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

Official title

A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase II Clinical Study to Evaluate the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of HRS-3095 in Patients With Chronic Spontaneous Urticaria

Overview

The study is being conducted to evaluate the efficacy, and safety of HRS-3095 with Chronic Spontaneous in adults, and to explore the reasonable dosage of HRS-3095 for Chronic Spontaneous Urticaria.

Interventions

• Drug HRS-3095 Tablet
  HRS-3095 tablet.
• Drug HRS-3095 Tablet Placebo
  HRS-3095 tablet placebo.

Primary outcome measures

• Change in Weekly Urticaria Activity Score (UAS7) from baseline at Week 4. [Time frame: Up to 4 weeks.]

Secondary outcome measures (12)

• The concentration of HRS-3095 in serum (Cmax) [Time frame: From the beginning of administration to the 4th week.]
• The time of metabolism of the drug in the serum [Time frame: From the beginning of administration to the 4th week.]
• The concentration of HRS-3095 in serum (AUC) [Time frame: From the beginning of administration to the 4th week.]
• Change in Weekly Urticaria Activity Score (UAS7) from baseline at Week 2 [Time frame: Up to 4 weeks.]
• Change in Weekly Itch Severity Score (ISS7) from baseline at Week 2 and 4 [Time frame: Up to 4 weeks.]
• Change in Weekly Wheal Severity Score (HSS7) from baseline at Week 2 and 4 [Time frame: Up to 4 weeks.]
• Percentage change in Weekly Urticaria Activity Score (UAS7) from baseline at Week 2 and 4 [Time frame: Up to 4 weeks.]
• Percentage change in Weekly Itch Severity Score (ISS7) from baseline at Week 2 and 4 [Time frame: Up to 4 weeks.]
• Percentage change in Weekly Wheal Severity Score (HSS7) from baseline at Week 2 and 4 [Time frame: Up to 4 weeks.]
• Proportion of patients with UAS7 ≤ 6 at Week 2 and 4 compared to baseline [Time frame: Up to 4 weeks.]
• Proportion of patients with UAS7 = 0 at Week 2 and 4 compared to baseline [Time frame: Up to 4 weeks.]
• Proportion of patients achieving the Minimum Important Difference (MID) in UAS7 at Week 2 and 4 [Time frame: Up to 4 weeks.]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Quadruple blind

Primary purpose

Treatment

Study locations

China · 2 centers

• Huashan Hospital Affiliated to Fudan University — Shanghai
• Affiliated Hangzhou First People's Hospital, School of Medicine, Westlake University — Hangzhou

Identifiers

NCT: NCT07613866 · HRS-3095-201

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗