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Not Yet RecruitingPhase 3NCT07402213

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

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

Lead sponsor: Jemincare•View source on ClinicalTrials.gov

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Contacts

Mingming Tan

CONTACT

021-58306003 tanmingming@jeyoupharma.com

Sponsors

Lead Sponsor

Jemincare

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.

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

No

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.

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Data from ClinicalTrials.govLast updated on ClinicalTrials.gov: February 11, 2026Terms

Trial snapshot

StatusNOT_YET_RECRUITING

PhasePHASE3

Enrollment180

Start dateMar 2026

Last updatedFeb 11, 2026

Condition

Chronic Spontaneous Urticaria

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 11, 2026Data synced to Clareo: May 25, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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