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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
240
300 mg JYB1904 injection administered SC every 12 weeks (Q12W) from Day 1 to Week 48.
Placebo administered SC on D1 and W12; 300 mg JYB1904 injection administered SC every 12 weeks (Q12W) from W24 to W48.
Peking University People's Hospital
Beijing, China
RECRUITINGUrticaria 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.
Time frame: Up to 12 weeks
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.
Time frame: Up to 12 weeks
Urticaria Activity Score Over 7 Consecutive Days(UAS7)
Proportion of participants with UAS7=0 at W12
Time frame: Up to 12 weeks
Urticaria Activity Score Over 7 Consecutive Days(UAS7)
Change from baseline in UAS7 at W24
Time frame: Up to 24 weeks
Urticaria Activity Score Over 7 Consecutive Days(UAS7)
Proportion of participants with UAS7=0 at W24
Time frame: Up to 24 weeks
Itch Severity Score Over 7 Consecutive Days(ISS7)
Change from baseline in ISS7 at W24
Time frame: 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.
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Time frame: 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.
Time frame: Up to 24 weeks
Urticaria Activity Score Over 7 Consecutive Days(UAS7)
Proportion of participants with UAS7≤ 6 at W12 and W24
Time frame: 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.
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Through study completion, an average of 72 weeks
Dermatology Life Quality Index(DLQI)
Change from baseline in DLQI over time during the study
Time frame: 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
Time frame: 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
Time frame: Up to 24 weeks
Angioedema Activity Score Over 7 Consecutive Days(AAS7)
Cumulative number of weeks with AAS7 = 0 by W12 and W24
Time frame: Up to 24 weeks
Rescue Therapy
Proportion of participants requiring rescue therapy by W12 and W24
Time frame: 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
Time frame: Through study completion, an average of 72 weeks