Chronic Spontaneous Urticaria
Conditions
Keywords
CSU
Brief summary
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
DRUGPlacebo+JYB1904
Placebo administered SC on D1 and W12; 300 mg JYB1904 injection administered SC every 12 weeks (Q12W) from W24 to W48.
DRUGJYB1904
300 mg JYB1904 injection administered SC every 12 weeks (Q12W) from Day 1 to Week 48.
Sponsors
Jemincare
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Urticaria Activity Score Over 7 Consecutive Days(UAS7) | Up to 12 weeks | Change from baseline in UAS7 at W12. The UAS7 is a composite score derived from the ISS7 and the HSS7, i.e., the sum of ISS7 and HSS7, ranging from 0 to 42 points. UAS7 = 0 indicates complete resolution of urticaria. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Itch Severity Score Over 7 Consecutive Days(ISS7) | Up to 12 weeks | Change from baseline in ISS7 at W12. The ISS7 is the sum of mean daily scores over the 7 days prior to the visit, ranging from 0 to 21 points. ISS7 = 0 indicates complete resolution of itch. |
| Urticaria Activity Score Over 7 Consecutive Days(UAS7) | Up to 12 weeks | Proportion of participants with UAS7=0 at W12 |
| Hive Severity Score Over 7 Consecutive Days (HSS7) | Up to 24 weeks | Change from baseline in HSS7 at W12 and W24. The HSS7 is the sum of mean daily scores over the 7 days prior to the visit, ranging from 0 to 21 points. HSS7 = 0 indicates complete resolution of hives. |
| Angioedema Activity Score Over 7 Consecutive Days(AAS7) | Up to 24 weeks | Change from baseline in AAS7 at W12 and W24. The AAS7 is the sum of the daily scores over the 7 days prior to the visit, ranging from 0 to 105 points.AAS7 = 0 indicates no angioedema. |
| Dermatology Life Quality Index(DLQI) | Up to 24 weeks | Change from baseline in DLQI at W12 and W24. The DLQI comprises 10 questions that assess the participant's skin symptoms and the impact of their dermatological condition on multiple life domains over the past 7 days. The total score ranges from 0 to 30. The higher the score, the worse the quality of life. |
| Efficacy Assessment Scale | Through study completion, an average of 72 weeks | Change from baseline in UAS7, ISS7, HSS7, AAS7 (AAS7 only in participants with baseline AAS7\>0) over time during the study |
| Rescue Therapy | Up to 24 weeks | Proportion of participants requiring rescue therapy by W12 and W24 |
| Safety and tolerability | Through study completion, an average of 72 weeks | Adverse events (AEs) and serious adverse events (SAEs), vital signs, physical examination, 12-lead electrocardiogram (ECG) and laboratory results |
Countries
China
Contacts
CONTACTMingming Tan
PRINCIPAL_INVESTIGATORJianzhong Zhang
Peking University People's Hospital
PRINCIPAL_INVESTIGATORCheng Zhou
Peking University People's Hospital
Outcome results
None listed