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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HRS-3095 Group | Experimental | HRS-3095 in different doses. |
|
| HRS-3095 placebo Group | Placebo Comparator | HRS-3095 blank preparation. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HRS-3095 Tablet | Drug | HRS-3095 tablet. |
| |
| HRS-3095 Tablet Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Weekly Urticaria Activity Score (UAS7) from baseline at Week 4. | Up to 4 weeks. |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yijia Xu | Contact | +86-0518-81220121 | yijia.xu@hengrui.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Huashan Hospital Affiliated to Fudan University | Shanghai | Shanghai Municipality | 200040 | China |
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| ID | Term |
|---|---|
| D000080223 | Chronic Urticaria |
| ID | Term |
|---|---|
| D014581 | Urticaria |
| D017445 | Skin Diseases, Vascular |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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HRS-3095 compared with placebo.
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| Drug |
HRS-3095 tablet placebo. |
|
| 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. |
| Affiliated Hangzhou First People's Hospital, School of Medicine, Westlake University | Hangzhou | Zhejiang | 310006 | China |
|
| D006969 |
| Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |