Trial of JYB1904 Injection in Adult Patients With Chronic Spontaneous Urticaria.
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: JYB1904, Placebo+JYB1904.
- Who it may be relevant to
- Registry conditions: Chronic Spontaneous Urticaria. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
A Multicenter, Randomized, Double-blind, Placebo-controlled Phase III Clinical Study to Evaluate the Efficacy and Safety of JYB1904 Injection in Adult Patients With Chronic Spontaneous Urticaria Inadequately Controlled by H1 Antihistamines
Overview
This Phase III Trial is Meant to Evaluate the Efficacy, and Safety of JYB1904 Injection in Adult Patients With Chronic Spontaneous Urticaria.
Detailed 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.
Interventions
- Drug JYB1904
300 mg JYB1904 injection administered SC every 12 weeks (Q12W) from Day 1 to Week 48. - Drug Placebo+JYB1904
Placebo administered SC on D1 and W12; 300 mg JYB1904 injection administered SC every 12 weeks (Q12W) from W24 to W48.
Primary outcome measures
- Urticaria Activity Score Over 7 Consecutive Days(UAS7) [Time frame: Up to 12 weeks]
Secondary outcome measures (12)
- Itch Severity Score Over 7 Consecutive Days(ISS7) [Time frame: Up to 12 weeks]
- Urticaria Activity Score Over 7 Consecutive Days(UAS7) [Time frame: Up to 12 weeks]
- Urticaria Activity Score Over 7 Consecutive Days(UAS7) [Time frame: Up to 24 weeks]
- Urticaria Activity Score Over 7 Consecutive Days(UAS7) [Time frame: Up to 24 weeks]
- Itch Severity Score Over 7 Consecutive Days(ISS7) [Time frame: Up to 24 weeks]
- Hive Severity Score Over 7 Consecutive Days (HSS7) [Time frame: Up to 24 weeks]
- Angioedema Activity Score Over 7 Consecutive Days(AAS7) [Time frame: Up to 24 weeks]
- Urticaria Activity Score Over 7 Consecutive Days(UAS7) [Time frame: Up to 24 weeks]
- Dermatology Life Quality Index(DLQI) [Time frame: Up to 24 weeks]
- Efficacy Assessment Scale [Time frame: Through study completion, an average of 72 weeks]
- Efficacy Assessment Scale [Time frame: Through study completion, an average of 72 weeks]
- Urticaria Activity Score Over 7 Consecutive Days(UAS7) [Time frame: Through study completion, an average of 72 weeks]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Quadruple blind
- Primary purpose
- Treatment
Study locations
China · 1 center
- Peking University People's Hospital — Beijing
Identifiers
NCT: NCT07402213 · JYB1904-301