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

NCT07402213 | Not Yet Recruiting Phase 3 DMC

• 1 other identifier: JYB1904-301
• Study Type: interventional
• Target: 180
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Chronic Spontaneous Urticaria

Keywords

CSU

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (18)

• Itch Severity Score Over 7 Consecutive Days(ISS7)

  Up to 12 weeks

• Urticaria Activity Score Over 7 Consecutive Days(UAS7)

  Up to 12 weeks

• Urticaria Activity Score Over 7 Consecutive Days(UAS7)

  Up to 24 weeks

• Urticaria Activity Score Over 7 Consecutive Days(UAS7)

  Up to 24 weeks

• Itch Severity Score Over 7 Consecutive Days(ISS7)

  Up to 24 weeks

Other Outcomes (3)

• Pharmacokinetic (PK) profile of JYB1904 injection

  Through study completion, an average of 72 weeks

• Pharmacodynamic (PD) profile of JYB1904 injection

  Through study completion, an average of 72 weeks

• Immunogenicity of JYB1904 injection

  Through study completion, an average of 72 weeks

Study Arms (2)

JYB1904 Injection Group

EXPERIMENTAL

300 mg JYB1904 injection administered SC

Drug: JYB1904

Placebo Group

PLACEBO COMPARATOR

Placebo and 300 mg JYB1904 injection administered SC

Drug: Placebo+JYB1904

Interventions

JYB1904 DRUG

300 mg JYB1904 injection administered SC every 12 weeks (Q12W) from Day 1 to Week 48.

Also known as: JYB1904 Injection

JYB1904 Injection Group

Placebo+JYB1904 DRUG

Placebo administered SC on D1 and W12; 300 mg JYB1904 injection administered SC every 12 weeks (Q12W) from W24 to W48.

Also known as: Placebo+JYB1904 Injection

Placebo Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Jemincare: lead

MeSH Terms

Conditions

Chronic Urticaria

Condition Hierarchy (Ancestors)

Urticaria; Skin Diseases, Vascular; Skin Diseases; Skin and Connective Tissue Diseases; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Jianzhong Zhang

  Peking University People's Hospital

  PRINCIPAL INVESTIGATOR

• Cheng Zhou

  Peking University People's Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mingming Tan

CONTACT

021-58306003; tanmingming@jeyoupharma.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 28, 2026
• First Posted: February 11, 2026
• Study Start: March 31, 2026
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): April 28, 2028
• Last Updated: February 11, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share