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

Jemincare

Status and phase: Not yet enrolling; Phase 3

Conditions: Chronic Spontaneous Urticaria

Treatments: Drug: Placebo+JYB1904; Drug: JYB1904

Study type: Interventional

Funder types: Industry

Identifiers

NCT07402213

JYB1904-301

Details and patient eligibility

About

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

Full description

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.

Enrollment: 180 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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180 participants in 2 patient groups, including a placebo group

JYB1904 Injection Group

Experimental group

Description:

300 mg JYB1904 injection administered SC

Treatment:

Drug: JYB1904

Placebo Group

Placebo Comparator group

Description:

Placebo and 300 mg JYB1904 injection administered SC

Treatment:

Drug: Placebo+JYB1904