JYB1904 Injection for Chronic Spontaneous Urticaria in Adults

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a multicenter, randomized, double-blind, placebo-controlled Phase 3 trial evaluating the efficacy and safety of JYB1904 injections in adults with chronic spontaneous urticaria (CSU) inadequately controlled by second-generation H1 antihistamines. Participants will be assigned to receive either JYB1904 or placebo, with outcomes assessed over a defined treatment period. The study includes adults with CSU of at least 6 months, active symptoms, and stable antihistamine use prior to randomization. Efficacy and safety will be compared between groups to determine whether JYB1904 provides additional benefit over placebo. The trial is sponsored by Jemincare and conducted at multiple centers, with the lead site in Beijing, China.

Why it matters

Who can join: the full rules

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.

Where it's running

• Peking University People's Hospital
  Beijing, China Recruiting

Study contacts

• Principal investigator: Jianzhong Zhang — Peking University People's Hospital
• Study coordinator: Mingming Tan
• Email: tanmingming@jeyoupharma.com
• Phone: 021-58306003

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Remibrutinib and omalizumab-based treatment approach for adults with chronic spontaneous urticaria not well controlled by antihistamines

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• Remibrutinib use in everyday US care for chronic spontaneous urticaria

  This US sub-study will test remibrutinib's real-world safety and effectiveness for adults with chronic spontaneous urticaria who are escalating or switching from second-generation H1 antihistamines.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.