Trial of JYB1904 in Chronic Spontaneous Urticaria.

Launched by JEMINCARE · Jul 13, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called JYB1904 for adults with Chronic Spontaneous Urticaria (CSU), a condition that causes persistent itching and hives without a known cause. The trial aims to see how well JYB1904 works, how safe it is, and how well patients tolerate it. To be eligible for this study, participants must be at least 18 years old, have had CSU for at least three months, and have not found relief from their symptoms with standard antihistamine medications.

Participants in this trial can expect to receive injections of JYB1904 and will be monitored by healthcare professionals throughout the study. The trial is currently recruiting patients, so if you or someone you know meets the eligibility criteria, it could be a chance to access a new treatment option. It’s important to note that people with certain other skin conditions or allergic reactions may not qualify for this study.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Male or female adult subjects (≥18 years of age).
• • Diagnosis of Chronic Spontaneous Urticaria(CSU) ≥ 3 months prior to Screening Visit 1 and previously inadequately controlled with a second-generation H1 antihistamine.
• • Itching and hives lasting ≥ 6 weeks prior to Screening Visit 1.
• • Have a UAS7 (range 0 - 42) ≥ 16, an ISS7 (range 0 - 21) ≥ 6, and an HSS7 (range 0 - 21) ≥ 6 within 7 days prior to randomization.
• Exclusion Criteria:
• • Induced urticaria with a defined trigger, including artificial urticaria (cutaneous scratches), cold-contact, heat-contact, solar, pressure, delayed-pressure, water-source, cholinergic, or contact urticaria
• • Any other dermatological condition with chronic itching, such as atopic dermatitis, herpetic pemphigoid, herpetic dermatitis, senile itching, or psoriasis, which in the opinion of the investigator may affect the study assessment and study results
• • Other conditions with symptoms of urticaria or angioedema, including but not limited to urticarial vasculitis, pigmented urticaria, erythema multiforme, mastocytosis, hereditary urticaria, or acquired/drug-induced urticaria.
• • Previous allergic reaction or poor efficacy with omalizumab.
• • Contraindication or hypersensitivity to antihistamines (e.g., fexofenadine, loratadine, desloratadine, cetirizine, levocetirizine, rupatadine, bilastine) or any of the ingredients.