Trial of JYB1904 Injection in Adult Patients With Chronic Spontaneous Urticaria.

A Multicenter, Randomized, Double-blind, Placebo-controlled Phase III Clinical Study to Evaluate the Efficacy and Safety of JYB1904 Injection in Adult Patients With Chronic Spontaneous Urticaria Inadequately Controlled by H1 Antihistamines

This Phase III Trial is Meant to Evaluate the Efficacy, and Safety of JYB1904 Injection in Adult Patients With Chronic Spontaneous Urticaria.

Study Overview

• Status: Not yet recruiting
• Conditions: Chronic Spontaneous Urticaria
• Intervention / Treatment: Drug: JYB1904; Drug: Placebo+JYB1904

Detailed Description

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
• Enrollment (Estimated): 180
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Mingming Tan; Phone Number: 021-58306003; Email: tanmingming@jeyoupharma.com

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

• Male or female participant must be ≥18 years old at the time of signing the informed consent.
• Participants are diagnosed with CSU for ≥6 months before screening.
• Participants suffer from itching and hives for at least 6 consecutive weeks at any time before screening.
• UAS7 (range 0~42) ≥16, ISS7 (range 0~21) ≥8 during 7 days before randomization.
• Participants treated with stable dose of second-generation H1 antihistamines (up to 4x approved dose) for at least 6 consecutive weeks before randomization, switching medications, or changing drug dosage or frequency is not allowed within 3 weeks before randomization.
• Participants have ≥6 days record of UAS7 before randomization.

Exclusion Criteria:

• Participants who suffer from inducible urticaria with definite inducements, including urticaria factitia (dermatographism), cold contact, heat contact, solar, pressure, delayed pressure, aquagenic, cholinergic or contact urticaria, etc.
• Participants who suffer from any other skin diseases with chronic itching, such as atopic dermatitis, bullous pemphigoid, dermatitis herpetiformis, senile pruritus or psoriasis, etc.
• Participants who suffer from other diseases with symptoms of urticaria or angioedema, including but not limited to urticaria vasculitis, urticaria pigmentosa, erythema multiforme, mastocytosis, hereditary urticaria or acquired/drug-induced urticaria.
• Participants who are contraindicated or hypersensitive to antihistamines or any of its component (such as fexofenadine, loratadine, desloratadine, cetirizine, levocetirizine, rupatadine, bilastine).
• History of anaphylactic shock.

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: JYB1904 Injection Group; 300 mg JYB1904 injection administered SC	Drug: JYB1904; 300 mg JYB1904 injection administered SC every 12 weeks (Q12W) from Day 1 to Week 48.; Other Names: JYB1904 Injection
Placebo Comparator: Placebo Group; Placebo and 300 mg JYB1904 injection administered SC	Drug: Placebo+JYB1904; Placebo administered SC on D1 and W12; 300 mg JYB1904 injection administered SC every 12 weeks (Q12W) from W24 to W48.; Other Names: Placebo+JYB1904 Injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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)	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

Other Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: Jemincare
• Investigators: Principal Investigator: Jianzhong Zhang, Peking University People's Hospital; Principal Investigator: Cheng Zhou, Peking University People's Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): March 31, 2026
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): April 28, 2028

Study Registration Dates

• First Submitted: January 28, 2026
• First Submitted That Met QC Criteria: February 3, 2026
• First Posted (Actual): February 11, 2026

Study Record Updates

• Last Update Posted (Actual): February 11, 2026
• Last Update Submitted That Met QC Criteria: February 3, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: CSU
• 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: JYB1904-301

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

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