Trial of JYB1904 in Chronic Spontaneous Urticaria.

Jemincare

Status and phase: Enrolling; Phase 2

Conditions: Chronic Spontaneous Urticaria

Treatments: Drug: JYB1904; Drug: Omalizumab

Study type: Interventional

Funder types: Industry

Identifiers

NCT06509334

JYB1904-202

Details and patient eligibility

About

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

Enrollment: 135 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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135 participants in 3 patient groups

JYB1904: Dose-1

Experimental group

Treatment:

Drug: JYB1904

Drug: JYB1904

JYB1904: Dose-2

Experimental group

Treatment:

Drug: JYB1904

Drug: JYB1904

Omalizumab

Active Comparator group

Treatment:

Drug: Omalizumab