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This Phase III Trial is Meant to Evaluate the Efficacy, and Safety of JYB1904 Injection in Adult Patients With Chronic Spontaneous Urticaria.
This study is a multicenter, randomized, double-blind, placebo-controlled Phase III study to evaluate the efficacy and safety of JYB1904 injection compared to placebo in patients with CSU inadequately controlled by second-generation H1 antihistamines.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| JYB1904 Injection Group | Experimental | 300 mg JYB1904 injection administered SC |
|
| Placebo Group | Placebo Comparator | Placebo and 300 mg JYB1904 injection administered SC |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| JYB1904 | Drug | 300 mg JYB1904 injection administered SC every 12 weeks (Q12W) from Day 1 to Week 48. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Urticaria Activity Score Over 7 Consecutive Days(UAS7) | Change from baseline in UAS7 at W12. The UAS7 is a composite score derived from the ISS7 and the HSS7, i.e., the sum of ISS7 and HSS7, ranging from 0 to 42 points. UAS7 = 0 indicates complete resolution of urticaria. | Up to 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Itch Severity Score Over 7 Consecutive Days(ISS7) | Change from baseline in ISS7 at W12. The ISS7 is the sum of mean daily scores over the 7 days prior to the visit, ranging from 0 to 21 points. ISS7 = 0 indicates complete resolution of itch. | Up to 12 weeks |
| Urticaria Activity Score Over 7 Consecutive Days(UAS7) |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetic (PK) profile of JYB1904 injection | Serum concentration of JYB1904 | Through study completion, an average of 72 weeks |
| Pharmacodynamic (PD) profile of JYB1904 injection | PD parameters: Changes in serum level of total and free IgE |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Mingming Tan | Contact | 021-58306003 | tanmingming@jeyoupharma.com |
| Name | Affiliation | Role |
|---|---|---|
| Jianzhong Zhang | Peking University People's Hospital | Principal Investigator |
| Cheng Zhou | Peking University People's Hospital | Principal Investigator |
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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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| Placebo+JYB1904 | Drug | Placebo administered SC on D1 and W12; 300 mg JYB1904 injection administered SC every 12 weeks (Q12W) from W24 to W48. |
|
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Proportion of participants with UAS7=0 at W12 |
| Up to 12 weeks |
| Urticaria Activity Score Over 7 Consecutive Days(UAS7) | Change from baseline in UAS7 at W24 | Up to 24 weeks |
| Urticaria Activity Score Over 7 Consecutive Days(UAS7) | Proportion of participants with UAS7=0 at W24 | Up to 24 weeks |
| Itch Severity Score Over 7 Consecutive Days(ISS7) | Change from baseline in ISS7 at W24 | Up to 24 weeks |
| Hive Severity Score Over 7 Consecutive Days (HSS7) | Change from baseline in HSS7 at W12 and W24. The HSS7 is the sum of mean daily scores over the 7 days prior to the visit, ranging from 0 to 21 points. HSS7 = 0 indicates complete resolution of hives. | Up to 24 weeks |
| Angioedema Activity Score Over 7 Consecutive Days(AAS7) | Change from baseline in AAS7 at W12 and W24. The AAS7 is the sum of the daily scores over the 7 days prior to the visit, ranging from 0 to 105 points.AAS7 = 0 indicates no angioedema. | Up to 24 weeks |
| Urticaria Activity Score Over 7 Consecutive Days(UAS7) | Proportion of participants with UAS7≤ 6 at W12 and W24 | Up to 24 weeks |
| Dermatology Life Quality Index(DLQI) | Change from baseline in DLQI at W12 and W24. The DLQI comprises 10 questions that assess the participant's skin symptoms and the impact of their dermatological condition on multiple life domains over the past 7 days. The total score ranges from 0 to 30. The higher the score, the worse the quality of life. | Up to 24 weeks |
| Efficacy Assessment Scale | Change from baseline in UAS7, ISS7, HSS7, AAS7 (AAS7 only in participants with baseline AAS7>0) over time during the study | Through study completion, an average of 72 weeks |
| Efficacy Assessment Scale | Proportion of participants with UAS7=0, ISS7=0, HSS7=0, AAS7=0 (AAS7 only in participants with baseline AAS7>0) over time during the study | Through study completion, an average of 72 weeks |
| Urticaria Activity Score Over 7 Consecutive Days(UAS7) | Proportion of participants with UAS7≤ 6 over time during the study | Through study completion, an average of 72 weeks |
| Dermatology Life Quality Index(DLQI) | Change from baseline in DLQI over time during the study | Through study completion, an average of 72 weeks |
| Dermatology Life Quality Index(DLQI) | Proportion of participants with DLQI=0/1 over time during the study | Through study completion, an average of 72 weeks |
| Urticaria Activity Score Over 7 Consecutive Days(UAS7) | Cumulative number of weeks with UAS7 ≤ 6 by W12 and W24 | Up to 24 weeks |
| Angioedema Activity Score Over 7 Consecutive Days(AAS7) | Cumulative number of weeks with AAS7 = 0 by W12 and W24 | Up to 24 weeks |
| Rescue Therapy | Proportion of participants requiring rescue therapy by W12 and W24 | Up to 24 weeks |
| Safety and tolerability | Adverse events (AEs) and serious adverse events (SAEs), vital signs, physical examination, 12-lead electrocardiogram (ECG) and laboratory results | Through study completion, an average of 72 weeks |
| Through study completion, an average of 72 weeks |
| Immunogenicity of JYB1904 injection | Immunogenicity parameters: Positive detection rate of anti-drug antibodies (ADA)/neutralizing ADA (Nab), ADA onset time, duration, and titer | Through study completion, an average of 72 weeks |
| D006969 |
| Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |