Trial of JYB1904 in Chronic Spontaneous Urticaria.
- Registration Number
- NCT06509334
- Lead Sponsor
- Jemincare
- Brief Summary
This Phase II Trial is Meant to Evaluate the Efficacy, Safety and Tolerability of JYB1904 Injection in Patients With Chronic Spontaneous Urticaria.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 135
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description JYB1904: Dose-1 JYB1904 - JYB1904: Dose-2 JYB1904 - Omalizumab Omalizumab -
- Primary Outcome Measures
Name Time Method Urticaria activity score used for 7 consecutive days(UAS7) Baseline through 16 weeks Change from baseline in urticaria activity score used for 7 consecutive days (UAS7) at weeks 8, 12, and 16.Score 0-42, UAS7=0 for complete remission
- Secondary Outcome Measures
Name Time Method Urticaria activity score used for 7 consecutive days(UAS7) Baseline through 32 weeks Proportion of subjects with UAS7=0 at weeks 4, 8, 12, 16, 24, 32.Score 0-42, UAS7=0 for complete remission
Itch severity score used for 7 consecutive days(ISS7) Baseline through 32 weeks Change from baseline in itch severity score used for 7 consecutive days(ISS7) at weeks 4, 8, 12, 16, 24 and 32.Score 0-21, ISS7=0 for complete remission of itch
Hive severity score used for 7 consecutive days (HSS7) Baseline through 32 weeks Change from baseline in hive severity score used for 7 consecutive days(HSS7) at weeks 4, 8, 12, 16, 24, 32.Score 0-21, HSS7=0 for complete remission of hives
Angioedema activity score used for 7 consecutive days(AAS7) Baseline through 32 weeks Change from baseline in angioedema activity score used for 7 consecutive days(AAS7) at weeks 4, 8, 12, 16, 24, 32.Score 0-105, higher scores mean a worse outcome
Dermatology Life Quality Index(DLQI) Baseline through 32 weeks Change from baseline in Dermatological Life Quality Index (DLQI) at weeks 4, 8, 12, 16, 24 and 32.Score 0-30, higher scores mean a worse outcome
Safety and tolerability Baseline through 32 weeks Adverse events (AEs) and serious adverse events (SAEs)
Trends in serum total immunoglobulin E(IgE) Baseline through 32 weeks Serum total IgE levels at weeks 4, 8, 12, 16, 24 and 32
Positive detection rate of anti-drug antibody (ADA) Baseline through 32 weeks ADA positive detection rate at 32 weeks
Trial Locations
- Locations (1)
Peking University People's Hospital
🇨🇳Beijing, Beijing, China