This Phase II Trial is Meant to Evaluate the Efficacy, Safety and Tolerability of JYB1904 Injection in Patients With Chronic Spontaneous Urticaria.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
135
Participants will receive JYB1904 at week0 and receive placebo at week4,8,12
Participants will receive JYB1904 at week0,8 and receive placebo at week4,12
Participants will receive Omalizumab every 4 weeks for 12 weeks
Peking University People's Hospital
Beijing, Beijing Municipality, China
RECRUITINGUrticaria activity score used for 7 consecutive days(UAS7)
Change from baseline in urticaria activity score used for 7 consecutive days (UAS7) at weeks 8, 12, and 16.Score 0-42, UAS7=0 for complete remission
Time frame: Baseline through 16 weeks
Urticaria activity score used for 7 consecutive days(UAS7)
Change from baseline in UAS7 at weeks 4, 24 and 32.Score 0-42, UAS7=0 for complete remission
Time frame: Baseline through 32 weeks
Itch severity score used for 7 consecutive days(ISS7)
Change from baseline in itch severity score used for 7 consecutive days(ISS7) at weeks 4, 8, 12, 16, 24 and 32.Score 0-21, ISS7=0 for complete remission of itch
Time frame: Baseline through 32 weeks
Hive severity score used for 7 consecutive days (HSS7)
Change from baseline in hive severity score used for 7 consecutive days(HSS7) at weeks 4, 8, 12, 16, 24, 32.Score 0-21, HSS7=0 for complete remission of hives
Time frame: Baseline through 32 weeks
Angioedema activity score used for 7 consecutive days(AAS7)
Change from baseline in angioedema activity score used for 7 consecutive days(AAS7) at weeks 4, 8, 12, 16, 24, 32.Score 0-105, higher scores mean a worse outcome
Time frame: Baseline through 32 weeks
Urticaria activity score used for 7 consecutive days(UAS7)
Proportion of subjects with UAS7=0 at weeks 4, 8, 12, 16, 24, 32.Score 0-42, UAS7=0 for complete remission
Time frame: Baseline through 32 weeks
Dermatology Life Quality Index(DLQI)
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Change from baseline in Dermatological Life Quality Index (DLQI) at weeks 4, 8, 12, 16, 24 and 32.Score 0-30, higher scores mean a worse outcome
Time frame: Baseline through 32 weeks
Safety and tolerability
Adverse events (AEs) and serious adverse events (SAEs)
Time frame: Baseline through 32 weeks
Trends in serum total immunoglobulin E(IgE)
Serum total IgE levels at weeks 4, 8, 12, 16, 24 and 32
Time frame: Baseline through 32 weeks
Positive detection rate of anti-drug antibody (ADA)
ADA positive detection rate at 32 weeks
Time frame: Baseline through 32 weeks