Trial of JYB1904 Injection in Adult Patients With Chronic Spontaneous Urticaria.
Recruiting now · Phase 3 · Has a placebo group
Conditions studied: Chronic Spontaneous Urticaria
In brief
This Phase III Trial is Meant to Evaluate the Efficacy, and Safety of JYB1904 Injection in Adult Patients With Chronic Spontaneous Urticaria.
Key facts
- Study ID
- NCT07402213
- Run by
- Jemincare
- People needed
- 240
- Starts
- 2026-03-09
- Expected to finish
- 2028-06-09
- Last updated by the study team
- 2026-08-03
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
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.
Where it is running
- Peking University People's Hospital — Beijing, China (enrolling)
Full record on ClinicalTrials.gov
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