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

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Chronic Spontaneous Urticaria
• Intervention / Treatment: Drug: HRS-3095 Tablet; Drug: HRS-3095 Tablet Placebo

• Study Type: Interventional
• Enrollment (Estimated): 190
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Yijia Xu; Phone Number: +86-0518-81220121; Email: yijia.xu@hengrui.com

Study Locations

• China
  • Shanghai Municipality
    • Shanghai, Shanghai Municipality, China, 200040
      • Huashan Hospital Affiliated to Fudan University
      • Principal Investigator: Wenyu Wu
      • Contact: Wenyu Wu; Phone Number: +86-021-52887783; Email: 13601983907@139.com
  • Zhejiang
    • Hangzhou, Zhejiang, China, 310006
      • Affiliated Hangzhou First People's Hospital, School of Medicine, Westlake University
      • Principal Investigator: Liming Wu
      • Contact: Liming Wu; Phone Number: +86-13750837205; Email: 18957118053@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. 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.
2. Participants must have a history of chronic spontaneous urticaria (CSU) with a disease duration of at least 6 months prior to screening.
3. 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.
4. At randomization, the UAS7 score must be ≥16 (range: 0-42) and the HSS7 score ≥ 8 (range: 0-21).
5. 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.
6. 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.
7. 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.
8. 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:

1. Any skin disease that could interfere with study assessment (e.g., chronic inducible urticaria, urticarial vasculitis, atopic dermatitis, psoriasis).
2. Use of systemic or topical medications with therapeutic or immunomodulatory effects on the study disease during the relevant washout period prior to screening.
3. 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.
4. 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.
5. 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).
6. History of liver disease or current treatment for liver disease (e.g., hepatitis, cirrhosis, liver failure).
7. History of systemic antimicrobial use or presence of superficial skin infection (e.g., impetigo) within 4 weeks prior to screening.
8. History of malignancy or current malignancy (excluding completely resected and recurrence-free basal cell carcinoma, squamous cell carcinoma, or cervical intraepithelial neoplasia).
9. Major surgery performed within 3 months prior to randomization or planned during the study.
10. Serious concomitant disease or any condition judged by the investigator to make the participant unsuitable for study participation.
11. 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.
12. Pregnant or breastfeeding women.
13. Allergy to the study drug or any of its components.
14. 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.
15. 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: HRS-3095 Group; HRS-3095 in different doses.	Drug: HRS-3095 Tablet; HRS-3095 tablet.
Placebo Comparator: HRS-3095 placebo Group; HRS-3095 blank preparation.	Drug: HRS-3095 Tablet Placebo; HRS-3095 tablet placebo.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Change in Weekly Urticaria Activity Score (UAS7) from baseline at Week 4.	Up to 4 weeks.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The concentration of HRS-3095 in serum (Cmax)		From the beginning of administration to the 4th week.
The time of metabolism of the drug in the serum	The concentration of HRS-3095 in plasma will be determined.	From the beginning of administration to the 4th week.
The concentration of HRS-3095 in serum (AUC)	The concentration of HRS-3095 in plasma will be determined.	From the beginning of administration to the 4th week.
Change in Weekly Urticaria Activity Score (UAS7) from baseline at Week 2		Up to 4 weeks.
Change in Weekly Itch Severity Score (ISS7) from baseline at Week 2 and 4		Up to 4 weeks.
Change in Weekly Wheal Severity Score (HSS7) from baseline at Week 2 and 4		Up to 4 weeks.
Percentage change in Weekly Urticaria Activity Score (UAS7) from baseline at Week 2 and 4		Up to 4 weeks.
Percentage change in Weekly Itch Severity Score (ISS7) from baseline at Week 2 and 4		Up to 4 weeks.
Percentage change in Weekly Wheal Severity Score (HSS7) from baseline at Week 2 and 4		Up to 4 weeks.
Proportion of patients with UAS7 ≤ 6 at Week 2 and 4 compared to baseline		Up to 4 weeks.
Proportion of patients with UAS7 = 0 at Week 2 and 4 compared to baseline		Up to 4 weeks.
Proportion of patients achieving the Minimum Important Difference (MID) in UAS7 at Week 2 and 4	≥ 10-point decrease from baseline.	Up to 4 weeks.
Proportion of patients achieving the Minimum Important Difference (MID) in ISS7 at Week 2 and 4	≥ 5-point decrease from baseline.	Up to 4 weeks.
Time to achieve the Minimum Important Difference (MID) in UAS7	≥ 10-point decrease from baseline.	Up to 4 weeks.
Time to achieve the Minimum Important Difference (MID) in ISS7	≥ 10-point decrease from baseline.	Up to 4 weeks.
Change in 7-day Angioedema Activity Score (AAS7) from baseline at Week 2 and 4		Up to 4 weeks.
Change in Urticaria Control Test (UCT) from baseline at Week 4		Up to 4 weeks.
Proportion of participants with UCT ≥ 12 at Week 4 compared to baseline		Up to 4 weeks.
Change in Dermatology Life Quality Index (DLQI) from baseline at Week 4		Up to 4 weeks.
Proportion of participants with DLQI = 0 or 1 at Week 4 compared to baseline		Up to 4 weeks.
Adverse events		From the beginning of administration to the 8th week.
Plasma concentrations of HRS-3095 and its metabolites		From the beginning of administration to the 4th week.
Relative change from baseline in serum total immunoglobulin E (IgE)		From the beginning of administration to the 4th week.

Collaborators and Investigators

• Sponsor: Chengdu Suncadia Medicine Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): March 1, 2027

Study Registration Dates

• First Submitted: May 22, 2026
• First Submitted That Met QC Criteria: May 22, 2026
• First Posted (Actual): May 29, 2026

Study Record Updates

• Last Update Posted (Actual): May 29, 2026
• Last Update Submitted That Met QC Criteria: May 22, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Chronic Disease; Disease Attributes; Immune System Diseases; Hypersensitivity, Immediate; Hypersensitivity; Skin Diseases; Urticaria; Skin Diseases, Vascular; Pathological Conditions, Signs and Symptoms; Skin and Connective Tissue Diseases; Chronic Urticaria
• Other Study ID Numbers: HRS-3095-201

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No