 3 months prior to randomization.
• History or current coagulation-related risk (e.g., bleeding diathesis, coagulopathy, GI bleeding with clinical significance, antiplatelet or anticoagulant use, history of thrombosis or thromboembolic events, or increased risk of thrombosis).
• History of liver disease or current treatment for liver disease (e.g., hepatitis, cirrhosis, liver failure).
• History of systemic antimicrobial use or presence of superficial skin infection (e.g., impetigo) within 4 weeks prior to screening.
• History of malignancy or current malignancy (excluding completely resected and recurrence-free basal cell carcinoma, squamous cell carcinoma, or cervical intraepithelial neoplasia).
• Major surgery performed within 3 months prior to randomization or planned during the study.
• Serious concomitant disease or any condition judged by the investigator to make the participant unsuitable for study participation.
• Abnormal findings in vital signs, physical examination, laboratory tests, ECG, chest X-ray/CT, or abdominal ultrasound during screening that have clinical significance and may affect study validity or participant safety.
• Pregnant or breastfeeding women.
• Allergy to the study drug or any of its components.
• History of alcohol abuse within 6 months prior to screening (e.g., > 14 units/week) or history of illicit drug abuse within 6 months prior to screening.
• Any condition judged by the investigator that may affect the safety or efficacy evaluation of the study drug or participant compliance with the study procedures or diary.